Circular Business Models in The Medical Device Industry - Paths Towards Sustainable Healthcare

 

Resources, Conservation & Recycling 160 (2020) 104904

Contents lists available at ScienceDirect at  ScienceDirect

Resources, Resou rces, Conservatio Conservation n & Recycling Recycling www.elsevier.com/locate/resconrec cate/resconrec  jo urn al ho me pag e:   www.elsevier.com/lo

Full length article

Circular business models in the medical device industry: paths towards sustainable healthcare

 

D. Guzzo1,2, , M.M. Carvalho3, R. Balkenende4, J. Mascarenhas1 ⁎

1

 Production Engineering Department, S ã o Carlos School of Engineering, University of Sã o Paulo, av. Trabalhado Trabalhadorr Sã ocarlense, ocarlense, 400, Sã o Carlos-SP 13566-590, Brazil  Insper Institute of Education and Research, Rua Quatá 300, Vila Olímpia, S ã o Paulo, SP 04546-042, Brazil 3  Production Engineering of Polytechnic School, University of Sã o Paulo, Av. Prof. Almeida Prado, 128 Tr.2 Biênio 2o. andar, S ã o Paulo, SP, 05508-900, Brazil 4  Faculty of Industrial Design Engineering, Delft U niversity of Technology, Landbergstraat 15, 2628 CE Delft, The Netherlands

2

A R T I CL E I N F O

ABSTRACT

 Keywords:

The medical device industry leads to high environmental footprint while holding fundamental social function. The panorama is composed of devices with rather specific lifecycles and impacts: imaging equipment that eventually become electronic waste, sophisticated invasive devices that require sterilisation before reprocessing, and potentially infected single-use devices that hinder recycling possibilities. It is, thus, challenging for practitioners to identify opportun portunitie itiess for circul circular ar bus busine iness ss mod model el (CBM) (CBM) innova innovatio tion n to the man manyy types types of dev device ices. s. The Theref refore ore,, this this res resea earch rch aim aimss to detail the application of CBMs in the medical device industry so that they can be used as benchmarks. Systematic literature review and content analysis of cases and research articles grounds the types of business models. Crosstabulation and network analysis ground the triangulation between cases and literature for discussion. Nine industryspecific CBMs were identified and positioned according to product value and criticality. An adapted version of the busine business ss mod model el can canvasdescr vasdescribi ibing ng eac each h CBM sus sustai tains ns dis dissem semina inatio tion n an and d discus discussio sion. n. Whi While le ide identi ntified fied CBM CBMss activa activate te the known technical cycles, there is potential to combine different types of circular solutions and enhance triple bottom line benefits. The good practices presented in this research are relevant for the medical device industry, and other industries as the CBMs are designed to meet different spectra of product value and needs for hygiene.

Medical device industry Medical equipment Circular business models Circular Economy Innovation

The Circular Economy is an economic system based on the systematic application of strategies that slow, close, or narrow material and energy loops aiming for a sustainable future (Geissdoerfer ( Geissdoerfer et al., 2017;;  Kirchherr et al., 2017). 2017 2017). Ideally, additional resource input and

Electronic Equipment (WEEE), and finally through the emergence of  disposable single-use devices. Medical device means any instrument or equipment used for diagnostic or therapeutic purposes, which not primarily achieve its function through chemical or biological treatment (European ( European Parliament and of  the Cou Council ncil,, 200 2007 7). They They are fundam fundament ental al to assist assist profes profession sionals als

leakage of waste and emissions to maintain a specific system are reduced to zero (Ellen (Ellen MacArthur Foundation, 2012 2012;;  Geissdoerfer et al., 2018a). 2018a ). In particular, healthcare is a resource-intensive and essential system to provide wellbeing to this and further generations. It generates large amounts of waste with complicated compositions. It includes both non-hazardous and many different types of hazardous materials, such as bodily fluids infectious waste, pharmaceuticals, sharps, and electronic waste from equipment (Jameton (Jameton and Pierce, 2001; 2001;   Minoglou et al., 2017;;  World Health Organization, 2018 2017 2018). ). The medica medicall device industry contribute to such wasteful panorama in diverse ways (Moultrie ( Moultrie et al., 2015): 2015 ): unco unconta ntamina minated ted rec recycl yclabl ablee dev devices ices ending ending up in bio biolog logica icall waste streams, the release of toxic substances from the end-of-life of  PVC (Polyvinyl chloride)-based devices and from Waste Electrical and

reestablish patients' health or avoiding they get sick. Such devices range from medical gloves and catheters to infusion pumps, and magnetic resonance imaging (MRI) scans. They range from critical products that get into contact with patient tissues and blood to highly complex electromedical devices closely connected to the WEEE issue. It is well disseminated that business model innovation is an essential bottom-up engine that can stimulate the private sector to accelerate the transition to a Circular Economy (Kirchherr (Kirchherr et al., 2017; 2017;  Lieder and Rashid, 2016). 2016). Potentially, the application of circular strategies to design and provide medical device solutions could zero its parcel of waste generation and need for resources while enhancing the prevention, diagnosing and treating of sickness. In practice, some circular strategies are already well established in specific markets and regions. As an

1. Introd Introductio uction n

⁎

Corresponding author.  [email protected] (D.  (D. Guzzo), [email protected] Guzzo),  [email protected] (J.  (J. Mascarenhas).  E-mail addresses:  [email protected]

https://doi.org/10.1016/j.resconrec.2020.104904 Received Receiv ed 2 June 2019; Receive Received d in revise revised d form 2 April 2020 2020;; Accepted 20 April 2020 Available online 16 May 2020 0921-3449/ © 2020 Elsevier B.V. All rights reserved.

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

example, medical devices reprocessing, and sterilisation of reusable sharps are among the main cost-saving initiatives for hospitals in the US (Greenhealth Practice, 2018). 2018). In 2014, the total market value of medical equipment remanufacturing remanufacturing activities in Europe was estima estimated ted to be higher than EUR1 bi, representing around 3% of the total market va valu luee fo forr th thee me medi dica call devi device ce se sect ctor or in that that re regi gion on – EUR35 EUR35 bi (Parker et al., 2015 2015). ). In addition to that, the remanufacturing market holds substantial growth rates in EMEA and Pacific-Asia regions, higher than rates in the general medical industry (Srivatsav ( Srivatsav et al., 2017 2017). ). The implementati impleme ntation on of circul circular ar strategies strategies is associ associated ated with significant significant economic potential. Specific work addressing circular strategies in the medical device industry is available in the literature as well. In order to understand the challenges around the so-called single-use devices or instruments, Viani and colleagues (2016 (2016)) investigate ways to recover value from used laryngoscopes in England and Italy. Fargnoli and colleagues (2018 (2018)) developed a detailed servitisation approach comprising needs identification, life-cycle assessment (LCA) and life-cycle costing (LCC) of the as-is system, followed by the definition of scenarios towards improved customer satisfaction, economic benefits and environmental impacts applied. Finally, Kane, Bakker, and Balkenende (2017 ( 2017)) proposed circular product design strategies considering devices criticality and value retained on them to foster circular product design in the medical sector. Research and practical initiatives indicate that the as-is situation of the medicall device industry is not entirely linear. medica While organisations are impelled by the narrative of contributing to a Circular Economy, limited transferability from specific circular cases is a notorious issue when designing a circular business model – CBM (Lewandowski, 2016 2016). ). In other words, it is challenging for practitioners to identify business opportunities that enable and maintain resource cycles. Furthermore, no comprehensive study taking a business model perspective towards a circular medical industry was identified. Therefore, the herein research research aims to detail the appli application cation of CBMs in the medical device industry so that it can be used as benchmarks for business model innovation. It includes the definition and characterisation of such types of business models based on a systematic review of  cases and research articles. Also, a cross-analysis of identified CBMs providee directions provid directions for further further application application and research. research. By encompassing all the technical cycles envisioned by the Circular Economy and the specific hygienic needs in healthcare, the outcomes of this research can contribute to the transition to a circular medical device industry. The following sections of this manuscript consist of a literature review focusing on the role of business models to enable resource cycles and an industry-specific perspective of the value and hygienic needs of 

co cont ntri ribu butte to know knowlledge edge for a spec specifi ificc fie field ld an and d pur urpo pose se (Lambert, 2005). 2005). Authors Autho rs from non-go non-governm vernmental ental organi organizatio zations ns and consult consultancies ancies (Ellen MacArthur Foundation, 2012; 2012;  Lacy and Rutqvist, 2015) 2015 ) as well en et al al., ., 20 2016 16;;   Lewan Lewandowski, dowski, 2016 2016;;   Lüdekeas acad academ emia ia (Bock Bocken Freund et al., 2018; 2018; Moreno et al., 2016; 2016 ; Planing, 2015 2015)) have developed classifications of circular business models to organize and make sense of  resource-effective strategies within the Circular Economy framework. Such literature offers a wide range of circular strategies applicable for business model innovation in any industry. They help to exemplify the manners that business can help to achieve a CE. Commonly, the classifications are followed by ideal cases which apply and benefit from the application of combinations of such strategies. Apart Apa rt fro from m creati creating ng cla classi ssifica ficatio tions, ns, bus busine iness ss mod models els are also also a powerful tool to describe business or solutions for benchmarking for variation variat ion and innovation innovation ((Bade Baden-fulle n-fullerr and Morga Morgan, n, 2010 2010). ). In this sense, the following elements form a business model: the value proposi positi tion on,, va valu luee cre creat atio ion n an and d deli delive very ry an and d valu valuee cap captu ture re 2018b;;   Richardson, 2008). 2008). In a circular business (Geissdoerfer et al., 2018b model, value proposition and capture represents the promise of value tha thatt lea leads ds to long-t long-term erm com compet petiti itive ve adv advant antage age con consid sideri ering ng tri triple ple bottom line impacts (Bocken (Bocken et al., 2018 2018). ). Value creation and delivery represent the means to continuously generate and provide established 2018). ). In a benefits based on circular flows of resources (Bocken ( Bocken et al., 2018 transition to a circular business model, additional actors are involved in designing, operating and being affected by the circular solution, e.g. operators of reverse logistics and waste management become strategic partners, and the environment a central stakeholder (Antika ( Antikainen inen and Valkokari, 2016; 2016;  Bocken et al., 2015 2015). ). In the medical device industry, the business model structure is useful to conceptualise circular business models as well. Nonetheless, particularities from risk and safety regulations demand additional analysis. Strict hygienic requirements to maintain health and prevent the spread of diseases leads to specific disinfection or sterilisation needs based on the risk of infection for the sequential safe use of a given device ( Rutala and Weber, 2013). 2013). Furthermore, multiple stakeholders are involved through medicall devices medica devices lifet lifetime ime and requi require re coordinat coordination ion for share shared d responsibi responsibility lity with regulatory control (World (World Health Organization, 2003). 2003). Considering 2017)) discussed the importance to this, Kane and colleagues (Kane (Kane et al., 2017 understand the perspectives of the product value and critically before addressing a particular circular strategy. As presented in Figure in Figure 1, 1, in the ‘product value’ axis, which indicates the economic value of a functional functional product, device devicess stem from high to low value. Devices with high value as imaging equipment are composed

3,, we present research medical products. In  section In section 3 4 shows  shows thethe nine CBMs methodology. proposed and The results presented in  section in section 4 how they are positione positioned d according to the value and criticality of medical products. Afterwards, the business logic of each CBM is detailed to facilitate application application in practice. practice. In In section  section 5 5,, the discussion is directed by the cross-analysis cross-analysis of CBM types considering cases and research articles to provide prov ide pat paths hs for further further researc research h and applica application tion.. Fina Finally, lly, the concluding section consolidates the research and its limitations.

Baden Baden-Fulle -Fullerr and Morga Morgan n (2010) (2010)   descri describes bes one of the roles roles of  business models as artefacts to describe types (within typologies) or kinds (within taxonomies) of manners to profitably create and distribut tributee val value ue and fac facili ilitat tatee compar comparing ing,, unde underst rstand anding ing and disdisseminating these business structures. Taxonomies are created based on inference infere nce and cluste clustering ring analysis to provide provide a base for generalisat generalisation; ion;

of high technology and low involve a wide range second-comand third-tier suppliers.subsystems Devices with product value as of syringes prise prise product productss comp compose osed d of few fewer er com compon ponent entss whi which ch rely rely on less less technological features to function. The term ‘equipment’ commonly describes descri bes capital electromedical electromedical devices, while ‘device’ is a more general term (Eze (Eze et al., 2018 2018). ). The World Health Organisation provides a comprehensive guide of medical equipment for preventive, diagnostic, Health h treatment treat ment or rehab rehabilitat ilitation ion procedures procedures in healt healthcare hcare (World ( World Healt Organization, 2011). 2011). The ‘criticality’ axis classifies medical devices according to risk level they carry to human health due to the type of contact with the patient. Classification systems as the Spaulding scale assist healthcare workers ell and in sele select ctin ingg ap appr prop opri riat atee disi disinf nfec ecti tion on me meth thod odss (McDonn McDonnell Burke, 2011). 2011). Following this scale, a device is either critical, semi-crisemi-critical, and non-critical. While a vital signs monitor is a non-critical device, since there is limited contact to patients and requires low disinfec fectio tion, n, surgic surgical al inst instrume ruments nts are critic critical al device devicess since since the theyy get in

typologies are created based on arbitrary classification scheme and a few characteristics, leading to reduced complexity to achieve parsi2005). ). While a taxonomy scheme may lead to a commony (Lambert, (Lambert, 2005 prehensive and self-adjusting classification of business models, a typology constituted by a few categories and based on a few variables can

contact with the bloodstream and requires sterilisation if there is an intention to use them again. The product value vs criticality matrix assists in visualising tradeoffs among circular strategies to be followed for product design: while design for refurbishment is appliable for devices of high value and low

2. Litera Literature ture Review

2

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

( 2017). ). Figure 1.  Product value vs criticality matrix based on Kane et al. (2017

framework based on critical dimensions identified by them to provide a CE definition.   Pieroni, McAloone and Pigosso (2019)  sought for sustainability-orient tainabili ty-oriented ed and CE-orient CE-oriented ed business model (BM) innovatio innovation n approaches to map their applicability in BM innovation stages, system boundaries considered, and the abstraction level of available approaches. Guzzoo and coll Guzz colleag eagues ues (2019) 2019) investigated investigated 45 sustainab sustainability-orie ility-oriented nted product-service product-se rvice system (PSS) cases following a coding system comprising CE strategies to identify practices to operationalise circularity. Finally, Homrich Homr ich (2018 2018)) and coll colleag eagues ues app applied lied a comb combinat ination ion of sema semantic ntic analysis, bibliometrics, networks and content analysis in a systematic literature review to identify the trends and gaps in CE literature. Figure depicts the steps follow followed ed in the herei herein n resear research. ch. An Figure 2   depicts iterative approach allowed opportunistic changes of sequences within steps while preserving the research goal. The steps taken to fulfil the proposed procedure are following detailed. Step 1a:  Identification of cases applying circular strategies in the medical device industry An extensive search of real cases was carried out, aiming to identify representative cases applying circular strategies in the medical device industry. These sources were sought by visiting medical device industry fairs and congresses and accessing companies’ websites, presentations, brochures, reports, press releases and news. Strings combining keywords wor ds and jargon jargonss relate related d to resour resource ce cyc cycles les (e. (e.g. g. “pay-p “pay-perer-use use”, ”, “sharing”, “shari ng”, “reuse”, “reuse”, “refu “refurbish rbishment”, ment”, “recy “recycling”, cling”, and other others) s) were employed employ ed in combina combination tion to “medica “medical”, l”, “heal “health”, th”, “healthcare”, “healthcare”, and “hospital” using an internet search engine to search for cases and related materials. The output of this step is a collection of 59 relevant CBM cases in the medical industr industry. y. Step 1b:  Identification of research articles discussing circular strategies in the medical device industry Similar strings from Step 1a were used to identify relevant academic and non-academic research. Considering the vast array of keywords to ide identi ntify fy public publicati ations ons relate related d to resour resource ce cyc cycles les in the indu industr stry, y,

criticality, design for reprocessi criticality, reprocessing ng is suitab suitable le for highhigh-value value products, high criticality devices (Kane (Kane et al., 2017). 2017). Some products may have specific critical components, e.g. the haemodialysis unit is a high value, low criticality product, whereas its filters are lower value items that get into contact to patient's bloodstream. Also, the criticality of some devices as IV bags and sharps will depend on the use case, e.g. if they will be used in potentially infectious situations (Lee ( Lee et al., 2002). 2002). The criticality analysis adds a clinical risk viewpoint to an economically oriented endeavour. The technical cycles must be coherently activated considering additional trade-offs to enable circularity in the medical device industry. These cycles are activated by (1) Repair and maintenance, (2) Reuse and redistribution, (3) Refurbishment and remanufacturing, and (4) Recycling Recycl ing (Lüdeke Lüdeke-Freun -Freund d et al., 2018 2018). ). A given solution can activate different cycles by combining synergistic circular strategies towards multiple lifecycles and lifetimes (Bocken ( Bocken et al., 2016 2016). ). The business model discussions in the Circular Economy already integrates the perspective of value retained in the products. Value is destroyed in the post-use phase unless one retains value through activating the cycles (Achterberg et al., 2016). 2016). The criticality aspect enriches the debate. The investigation of circular strategies taking into account product value vs criticality critic ality is highly desirable desirable in the conceptua conceptualisati lisation on of circular circular business models in the medical device industr industry. y. 3. Resea Research rch Methodolo Methodology gy

Three methodological procedures were employed in this research: first, systematic literature review (Moher (Moher et al., 2009 2009)) adopting an evidence-based approach (Tranfield (Tranfield et al., 2003), 2003), second, deductive content analysis following  Elo and Kyngäs (2008), (2008), third, network analysis to identify relatio identify relationshi nships ps among among key variabl variables es followin followingg   Borgatti Borgatti and Everett (1997). (1997). Several studies in the CE field employ systematic literature review in combination with content analysis. Kirchherr and colleagu gues es (2017) 2017) inves investig tigat ated ed 11 114 4 CE de defini finiti tions ons fo follo llowin wingg a cod coding ing 3

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Figure 2.  Research design.

snowballing (Wohlin, (Wohlin, 2014) 2014) was consistently used to identify titles and aut author horss for furthe furtherr inq inquir uiry. y. The resear research ch of Kane Kane and collea colleague guess (Kane et al., 2017) 2017) was helpful to identify references since it already follows circular and medical perspectives in their investigation. Industry association association reports were relev relevant ant sources since there is limite limited d knowledge consolidated in research outlets. Reports released by the Centre for Remanufacturing and Reuse (2008)   and by the European 2015)) are essential pieces of  Remanufacturing Network (Parker (Parker et al., 2015 secondary sources. The output of this step is a collection of 65 relevant research articles, including journal and conference articles, technical reports, and news. Step 2:  Analysis of cases and research articles according to circular strategies and industry-specific framework

available), a description of the business model and relevant information of the primary provider of the solution. The unit of analysis applied to define a case in this research is the business model. Business model is considered the appropriate unit of  analysis as it spans the focal organisation's boundaries and provides a systemic view to understanding the logic of value creation, delivery and capture (Massa (Massa and Tucci, 2017; 2017;  Zott et al., 2011). 2011). Second, the circular resource cycle(s) implemented in the solution was identified — the cycles described by Ludeke-Freund and colleagues 2018). ). The technical cycle activated was characterised either as a core (2018 element of the value proposition or an additional feature of the BM. Finally, medical devices involved in the offer were analysed following the selling price of medical devices and the complexity of its

1) to and analyse and categorise A coding scheme (Table (Table 1) was designed cases and research article articles s selected in steps 1a 1b. First, the cases were described, described, includi including ng the company and soluti solution on names (when

subsystems subsys temsbyfor the value perspectiv persp ective, e, and the classification ion described McDonnel and Burke ( 2011) (2011 ) for theSpaulding criticalityclassificat perspective. Step 3:  Categorisation and description of industry-specific business

Table 1

Scheme to analyse cases and research articles identified. Brackets indicate the format of catalogued content. Case description – Applied to cases Company and solution names [short text]

Business model description [short text]

Main provider [options: OEM (Original Equipment Manufacturer) / service provider]

Circular strategies perspective – Applied to cases and research articles Activated technical cycle [multiple selection: 1. Repair and maintenance; maintenance; 2. Reuse and Redistribution; 3. Refurbishment and Remanufacturing; 4. Recycling.]

Evidence [short text]

Medical devices perspective – Applied to cases and research articles Medical devices involved [tabulation]

Value dimension [multiple selection: high / medium / low]

4

Criticality dimension [multiple selection: high / medium / low]

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 2

A BM structu structure re used to descr describe ibe each identi identified fied business model type. CBM type name and a brief description of the Value Proposition Value Creation

Value Capture

Value Delivery

Description of the  key stakeholders  involved,  key activities  performed by business model actors, and key resources and capabilities  needed to provide the specific type of business model

Description of the potential value captured by organisations (Profit), individuals and society (People), and the environment (Planet) in comparison to business as usual solutions

Description of the  customer segments  reached, customer relationships  maintained to enable the offer, and channels to continuously deliver the specific type of  business model

Cases Exemplary instances that symbolise the specific type of business model

models The types of business models were identified by analysing the recurrence of the parameters considered in the previous step: activated technical cycle, criticality and product value. An adapted version of the bu busi sine ness ss model model canv canvas as (Bo Bock cken en et al al., ., 20 2018 18;;   Osterwalde Osterwalderr and Pigneur, 2010) 2010) was used to describe the composition of each industryspecificc circula specifi circularr business business model type – see see Table  Table 2 2.. It consolidates the commonalities of the value proposition and how solution providers create and deliver value to customers. Step 4:  Analysis of relationships among key variables and triangulation between cases and literature For the triangulation between literature and cases, a coding schema (Table 3) 3) was designed to understand both literature and cases through the same lens. The relationships among variables were investigated through cross-tabulation and network analysis. First, we analysed codes frequency in research articles and cases through descriptive statistics. Second, we performed a cross-tabulation analysis of the relationship among variables (codes), applying the IBM SPSS software by systematising the joint identification of codes in analysed documents. The resulting cross-tabulation matrix was the input for the network analysis per perfor formed med in the UCI UCINET NET6 6 and Net NetDra Draw w softwa software re (Borga Borgatti tti et al., 2002), 2002 ), which enables visual representations of the association of codes. Then, The n, we per perfor formed med a two two-st -steps eps net networ workk analys analysis is to exp explor loree the relationships among the CBMs to activated technical cycles, and value and criticality of medical devices, and a network exploring the relationship among technical cycles. In the network analysis of cases, the codes are nodes connected by lines. The more a given pair of codes is  joint identified, the thicker is the line li ne connecting the nodes.

4. The nine medical device industry circula circularr business model (CBM) types

Nine medical device industry circular business models (CBM) types were identified: CBM1. Full care equipment-as-a-Service; CBM2. Inhospital lifecycle care services, CBM3. Support for hospital-based reprocessing, CBM4. Mobile solutions; CBM5. Platform for devices circulation; culati on; CBM6. Refurbis Refurbished hed Systems; CBM7. Full-provis Full-provision ion of reproces processed sed dev device ices; s; CBM CBM8.E 8.End-o nd-of-l f-life ife (EO (EOL) L) equipm equipment ent collec collectio tion; n; CBM9. Continued collection of disposables. The CBM types are represented in Figure in  Figure 3 3,, followed by one exemplary case for each type. The coverage represented by the format and size of rounded rectangles considers product value and criticality. While CBM5 can potentially enable circularity to all types of products, CBM9 is only valid for low value, non-critical medical devices. The CBMs are composed of combinations of products and services alterations that enable the technical cycles and make more effective use of resources than business as usual.   Table 4  describes the technical cycles most strongly activated by each CBM type. Some cases robustly activated more than one technical cycles as a core element of the value proposition: two cases activated TC1. Repair and TC3. Refurbishment, combining CBM1 and CBM7, and one activated TC1. Repair and TC2. Reuse, combining CBM3 and CBM4. Within the sample of cases, CBM3, CBM5 and CBM7 were the most frequent. Also, there is a significant concentration on the repair flow: 24 identified cases activated TC1. Repair as a core elemen elementt of the value proposi proposition. tion. Most types of CBMs involve low criticality equipment holding medium to high value. All technical cycles can be activated for this type of equipment. The relation among TCs and CBMs show that the CBM5 can activate the four TCs, while most CBMs can activate one or two TCs at the same time. Following, each of the nine proposed CBMs are described. 4.1. CBM1. Full-care equipment-as-a-s equipment-as-a-service ervice

Table 3

Coding schema for triangulation. Circ Ci rcul ular ar Busi Busine ness ss Mode Modell (C (CBM BM))

Providing access to devices through a fee-based contract is a significant CBM within medical devices. Lifecycle services as calibration, maintenance and repair are central to this business model as the provider holds devices ownership. The fleet of equipment becomes a critical resource to OEMs, subsidiary service providers or independent providers. Floating demand for equipment enabled by service contracts and the age profile of installed base makes it also a source of risk. To mitigate those risks and maintain long relationships with customers, the providers’ team keeps close contact with facility managers and clinical engineers to guarantee peace of mind during the contract duration. The logic of value creation, delivery and capture of CBM1 is detailed in 5. The need to provide continuous availability of equipment, to Table 5. guarantee full performance when needed and the requirement of ad-

Tech Techni nica call Cycl Cycles es (T (TC) C)

CBM1: CBM1: Ful Full-c l-care are equ equipm ipment ent as a ser servic vicee TC1 TC1:: Repair Repair and Mai Maint ntena enance nce CBM2:: In-ho CBM2 In-hospita spitall lifecycl lifecyclee care services services TC2: Reuse and redi redistrib stributio ution n CBM3: Support ffor or hospital-based hospital-based reproc reprocessing essing TC3: Refurbishment and Remanufacturing CBM4: Mobile solutions TC4: Recycling CBM5: Platform for devices circulation   Value (V) CBM6. Refurbished system CBM7. Full-pro CBM7. Full-provisio vision n of reprocesse reprocessed d de devices vices VH: High High CBM8. End-of-life End-of-life (EOL) equipment collection VM: Medium CBM9.. Cont CBM9 Continue inued d coll collecti ection on of disposable disposabless VL: Low Criticality (C)

ditional services such as training and equipment update are mentioned by Fargnoli by  Fargnoli et al. (2018)   as fundamental reasons that product-service systems are especially promising in the medical device industry. Contract length and conditions vary according to cases. In mediumvalue products, rental packages starting by three months contracts were

C: Critical C: Semi-Critical Semi-Critical NC: Non-Critical

5

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Figure 3.  Nine medical device industry CBM types and their coverage on product value and criticality.

impacts in eco-points and overall costs are approximately half for the servitised in comparison to the baseline. It is possible to offer solutions that require less capital expenditures, increased revenues from services and decreasing operational expenditures in the long term to hospitals while providing business opportunity for manufacturers sustaining positive environmental impacts in equipment equipment-as-a-serv -as-a-service ice offers.

rec recogn ognise ised d in the servit servitiza izatio tion n of defibri defibrilla llator torss by Med Medigo igo – Ren Rentt (Medigo, n.d. n.d.). ). Cardiac starters are lower value and relatively standardised equipment when compared to clinical centres equipment, and thus enable shorter-term standard contracts. The service-based offering of high value, low criticality equipment can involve long-term contracts, often employing leasing. One such case is the Integrated Health Solutions case offered by Medtronic, which provides turn-key equipment for hospital departments as Intensive Care Unit, and Operating 2015). ). Room on a ‘fee-per-procedure’ basis (Medtronic, ( Medtronic, 2015 Full-care Equipment-as-a-Service is a suitable solution to healthcare organisations with limited investment capacity and willing to shift from ownership-based solutions. The drop in capital expenditures – CAPEX –

4.2. CBM2. In-hospital lifecycle care se services rvices

Usually, the most relevant lifecycle costs of medical equipment are due to maintenance and may escalate when healthcare institutions lack the capabilities to maintain them (Jamshidi (Jamshidi et al., 2014 2014). ). This way, services are often offered to hospitals to extend the life of owned medical equipment. Service packages consist of combinations corrective to predictive maintenance aiming to achieve agreed service levels. Spare parts and consumables are frequently part of the solution. The capabilities of the support team to keep equipment in good condition of  use and to establish a close connection to hospital employees as facility managers manage rs and clinica clinicall engine engineers ers is criti critical cal to achie achieving ving peace of mind. While OEM or service providers benefit from continuous revenues from

of healthcare wasfrom expected in the US and Europe ( Morgan (Morgan Stanley, 2017organisations 2017). ). Also, shifting capital expenditures to more predictable operational expenditures through service-based solutions was prescribed prescrib ed “as a manner to assure long-term access to quality healthcare services for citizens” (COCIR, (COCIR, 2016). 2016). In a simulation compar comparing ing selling of  haemodialysis haemodial ysis unities and providing it as a service to hospitals including all main maintena tenance nce interve interventio ntions ns and refurb refurbishm ishment ent after after the cont contract ract period, Fargnoli and colleagues (2018 (2018)) show that the environmental Table 4

Number of identified cases according to Technical Cycles activated by CBM types. BM centrality indicates if the Technical Cycle is activates as a core element of the value proposition or as a peripheral feature of the business model. Technical Cycles

BM centrality

TC1. Repair TC2. Reuse TC3. Refurb. TC4. Recycling

CBM1

CBM2

CBM3

Core Peripheral Core

7

6

9

Peripheral Core Peripheral Core Peripheral

1

1

CBM4

CBM5

1 5

2 9

CBM6

CBM8

CBM9

2

5 1

CBM7

1

9

3 3

5 6 3

6

3

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 5

CBM1. Full-care Equipment-a Equipment-as-a-Service s-a-Service Contract-based access to equipment through renting or leasing, including lifecycle services Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

OEM / service provider: Continuous revenues from services. Hospital: Shift from capital expenditures (CAPEX) to operational expenditures (OPEX) costs to access

Products are offered as services in long-term leasing or short-term renting contracts.

Original Equipment Manufacturer (OEM), service provider, Hospital, Facility manager

equipment. Key Activities

Facilitated financing of equipment Continuous provision of support and maintenance services during the service contract. May include spare parts.

Key Resources and capabilities

Fleet of equipment becomes a key asset for OEM/service providers The support team capabilities to maintain equipment and keep a close relationship to customers is critical.

People

Channels

Facility manager: peace of mind from the fleet of  equipment functioning. Physician: Increased satisfaction due to increased access to equipment. Society: Increased access to healthcare services.

Close contact to OEM or service provider support team guarantees peace of mind to hospital employees.

Planet

Customer Segments

Environment: Enhanced lifetime of products due to services and potentially increased use rate from equipment.

Healthcare organisations with limited investment capacity and willing to shift from ownership based solutions.

Cases Medigo — Rent: Renting of defibrillators; Medtronic — Integrated Health Solutions: Provision of health solutions based on long-term contracts.

services, hospitals can rely their equipment functions well while depending on less internal personnel. The logic of value creation, delivery and capture of CBM2 is detailed in Table in  Table 6. 6. Steris’ Ster is’ Service Service Contr Contracts acts is an emble emblematic matic case of customizable customizable mainten main tenanc ancee servic services es for equ equipm ipment ent,, app applie lied d to steril sterilee proces processing sing equipment (STERIS, (STERIS, n.d. n.d.a) a) and operating rooms equipment (STERIS, (STERIS, n.d.a). n.d. a). Such kind of solutions is provided for imaging equipment by Phil Philip ip's 's Ri Righ ghtt fit pr prog ogrram (Phi Philip lips, s, 201 2015 5). Remo Remote te Se Serv rvice icess 2013)) is an additional feature of Philips service agreements (Philips, Philips, 2013 which enables predictive maintenance through a remote monitoring system system (RADAR (RADAR)) and rem remote ote repair repair whe when n pos possib sible. le. Gai Gaiard ardell ellii and

colleagues (2014 colleagues 2014)) describe Philips Remote Services as a maintenance product-related service. In order order to assist assist hea health lthcar caree institu institutio tions, ns, the trade trade associa associatio tion n COCIR (2013)  provides good practices to develop maintenance processes and to select service providers. It is central to develop a partnership among service providers and healthcare institutions. Moreover, Jamshidi and colleagues (2014 ( 2014)) affirm that outsourcing of maintenance is a promising practice, which requires further empirical studies. The limits limi ts for mai mainte ntenanc nancee servic services es are also also wel welll discuss discussed. ed. COCIR COCIR (COCIR, 2016 2016)) recommends replacing medical devices older than ten years as they are challenging to maintain. Maintenance expenditures

Table 6

CBM2. In-hospital lifecycle care services Contract-based provision of maintenance services encompassing different service levels Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

OEM or service provider: Continuous revenues from services. Hospital: Increased reliability of equipment functioning. Reduced need for personnel to maintain products.

Offers different contracts encompassing types of maintenance services, including or not the provision of spare parts to achieve a given agreed service level.

People

Channels

Facility manager: peace of mind from a functioning fleet of equipment. Physician: Increased satisfaction due to fully functional equipment. Society: Increased access to healthcare services.

Close contact to OEM or service provider support teams guarantees peace of mind to hospital employees.

Planet

Customer Segments

Environment: Greater lifetime of products due to services.

Healthcare organisations willing to source the maintenance of  equipment fleet.

Original Equipment Manufacturer (OEM), service provider, Hospital, Facility manager.

Key Activities

Provision of support and maintenance services (combinations of predictive, preventive and reparative options). Provision of spare parts and maintenance kits may be included or provided separately. Key Resources and capabilities

The support team capabilities to maintain equipment and keep a close relationship to customers is key. Cases

Steris — Service Contracts: Customizable service contracts for equipment; Philips — Remote Services: Predictive maintenance services through remote monitoring.

7

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 7

CBM3. Support for hospital-based reprocessing Provision of equipment and consumables for hospital-based cleaning, disinfection and sterilisation of devices Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Hospital: reduced costs to purchase and dispose of single-use devices for hospitals.

Categorises equipment and consumables according to the level of  disinfection they provide and reprocessing steps, e.g. ‘bedside precleaning’, ‘high-level disinfection’, ‘storage’.

Key Activities

People

Society: Increased access to healthcare services.

Channels

Key Resources and capabilities

Planet

Customer Segments

Reduced use of resources to manufacture single-use devices due to increased use cycles.

Healthcare organisations holding enough demand and structure to reprocess devices using their personnel.

Original Equipment Manufacturer (OEM), service provider, Hospital, Purchasing manager, Health regulatory agency (single-use devices reprocessing restrictions)

Provision of equipment and consumables to facilitate cleaning, disinfection and sterilisation of devices by the hospital personnel. Consultancy for improved hospital-based reprocessing.

The hospital personnel capability to manage and operationalise the reprocessing process is critical.

Transaction-based provision of equipment and consumables.

Cases Medivators — Renatron: Provision of products to facilitate dialyzer reprocessing; Cantel Medical + EMS Healthcare — Quest+ Decontamination: Mobile endoscope decontamination unit

is detailed in Table in  Table 7. 7. Medivators offers equipment and products for hospit hospitalal-bas based ed reproc reprocess essing ing of dialys dialyser er filters filters thr throug ough h Renatr Renatron on n.d.). ). Cantel Medical and EMS Healthcare, in partner(MEDIVATORS, n.d. ship, provide a mobile endoscope decontamination unit (EMS ( EMS Mobile Healthcare, n.d.), n.d.), combining CBM3 and CBM4. In-house reprocessing of single-use and reusable devices are recurrent practice in Europe, the U.S., Japan, and Australia (Popp (Popp et al., 2010). 2010). Although Alth ough in-hous in-housee rep reproce rocessin ssingg is an old practic practicee in heal healthc thcare, are, the transition from stainless steel and ceramics to less durable materials has brought complexity (Verdict (Verdict Management, 2010 2010). ). Costs and risks are the main trade-offs considered by healthcare facilities. According to the American agency FDA agency FDA (2015) (2015),, the English agency MHRA agency MHRA (2018) and (2018) and the German agency GMS (Grosskopf (Grosskopf and Jakel, 2008), 2008), anyone reprocessing a given device holds the same responsibility as the manufacturer. In other

and downtime cost have been essential factors influencing the calculation to replace devices (Christer ( Christer and Scarf, 1994). 1994). Thus, CBM2 can be more productive during the initial life of the equipment. 4.3. CBM3. Support for hospital-base hospital-based d reprocessing 

The provision of consumables, equipment and services to support in house-reprocessing house-repro cessing of device devicess can provide provide significant significant circula circularr impact. impact. As noticed by Viani and colleagues (2016 ( 2016), ), owning a sterilisat sterilisation ion unit and not owning in-house waste management facilities favour the use of  reusable devices. In CBM3, consumables and equipment assist different levels of disinfection – from bedside cleaning to sterilisation – and storage of devices. Consultancy to improve hospital processes is also provided. The logic of value creation, delivery and capture of such CBM Table 8

CBM4. Mobile s olutions Short-term access to equipment through mobile medical units Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

OEM / service provider: Continuous revenues from services. Hospital: Revenues from services that would not justify the investment in new equipment.

Large and expensive equipment are offered as services in trucks or temporary buildings in short-term renting scheme.

People

Channels

Physician: Increased satisfaction due to increased access to equipment. Society: Increased access to healthcare services.

Set up of medical units in pre-defined days of the week or for a short period enables dealing with demand.

Planet

Customer Segments

Environment: Increased use rate from equipment.

Healthcare organisations dealing with fluctuating demand for specific treatment or interested in expanding.

Original Equipment Manufacturer (OEM), service provider, Hospital, Facility manager

Key Activities

Continuously setting up mobile medical units in different hospitals. Provision of personnel for diagnosis and therapy from the use of  equipment is optional.

Key Resources and capabilities

Fleet of mobile medical units (trucks and temporary buildings + medical equipment) is a critical asset for the OEM or service providers. Cases

Shared Medical Solutions — Mobile and Modular Solutions: Rent of imaging equipment for a defined time enabled by trailers or modular buildings; Canon (former Toshiba) — Mobile Solutions: Rent of equipment through mobile solutions.

8

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 9

CBM5. Platform for devices circulation Sharing, renting or facilitating sales of medical devices among healthcare institutions through a third-party platform Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Platform, Broker (only on reselling platforms), Hospital (Owner): Revenue from underused assets. The platform enables and fosters trust-building and transactions Hospital (devices owners), Hospital (devices Hospital (Borrower): Shift from capital expenditures among members - peer-to-peer reviewing, litigation support, borrowers or buyers), Facility manager (CAPEX) to operational expenditures (OPEX) costs to access and community good practices are commonly available. equipment or reduced costs of investment. Improved revenues from new services. Key Activities

Matchmaking of medical devices needs and availability, the agreement among hospitals and post-transaction support. Additional services as uninstalling, training, maintenance and insurance are available.

Key Resources and capabilities

Online platform usability Quantity of platform members and available devices in the platform Level of trust and engagement of platform members.

People

Channels

Facility manager: Additional option to access medical Members should coordinate shared used, collecting and equipment and achieve business goals. retrieving, or ownership transfer, which is facilitated by the Physician: Increased satisfaction due to met needs for platform. equipment. Society: Increased access to healthcare services. Increased cooperation among healthcare institutions in a given region. Planet

Customer Segments

Environment: Increased use rate from equipment.

Healthcare organisations with surplus capacity and willingness to make use of used products.

Cases Floow2Healthcare: Platform for sharing medical devices; DOTmed: Marketplace for buying and selling used medical devices and parts.

and sell platforms and sharing/renting ones. The ownership aspect differentiates both. The first type of platform facilitates the transfer of  ownership of pre-owned devices between owners and purchasers. The second type facilitates sharing of devices, keeping ownership with the lender that may receive a fee as a counterpart. In both cases, matchmaking of medical devices supply and demand, and nurturing users’ community are central. Also, both revenue from fees per ad and by offering premium services. The logic of value creation, delivery and capincreased d number of devices per ture of CBM5 is detailed in Table in  Table 9. 9. The increase bed and decreased level of use (Horblyuk ( Horblyuk et al., 2012) 2012) may enhance the potential of such a solution in the medical industry. Buy and sell platforms are significantly widespread. Third-party platforms as DOTmed (DOTmed, (DOTmed, n.d.) n.d.) facilitate buying and selling of  high value, non-critical equipment as MRI machines to low-value, high criticality devices as surgical scissors. Srivatsav and colleagues (2017 ( 2017)) describe the role of tier 2 and tier 3 brokers, experts in de-installation, logistics, and installation that buy and sell products with little intern.d.)) is such a broker company, that intervention. Promed (Promed, (Promed, n.d. mediate deals through online platforms or direct contacts. An extensive ecosystem ecosys tem of compa companies nies enables the marke markett of pre-owned medical devices. The US Department of Commerce (Francis, ( Francis, 2007 2007)) compiles regulations ulatio ns relating to the importat importation ion of pre-o pre-owned wned (used and refur refur-bished) capital medical equipment in countries around the world which help to understand the rules for international transaction. ‘Uberisatio ‘Uber isation’ n’ is also a trend in healt healthcare hcare to addre address ss underunder-utilise utilised d capacity capaci ty (Srivatsav et al., 2017 2017). ). Cohealo (Cohealo, (Cohealo, 2019; 2019;  Muñoz and Cohen, 2017) 2017) and Floow2healthcare (Floow2healthcare, (Floow2healthcare, n.d.) n.d.) are examples that facilitate sharing and peer2peer renting as a central element of their value proposition. They offer closed or open platforms. While Cohealo mentions “sensitive and expensive equipment” to be shared, share d, Floow2healt Floow2healthcare hcare mentions “furni “furniture”, ture”, “stock items” items”,, and “MRI scanner”, comprising a more comprehensive range of products. Sharing or renting higher value equipment means providing its use, while lower value consumables imply the exchange of ownership.

words, the hospital needs to meet the same regulatory requirements imposed for manufacturers. In the other hand, the costs of in-house reprocessing of devices tend to be lower than using single-use devices. Viani and colleagues (2016 (2016)) show one hospital using single-use blades, laryngoscopes and handles over one year spent an average of 57 pounds per bed while a hospital reprocessing the same devices spent an average of 4 pounds per bed. Bang and colleagues (2019 ( 2019)) show that hospital reproce reprocessin ssingg of duodenos duodenoscope cope bri brings ngs bet better ter financial financial outcomes outcomes than than disposable ones, including service and infection costs, except for lowvolume institutions, and emergency rooms. This way, healthcare institutions holding enough demand and structure to reprocess devices using their personnel are the main segment of customers. Moreover, Eckelman (2012 (2012)) and colleagues show that a 40-times reusable laryngeal mask airway presented better results in all impacts categories of an LCA when comparing to a single-use version, version, constituting a smart decision for healthcare healthc are facilities aiming to decrease their environmental environmental impacts. 4.4. CBM4. Mobile solutions

In cases which healthcar healthcaree instit institutions utions are dealing with fluctua fluctuating ting demand or considering expansions, mobile solutions should be considered. Trucks or temporary buildings are employed to offer mainly high-value high-v alue equipment in short short-term -term renting schemes. In any case, the same equipment is used by multiple hospitals in a given period. The fleet of mobile medical units and the process of setting them up in predefined dates and places enable the solution. The logic of value creation, delivery and capture of CBM4 is detailed in   Table 8. 8. Among identified cases, Shared Medical Solutions provides Mobile and Modular solutions in the US (Shar ( SharedMed edMed,, 2019 2019)) and Agito Medical in Europe (Krarup (Krarup et al., 2015). 2015). 4.5. CBM5. Platform for device devicess circulation

Addressess hospitals’ willingness to make use of used products, mainly Addresse motivated by constrained budgets and availability of underused devices and equipment. Two types of platforms enhance devices circulation: buy 9

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 10

CBM6. Refurbished Systems Acquisition of turn-key refurbished and upgraded equipment with same as new warranty Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Hospitals: reduced capital expenditures (CAPEX) costs to access high-quality equipment. OEM / service provider: Increased revenues

Provision of same as new warranty and consumables enables trust-building among OEM / service provider and Hospitals.

Original Equipment Manufacturer (OEM), service provider, Hospital, Purchasing manager, Health regulatory agency (import and refurbishment restrictions)

from the same equipment. Key Activities

Product procurement, de-installing, refurbishment, installing, warranty and spare parts provision.

Key Resources and capabilities

Equipment fleet in hospitals is a critical resource to be traded-in for refurbishment. Remanufacturing facilities and corresponding process are critical. OEM develop new brands and pricing strategies to avoid market cannibalisation.

People

Channels Two main touchpoints:

Facility manager: Additional option to access medical equipment and achieve business goals. Society: Increased access to healthcare services. Creation of skilled labour job positions.

1. Coordination of trade-in and de-installation of old equipment for smooth operation; 2. Site planning and efficient installation enable turnkey delivery of equipment.

Planet

Customer Segments

Environment: Environmen t: Additional lives to equipment.

Healthcare organisations willing to make use of used products in same as new conditions.

Cases Siemens — Ecoline: Provision of refurbished imaging system by OEM; Philips — Smart Path: Provision of equipment with added functionality and extended life through upgrading.

JIRA, and the American association MITA (Global ( Global Medical Imaging Industry, 2013) 2013) should be accepted internationally so that clients and governments gover nments trust refurbishe refurbished d syste systems. ms. Moreover, Moreover,   Plume Plumeyer yer and Braun (2011) present (2011)  present good remanufacturing practices applied at Siemens. Finally, the European Remanufacturing Network (Butzer ( Butzer and Schötz, 2016) 2016) prescribes and details a remanufacturing process to be followed.

4.6. CBM6. Refurbish Refurbished ed systems

Providing medical equipment in the same-as-new condition is a widely applied and discussed CBM. Although same as new indicates the pro proces cesss of remanu remanufac factur turing ing,, refurb refurbish ishmen mentt is the ter term m com common monly ly ad adop opte ted d in th thee indus industr tryy for for high higher er-va -value lue me medi dica call eq equi uipm pmen entt atsa savv et al al., ., 20 2017 17;; the   United United Sta States tes Int Intern ernati ationa onall Tra Trade de (Sriv Srivat Commission, 2012). 2012). Refurbished systems providers commonly mention selection, de-installation, inspection and replacement of non-functional parts, software upgrades, cosmetic changes, performance checking, reinstallation, and warranty as critical processes. The refurbishment site and the accumulated knowledge on extending the life of devices are critical resources. The logic of value creation, delivery and capture of  10.. Active procurement of equipment charCBM6 is detailed in Table in  Table 10

4.7. CBM7. Full-provision of reprocess reprocessed ed devices

The high risks of devices reprocessing drives hospitals to outsource  Sloan (2007)   provides a decision model such process (Hanlon, (Hanlon, 2013). 2013). Sloan based on the device cost, failure probabilities and failure penalty cost to help hospitals define single-use medical devices for reprocessing. Service

acterises a win-win hospitals gain the flexibility to invest, and providerssituation obtain a because continued source of revenue. Internal cannibalization and organisational conflicts are the most re rele leva vant nt th thre reat atss to re rema manuf nufac actu turi ring ng in the the me medic dical al indus industr tryy (Adamo and Rosa, 2016 2016). ). Commonly, OEMs provide such equipment using a specific label differentiating from new products, e.g. Siemens through throu gh ecolin ecoline, e, GE Healt Healthcare hcare through GoldSeal GoldSeal,, Philips Philips throu through gh Diamon Diamond d Sele Select ct,, Ca Cano non n (f (for orme merr Tosh Toshib iba) a) thro throug ugh h Se Seco cond ndli life fe (Parker et al., 2015 2015). ). A significant strength of refurbished systems is the association with eco-friendly solutions, acting as an order winner to 2016). The enrefurbishe refur bished d medica medicall equipme equipment nt (Adamo Adamo and Rosa, 2016). vironmental and economic gains of refurbishment are used to acquire new customers. Steinsdoerfer customers. Steinsdoerfer (2013) claims (2013) claims that a refurbished Magnetic Resonance machine saves 108 tons of CO2 while saving around 30% of  the acquiring cost when comparing to a new product. Hempel shows a reduction reduct ion of 95% of climat climatee change and human toxicit toxicityy impact impactss when comparing the LCA of a new with a refurbished MRI machine (Hempel, ( Hempel,

providers incorporate these risks and rebate providechecks, reprocessed devices aiming for long-term relationships through discounts, and payper-use. The process relies on initial disinfection and sorting of devices using appropriate containers by hospital employees. Reprocessing facilities and capability to verify, sort, reprocess, inspect, and repackage  FDA (2015) provides devices following following regional regulat regulation ion is critical. The The FDA (2015) provides detailed guidance for reprocessing process definition and validation of  reprocessed reproce ssed devices. In the UK, the the MHRA  MHRA (2016) (2016) provides  provides specific rules for third party reprocessing. The logic of value creation, delivery and capture of CBM7 is detailed in Table in  Table 11 11.. Ste Sterilm rilmed, ed, a J&J Comp Company, any, assists assists hospita hospitals ls to reproce reprocess ss devi devices ces original orig inally ly manufact manufactured ured by J&J and other other manuf manufact acturer urers, s, incl including uding reusabl reus ablee and single-u single-use se devi devices. ces. Gyna Gynaecol ecologic ogical al OR instrume instruments, nts, Orthopedic Orthope dic OR instruments instruments,, cathete catheters rs and forceps are among reproce reprocessed ssed n.d.). ). Reprocessed Sterilmed devices cost devices (Johnson (Johnson & Johnson, n.d. 50% of new ones and also reduce the disposal costs to around 70% (Morgan Stanley, (Morgan  Stanley, 2017). 2017). Potential benefits are high. From the viewpoint

2016). 2016). Good refurbishment practices are provided by industry associations and by market leaders.   Hempel (2016)  claims that the Good Refurbishment Practice proposed by the Global Medical Imaging Industry, congregating the European association COCIR, the Japanese association

of healthcare institutions, Viani and colleagues (2016 ( 2016)) describe the use of  full-provision of reprocessed devices by one Italian hospital because "it guaranteed a steady, known cash outflow and did not require a huge start-up capital investment". From the viewpoint of waste generation, when reprocessed by a third party, the odds of recycling are high: 95% of  10

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 11

CBM7. Full-provision of reprocessed devices Collection, reprocessing and provision of higher criticality medical devices Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Hospital: Reduced costs to purchase and dispose of single-use devices for hospitals. OEM / service provider: Increased revenues from the same device.

Rebate checks, discounts, and pay-per-use are some of the price mechanisms for long relationships. Continuous fitting of devices collection and

People

Channels Two main touchpoints:

Purchasing manager: Increased reliability and tranquillity for devices availability. Society: Increased access to healthcare services. Creation of skilled labour job positions.

1. Collection of used devices initially disinfected by hospital team; 2. Provision of reprocessed and inspected devices according to the hospital's needs.

Planet

Customer Segments

Environment: Reduced use of resources to manufacture single-use devices due to increased use cycles.

Healthcare organisations willing to make use of  reprocessed devices from an external supplier.

Original Equipment Manufacturer (OEM), service provider, Hospital, Purchasing manager, Health regulatory agency (single-use devices’ reprocessing restrictions).

provision is needed. Key Activities

In-house initial disinfection, a collection using appropriate containers, verification and sorting, reprocessing, inspection, repackaging and provision of reprocessed.

Key Resources and capabilities

Reprocessing facilities and corresponding processes meeting regional regulation are key Hospital employees ability for collection and initial disinfection is critical. Cases

Sterilmed: Collection, reprocessing and provision of single-use medical devices; Pioneer Medical Devices — MasterCut I.S.S.: Shaver System designed for multiple uses before reprocessing offered in a pay-per-use contract.

devices that achieve the end of life are recycled by the AMDR's members 2011). ). (Association of Medical Device Reprocessors, 2011 Collaboration among hospitals, service providers and manufacturers is a central topic to enhance reprocessing (Sloan, ( Sloan, 2007). 2007). Product-service systems may be a manner to improve collaboration and value captured by multiple stakeholders holding conflicting interests when reprocessing devices – e.g. manufacturers that rely on selling a stream of single-use goods, and hospitals that wish to cut costs as safely as possible ( Moultrie et al., 2015). 2015 ). Also, one should consider that the frequency of reprocessing singleuse devices is reportedly limited (Popp (Popp et al., 2010 2010). ). The modular shaver system designed by Pioneer Medical Devices exemplifies a system that solves the need for collaboration while dealing with limited reprocessability. To enhance the total lifetime of the device while decreasing risks, the invasive part was designed for five use cycles, and is continuously reprocessed through a pay-per-use contract (Schrödel, ( Schrödel, 2015). 2015).

are usually high quality and constitute a stable financial source for local recycling companies. Healthcare institutions benefit from decreasing costs for waste treatm treatment ent by diverting diverting recyclabl recyclablee materials. materials. Manufacturers and providers benefit from promoting this type of sustainable initiative. Reporting hospitals’ economic and environmental benefits help to maintain the relationship relationship in this type of CBM. Lee and colleagues (2002 (2002)) affirm that high recycling potential of IV bags – 90% of which are not infected during use, and plastic syringes – constituted of around 85% of plastics. Nation-wide PVC recycling programs are carried out by the Vinyl Council Australia supported by Baxter (Vinyl Council Australia Council  Australia et al., n.d.). n.d.). They argue that recycling PVC reduces by 77% of the carbon dioxide emission when comparing to incineration. The initiative collected an average of 13 tonnes of PVC per mont month h in Au Aust strral alia ia and New Zeal Zealan and d in 2018 2018 (Vin Vinyl yl Cou Council ncil Australia, 2018). 2018). Also, the medical devices manufacturer BD partnered up with Waste Management Healthcare Solutions to provide the BD ecoFinity

4.8. CBM8. End-of-life (EOL) equip equipment ment collection

Lifecycle Lifecy cle Solut Solution, ion, thatMcCord, continuou continuously sly ).colle collects cts shar sharps and recyc recycles lescycle the 2011). Recycling ispsthe technical plastic material (Ji and (Ji 2011 activated in this CBM that applies for low value, non-critical devices.

Equipment collection for parts harvesting and recycling constitutes CBM8, detailed in Table in  Table 12. 12. Waste Electrical and Electronic Equipment (WEEE) recyclers recyclers are responsi responsible ble for removi removing ng equipm equipment ent and destructing data. They inspect equipment to find functional parts and recycle non-functional ones. Certificate of the destruction of equipment and compliance to WEEE recycling good practices are critical. Hospitals have their costs for equipment disposal reduced and can receive money back. Advanced Technology Recycling provides certified recycling of  medical equipment in the US (Advanced (Advanced Technology Recycling, n.d.). n.d. ).

5. Triangulation and discussion

Continuous collection of disposable devices deals with the complexity of medical waste. Such CBM is detailed in Table in  Table 13. 13. PVC plastics recycling (or even substitution) is critical to reducing the release of 

The technical cycles most applied in cases and discussed in research articles are TC1. Repair and TC3. Refurbishment. Also, there is an evident recurrence on non-critical devices. However, different focuses have been given by literature and practice concerning the value dimension and the circular business models. While the literature focuses on products covering high-value products (VH), cases focus on both products produc ts with high and medium selling prices (VH and VM). Similarly, Simila rly, while the literature literature highlights discussions regar regarding ding CBM3, CBM6, and CBM7, cases demonstrate CBM3, CBM5, and CBM7. There is a high number of cases relying on platforms for sharing, renting, and second-hand transactions, nevertheless few research arti-

2006;; toxic gases from the incineration of medical waste (Jang ( Jang et al., 2006 2002). Such initiatives involve the manufacturer of single-use Lee et al., 2002). devices, device s, provid providers, ers, and recycling recycling promot promotion ion organ organisatio isations ns to assist hospitals in sorting disposable devices using appropriate containers and procedures. Drivers for low-value devices recycling are that materials

cles investigate them. The same applies to discussions about short-term renting of Mobile solutions. A full overview of the occurrence of variables in cases and literat literature ure is provid provided ed in in Table  Table 14 14.. Connections Connectio ns among variable variabless are clarified by the network analysis of  cases (Figure (Figure 4). 4). As the value of products increase increasess towards medium and

4.9. CBM9. Continued collection of disposa disposables bles

11

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 12

CBM8. End-of-life (EOL) equipment collection Facilitated collection, parts harvesting and certified recycling of medical equipment Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Hospital: Reduced costs of equipment disposal. WEEE recycling company: Revenues from selling functional parts and from recycling.

Solving the issue of dealing with WEEE and the possibility of  money back In cases which equipment has considerable amounts of  valuable parts, makes it an option for hospitals.

Key Activities

People

Channels

Key Resources and capabilities

Planet

Customer Segments

Environment: Suitable treatment of WEEE.

Healthcare organisations with old or worn-out equipment requiring facility space.

Hospital, Waste Electrical and Electronic Equipment (WEEE) recycling company.

De-installation and collection of equipment. Data destruction, parts harvesting, and recycling of non-valuable parts.

The capability of dismantling and finding valuable parts makes recycling company competitive. Certification of destruction and compliance to WEEE recycling good practices are critical.

Society: Job creation in recycling companies.

Material is collected by WEEE recycling company on demand.

Cases Advanced Technology Recycling: Certified recycling of medical equipment

high value, more significant the odds of a viable circular solution that does not rely only on recycling. An interesting phenomen phenomenon on to be looked

reprocessing by the provider. Meanwhile, the FDA has approved the first fully disposable duodenoscope in the United States as they iden-

at by push this spectrum is the increasing use ofvalue, single-use SUDs devices towards lower product whichdevices hinders(SUDs). the appeal for reprocessing, in particular, if higher levels of decontamination are required. Critical devices are not frequently recycled because sterilisation is necessary, increasing the price and risks to fulfil the process. In fact, no case specialised in recycling such devices was identified. Designing for longer may make reprocessing more appealing. The challenge challe nge is to design busine business ss model modelss where OEMs, reproces reprocessors sors and hospitals benefit from multiple-use devices. Following verified cases, in-housee reprocessin in-hous reprocessingg tends towards lower value devices, whereas third-party reprocessing towards higher-value ones. Logistics and outsourced reprocessing costs are balanced by the value retained in devices and risks absorbed by the provider. To mitigate risks and balance costs, propos posee limited limited cycles of hospit hospital al reBangg and colleague Ban colleaguess (2019) 2019) pro processing proce ssing of duoden duodenoscop oscopee (~60-80 (~60-80 proce procedures dures)) follo followed wed by full

tified more than 5% reprocessed duodenoscopes infected by high concern organisms forofreasons including damaged devices and errors in 2019;;  Rabin, 2019). 2019). Redesigning products and dereprocessing (FDA, (FDA, 2019 veloping compliant services is critical to developing CBMs that can cope with the criticality risks inherent to healthcare. Conside Con sidering ring the Technic Technical al Cycles Cycles relati relations onship hips, s, TC1 TC1.. Rep Repair air and Maintenance and TC4. Recycling are the less connected. However, as an example, exampl e, it is expec expected ted that Equipment-as-a-ser Equipment-as-a-service vice solutio solutions ns recycl recyclee equipment and components when they cease functioning. It may not be mentioned in considered references because recovering the material is little relevant to the value proposition, mostly connected to the use of  equipment. TC2. Reuse and redistribution and TC3. Refurbishment and remanufacturing are well connected because refurbished products are commonly sold in platforms. The connection between TC4. Recycling and TC3. Refurbishment Refurbishment and remanufacturi remanufacturing ng may be explained explained because

Table 13

CBM9. Continued collection of disposables Take-back schemes for disposable devices Value Creation

Value Capture

Value Delivery

Key stakeholders

Profit

Customer Relationship

Hospital: Reduced costs to waste disposal OEM / service provider: Increased brand value due to the sustainable initiative.

Reports of economic and environmental benefits of  collecting initiatives in the hospital.

People

Channels

Society: Job creation in recycling companies.

A local recycling company continuously collects material.

Planet

Customer Segments

Environment: Reduced generation of  medical waste.

Healthcare organisations willing to adapt their internal process regarding disposables and cut waste management costs.

Original Equipment Manufacturer (OEM), service provider, Hospital, recycling promotion organisations, a local recycling company. Key Activities

In-house sorting of disposable devices using individual containers, collection, recycling. Key Resources and capabilities

Hospital employees ability for sorting is critical. Partnership capabilities among providers, hospitals, and local recycling companies are critical. Cases

PVC (Polyvinyl chloride) Recycling in Hospitals (an initiative of the Vinyl Council Australia supported by Baxter): Take-back scheme for PVC single-use medical devices; BD ecoFinity Life Cycle Solution (BD and WM Healthcare Solutions): Facilitated collection and recycling of sharps.

12

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

Table 14

Occurrence of variables in cases and literature. Element of analysis

Coding Schema

Cases Total

Literature

Code

Description

Technical Cycles (TC)

TC1 TC2 TC3 TC4

Repair and Maintenance Reuse and redist. Refurbishment and Remanufacturing Recycling

27 19 21 15

46% 32% 36% 25%

41 5 41 10

61% 7% 61% 15%

Value (V)

VH

High

37

63%

40

60%

V VM L

M Lo Loewdium

398

6 14 5% %

1 28 5

2 37 7% %

Criticality (C)

C SC NC

Critical Semi-Critical Non-Critical

23 22 39

39% 37% 66%

25 28 43

37% 42% 64%

Circular Business Model (CBM)

CBM1 CBM2 CBM3 CBM4 CBM5 CBM6 CBM7 CBM8 CBM9

Full-care equipment as a service In-hospital lifecycle care services Support for hospital-based reprocessing Mobile solutions Platform for devices circulation Refurbished system Full-provision of reprocessed devices End-of-life (EOL) equipment collection Continued collection of disposables

7 6 9 5 9 5 9 3 6 % in 59 cases

%

12% 10% 15% 8% 15% 8% 15% 5% 10%

Total

10 13 19 1 5 21 24 6 8 % in 67 refs.

%

15% 19% 28% 1% 7% 31% 36% 9% 12%

positive impacts by aligning the equipment results to people's health. 'pay-perscan' business model for medical is envisioned byALaubscher ), where product management and data manageand Marinelly (2014 (2014), ment would be entirely provided in the offer. Focusing on health outcomes may deliver better care while decreasing the use of resources (Shah, 2016 2016). ). Such a system could connect the use of medical devices to improved patients' health in the contract, potentializing societal benefits while decreasing the use of resources and waste generation.

recycling is an essentialequipment, feature of refurbishing. Seeking connects for functional parts before recycling i.e. parts harvesting, TC4. Recycling Recycli ng to TC2. Reuse and redis redistribut tribution. ion. Provid Providing ing repr reprocesse ocessed d devices as a servic service, e, which includes includes full manageme management nt of product products, s, connects TC3. Refurbishment and remanufacturing to TC1. Repair and Maintenance. Although Altho ugh no case mentioned the servit servitisatio isation n of refurbishe refurbished d devices, devices, equipment-as-a equipme nt-as-a-servi -service ce settin settings gs could increase the profitabilit profitabilityy of re). manufacturing manufac turing,, according according to Widera and Seling Selinger er (2015 ( 2015). The con concep ceptt of val value-b ue-base ased d hea health lthcar caree cou could ld pot potent ential ialize ize the

Figure 4.  Network analysis of cases. On the upper side (4a), the graph represents all four dimensions of analysis. On the lower side (4b), the Technical Cycles

relationships are detailed.

13

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

6. Conclu Conclusion sion

Acknowledgements

In this work, nine CBMs were categorised following the design fra2017), ), which remework for circular medical product mework productss (Kane et al., 2017 presents the state of the art of circular product design in the industry. The systematic identification and analysis of cases and research articles about the use of circular strategies within the boundaries of the industry ground the types of business models. Triangulation of variables used to define the Circular Business Models through network mapping enables connecting the types of circular solutions and identifying paths for future research. The classification proposed is adequate to create a benchmark for BM innovation and enable fruitful discussions to enhance sustainability in the medical device industry. An adaptation of the BM canvas facilitates communication, dissemination and discussion. OEM and service pro provide viders rs can use it to partne partnerr up and des design ign circul circular ar inno innovat vation ion combining combini ng products products and services services alterations alterations that enable the techni technical cal cycles. Companies that still not enable circular flows through their business models can identify opportunities according to the value and criticality critic ality analysis of the medical products they provi provide. de. The busine business ss model description, related information, and specific cases are useful as benchmarks to design the business model structures that maintain a given resource cycle. The CMBs are also appliable to other industries as benchmarks since the criticality criticality aspec aspectt is decisive decisive to enable additional lifecycles lifecycles and lifetimes when high levels of hygiene are needed. Packaging, waste management, and durables suitable for sharing are some of the industries that can turn attention to the medical industry. Within high-

The aut author horss wou would ld like to sinc sincere erely ly tha thank nk the Higher Edu Educat cation ion Personnel Improvement Coordination (CAPES), from Brazil, for financially supporting this research under the process 88881.187598/2018-01.

Adv. Manuf. Technol. 2575–2584. 2575–2584.  https://doi.org/10.1007/s00170-016-8346-5   https://doi.org/10.1007/s00170-016-8346-5. . Advanced Technology Recycling, n.d.Medical Equipment Disposal [WWW Document]. https://www.atrecycle.com/med le.com/medical-equipmen ical-equipment-disposal/ t-disposal/ (accessed  (accessed 5.31.19). URL URLhttps://www.atrecyc Antikainen, M., Valkokari, K., 2016. A Framework for Sustainable Circular Business Model Innovation. Technol. Innov. Manag. Rev. 6, 5–12.   https://doi.org/10.22215/ timreview/1000.. timreview/1000 Association of Medical Device Reprocessors, 2011. The business case for reprocessing. Baden-fuller, C., Morgan, M.S., 2010. Business Models as Models. Long Range Plann 43, 156–171.   https://doi.org/10.1016/j.lrp.2010.02.005. 156–171. https://doi.org/10.1016/j.lrp.2010.02.005. Bang, J.Y., Sutton, B., Hawes, R., Varadarajulu, S., 2019. Concept of disposable duodenoscope: at what cost ?1–3.  ?1–3.   https://doi.org/10.1136/gutjnl-2019-318227. https://doi.org/10.1136/gutjnl-2019-318227. Bocken, N.M.P., de Pauw, I., Bakker, C.A., van der Grinten, B., 2016. Product design and business model strategies for a circular economy. J. Ind. Prod. Eng. 33, 308–320. https://doi.org/10.1080/21681015.2016.1172124 . Bocken, N.M.P., Rana, P., Short, S.W., 2015. Value mapping for sustainable business thinking32, 67–81. Bocken, N.M.P., Schuit, C.S.C., Kraaijenhagen, C., 2018. Experimenting with a circular business model: Lessons from eight cases. Environ. Innov. Soc. Transitions 28, 79–95. https://doi.org/10.1016/j.eist.2018.02.001 . Borgatti, S.P., Everett, M.G., 1997. Network analysis of 2-mode data19, 243–269. Borgatti, S.P., Everett, M.G., Freeman, L.C., 2002. UCINET for Windows : Software for social network analysis.

value, non-critical devices, where hygiene not the primaryfor challenge, the medical industry can provide severalisgood practices servicebased contracts and remanufacturing. Some limitations can be pointed out. First, in-depth case studies may elucidate the business rationale within each CBM type further. Cases studies can seek synergies among pairs or groups of CBM types in the same healthcare system. Second, the potential impacts of the business transition to a circular economy differ from CBM to CBM and even from case to case. There is room for a systematic analysis of the potential impacts of implementing them. In that direction, sustainability-rela sustainability-related ted case studies in the medical device industry must investigate and provide the financial and environmental impacts of CBMs in comparison to business as usual. The total cost of ownership, LCA Eco-indicator points, carbon dioxide equivalent, kilograms of plastics diverted from waste streams are metrics to be used. Third, there is a potential discussion on the application of circular strategies in low and medium HDI countries (Diaconu ( Diaconu et al., 2017 2017;;

Butzer, S., Remanufacturing Schötz, S., 2016. Remanufacturing Processes Landscape. Centre for Remanufact uring and Reuse, 2008. Remanufacture of medical imaging devices. Christer, A.H., Scarf, P.A., 1994. A Robust Replacement Model with Applications to Medical Equipment. J. Oper. Res. Soc. 45, 261–275. 261–275. COCIR, 2016. Medical Imaging Equipment: Age Profile & Density. COCIR, 2013. Good maintenance services practical guide: optimising the equipment life cycle. Cohealo, 2019. Taking Aim At A Multi-Million Dollar Blind Spot: How Underutilized Medical Equipment is Shrinking Hospital Margins. Diaconu, K., Chen, Y., Cummins, C., Moyao, G.J., Manaseki-holland, S., Lilford, R., 2017. Methods for medical device and equipment procurement and prioritization within low- and middle-income countries : findings of a systematic literature review 1–16. https://doi.org/10.1186/s12992-017-0280-2 . DOTmed, n.d.DOTmed [WWW Document]. URLhttps://www.dotmed.com/ URLhttps://www.dotmed.com/ (accessed  (accessed 5. 31.19). Eckelman, M., Mosher, M., Gonzalez, A., Sherman, J., 2012. Comparative life cycle assessment of disposable and reusable laryngeal mask airways. Anesth. Analg. 114, https://doi.org/10.1213/ANE.0b013e31824f6959.. 1067–1072.   https://doi.org/10.1213/ANE.0b013e31824f6959 1067–1072. Ellen MacArthur Foundation, 2012. Towards the Circular Economy: Economics and business rationale for an accelerated transition. Elo, S., Kyngäs, H., 2008. The qualitative content analysis process. J. Adv. Nurs. 62, 107–115.   https://doi.org/10.1111/j.1365-2648.2007.04569.x. 107–115. https://doi.org/10.1111/j.1365-2648.2007.04569.x.

Eze al., 2018; ;  Perry and Malkin, 2011 2011), ), whichinwas not considered in 2018 this et research. Most identified cases are available Europe, US, Canada, and Australia. Assessing the maturity of CBMs implementation in the medical industry of low and medium HDI countries is a remarkable opportunity to help these countries developing their healthcare services grounded on the sustainability path. Third, assessing the application of  CBMs in countries with socialised and privatised healthcare can provide benchmarking of the application of circular strategies in both types of  healthcare systems. Finally, the technical cycles scope adopted in this research disregard some possible avenues for sustainable healthcare. Bio-based solutions for single-use devices as biodegradable aprons and gloves can be an alternative to the recycling of low-value devices. Moreover, the application of tags, sensors and asset management platforms hold high poten tentia tiall to decrea decrease se produc products ts idlene idleness ss or enhanc enhancee repair repairing ing and remanufacturing services supported by the evolution of digitalisation and Industry 4.0. The research methodology applied in this work can be

EMSURL Mobile Healthcare, n.d.QUEST+ DECONTAMINATION [WWW Document]. URLhttps://www.ems-hea https://www.ems-healthcare.com/m lthcare.com/mobile-medic obile-medical-units/questpl al-units/questplususdecontamination/  (accessed 5.31.19). European Parliament and of the Council, 2007. Council Directive 93/42/EEC. Off. J. Eur. Union 1–60 https://doi.org/2004R0726 - v.7 of 05.06.2013. 05.06.2013. Eze, S., Ijomah, W., Wong, T.C., 2018. Accessing medical equipment in developing countries through remanufacturing. remanufacturing. Fargnoli, M., Costantino, F., Di Gravio, G., Tronci, M., 2018. Product service-systems implementation: A customized framework to enhance sustainability and customer j.jclepro.2018.. satisfaction. J. Clean. Prod. 188, 387–401. https://doi.org/10.1016/ https://doi.org/10.1016/j.jclepro.2018 03.315.. 03.315 FDA, 2019. The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication. FDA, 2015. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Floow2healthcare, n.d.What is Floow2? [WWW Document]. URLhttp://www. URL http://www. floow2healthcare.com/abou floow2healt hcare.com/about-us-hc.html t-us-hc.html (accessed  (accessed 5.31.19). Francis, S., 2007. Global Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices 6th edition 1–185. Gaiardelli, P., Resta, B., Martinez, V., Pinto, R., Albores, P., 2014. A classification model https://doi.org/10.1016 /10.1016/j. /j. for product-service offerings. J. Clean. Prod. 66, 507–519. https://doi.org  jclepro.2013.11.032  jclepro.2013 .11.032.. Geissdoerfer, M., Naomi, S., Monteiro, M., Carvalho, D., Evans, S., 2018a. Business models and supply chains for the circular economy 190. Geissdoerfer, M., Savaget, P., Bocken, N.M.P., Hultink, E.J., 2017. The Circular Economy – a new sustainability paradigm? J. Clean. Prod. 143, 757–768.  757–768.   https://doi.org https://doi.org/10. /10. 1016/j.jclepro.2016.12.048 . Geissdoerfer, M., Vladimirova, D., Evans, S., 2018b. Sustainable business model

References Achterberg, E., Hinfelaar, J., Bocken, N.M.P., 2016. Master Circular Business with the Value Hill. Circ. Econ. 18. 18. Adamo, I.D., Rosa, P., 2016. Remanufacturing in industry : advices from the field. Int. J.

useful to further identify and characterise CBMs in the medical device industr indu stryy if the scope for cir circula cularr sol soluti utions ons is exp expand anded. ed. It can be adapted to foster business model innovation in other industries as well.

14

 

 D. Guzzo, et al.

 Resources, Conservation & Recycling 160 (2020) 104904

363–376.   https://doi.org/10.1016/j.jclepro.2015.06.014. 363–376. https://doi.org/10.1016/j.jclepro.2015.06.014. Muñoz, P., Cohen, B., 2017. Mapping out the sharing economy: A configurational approach to sharing business modeling. Technol. Forecast. Soc. Change 125, 21–37. https://doi.org/10.1016/j.techfore.2017.03.035 . Osterwalder, A., Pigneur, Y., 2010. Business Model Generation, 1st ed. John Wiley & Sons, Inc., New Jersey. Jersey. Parker, D., Riley, K., Robinson, S., Symington, H., Tewson, J., Jansson, K., Ramkumar, S., Peck, D., Hollins, O., Vtt, K.J., Deegan, K., Hollins, O., 2015. Remanufacturing Market Study, European Remanufacturing Network. https://doi.org/EC–09 404 ERN WP2.2. docx. Perry, L., Malkin, R., 2011. Effectiveness of medical equipment donations to improve health systems : how much medical equipment is broken in the developing world ?719–722.  ?719–722.  https://doi.org/10.1007/s11517-011-0786-3 https://doi.org/10.1007/s11517-011-0786-3.. Philips, 2015. Flexible progression 4. Philips, 2013. Enjoy ‘ Peace of Mind ’ with Remote Services. Pieroni, M.P.P., McAloone, T.C., Pigosso, D.C.A., 2019. Business model innovation for circular economy and sustainability: A review of approaches. J. Clean. Prod. 215, 198–216.   https://doi.org/10.1016/j.jclepro.2019.01.036. 198–216. https://doi.org/10.1016/j.jclepro.2019.01.036. Planing, D.P., 2015. Business Model Innovation in a Circular Economy - Reasons for NonAcceptance of Circular Business Models. Plumeyer, M., Braun, M., 2011. Medical Electrical Equipment - Good Refurbishment Practice at Siemens AG Healthcare. In: 18th CIRP International Conference on Life Cycle Engineering, pp. 497–500.  497–500.   https://doi.org/10.1007/978-3-642-19692-8. https://doi.org/10.1007/978-3-642-19692-8. Popp, W., Rasslan, O., Unahalekhaka, A., Brenner, P., Fischnaller, E., Fathy, M., Goldman, C., Gillespie, E., 2010. What is the use? An international look at reuse of single-use medical devices. Int. J. Hyg. Environ. Health 213, 302–307.   https://doi.o https://doi.org/10. rg/10. 1016/j.ijheh.2010.04.003 . Promed, n.d.Promed Medical Parts & Equipment [WWW Document]. URLhttps://www. URL https://www. promed-online.com/  (accessed 5.31.19). Rabin, R.C., 2019. To Prevent Deadly Infections, F.D.A. Approves the First Disposable ‘Scope’ - The New York Times. Richardson, J., 2008. The business model: an integrative framework for strategy execution. Strateg. Chang. 17, 133–144. https://doi.org/10.1002 https://doi.org/10.1002/jsc.821 /jsc.821.. Rutala, W.A., Weber, D.J., 2013. Disinfection and sterilization : An overview. Am. J. https://doi.org/10.1016/j.ajic.2012.11.005.. Infect. Control 41, S2–S5.  S2–S5.  https://doi.org/10.1016/j.ajic.2012.11.005 Schrödel, R., 2015. Reprocessing Complex Medical Medical Devices – The Way of the Future 1–16. 32.. Shah, A., 2016. Value-based healthcare: A global assessment. Econ. Intell. Unit 32 SharedMed, 2019. Shared Medical Devices Solutions [WWW Document]. URLhttps:// URLhttps:// sharedmed.com/solutions/ (accessed 5.31.19). Sloan, T.W., 2007. Safety-cost trade-offs in medical device reuse: A Markov decision process model. Health Care Manag. Sci. 10, 81–93. 81–93.   https://doi.org/10.1007/s10729006-9007-2.. 006-9007-2 Srivatsav, N., Dervojeda, K., Legton, M., Koonstra, A., 2017. Refurbishment of medical equipment Report on promising KETs-based product nr . 4. Steinsdoerfer, T., 2013. Ecoline – A Convincing Approach for Customers. Companies and the Environmen Environmentt. STERIS, n.d.aService Contracts for Sterile Processing Equipment [WWW Document]. URL URLhttps://www.steris.co https://www.steris.com/healthcare/serv m/healthcare/service/securecare-servi ice/securecare-services/serviceces/servicecontracts/sterile-processing (accessed contracts/sterile-processing  (accessed 3.13.20a). https://www. STERIS, n.d.b Service Contracts for OR Integration [WWW Document]. URL URLhttps://www. steris.com/healthcare/service/secur steris.com/heal thcare/service/securecare-services/service ecare-services/service-contracts/or-contracts/or-integration integration (accessed 3.13.20b). Tranfield, D., Denyer, D., Smart, P., 2003. Towards a Methodology for Developing Evidence-Informed Management Knowledge by Means of Systematic Review14, 207–222. United States International Trade Commission, 2012. Medical Devices: Description of  Medical Device Remanufacturing. In: Remanufactured Goods: An Overview of the U.S. and Global Industries, Markets, and Trade, pp. 1–17. 1–17. Verdict Management, 2010. Reduce, Reuse, Recycle: Reprocessing Medical Devices [WWW Document]. URLhttps://www.hospital URLhttps://www.hospitalmanagement management.net/features/ .net/features/ feature80981/  (accessed 5.31.19). Viani, C., Vaccari, M., Tudor, T., 2016. Recovering value from used medical instruments: A case study of laryngoscopes in England and Italy. Resour. Conserv. Recycl. 111, 1–9. https://doi.org/10.1016 https://doi.org/10.1016/j.resconrec.201 /j.resconrec.2016.03.025 6.03.025. Vinyl Council Australia, 2018. PVC Recycling Hospitals Newsletter March 2018. Vinyl Council Australia, Baxter Matta, Welvic, n.d.PVC recycling in hospitals [WWW Document]. URLhttp://recyclinginhospitals.com.au/ URLhttp://recyclinginhospitals.com.au/ (accessed 5.31.19). Widera, H., Seliger, G., 2015. Methodology for exploiting potentials of remanufacturing by reducing complexity for original equipment manufacturers64, 463–466.  https:// doi.org/10.1016/j.cirp.2015.04.111 . Wohlin, C., 2014. Guidelines for Snowballing in Systematic Literature Studies and a Replication in Software Engineering. World Health Organization, 2018. Health-care waste: Key facts [WWW Document]. URL https://www.who.int/news-room/fa https://www.who.in t/news-room/fact-sheets/detail ct-sheets/detail/health-care-wa /health-care-waste ste (accessed 5. 31.19). World Health Organization, 2011. Core Medical Equipment 2011, 5. World Health Organization, 2003. Medical device regulations: Global overview and guiding principles. Zott, C., Amit, R., Massa, L., 2011. The Business Model: Recent Developments and Future Research. J. Manage. 37, 1019–1042. 1019–1042.   https://doi.org/10.1177/0149206311406265 https://doi.org/10.1177/0149206311406265..

innovation: A review. J. Clean. Prod. 198, 401–416.   https://doi.o https://doi.org/10.1016 rg/10.1016/j. /j.  jclepro.2018.06.240..  jclepro.2018.06.240 Global Medical Imaging Industry, 2013. Good Refurbishment Practice. https://doi.org/ Zuletzt zugegriffen am 05.01.20 05.01.2014 14 unter http://www.cocir. http://www.cocir.org/site/filead org/site/fileadmin/6.1_ min/6.1_ Initiatives_Refurbishment/Good Initiatives_Refu rbishment/Good_Refurbishment_Pract _Refurbishment_Practice_V2.pdf. ice_V2.pdf. Greenhealth Practice, 2018. Engaged Leadership and the Value of Sustainable Health Care. Grosskopf, V., Jakel, C., 2008. Legal framework conditions for the reprocessing of medical devices. GMS Krankenhhyg. Interdiszip 3. 3. Guzzo, D., Trevisan, A.H., Echeveste, M., Costa, J.M.H., 2019. Circular Innovation Framework : Verifying Conceptual to Practical Decisions in Sustainability-Oriented Product-Service System Cases. Sustainability 11. 11. Hanlon, P., 2013. One More Time: Medical Device Recycling is Good Business [WWW Document]. URL https://www.rtma https://www.rtmagazine.com/ gazine.com/products-treatm products-treatment/monito ent/monitoringringtreatment/patient-monit treatment/pat ient-monitoring-product oring-products/one-more-ti s/one-more-time-medicalme-medical-device-recycl device-recycling/ ing/ (accessed 5.31.19). Hempel, F., 2016. Remanufacturing Medical Equipment – Opportunities and Challenges. Homrich, A.S., Galvão, G., Abadia, L.G., Carvalho, M.M., 2018. The circular economy umbrella: Trends and gaps on integrating pathways. J. Clean. Prod. 175, 525–543. https://doi.org/10.1016/j.jclepro.2017.11.064 . Horblyuk, R., Kaneta, K., Mcmillen, G.L., Mullins, C., Brien, T.M.O., 2012. out of control little-used clinical assets are draining healthcare budgets 68–72. Jameton, A., Pierce, J., 2001. Environment and health: 8. Sustainable health care and emerging ethical responsibilities 164, 365–369. 365–369. Jamshidi, A., Rahimi, S.A., Ait-Kadi, D., Bartolome, A.R., 2014. Medical devices inspection and maintenance: a literature review. IIE Annu. Conf. Expo 2014, 3895–3904. 3895–3904. Jang, Y., Lee, C., Yoon, O., Kim, H., 2006. Medical waste management in Korea. J. Environ. Manage. 80, 107–115.  107–115.   https://doi.org/10.1016/j.jenvman.2005.08.018 https://doi.org/10.1016/j.jenvman.2005.08.018.. Ji, R., McCord, K., 2011. BD ecoFinity Life Cycle Solution - Turning a waste stream into a resource stream : Landfill diversion and recycling of sharps waste. Johnson & Johnson, n.d.Reprocessing: Sustainability through reprocessing [WWW Document]. URL https://www.jnjmed https://www.jnjmedicaldevices.co icaldevices.com/en-US/servi m/en-US/service/reprocessing ce/reprocessing (accessed 5.31.19). Kane, G.M., Bakker, C.A., Balkenende, A.R., 2017. Towards design strategies for circular medical products. Resour. Conserv. Recycl. 0–1.  0–1.  https://doi.or https://doi.org/10.1016 g/10.1016/j. /j. resconrec.2017.07.030 . Kirchherr, J., Reike, D., Hekkert, M., 2017. Conceptualizing the circular economy: An https://doi.org// analysis of 114 definitions. Resour. Conserv. Recycl. 127, 221–232.  221–232.  https://doi.org 10.1016/j.resconrec.2017.09.005 . Krarup, M., Kiørboe, N., Sramkova, H., 2015. Moving towards a circular economy - Agito Medical. Lacy, P., Rutqvist, J., 2015. Waste to Wealth, 1st ed. Palgrave Macmillan, Basingstoke Basingstoke.. Lambert, S., 2005. Do We Need a “Real” Taxonomy of e-Business Models? Sch. Commer. Res. Pap. Ser 06–6, 1–11 https://doi.org/Doi 10.1897/04-469r.1. 10.1897/04-469r.1. Laubscher, M., Marinelli, T., 2014. Integration of Circular Economy in Business. Conf. Going Green - CARE Innov. 2014.   https://doi.org/10.13140/2.1.4864.4164 https://doi.org/10.13140/2.1.4864.4164.. Lee, B.K., Ellenbecker, M.J., Moure-Eraso, R., 2002. Analyses of the recycling potential of  medical plastic wastes. Waste Manag 22, 461–470.  461–470.   https://doi.org/10.1016/S0956053X(02)00006-5.. 053X(02)00006-5 Lewandowski, M., 2016. Designing the Business Models for Circular Economy — Towards https://doi.org/10.3390/su8010043.. the Conceptual Framework. Sustainability.   https://doi.org/10.3390/su8010043 Lieder, M., Rashid, A., 2016. Towards circular economy implementation: a comprehensive review in context of manufacturing industry. J. Clean. Prod. 115, 36–51. https:// 36–51. https:// doi.org/10.1016/j.jclepro.2015.12.042 . Lüdeke-Freund, F., Gold, S., Bocken, N.M.P., 2018. A Review and Typology of Circular Economy Business Model Patterns. J. Ind. Ecol. 00, 1–26.  1–26.  https://doi.org/10.1111/  jiec.12763..  jiec.12763 Massa, L., Tucci, C.L., 2017. A critical assessment of business model research. Acad. Manag. Ann. 11, 73–104. 73–104. McDonnell, G., Burke, P., 2011. Disinfection: Is it time to reconsider Spaulding? J. Hosp. https://doi.org/10.1016/j.jhin.2011.05.002.. Infect. 78, 163–170.  163–170.   https://doi.org/10.1016/j.jhin.2011.05.002 Medigo, n.d.Medigo - HYRA HJÄRTSTARTARE [WWW Document]. URL URLhttps://www.hlrhttps://www.hlrkonsulten.se/hyra-hjartstartare (accessed 5.31.19). MEDIVATORS, n.d.Endoscope Reprocessing [WWW Document]. URLhttp://www. URLhttp://www. medivators.com/products-an medivators.co m/products-and-services/endo d-services/endoscope-reprocessing scope-reprocessing (accessed  (accessed 5.31.19). Medtronic, 2015. Solutions for excellence in cardiac services. MHRA, 2018. Single-use medical devices : implications and consequences of reuse. MHRA, 2016. Single-use medical devices : UK guidance on re-manufacturing. Minoglou, M., Gerassimidou, S., Komilis, D., 2017. Healthcare Waste Generation Worldwide and Its Dependence on Socio-Economic and Environmental Factors. https://doi.org/10.3390/su9020220 . Moher, D., Liberati, A., Tetzlaff, J., Altman, D.G., 2009. Academia and Clinic Annals of  Internal Medicine Preferred Reporting Items for Systematic Reviews and MetaAnalyses : Ann. Intern. Med. 151, 264–270.  264–270.  https://doi.org/10.7326/0003-4819151-4-200908180-00135.. 151-4-200908180-00135 Moreno, M., de los Rios, C., Rowe, Z., Charnley, F., 2016. A Conceptual Framework for Circular Design. Sustainability. Sustainability.   https://doi.org/10.3390/su8090937 https://doi.org/10.3390/su8090937.. Morgan Stanley, 2017. Combining the Circular Economy and Affordable Healthcare. Moultrie, J., Sutcliffe, L., Maier, A., 2015. Exploratory study of the state of environmentally conscious design in the medical device industry. J. Clean. Prod. 108,

15