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EVIDENCE BASEDÌýINSIGHT

From Design to Deployment: Product Lifecycle Management Across Europe, Middle East, and Africa

September 21, 2020 Ä¢¹½´«Ã½¢ 4 min read

Product lifecycle management (PLM) for medical products is more complex than ever before. Major stakeholdersÄ¢¹½´«Ã½”including physicians, payors, purchasers, and regulatorsÄ¢¹½´«Ã½”require ongoing and detailed clinical data and evidence of a positive cost/benefit ratio. As a vertically integrated company, Ä¢¹½´«Ã½ is in an ideal position to not only meet these demands, but also create a PLM process that encourages cross functional collaboration and innovation throughout a productÄ¢¹½´«Ã½™s entire lifecycle.

Ä¢¹½´«Ã½ is a vertically integrated companyÌýproviding both products and services. It is a success story thatÌýstarted as a classic medical device manufacturer in 1912 butÌýhas grown to include a product portfolio that is diversified andÌýgoes well beyond the care of patients living with renal disease.ÌýExcellent products are one of the key factors to being able toÌýprovide the best possible treatment. They need to be managedÌýduring the entire lifecycle to ensure continued efficacy andÌýmaintain both regulatory approval and authorization to be soldÌýon the market.

Product lifecycle management (PLM) considers the full spectrumÌýof a productÄ¢¹½´«Ã½™s journey from ideation in the predevelopmentÌýphase through design, development, and engineering. PLM alsoÌýaccompanies pre-launch and manufacturing, playing an integralÌýrole during the growth and maturity phases when the productÌýis actively sold in the marketplace, as well as during the phaseoutÌýperiod as the company issues a product discontinuationÌýnotification. Phase-out periods of certain medical devices can beÌýextensive, lasting as long as 10 years. Active obsolescence planningÌýand management are components of the overriding productÌýportfolio and represent another key complex system componentÌý(Figure 1).¹ÌýObsolescence of a single but crucial component mayÌýjeopardize the entire system.

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FIGURE 1Ìý| Schematic product lifecycle for medical devices and drugs

Distinctive PLM methods, processes, and infrastructure exist forÌýpharmaceuticals and medical devices. The processes differ becauseÌýof considerations such as incremental product improvements andÌýsuccessively added features, which are quite common in medicalÌýdevices as opposed to pharmaceuticals (Figure 1). The applicableÌýregulatory and legal requirements, as well as standards in bothÌýsectors, must be adequately considered in the design of clinical dataÌýgeneration plans, pre- and post-market phase.

With its dialysis, apheresis, and multiple organ support systems,ÌýÄ¢¹½´«Ã½ manufactures a catalog of more than 733Ìýcomplex, PLM-intensive medical device products. Sixty percentÌýof those products belong to the second highest risk class pursuantÌýto EU medical device provisions and classifications. Around theÌýglobe, regulatory authorities recognize distinct classes of medicalÌýdevices based on their potential for harm to patients and users,Ìýtheir design complexity, and other product-specific characteristics.ÌýIn the European Union, these risk classes are defined in AnnexÌýVIII of the EU Medical Device Regulation (MDR) (Figure 2). EachÌýproduct or product group requires ongoing PLM activities. AllÌýin all, the PLM-derived workload for the benefit of ConformitéÌýEuropéenne-marked (CE-marked) products is substantial underÌýthe Medical Device Directive, which will be superseded by theÌýMDR in May 2021.

FIGURE 2Ìý| Product risk classes

The paradigm shifts toward value-based care changes from aÌýprice-focused to a value-focused model. This impacts productÌýÌýbusinesses in the medical technology sector as associatedÌýtreatments are being considered a major cost-driving force.ÌýThe medical device industry is under intense scrutiny withÌýincreasing regulation: payors and purchasers rigorously demandÌýthe demonstration of a positive cost/benefit ratio of productsÌýand associated treatments. The economic impacts are moreÌýprominent decision drivers in healthcare today than in the past.ÌýCost effectiveness analyses are broadly applied tools in healthÌýeconomics and are included in procurement plans of healthcareÌýservice providers.

Physicians and other stakeholders in the healthcare sectorÌýare increasingly demanding more clinical dataÄ¢¹½´«Ã½”well beyondÌýthat provided by randomized controlled trials (RCTs)Ä¢¹½´«Ã½”that isÌýindependent from the regulatory and economic context. EvidencebasedÌýdata would measurably demonstrate patient benefit for aÌýproduct at all stages of its lifecycle. According to a poll conductedÌýby Bain and Company in 2015, physicians in the United StatesÌýand Europe considered real-world evidence and patient outcomeÌýreports, in conjunction with solid safety data, as top criteria forÌýproduct prescription (Figure 3).²

FIGURE 3Ìý| Prescribing criteria for medicinal products according to non-surgical physicians in the United States and Europe

In the Europe, Middle East, and Africa (EMEA) region, as wellÌýas other parts of the world, a convergence of drugs and medicalÌýdevices in terms of regulatory requirements is ongoing. TheÌýadaptation happens almost exclusively for medical devices whereÌýa significant tightening of the regulatory catalogs continues. InÌýthe European Union region of EMEA, this culminated in theÌýinception of the MDR in May 2021.

Throughout the region, the EMEA Medical Office is charged withÌýdemonstrating the value, performance, and safety of productsÌýmanufactured by Ä¢¹½´«Ã½. As a component ofÌýthe Global Medical Office, the regional Medical Office in EMEAÌýcomprises three specific departments, each contributing specificÌýskill sets and unique qualifications to medical PLM. As of Q1 2020,Ìýmost PLM-associated activities focus on maintaining marketingÌýauthorizations of existing products, with the EMEA Medical OfficeÌýregularly involved in projects in the development phase (Figure 4).

FIGURE 4Ìý|ÌýEMEA Medical Office

An effective and efficient PLM brings together people, processes,Ìýand technology, and is a huge collaborative cross-functional effort.ÌýDemand for state-of-the-art PLM is significantly higher than inÌýthe past decades for many reasons. Of outstanding importance isÌýthe fact that development of healthcare devices is more holisticÌýand system centric. The sustainability-focused future will changeÌýthe face of industry and manufacturing. While it has alwaysÌýbeen important, up-to-date PLM is indispensable in the era ofÌýdigitalization and artificial intelligence. Additionally, companiesÌýare expected to prove the therapeutic value of products beyondÌýmere demonstration of safety and efficacy, and proactively provide data that underpins the quality and reliability of devices.

PLM is a continuous process for medical device development andÌýmaintenance. To ensure success, a high degree of interprofessionalÌýand cross-functional collaboration is required. With profoundÌýtechnical and risk management skill, regulatory expertise, andÌýmedical competence, PLM is critical in fostering innovation,Ìýenhancing overall product quality, reducing cost, optimizingÌýhealthcare professionalsÄ¢¹½´«Ã½™ experience with devices, and deliveringÌýbetter products that improve patient lives.

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References

1. Santos I, Rocha L, Gazelle G, Tavares J. Medical device specificities: opportunities for a dedicated product development methodology.ÌýExpert Review of Medical DevicesÌý9(3):299-311. https://www.researchgate.net/publication/227160554.
   
2. Reichheld F. Front Line of Healthcare Report 2015: the shifting US healthcare landscape. Bain & Company, June 5, 2015. https://www.bain.com/insights/frontline- of-healthcare-report-2015/.