Distinctive PLM methods, processes, and infrastructure exist for pharmaceuticals and medical devices. The processes differ because of considerations such as incremental product improvements and successively added features, which are quite common in medical devices as opposed to pharmaceuticals (Figure 1). The applicable regulatory and legal requirements, as well as standards in both sectors, must be adequately considered in the design of clinical data generation plans, pre- and post-market phase.

With its dialysis, apheresis, and multiple organ support systems, Fresenius Medical Care manufactures a catalog of more than 733 complex, PLM-intensive medical device products. Sixty percent of those products belong to the second highest risk class pursuant to EU medical device provisions and classifications. Around the globe, regulatory authorities recognize distinct classes of medical devices based on their potential for harm to patients and users, their design complexity, and other product-specific characteristics. In the European Union, these risk classes are defined in Annex VIII of the EU Medical Device Regulation (MDR) (Figure 2). Each product or product group requires ongoing PLM activities. All in all, the PLM-derived workload for the benefit of Conformité Européenne-marked (CE-marked) products is substantial under the Medical Device Directive, which will be superseded by the MDR in May 2021.

The paradigm shifts toward value-based care changes from a price-focused to a value-focused model. This impacts product  businesses in the medical technology sector as associated treatments are being considered a major cost-driving force. The medical device industry is under intense scrutiny with increasing regulation: payors and purchasers rigorously demand the demonstration of a positive cost/benefit ratio of products and associated treatments. The economic impacts are more prominent decision drivers in healthcare today than in the past. Cost effectiveness analyses are broadly applied tools in health economics and are included in procurement plans of healthcare service providers.

Physicians and other stakeholders in the healthcare sector are increasingly demanding more clinical data—well beyond that provided by randomized controlled trials (RCTs)—that is independent from the regulatory and economic context. Evidencebased data would measurably demonstrate patient benefit for a product at all stages of its lifecycle. According to a poll conducted by Bain and Company in 2015, physicians in the United States and Europe considered real-world evidence and patient outcome reports, in conjunction with solid safety data, as top criteria for product prescription (Figure 3).²

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

Throughout the region, the EMEA Medical Office is charged with demonstrating the value, performance, and safety of products manufactured by Fresenius Medical Care. As a component of the Global Medical Office, the regional Medical Office in EMEA comprises three specific departments, each contributing specific skill sets and unique qualifications to medical PLM. As of Q1 2020, most PLM-associated activities focus on maintaining marketing authorizations of existing products, with the EMEA Medical Office regularly involved in projects in the development phase (Figure 4).

An effective and efficient PLM brings together people, processes, and technology, and is a huge collaborative cross-functional effort. Demand for state-of-the-art PLM is significantly higher than in the past decades for many reasons. Of outstanding importance is the fact that development of healthcare devices is more holistic and system centric. The sustainability-focused future will change the face of industry and manufacturing. While it has always been important, up-to-date PLM is indispensable in the era of digitalization and artificial intelligence. Additionally, companies are expected to prove the therapeutic value of products beyond mere 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 and maintenance. To ensure success, a high degree of interprofessional and cross-functional collaboration is required. With profound technical and risk management skill, regulatory expertise, and medical competence, PLM is critical in fostering innovation, enhancing overall product quality, reducing cost, optimizing healthcare professionals’ experience with devices, and delivering better products that improve patient lives.

References

1. Santos I, Rocha L, Gazelle G, Tavares J. Medical device specificities: opportunities for a dedicated product development methodology. Expert Review of Medical Devices 9(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/.