I recently attended the American Medical Device Summit hosted by Generis, which was targeted towards senior managers in the main areas of engineering, manufacturing, quality management and regulatory affairs – so the conference covered broad topics ranging from R&D to quality management and compliance to risk management and M&A. I first wondered if this topic selection wouldn’t be too broad. But there was one element that tied everything together: the patient.
Best run medical devices companies probably always have thought of the patient first. But now as in many countries, reimbursements are being paid based on patient outcomes, patient satisfaction becomes even more important. A patient centric approach was vividly illustrated within the innovation process by one of the speakers. What many consumer products companies do with their consumers, best-run medical devices companies apply as well: they go out to those patients who are willing to share real-life experiences and observe how products are being used in reality. This way they can see what patients may not even recognize to be worthwhile to tell – a huge potential for new innovative ideas to improve existing products or to optimize design of new prototypes.
From many presentations, one message came out clearly: Patient-centricity is also key when it comes to product quality and compliance. How would you define quality criteria if not from a patient perspective on safety and efficacy? And what happens to quality if this is not perfectly understood on all levels within the medical device manufacturer and its suppliers? To make sure top quality is achieved, all employees need to execute on quality. Similarly to visiting patient to explore their real needs, quality managers need to get a deep understanding of the environment employees are working in before defining measures to ensure process and product quality. This implies walking directly to them, asking them, and collaborating with them. Top quality also means applying the same quality standards across the enterprise. I can only stress this, since I have heard from many of our life sciences customers that the FDA wants to see what the company does as a whole, not fractures of various locations. This is why medical device companies should stick to one process, implement one single source of truth, and take advantage from automated workflows, e.g. for approval of documents, assigning responsibilities, or guided escalation processes.
Talking about escalations, in order to prevent them, medical devices manufacturers need a solid risk management system – which is a science in itself. You can always strive to minimize risk, you can benchmark within and across industries, but you will always be left with a residual risk. Risk with the highest priority rating concern patient safety, immediately followed by risk affecting product efficacy. What is the best advice to avoid quality risk of medical devices? Strive for highest quality and don’t hesitate to apply most sophisticated risk models if needed. If you try this and miss some points, you will most probably still arrive in an acceptable range. If you just aim for the average, you may run the risk of falling below acceptable quality.
And how does M&A fit into the concept of patient-centricity? When running post-merger integration, one key advise stated at the event should be kept in mind: don’t lose focus on the value that is pursued through the investment – which in the end should be to serve the patient better.
Summing up the three best practices I took from the summit are: put the patient in the center of all actions, patient safety and product efficacy come first, and strive for best-in class quality rather than for the average level.