Six Q & A’s about Innovation in the Medical Device Industry

The PDA Letter asked the program committee for the upcoming PDA EU Medical Devices and Connected Health Conference six questions about innovation in the medical device industry, the focus of the upcoming meeting. Below are their responses.

1. PDA Letter: What are the major innovations and trends in drug delivery and the medical device industry?

In my view, there’s two major developments ongoing in the industry that eventually may not, but are likely, to converge. First, the digitalization of drug delivery devices and medical devices is rapidly increasing—maybe even faster in the Med/Dev industry than in Pharma. This will provide the source of an enormous amount of (anonymized?) data with respect to many different treatments and therapies. Second, data mining, pattern discovery, predictive models and, in the end, “Artificial Intelligence” (AI) will take care of these data sources and provide new insights from patient behavior to new therapies and eventually drug discovery. It may sound futuristic now, but possibly we will see these emerging technologies in about ten years. However, there’s already glimpses here and there that provide us with this picture.

2. PDA Letter: What are the major impacts of the COVID-19 pandemic?

The COVID-19 pandemic is accelerating and driving a lot of digitization efforts that seemed to have been stuck prior to the pandemic. One example (especially in Germany) was/is the current possibility to have remote consultation by your local doctor or hospital. From regulatory perspective also the possibility of remote audits has been tested and executed. It remains to be seen what persists of these trials. In the end it will change our way of thinking towards a lot of processes, from virtual office to new ways in healthcare systems.

3. PDA Letter: Tell us about the background to the 2020 inaugural PDA Europe Virtual Conference – Medical Devices and Connected Health?

There are many “healthcare digitization” conferences out there that provide good insights into current trends and technologies. What we feel was missing somehow, is the practical side from development to market launch of a “digital healthcare product.” Because from the technical point of view, a lot is already possible and thinkable, the challenge is to build a suitable business case around the device to be able to generate a successful market launch, including such topics as data integrity, data ownership and data security. With this in mind, we attempted to gather people that will be able to speak about and cover the entire journey of a connected drug device from idea to application.

4. PDA Letter: Can you elaborate on the Conference theme “Digital Products Development & Commercialization”?

What we attempt to bring into this conference as a main benefit to the attendee is to provide the full picture from the idea to the market, backed with real-life case studies. During this challenging journey, companies must tackle a lot of different topics that might not be in their main working field, such as international data and privacy laws, data ownership, insurance reimbursement, cyber-security and data integrity. This conference and their speakers try to address the main hurdles and make the attendee aware of what she/he must think about, already at early stages in the development lifecycle.

5. PDA Letter: Can you describe the central Medical Device Regulation (MDR) challenges the industry is facing?

MDR was and is a major impact for both involved parties in the system, regulatory bodies and industry partners. There is only one way out: Cooperation. Since there are some loose ends that still need to be addressed (e.g. EudaMed database), there is uncertainty on both sides. Another effort will involve the transition of product portfolios, of which some may be senior established products in the market, und the scope of new assessments reflecting the state-of-the-art. Also, the new MDCG guidances on cybersecurity will have an impact on current and upcoming developments in the active medical device field.

6. PDA Letter: What is your understanding of a patient-centric drug delivery system?

A patient-centric drug delivery system in my opinion provides not only a drug device, but an ecosystem comprising drug device as well as patient and healthcare professional services (e.g. apps, data analysis, therapy recommendations, and guidance). It will be a major challenge for the triangle of players in healthcare (insurance companies, legal manufacturers, patients) to not lose focus on the patient benefit and still provide an increase in quality of life, e.g., for long-term recurring treatments.