Best Practices in Medical Affairs for Medical Devices

Medical Affairs Best Practices

Best Practices in Medical Affairs for Medical Devices

I recently had the privilege of attending the NextLevel Medical Affairs Leaders Forum in London, and chairing the special session for medical device professionals. Overall, the conference was fantastic and a great opportunity for collaboration of like-minds. In particular, the medical device session was ripe with new perceptions on how best to navigate our changing regulatory environment. While many good points were made, I’ve highlighted the top five key takeaways for medical affairs professionals:

 

1. The differences in medical devices and pharmaceuticals directly impacts the role of medical affairs
We enjoyed considerable discussion on the comparison of the role and activities of medical affairs in the pharma industry compared to that of the medical device industry. Based on our discussion, I’ve highlighted some of the inherent differences between medicines and devices, such as:

  • In Europe, data for approval (CE mark) of devices can be based upon literature or data on similar devices. For medicines, the data must come from the product itself.
  • Devices evolve and change over time; medicines do not (although indication can change).
  • Devices and medicines are regulated differently in terms of acceptable promotional activities.
  • Real-world evidence may be crucial for devices as it may be the only data. This generally needs to be prospective. It was recognised that retrospective databases may be of limited use, because in many the device or procedure may not be coded.

2. Size matters in resourcing
There is a huge difference in medical affairs resourcing between the pharmaceutical and medical device industry reflecting differing revenues of the two. Medical device companies tend to be smaller and, as a result, the medical affairs roles are more diverse. Frequently, these roles span clinical development as well as medical affairs and support sales and marketing.

3. Off-label isn’t off the table
Sixty-percent of medical device use is “off-label”. That’s a much higher percentage than is seen in pharmaceuticals.

4. Publish or perish
Peer-reviewed publications have been shown to have the largest influence on physicians at 80%, compared to 15-30% for conferences, manufacturer representatives, colleagues and the internet.

5. Don’t get comfortable
Our team shared several best practices for medical affairs management for medical devices in our presentation.  Perhaps most noteworthy is the need to constantly prepare for the changes that will impact the industry in significant ways.  These changes include:

  • Medical device/IVD regulation is changing; key decisions are expected in 2016.
  • The updated regulation will likely include an increased demand for post-marketing studies to demonstrate safety and performance.
  • An increased awareness for “evidence of value” and comparative effectiveness in medical devices is expected.
  • Demand for economic evidence for medical devices is growing.  Process simplification and efficiency will be key components.
  • Time and Motion studies will be increasingly applied in healthcare to quantify real-world efficiency.
  • Evidence on time and cost are expected to be determinant in the launch and commercialization of medical devices.

As our regulatory environment continues to evolve, it’s important to align with partners who know how to adapt their approach to medical affairs in a way that equals success for the manufacturer and their patients. We’re helping our clients navigate the regulatory landscape and demonstrate value in Europe with our global Real-World Evidence solutions in both the pharmaceutical and the medical device arenas.