Traversing the Medtech Regulatory Landscape in the Interest of Patients

Podcast, Videos


Dr. Bassil Akra, CEO of AKRA TEAM GmbH, sat down with me for a deep dive into the new approval process for medical devices in the EU. Among many other things, he shared his insights into how Medical Device and In Vitro Diagnostic companies can get safe, qualitative, and well-performing products onto the EU market with minimal delays.

Here is a sneak peek of our conversation:

Q: I’m curious if these new regulations relating to medical devices are also correlated with the private and public payer reimbursement system in terms of market access, and who and how these products are eventually paid for, and everything around outcomes based agreements, etc. Tell us a little bit about how AKRA TEAM or this whole regulations piece comes into play for the eventual payment or reimbursement of these kinds of products.

A: The new regulation doesn’t care actually about reimbursement. The new regulation tells you whether you are allowed to place a device on the market or not. There are additional obligations and requirements in various European countries with regard to reimbursement. Passing the burden of being certified to access a market doesn’t guarantee that you’re going to get paid for the product that you’re going to be placing on the market. The problem is, and this plays an important role, in the end, the patient is going to decide, the healthcare system is going to decide.

Even if you get all of these efforts and you could achieve re-certification of your product on the market, it doesn’t mean that you can increase your price unbelievably high because it’s not doable. In the end, they will tell you this is the reimbursement fee that you will get for your product.

This is why, when we look at your strategy and every organization which we are supporting, we look at two parts. One part is, “Is it doable to achieve compliance?” and the other part is, “Does it make sense business-wise to really get that product approved in Europe considering the business case connected to it?”. Reimbursement is going to play an important role here and in the end, even if you invest in a product, you need to think as an organization, “Can I get my investment paid back or it’s not doable considering the pricing and the way how reimbursement is happening?”

For more of our discussion, you can watch the whole Fireside Chat with Dr. Bassil Akra, or listen to the podcast version, below.

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About Impetus Digital

Impetus Digital is the spark behind sustained healthcare stakeholder communication, collaboration, education, and insight synthesis. Our best-in-class technology and professional services ensure that life science organizations around the world can easily and cost-effectively grow and prosper—from brand or idea discovery to development, commercialization, execution, and beyond—in collaboration with colleagues, customers, healthcare providers, payers, and patients.