Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.

SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.

Some of the highlights of this episode include:

• EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.
• Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new products getting to market.
• Pre- and post-market data is to get medical devices to market and continue to be adopted, reliable, effective, and not discontinued due to new products.
• Another type of data that SMART-TRIAL can capture is related to payors. Does your product show an economic benefit to get reimbursed? 
• It’s difficult to get feedback from those in the field, during tests, and clinical trials. If something’s not working, expect more feedback. If it’s working, you get less.
• EU MDR has had two significant impacts: the number of notified bodies is still not where it needs to be and it has created rationalization of product SKUs.
• Decentralization or remote patient care can change data results in clinical trials by using medical devices and technology to work more efficiently. For example, what’s the difference between medical device vs. health/lifestyle product data?
• Rules are slightly different when developing algorithms and software for medical devices. They’re not written that differently and updated standards are not typically complete overhauls.

Memorable quotes from Adam Steadman:

“The device industry in terms of automating from a clinical trial perspective has been a little bit slower than the pharma side of things. One of the reasons is we have much smaller sample sizes.”

“Technology has gotten to the point now where we can do it efficiently and inexpensively at the same time.”

“What’s really happening in Europe now is that you’re being forced to prove to the world that your device continues to be effective against its peers and against other products that are coming out on the market as new products.” 

“There’s a good reason for regulation. There’s a good reason why we changed the regulations in Europe. We’ve got to have these standards for everyone’s benefit.”

“When you’re developing algorithms, when you’re developing software for medical devices, the rules are slightly different and they’re not written that differently.”

Links:

SMART-TRIAL

Adam Steadman on LinkedIn

ISO 14155:2020

ISO 20916:2019

European Union Medical Device Regulation (EU MDR)

FDA - Medical Device Overview

FDA - 510(k) Process

FDA - Premarket Approval (PMA)

Quality is Free by Philip B. Crosby

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

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