Trial Design For Medical Devices: Regulatory Challenges, Opportunities

February 3, 2021 | Teri Takle-Flach believes that a clinical protocol is the roadmap to conducting a successful study. Takle-Flach came to clinical project management with a background in math, chemistry, and statistics. For more than 25 years, she’s worked to develop statistically sound clinical development plans for Medtronic and now Boston Scientific around medical devices.

Sucessful trials depend on a firm grasp of the clinical questions we’d like to answer, but also an understanding of the questions that can actually be answered with available data. Start by asking: “What is the unmet need that you're trying to solve? How does your device fit into that therapy paradigm?” she advises. Only then can you understand how to collect data that reflects actual benefit to the patient.

“Whether your device is a new concept or already commercialized, any new study needs to weigh the risks to patient participants against the potential benefits the study may yield,” Takle-Flach says.

On behalf of Clinical Research News, Bridget Kotelly spoke with Takle-Flach about the biggest challenges planning clinical studies today and the impact EU Medical Device Regulation.

Editor’s note: Takle-Flach will be speaking at SCOPE, the Summit for Clinical Ops Executives on Tuesday, March 2 in the Medical Device Clinical Trial Design and Operations program.


In your experience in the medical device industry, what are you finding the biggest challenges in planning and executing clinical studies today?

Teri Takle-Flach: I think the key to planning trials that can be successful is to really understand what the question is that you're trying to answer. And then how do you set that question to data that you can collect? There are lots of questions out there that we think we want answered, but there's really no way to collect the appropriate data. The key to success is that you understand the therapy area that you're working in, you understand what the physician's needs are within that therapy area, especially if you're looking at new technology. What is the unmet need that you're trying to solve? How does your device fit into that therapy paradigm? And then you understand how to collect data so that will show clinical benefit.

I really feel strongly that any device needs to be safe. It needs to be effective at what it does, but there also needs to be clinical benefit. When we think about protocol development, I spend time thinking about the differences between statistical and clinical significance for an important end point. You can show a 1% improvement in whatever your end point is, but does that improvement really translate into something that is beneficial to the patient, that a physician thinks is worth moving from one therapy to another therapy, and that a payer is willing to pay for?


And what is Boston Scientific doing to overcome these challenges?

What I like about the process at Boston Scientific is that when new therapies are developed, the clinical team is involved early on in strategy development. We walk side by side with our regulatory partners helping to define what the regulatory pathway is. In the US, is it a product that requires the PMA process or the 510(K) process? Is human clinical data required or is it not? Are animal and bench data sufficient?

We spend a fair amount of time with our regulatory partners and with the regulatory bodies really partnering to define what our clinical trials will look like. And I think that really helps us. I think that discussion is really healthy in helping us to select end points that are measurable and that have meaning.

The other thing that we do on a regular basis is partner with key opinion leaders in the physician communities that we serve so that we develop good relationships with physicians that we plan to work with in our trial setting.

That really helps us understand the cadence of how we do studies efficiently at clinical sites. If we're collecting data, we collect data in the same way that a physician and/or nurse coordinator is collecting data; i.e. our case report forms mimic how a follow-up visit might happen in the clinic.  

When we arrive at end-point analysis, it's that continued discussion across both the business unit and with our key physician counterparts that makes sure we really understand the data that we have. I've been involved with trials in which we failed endpoints; I've obviously been involved with trials that we have successfully met our endpoints. In both of these cases, we need to learn from what the data tells us and go back to that key question: Are we really adding benefit to the patient with this technology?


When it comes to EU Medical Device Regulation, how has that changed the types of trials that you're thinking about doing going forward?

Currently I'm the Director of Clinical Operations in the Urology and Pelvic Health division at Boston Scientific. This division has a large portfolio of products, many of which have been approved and commercialized worldwide without the need for human clinical data. That gets products to the market faster, but with the new European Medical Device Regulations that are coming on board now, there is an absolute requirement for active surveillance of these same products. If we don't have human clinical data, we must collect it.

I think that's important because at the end of the day, the safety and performance of a device is defined in the body in which it is used.  So we have found ourselves in my division really thinking critically about how we collect data on a number of products in which human clinical data has never been collected before.

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