Thought Leader Spotlight: Laurie Hook on Medical Device Research, Regulations, and More

Laurie Hook is a clinical and regulatory research consultant and a seasoned expert in electronic data capture implementation. She specializes in medical device clinical research in startup environments, and has worked closely with Medrio customers conducting innovative clinical trials in this space and elsewhere.

We recently got the chance to chat with Laurie about the big issues in her space today. Our conversation covered regulation and technology, trends and challenges, and how researchers can leverage eClinical technology to navigate today’s clinical research landscape.

Medrio: Thanks for speaking with us today, Laurie. Can you start by talking a bit about your background, your experience with Medrio, and the kinds of companies you work with?

Laurie Hook: No problem. I started my career in private veterinary practice after earning degrees in biology and veterinary medicine. From there I moved on to biomedical research at Stanford, and eventually transitioned back to industry, working primarily with startups conducting medical device clinical research, where I’ve been for 18 years now. As a consultant, I guide startup and early-stage medical device companies through all phases of clinical development and the complex U.S./international regulatory landscape. One of my additional roles with these companies that relates to the clinical side of their business is to build and validate their EDC databases, and help tailor their EDC to their needs in feasibility, pivotal, and post-marketing studies. I’ve used Medrio EDC a lot in my work – the flexibility of the system is really well-suited for transitioning from a feasibility study, say, to a pivotal study, both for me and my clients.

Medrio: Based on what you’ve seen working with medical device organizations, what are some interesting trends or activities currently taking place in that space?

Laurie Hook: There are plenty of fascinating things happening in med-dev today, though I think one of the most exciting is the advancements we’re seeing in the technology behind the devices. It really amounts to an expansion of the very definition of a medical device. Traditionally, medical devices were almost all hardware-based – implants, braces, and the like – but we’re now seeing an incorporation of software along with the hardware. We’re increasingly seeing complex treatment-based algorithms. Some of these technologies will even move across multiple platforms – they’ll be on a monitor in a hospital during ICU surgery, and then a tablet in a clinic, or even on an iPhone in an outpatient setting. It has potential to really expand what the industry can achieve, both in terms of treatment and from a patient engagement perspective. It’s very exciting stuff.

Medrio: Different industries in clinical research deal with different regulatory landscapes. How do these differences affect the way your clients approach things like trial design and clinical trial technology?

Laurie Hook: In the device field, you typically deal with three regulatory pathways: Premarket Approval (PMA), 510(k), and the less-used De Novo pathway. People used to avoid this last pathway because of uncertainties in the FDA review process, but recent regulatory reforms have made it much more inviting. De Novo studies are now covered by the FDA’s new MDUFA fees, which are paid by device organizations, and so the FDA now has to meet certain criteria when evaluating device applications. This makes the De Novo pathway less risky to investors in medical device startups, so more of them are willing to invest in and pursue technologies that are potentially headed for that review pathway.

This also impacts trial design. The FDA may require a bit more clinical evidence in a De Novo setting versus traditional 510(k), so with more of my clients moving toward De Novo, there’s a lot of variety in terms of clinical evidence requirements. Researchers are tailoring their study designs to specific situations and specific products based on the amount of evidence required. This is a part of my job that I really enjoy: addressing what evidence the FDA wants to see in a given study, and designing a study that will deliver that data.

Medrio: What are some of the challenges the medical device industry is facing today? What does this industry need, more than others, in order to run an efficient trial?

Laurie Hook: In the device space – especially in the startup world – organizations need to be able to do more with less. Funding can be scarce, especially in the early stages when they’re trying to get through concept and into feasibility studies. It’s really challenging to get a prototype developed and get it into trials efficiently.

This is why I tend to recommend solutions like Medrio for medical device clinical research. I can get a database up and running quickly and without a lot of overhead costs, which can yield huge savings for these companies. And I can handle the builds myself without relying on IT resources that my clients often don’t have in-house and don’t have the budget to outsource to. I can also easily scale up for future studies. For example, I can create a 10-form database for a simple feasibility study, and can add additional forms when we go into pivotal studies without worrying about programming. It’s this kind of flexibility and independence that really can make all the difference for small medical device companies.

Medrio: I understand you work with sponsor organizations who are weighing whether to outsource to CROs. What factors play into these decisions? How do you explain the rise of the CRO today?

Laurie Hook: Increased outsourcing is a multifaceted trend with lots of factors. But in my experience, it really comes down to expertise. CROs possess a lot of know-how that sponsor organizations might not have in-house, especially on the regulatory side. It can be hard to find someone who knows how to implement regulatory requirements in medical device clinical research, who can – to go back to our discussion of clinical trial pathways – implement a trial design that will yield the evidence that FDA demands in a De Novo setting. It also can be hard to find sufficient clinical resources – that is, “boots on the ground” clinical research associates and project managers – to execute the studies. CROs are a great source of people with these kinds of expertise. And again, in a small startup environment, many sponsors don’t have the resources to handle these matters themselves.