Working Inside Translational Development for Medical Devices

Translational Development: An Exciting Field for Innovation

Translational development is a growing field for clinicians, bench scientists, and bioengineers. The discipline began in the 1990s and was formalized in the 2000s. Today, graduate programs in translational research and development are increasing across the country. It’s an exciting, multidisciplinary profession requiring meaningful partnerships with stakeholders and experts. The challenges for researchers seeking to bring an innovative medical device to market include securing funding, engaging stakeholders, navigating regulatory requirements, and adopting an entrepreneurial mindset.

To learn more about working in translational development for medical devices, we spoke with Erin McKenna, Head of Medical Devices and Operating Partner of the Amplify Program at Mass General Brigham, and Program Director for Brigham Ignite, an early-stage translational program for Brigham and Women’s researchers and clinicians.

Goals for Researchers in Medical Devices

Medical device researchers today bring a range of perspectives and goals to translational development. In most academic settings, it's challenging to remain within the academic environment while developing and commercializing a product, and institutions have different rules about when you must leave an academic role to join a company. Some investigators prefer to serve as founders while remaining in academia, playing an advisory role in the development of the technology.

Other researchers just want to contribute their work; they aren't necessarily looking for direct involvement in the commercialization effort. If you feel this way, you might not have an official role at a company, but you can make yourself available to consult, share your perspective, or pass along any recent discoveries.

But some inventors feel so strongly about their idea that they want to leave academia and help move it forward as part of this new company, becoming entrepreneurs. At Mass General Brigham, Erin regularly meets with investigators to understand their technology and help them connect with potential partners.

Getting Started

Unmet Needs

Erin observed, “You must have a good clinical unmet need; otherwise, nothing else matters. But I think that the development space is a little messier than that.” Investigators come to their unmet needs through a wide range of paths. Often, researchers focus on making interesting discoveries they can publish, but do not necessarily consider how those discoveries could be used. Some are highly motivated to solve problems for a patient set experiencing a particular type of disease. Technology discovery can also arise from a clinical interest in solving a particular problem, with physicians motivated to find a solution for patients; sometimes they start working on their idea and then bring it to a bioengineer or researcher to take it further.

No matter how you come at it, you must not only carefully define but also characterize and validate your unmet need. One question to ask is whether this need is coming from the perspective of a particular healthcare provider or category of providers. Is the need uniformly experienced across all healthcare providers in that category, or is it related to different types of healthcare institutions? Certain problems are more likely to be experienced in different settings. Erin says, “If you're not aware of how uniformly the unmet need is experienced, then you might make assumptions that result in a product that isn't usable in all settings or is not driven by a widespread need. The goal is that the solution you're developing will address the real problem and not necessarily a perceived or niche problem.”

Collaboration

No matter what the innovation is or what unmet need it addresses, at some point, you need to bring in outside experts. You’re probably a specialist, so you’ll need help developing the product by engaging multiple perspectives and expertise beyond your area. “No one person can wear all the hats,” Erin notes.

The experts you connect with in order to move your project forward could be consultants, board members, a contract research organization, or a contract development organization. While there is a cost associated, Erin observes that, “Their expertise hopefully means that you can skip past three or four mistakes that you might have made without them.”

Competition

Erin says, “You always need to understand what's happening today and what current treatments exist. And you must also understand that if no treatment options are available today, there’s probably somebody out there that's trying to develop a solution.” You need to follow what’s going on in the biomedical community to understand whether other companies are trying to solve this particular problem or working on a similar device; even when there are existing treatment options, you must assume that others are developing technologies that will either compete with or be adjacent to them. Ask these questions:

• What research is happening in this therapeutic area to address this unmet need?
• Is any of that work progressing towards commercial products?
• How similar or different are those from what you have?
• What competitive advantages can you offer compared to the existing and anticipated technologies?
• What does your product require of patients, and will they be the main users?
• How complicated is it to use?
• Do they need to use the device at home or in a clinical setting?
• How often do they need to see a clinician? Is that feasible given their condition?
• Will a caregiver need to be involved in using the device?
• What training will be required?
• Who will interpret results from the device?
• Will the patient need to wear the device, and is that feasible?

Challenges for Translational Researchers

Erin provided these four key challenges facing translational researchers.

Funding

Medical device fundraising is challenging but not impossible. You can potentially access grants, including federal programs such as Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR). The military has also been a major funder of medical device product development. Erin says, “You can usually access those types of funds at a much earlier point, where a lot of the traditional investors may be reluctant to come in, especially if you're focused on a small market or if you're developing a highly novel technology.” While you need to create a company to tap those kinds of resources, that early funding enables you to keep product development moving forward.

In some cases, you can benefit from collaboration with existing companies, “strategics” that are active in the space that also invest in it. Launching a medical device product requires a sales force, inventory, and other operational needs, all of which require large investments that are easier to access if you can partner with other organizations that have the resources and infrastructure. Ultimately, your goal might be acquisition by such a strategic.

Investors, in general, are drawn to therapeutic intervention-type medical devices that serve large patient populations, such as cardiovascular devices or neuromodulation technologies that use electricity to address specific diseases or morbidities throughout the body.

Erin adds, “If you can provide promising clinical data, or in some cases successfully demonstrate the product in a limited market launch, it’s possible to obtain funding for your commercialization effort.”

Stakeholder Engagement

Key stakeholders need to buy into your vision; otherwise, you’ll never win them over to using your solution. Your approach depends on who, in the end, will implement the solution. If clinicians will primarily interact with your device, you need to calibrate your unmet need early by confirming that they actually see it as a problem. You should explore how they treat these patients today, what their current workflow is, and where the challenges lie. And if your design assumes that clinicians will change their workflow, but you haven’t discussed that with them, you’re going to have a hard time.

Getting clinicians on board may also require you to adjust your thinking, and your ability to do so helps build the necessary relationship so they'll continue to give you helpful input and feedback. Once you have a clinician's agreement that the problem is a real unmet need, and they can see how this technology could solve the problem, Erin says, “They can help you understand what's going to need to be true to fully realize your idea as a new invention as well as what evidence you’ll need to show that it will work.”

If your device involves patients directly, you need to explore:

Regulatory

Many academic hospitals and institutions have their own institutional review boards that oversee clinical studies conducted there. These boards have some experience navigating regulatory issues, including determining which studies you can conduct that pose low risk and will be informative, and providing oversight for surveys you may want to conduct.

Also, these boards can help you understand that beyond a certain point, your clinical studies become an FDA question. Starting conversations with the FDA early is to your benefit, and it’s what they prefer. But it needs to occur in a particular way, otherwise you won’t get clear answers. You’ll want to connect with someone who has direct experience engaging with the FDA on the technology you're trying to develop. Erin has seen teams approach the FDA without sufficient data for the FDA to respond, causing frustration on both sides. Working with partners that can help manage the regulatory relationship can be very valuable.

Adapting the Right Mindset

When shifting from academia to entrepreneurship, it helps to recognize the difference between understanding what will help your discovery be published and recognized as a significant achievement in an academic setting and understanding what will be required from a product development and investment standpoint to successfully commercialize that product.

For example, with an academic mindset, you might think you can convince regulators to look at the situation and evaluate your technology from your perspective. Or you might go to the FDA and ask them how to test and validate your device. But the regulator expects you to be the expert on your product. They want you to explain, “I have this device, and this is the problem it's intended to solve, and this is how I believe we can demonstrate that we’ll achieve this solution.” Then they’ll give you feedback.

You need to approach this undertaking with the willingness to learn what you don’t know and to think differently as a newly minted entrepreneur.

Strategic Solutions to Challenges

Strategic approaches include finding the right people to help you, tapping into available resources, and being flexible, realistic, and open to suggestions.

Erin suggests, “Appreciate your areas of expertise and identify those areas where you need help. Then you need to find the right people who can bring their capabilities and fill your knowledge gaps.” You might also need help assessing people for a skill set that you don't have or in vetting vendors who can help you with a particular subject, such as regulatory or market access.

Medtech Innovator and other groups provide educational and networking opportunities to help people with early-stage concepts. The Mass General Brigham ecosystem and other academic institutions offer many resources, as well as nonprofits and industry groups, like MassMedic, which have educational and advisory programs that you can tap.

Erin says, “One thing I try to introduce to people is recognizing how married they are to solving a particular problem. I might ask whether they would pivot to a broader problem that is more likely to attract investment, which could ultimately serve as a pull-through for advancing the technology they hope to develop. Maybe it’s developing a solution for a different unmet need or therapeutic area that isn’t what they were originally excited about. But sometimes making that shift helps get access to resources more quickly, enabling their development work to move forward.”

This doesn’t mean you need to give up on solving a particular problem, but you might have to temper expectations around it and be willing to get there in a different way. Erin says, “The key is recognizing what you have and what potential paths to development and commercialization are available to you.”

She advises, “You must be persistent and focused but also open to hearing feedback and perspective from others.”

The Outlook for Translational Development in Medical Devices

Medical device solutions are in high demand for unmet patient needs, and that demand will only increase. Erin says, “I think what will drive the cadence of development is how many resources will be made available for how many different people to access. I’d like to see funders providing a smaller amount of resources for early stage technologies to as wide a set of people as possible. Ultimately, the overall amount of investment made in a space and who receives it will drive what comes forward and the breadth of products that are actually realized.”

She adds, “The line of progress is seldom a straight line. It’s big upswings and downswings, peaks and valleys. So you must become ready to endure that, but with enough clarity around where you're trying to go so that you get there eventually.”

While significant challenges exist in translational development, strategic and practical approaches, including collaboration, can help to overcome them. It’s an exciting and rewarding field for scientists, clinicians, and biomedical engineers who want to find solutions to pressing healthcare problems and help patients to live better lives.

About Erin McKenna

Erin McKenna is Head of Medical Devices and Operating Partner of the Amplify Program at MGB and also serves as Program Director for Brigham Ignite, an early-stage translational program for Brigham and Women’s researchers and clinicians. The Ignite program is based in part on the successful Boston Biomedical Innovation Center (B-BIC), a life science accelerator program funded by the National Institutes of Health, where Erin was the Deputy Director.  Projects receiving B-BIC awards have generated over 20 times their initial return on investment on average.

Previously Erin worked at Boston Scientific in Research and Development, where she launched several vascular graft and peripheral embolization products before shifting her focus to identifying and implementing company-wide product development lifecycle process improvements. Erin earned MBA and MS degrees in Global Management from Babson College, a BE in Chemical Engineering from Stevens Institute of Technology, and holds 9 issued patents.