Lessons for Life Sciences Startups from a Former Medical Device Exec

Lessons for Life Sciences Startups from a Former Medical Device Exec

Throughout my 30-plus years with one of the world’s best-known medical device companies, Zimmer Biomet, in a wide range of roles from design to product development and commercialization to corporate strategy, innovation has been an integral part of my career. So when Oscar Moralez invited me to join Boomerang Venture Studio as chief innovation officer, I was intrigued by the opportunity to approach life sciences innovation from a new vantage point, that of a startup facilitator who helps take promising technologies from concept to commercialization.

I said yes. My career has truly led me to this place. At every point along the way, from helping develop and commercialize what became the world’s best-selling knee replacement system to moving promising devices through the FDA and EU approval processes to engaging clinical champions with technical teams, I have built a knowledge and experience base that now can be leveraged for the next generation of innovators and their ideas.

Boomerang Venture Studio provides the perfect vehicle to do just that. Based in the center of one of the nation’s most vibrant life sciences ecosystems, Indianapolis, Boomerang Venture Studio is unique among other venture studios due to its focus on life sciences. This allows the studio to concentrate 100 percent of its efforts on bringing technologies that improve lives to market.

Demand for such technologies has never been greater. COVID-19 has forced all of us to be more cognizant of health issues and health technology. With all the negatives associated with COVID-19, a positive outcome is the exponential increase in healthcare innovation. As new vaccines to combat the virus are rolling out in record time, now is a great time to grow ideas for new healthcare technologies into life science businesses!

Where does Boomerang Venture Studio fit in the innovation universe? We cater specifically to corporate partners seeking to fast track their early-stage technology as well as to entrepreneurs with novel life sciences tech-based products or services to accelerate the de-risking and commercialization process. And we do so by bringing a diverse set of experiences to the table, including medical device, diagnostics, life science equipment and logistics, medical practice and administration. The Boomerang Venture Studio team knows how to design, develop, and bring life science products to market, maximizing the market potential for novel approaches. Our founders have started, acquired, and sold life science companies as well as designed and developed multi-generational product systems sold on a global basis. This broad experience base is ready to work for and with our clients.

One of our core competencies is in market research as both a component of product design and product-market fit. Here’s a lesson I learned early in my career in medical devices.

Lesson Learned. My team and I were working on a high flexion knee implant to safely accommodate deeper flexion, while maintaining stability throughout the range of motion. Prior to this time, most knee replacement implants were designed to accommodate 125 degrees of flexion or less. Thus deep flexion was out of the question for most implant recipients. Before we started product design, we conducted market research to better understand the market and to de-risk our concepts. This included several trips to Japan to talk with both surgeons and patients, as well as observe patients perform activities of daily living. Why Japan? The Japanese spend a lot of time in squatting positions, which require the knee to flex deeply. They sit on the floor to eat, they squat while waiting for the train, and even while attending to personal hygiene. The time in Japan was invaluable, resulting in first-hand experiences which shaped the design of a new generation of knee replacement implants. The clinical and human insights we gained during this critical step of market research profoundly impacted our approach to our new implant technology not to mention how we marketed the device.

Many life science entrepreneurs have a personal experience which inspired a new idea. However, what starts as a passion to improve people’s lives can quickly get mired in the complexities of regulatory requirements, confusing markets and payer systems, not to mention the day-to-day running of the business. Boomerang Venture Studio is uniquely positioned to help clients clear these and other hurdles, balancing risk and opportunity to get an idea launched as a company with a revenue stream faster than a typical life science startup. 

Here’s how it works. When an entrepreneur and his or her technology are accepted into the Studio, our team assumes many responsibilities integral to the commercialization process. This is part of something we call  the Boomerang Launch System, a proprietary, five-stage process for growing life science companies. As we progress through the five stages, we build the value proposition for the client’s solution, identify target customers and the best market opportunities, in addition to designing the product or service. We also test multiple business models and access advice from healthcare experts in Indiana and beyond.  We work opportunities and issues throughout all five stages, covering everything from design to supply chain decisions in all five stages, ensuring that risks are identified then mitigated in a way that keeps your company moving forward.  We work alongside you, getting into the details together. 

Our system allows entrepreneurs to continue to advance their technology while we progress all other needs in tandem. This includes oversight of regulatory requirements that is part of the Studio’s go-to-market strategy from day one. Because of our deep experience working with the FDA along with our partnership with Pearl Pathways, we help clients navigate the FDA approval process and most importantly, do it right the first time. If you’re not experienced in the ways of the FDA, it’s easy not to take the straightest path. Which leads me to another lesson  learned.

Lesson Learned. My last major project in corporate life was a quality remediation program. In a nutshell, my team and I reviewed legacy product documentation to make sure it met current FDA requirements, involving thousands of documents. That may sound curious; these were all FDA-cleared devices. However, over time, the FDA changes regulations which may impact the documentation for legacy devices. Therefore, companies have to be proactive in monitoring FDA changes, how they apply to their product portfolios and then make any necessary changes. Many start-ups have not experienced the profound impact of a regulatory agency like the FDA on running a business.  Understanding not just the importance of a quality management system but also how to maintain it as an evolving system, is critical to the long term success of any life science company.

In addition to our in-house experts, Boomerang Venture Studio partners with numerous clinicians and life science service providers to provide clients with the specialized knowledge and up-to-date expertise needed. Their input is essential to product design, market understanding and education, and ultimately the success or failure of a new technology. Our deep rolodex of these experts as well as business, technical, and supply chain resources are always at the ready. 

This saves precious time vetting consultants as well as interviewing and onboarding staff, activities which must be repeated as the company grows. Finding the right clinical and business talent fits at the right time is time consuming, and it provides only a short-term fix. Companies in rapid growth stages have fast-changing needs. Boomerang Venture Studio provides access to these resources without you having to try to find them or to vet providers. Sharing talent within The Studio also enables companies to scale faster. 

Lesson Learned. This is a big one in the world of life sciences technology commercialization:  involving experienced clinicians in developing your technology. Clinicians who are involved in research, clinical research, and education have a breadth of perspective which is invaluable to commercialization teams.  Likewise, involving thought leader clinicians in your clinical education effort improves the effectiveness of the education as clinicians are typically trained by other clinicians. The goal is to create a paved path for a broad market release, with supporting scientific studies, experienced surgeon perspectives, and a strong education program for new customers. Throughout my corporate career, the best internal technical teams had strong, collaborative relationships with diverse surgeon teams.

Startups, corporate and private entrepreneur led, nearly always need funding. Here’s some great news. Boomerang Venture Studio helps with that, too. We provide initial funding for the business, which means clients don’t have to court investors, which takes precious time away from the business. As funding needs increase, Boomerang Ventures either provides funding or connects the business to investors. We work with our clients as a co-founder to raise the funding necessary to run the business, enter the market, and reach the scale needed to be successful.

Boomerang Venture Studio starts each company with the exit in mind. To that end, not only do we work with clients to build an attractive business, we also create a network of potential acquirers. We put our experience to work in finding the right acquirer for the business, negotiating attractive terms and closing the deal with finesse. 

Boomerang Venture Studio leaders have worked in the corporate and startups worlds. We’ve designed and commercialized technologies on a global scale as I did and launched, acquired and sold businesses like my partners have. Along the way, we’ve learned many important lessons that make the process easier for our clients and we’re ready to share them now at Boomerang Venture Studio. If you are looking for a partner who will work with you, provide expertise and funding, connect with us today!