A Conversation with Nancy Lynch, MD, MBA, FAAOS
We have been so fortunate to benefit from the expertise and guidance of Nancy Lynch as one of our independent board members. Recently we spoke about her background and work with BHT – highlights from that conversation are below.
Tell me about your experience in the medical technology field – what were some of your key roles and accomplishments?
Currently, I run my own consultancy providing services mostly, but not exclusively, to companies developing innovative technologies in the musculoskeletal health space seeking regulatory approval, be they devices, combination products, biologics, or even pharmaceuticals. In that position, I’ve been a full-time in-house Chief Medical Officer and an acting CMO of two orthopedic companies that IPO’d, and, by virtue of the importance the CMO plays in clinical-stage companies, I performed a key role in each of those IPO processes.
How did you get involved in this field?
First, as an orthopedic surgeon, I was an end-user of many different medical technologies for several years. I employed some great technologies, but I also saw some technologies that either didn’t completely meet the need for which they were designed or frankly fell far short of achieving their intended purpose. But my direct involvement in the medical technology field started when I spent four years with a Bay Area venture capital firm, Scale Venture Partners. There, I got immersed in the Medtech startup world. Our team evaluated thousands of technologies in the life sciences. One, a cartilage regeneration technology, was of great interest to me. It’s one of the companies for which I ultimately served as CMO through an IPO while overseeing a major clinical trial.
In addition to BHT, what other companies or organizations are you involved with?
I’m engaged with several companies currently pursuing regulated paths to market. Most of these are companies with technologies focused on musculoskeletal care. When I engage with these companies, I usually assist them at an executive level – a bridging CMO – with their clinical program strategies. Ultimately, I get very involved as their programs develop into active clinical trials and submissions for approval. I also get involved in capital raises and other business needs for some of the earlier-stage companies.
In my free time, I am involved with two unique professional organizations, DOCSF (Digital Orthopaedics Conference – San Francisco) and MedtechWomen. DOCSF is a forward-thinking organization focused on accelerating the adoption of digital health technologies in the care of musculoskeletal conditions. While I’m involved in all the organization’s programming, my main role is director and co-chair of DOCSF Venture, an initiative we launched this year on the eve of the 2022 JP Morgan Healthcare Conference. MedtechWomen formed in the Bay Area just over ten years ago. Its primary focus is highlighting and promoting women Medtech leaders and innovators. I serve as the co-chair of the Board Development Committee, an initiative to educate, position, and promote women Medtech executives for Board service.
What attracted you to get involved with Bone Health Technologies?
Three things. First, as an orthopedic surgeon, I cared for thousands of osteoporotic fractures. I saw the devastating shift in a patient’s life these fractures usually caused. Second, as the daughter and granddaughter of two women who sustained important osteoporotic fractures, I have experienced the life-changing impact of these fractures – not just for the person with the fracture but for the families as well. Finally, I’m frustrated that current options for osteoporosis care begin too late and take a systemic therapeutic approach to a condition that, although it affects the entire skeletal system, predictably manifests focally. In most cases, the systemic pharmacological approach is unnecessary – it’s too much therapy for a focal problem and, in some cases, results in unintended consequences.
I trained at a time when more aggressive treatment of, for instance, osteoporotic distal radius fractures to preserve pre-fracture function was finally becoming generally accepted practice. That wasn’t that long ago. During that same time, optimization of the osteoporotic hip fracture patient – quickly improving underlying active medical problems preoperatively coupled with urgent surgical intervention (within 24 hours) – became the gold standard. In fact, it still is. These were great steps forward in the care of established osteoporotic fractures (and accelerated some innovation in devices that are better for osteoporotic bone). However, we were not changing the incidence of those fractures.
BHT has the possibility of moving the care of the aging skeletal system upstream to a time when bone density in critical locations, such as the spine and important metaphyseal regions of long bones (hips, wrist, shoulder, knee), can be maintained at a level at which fractures are unlikely to occur. I also like the more practical aspects of BHT’s approach. BHT’s device is removable, which makes the discontinuation of therapy to address possible side effects very easy. Its mechanism of action is mechanical. Bone responds to and grows in response to mechanical stimuli. Plus, BHT’s platform leverages digital technology for patient engagement and education, allowing for a more proactive approach to bone health. Patient engagement is the future.
What have you most enjoyed in your work with BHT?
I serve on BHT’s Board as an independent director. In that role, I get to interact with the other directors regularly. We routinely have robust discussions about the direction of the company, discussions I thoroughly enjoy.
I likewise enjoy being involved with the company’s clinical strategy from a 30,000-foot view. (If I’m being honest, occasionally, it’s a 10,000-foot view. That’s the nature of a Series A company – Board members roll up their sleeves to help in any way they can.) Frankly, a company’s clinical strategy sets the strategy for everything else that follows. A highly functioning clinical team includes people who serve many important roles, including seasoned clinical operations people, experienced regulatory and quality personnel, external champions (investigators and their research coordinators), and, occasionally, those who plan for reimbursement and market launch and adoption. In my consulting role, I’ve worked with a lot of great teams. Although the trials I usually work on are large, multicenter (sometimes global) studies for highly regulated products, I find my experience quite relevant to BHT’s overall plan. Since joining the Board in early 2021, I’ve been able to leverage my clinical trial experience and knowledge on behalf of BHT at its current stage by sharing input on key issues. Interacting with the clinical and regulatory team at BHT by providing guidance and advice, both strategic and operational, is very rewarding from a professional standpoint.
I, as a director, find it gratifying to serve as a “connector” for the company. In business school, Malcolm Gladwell’s “The Tipping Point” was required reading. After reading it, a classmate I didn’t know well said to me, “You’re a connector.” For a while, I was a bit perplexed by this description. My professional identity was as a physician and surgeon. But I’ve come to understand I gravitate toward connecting people. I enjoy introducing people and seeing collaborations happen. I’m gratified that I’ve introduced experts in my network to the BHT team to facilitate its productivity – and I will continue to do so.
What do you see as the biggest challenges and opportunities for the company?
Changing the mindset that osteoporosis needs a systemic pharmacological approach. This is a challenge for BHT. Convincing physicians that focal treatment is adequate and all that’s needed is a medical device worn 30 minutes a day to improve bone density will be a challenge for BHT. Clinical data is paramount to achieving this goal and to the related challenge of anchoring reimbursed intervention to osteopenia instead of osteoporosis. Intervention these days often begins after the initial osteoporotic fracture – certainly no sooner than before one’s T-score is <-2.5. That’s too late. But that’s the accepted standard of (reimbursed) care. Payors have strict criteria they apply before paying for expensive osteoporosis drugs. Strong clinical data supplemented with health economic, and outcome data will help us affect these changes.
As for opportunities, BHT has a wide-open field to create a patient engagement platform for bone health. My specialty, orthopedic surgery, launched a program, Own the Bone, several years ago. This initiative was meant to help orthopedic surgeons incorporate osteoporosis care – not just surgical fixation but long-term management of their osteoporosis patients – into their routine practice. While the initiative is well-intentioned, as I mentioned earlier, we can have the most impact with intervention before a fracture occurs. BHT has an opportunity to be an instrumental part of ‘owning the bone.’ The approach will rely on patient engagement – education, motivation, compliance – in owning their own bone. Together with their physicians, patients can be much more participatory in their own care. BHT can be the facilitator of bone health between patient and doctor. The result will ultimately be better comprehensive care, improved bone health, and far fewer (expensive) fragility fractures.
How do you see the medical technology field changing?
With the convergence of conventional medical devices and digital technologies, the medical technology field is undergoing a revolution. The emergence of ‘smart devices’ is particularly intriguing. We are beginning to capture continuous data of all kinds from, say, a total knee. One of the first examples of this kind of device was the wearable continuous glucose monitor for outpatient use. Perhaps earlier examples are devices pulse oximetry and continuous 3-lead EKGs, the uses of which were confined initially to the ICU. In the beginning, physicians didn’t know what to do with this massive amount of real-time data, especially continuous glucose readings.
Orthopedic surgeons are experiencing something similar. What might be a bit different now is that artificial intelligence augments the interpretation of that data. These devices and the data they produce will allow us to be much more precise in applying technologies. Although it’s uncomfortable for surgeons to hear this, it’s possible this level of precision will reduce the total number of surgical procedures performed. When I was early in my practice, one of my partners shared his philosophy on when to offer surgery: “Only do a procedure on a patient when you believe there is a 70% chance the patient will get 70% better.” That was his version of AI based on his experience to date. At the time, that seemed quite reasonable to me. But think about that for a moment. That’s only a 49% chance of someone getting better. Would you as a patient take that chance if your surgeon said that to you? Data from devices (wearables, implants, external navigation devices, etc.) coupled with artificial intelligence will improve the predictability of outcomes for patients and reduce the physician-to-physician variability in the delivery of care.
Connect with Nancy on LinkedIn
This interview was conducted by Bone Health Technologies CEO and Board Member Laura Yecies. She regularly writes and speaks on topics of female entrepreneurship, women working in technology and med tech, industry news, and Bone Health Technologies. Connect with Laura on LinkedIn.