As an advisor to emerging med tech companies, I am always on the lookout for attractive niche markets where new technologies might get a foothold and demonstrate their value before taking on the (often mythical) billion-dollar opportunity. To this end, for years I have instinctively gravitated toward the transplant market (the solid organ kind, e.g. kidneys, livers, hearts, pancreases, etc…) as a nifty space for novel medical devices and diagnostics. It’s not a very big market, with only 28,000 solid organ transplants per year in the US (as compared to 600,000 hernia repairs) and 100,000 worldwide. The national system for managing transplants is complex and political (a proposed rule to allocate the best kidneys to the patients with the highest life expectancy made headlines this month). And I’ve heard tales of woe about the challenges of studying interventions in this small, unpredictable and highly regulated specialty.
So why do I like organ transplantation as a target for innovation?
- Transplants are high value procedures in the truest sense, often dramatically impacting survival, productivity and quality of life when successful. Check out this story about a heart recipient who completed an Ironman 25 years after his procedure.
- While transplant outcomes continue to improve, with 1-year survival now ranging from 96% for living donor kidney transplants to 65% for heart-lung, and many patients surviving with transplanted organs for many years, there are still oodles of unmet needs at every step of the process.
- There is room for adopting new technologies, and also for showing economic benefit, with average costs of greater than $500,000 per transplant episode.
- The customer base is highly targetable, consisting of large transplant centersand specialized surgeons who all probably know each other.
- The patients are highly motivated, being thoroughly screened for eligibility and generally quite aware of the tremendous gift they’ve been given.
- Reimbursement is available, and trying to cut it appears to be politically risky; Arizona’s attempt (and reversal) made national news back in 2011. The transplant market will also be helped by the Accountable Care Act, which prohibits lifetime caps on health insurance coverage.
Though I don’t usually let data get in the way of a good hypothesis, I confess that lately I’ve longed for a little validation of my fondness for the transplant market. The recent acquisition by Thermo Fisher of One Lambda, which has a diagnostic for tissue compatibility in transplant, for $925M in cash was somewhat confirming, but being a marketing professional I needed the scoop from the front lines. So on a recent visit to my hometown of Cleveland, I visited with renown Cleveland Clinic hepatobilliary transplants surgeons Dr. John Fung and Dr. Bijan Eghtesad (from here on out “the surgeons”). Over a cup of coffee at the Au Bon Pain, the surgeons administered a dose of reality about the challenges in transplantation, and some inspiration for med-tech innovators with transplant-relevant technologies.
According to the surgeons, organ availability is “the bottleneck” in transplant; there are currently 73,660 people in the US on the active waiting list for solid organ transplantation (compare this number to the 28K who got one last year). The lack of organ supply means that patient who might benefit greatly from a solid organ transplant, for example cancer patients, are not considered candidates. The surgeons listed a number of initiatives, many involving policy vs. technology, to improve the supply of organs, including greater use of living donors. Once just for kidneys (since people conveniently have two), a more recent innovation is the use of partial livers from live donors (4% of liver transplants in 2011). “Although the number of living donor transplants is increasing, this has its own limits,” said the surgeons.
Improving the function of organs available for donation would also help supply. “8-9000 people in the US consent to donate livers each year, and only get 6000 get transplanted; that means we are throwing more than 2000 livers away,” lamented the surgeons. New technologies for maintaining organ function after harvesting, such as Transmedics’ Organ Care System (beginning to replace the “ice bucket” in Europe for hearts and lungs), have the potential to increase organ availability by enabling donor organs to withstand longer transport. Further off, “maybe in 10-15 years,” according to the surgeons, we might see the repair of currently rejected organs using functioning cells (check out this New York Times article about growing organs in the lab).
Keeping patients awaiting transplant alive longer is another area for innovation. Dialysis can keep patients in kidney failure alive for years, but for liver failure and newly transplanted livers needing time to settle in and function, “there is not much we can do,” explained the surgeons. One company, Vital Therapies, is developing a “bio-artificial liver” to temporarily support liver function; the system is still in clinical trials. For heart transplant patients, Heartware’s miniaturized ventricular assist device for bridge-to-transplant is expected to gain FDA approval any day now.
Monitoring and maintaining the health of patients running around with transplanted organs is also a hot target for innovation. Molecular diagnostics companies such as XDx are developing tests for non-invasively detecting early signs of transplant rejection, and predictive biomarkers for rejection predisposition are being pursued for personalized immunosuppressive therapy. On the bio-behavioral end of the spectrum, companies such as iReminder are developing novel medication adherence programs targeted to transplant patients and showing reduction in rejection episodes.
After my little journalistic exploration, I still like the transplant opportunity for emerging med-tech. And I checked the back of my driver’s license (yes, I’m an organ donor, and I hope you are, too). Drs. Fung and Eghtesad certainly confirmed my high-value theory; my attempt to get one “miracle story” out of them drew puzzled looks. They are all miracle stories.
For More data on Solid Organ Transplants (and there is a ton of it), visit:
- The Scientific Registry of Transplant Patients http://srtr.org/
- The United Network for Organ sharing http://www.unos.org/
- American Society of Transplantation http://www.a-s-t.org/content/resources-transplant-patients
- American Society of Transplant Surgeons http://www.asts.org/