In my May 17 blog post, I introduced Dr. Andreas Muehler as one of Popper and Co.’s new strategic advisors. Dr. Muehler brings broad perspectives and business insights, owing in part to his close relationships with established industry leaders in the joint development and commercialization of medical products worldwide. Building upon our last discussion, where I was caught by his enthusiasm as we talked about his past role as CEO for a struggling medical device firm and his experiences positioning products in the global marketplace, I recently talked with Dr. Muehler again to further explore his impressions on the differences between the E.U. and U.S. markets for new life science technologies.
CP: You’ve served within or supported the pharmaceutical and medical device industries in both Europe and the U.S. What do you see as some of the differences?
AM: There are differences in the health care system itself – mainly how you pay for health care delivery, what gets reimbursed, and what control in decision making a physician has in terms of technologies used. For example, the U.S. has good reimbursement for breast biopsies using MRI. In Europe, it’s mainly done with ultrasound because MRI isn’t paid for at all. So in the U.S., technologies are being used when insurance will reimburse for testing and therefore provide a financial benefit to the hospital or physician. In Europe, however, clinical data around a technology is very important in terms of benefit for patient or patient outcome. In Europe, there’s a higher likelihood that good technology, which is backed by good clinical data, will be used when all ducks line up, and the financial benefits to physicians may be less of an overriding issue.
CP: When it comes to launching a new technology, can you tell us more about some of the pros and cons for each geographic locale?
AM: The advantage of Europe for marketing a new technology is that physicians are free (in particular in the hospital setting) to choose their technology if they believe it has a benefit. In Germany, for example, there is a general pricing reimbursement system in hospitals through which the hospitals receive a lump sum payment for a patient with a certain diagnosis but are basically free to use any products and technologies as they see fit. The hurdle to get into market is less as long as you have good clinical data. In the U.S., however, physicians are more open to trying new technology even without clinical data, which can be good for companies. Physicians in the U.S. are also very open to use of electronic patient records (EPR); whereas in Europe, physicians are not as convinced that EPR makes a difference and have more concerns around patient privacy.
CP: What’s different today than five years ago in terms of health technology adoption?
AM: On both sides of the Atlantic, there’s an increase in need for good clinical data for adoption of new devices, in part because of financial pressures on the systems themselves. To successfully market your device, the importance of large-scale clinical data has grown if you want market penetration of your product. In the past, a small clinical observation was sometimes enough to get adoption of your device. Now physicians ask for clinical outcome data and payers and hospitals ask for pharmaco-economic data.
CP: What will be different five years in the future?
AM: The pendulum swings back and forth. The U.S. will realize that a lot of innovation in medical devices will go to Europe because of current restrictions within the FDA’s 510K process. If good examples of important medical breakthrough technologies emerge in Europe that America doesn’t have access to, I believe some new processes will evolve that will allow medical technologies to get approved quicker in the U.S. One such example is hearing implants. Countries like Austria and Germany had in the past instituted mandatory routine hearing tests for babies, and, if needed, paid routinely for hearing implants while the children were still quite young. As a result, most educational facilities for children with hearing disabilities in Austria and Germany actually closed since implanted children undergo an almost normal linguistic development. In the U.S., hearing implants aren’t yet available as widely because they are seen as expensive for the healthcare system and by payers, even if they save more than their share of costs down the road by removing special educational requirements. If this continues, the industry should lobby to politicians and changes may occur in the regulatory process. Then, hearing implants will likely be made more widely available. By the way, the European policy for early hearing tests and hearing implants produced a market leader in hearing implants that is located in Austria.
There are important insights here, especially the need to track the level of clinical research attached to a product as it’s introduced to the E.U. market. It’s also important to note how receptive the European medical community is to new technologies introduced from the U.S. We’ll continue to focus on this important topic, and to share additional insights from Dr. Muehler and our second advisor, Dr. Mills.
We welcome your thoughts on the importance of clinical data in selling medical technologies and how the pendulum of restrictions continues to swing. Where do you think we are now in the U.S. as far as restrictions and our ability to sell in the E.U.? Share your thoughts below.
Tags: Dr. Andreas Muehler, health technology, life science, life science technologies, medical devices
Posted in Interviews | No Comments »
Having a pulse on global trends in the biopharmaceutical industry requires a wide range of insights from experience in pharmacological research and technology development through to the core operations of large-scale and startup life science businesses. With this in mind, I’m pleased to welcome Dr. Andreas Muehler as our second strategic advisor. Dr. Muehler’s experience with preclinical and clinical development, major product launches, licensing, business development, and marketing provide him with a unique combination of technical and business perspectives.
In the United States, Dr. Muehler developed and managed multiple startup medical device and medical technology companies. Among them were 3TP LLC d/b/a CAD Sciences (White Plains, NY), a medical software company that was sold to iCAD Medical in 2008. Dr. Muehler was also President & CEO of MicroMRI Inc (Langhorne, PA), a medical device company that received FDA clearance for both hardware and software components during his tenure. Dr. Muehler has also been managing director of a German healthcare private equity fund, Palladius Healthcare GmbH in Munich, which acquired distressed medical device companies. Read the rest of Dr. Muehler’s impressive bio here.
Dr. Muehler’s role as a strategic advisor to Popper and Company, along with Dr. Mills who we wrote about earlier this month, provides a wonderful opportunity for us to convey a truly global view of the industry on behalf of our clients. We’re especially excited about Dr. Muehler’s in-depth knowledge of the medical device marketplace, and look forward to featuring his insights via our blog. I was able to spend a few moments with Dr. Muehler recently and following are some of the highlights of our discussion about his background and experience:
CP: You were trained as a physician. How did you first enter the industry side of things? Was it a deliberate move from medicine to industry? Would you have done anything differently?
AM: When I went to medical school, what interested me and was exciting to me was the technology involved in health care. When I started in radiology – CAT scans were new, MRI was brand new – and the technology was of interest to me. After doing clinical work during the day, the most exciting time for me was after 5 p.m. when I could do new things with technology. So, I went to UCSF for a post doctorate fellowship to see what it was like to focus on technology all day. From there, I stayed with what I really like to do.
CP: You’ve engaged in many roles within the industry. Which was your favorite and why?
AM: I very much enjoyed serving as CEO of a medical device company dealing with diagnosis of and therapy control for osteoporosis. When I came in, the company was building large, expensive-to-develop devices. It was a difficult time. I was able to work with the people holding the technical expertise while at the same time I tried to understand the market, leveraging good people and positioning the company as a provider of software and algorithms, which was less expensive. Implementing change was at first a tough decision for the founder, but then he was supportive and we were successful. A year later, results of the new strategy were evident with an FDA approval of the software package. The employees were on board and the company was going in the right direction.
CP: Are there examples of business leaders others should emulate?
AM: There are lots of excellent leaders out there. Learn from them and take the best from each. As a leader, you have to have versatility and flexibility. You have to be able to listen and convince others—win their hearts and minds. You have to make tough decisions quickly and you have to adapt to situations with your own leadership style in a thoughtful way. And you must be careful to avoid generalizing. Examples from other business leaders work well in some situations but not others. You have to learn, but adapt as you go. And be aware of your own myopia sometimes as one often duplicates where you had success in the past. Don’t rely on assumptions of how it should be done.
CP: What’s your key business philosophy?
AM: I’ve mainly been involved in startups and early growth settings. I’ve met a lot of people who want to be involved in startups or form their own companies. I always tell them, it can be very rewarding. They usually say “I know” because they’ve seen examples of amassed wealth. But, I always warn people not to get involved in startups only because they believe it will lead to wealth. You’ll see that only one in five turn out to be successful and even then, it’s a rare example when one gets lost in wealth. Basically, you should get involved early so you can experience the excitement of a startup. Look back every two months or so and you’ll be amazed and how much you’ve contributed versus working in a larger company. It has to be more than the money. Enjoy what you do and where you are doing it. The financial rewards will come eventually.
We’re fortunate to have Dr. Muehler working along with us, lending his wealth of knowledge and international experience. We’ll provide more on his take on the differences in the device markets between the U.S. and EU soon. Until then, please feel free to let us know what you think about the European and U.S. markets for new medical technologies. Processes and legislation are constantly changing so it’s an ever-changing course. What agencies, trends, topics are you watching? Share your thoughts here.
Tags: business, Dr. Andreas Muehler, leadership, life sciences, Popper and Co, startups, Strategic Advisors
Posted in Our News | No Comments »