Admedus COO David St. Denis on Courage, Commitment and Conversation

David St. Denis is currently Chief Operating Officer and member of the executive board at Admedus, a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. Its focus is on investing in and developing next generation technologies with world class partners and acquiring strategic assets to grow product and service offerings. Its current product, based on its revolutionary tissue engineering platform, is focused on the development of treatments for aortic stenosis.

What journey took him to this position?

He had an auspicious start with ten years at Millennium Pharmaceuticals, now Takeda Oncology, starting in 1996. He grew with the company as it progressed through its lifecycle and evolution from R&D through to commercial entity, rising from database management in Genomics Discovery, to portfolio management, and commercial operations. That experience gave him a significant portfolio of skills.

It was also during his time at Millennium when David faced his own cancer diagnosis and treatment – an experience that had a profound impact on his patient-focused approach to the healthcare business.

From there he took an interesting assignment as Engagement Manager at Model N, the leading provider of revenue management solutions for the life sciences and technology industries. The company helps customers maximize revenues, drive growth and reduce compliance risk by transforming the revenue lifecycle from inefficient disjointed operations into a strategic end-to- end process. David delivered projects for managing government pricing, Medicare rebating, managed care contracting and rebating, as well as GPO/IDN contract management.

Moving to Merck, he spent the next nine years in numerous roles of diverse responsibility. He began as Associate Director of Marketing Information Systems for their healthcare business, leading the development and global implementation of a digital therapeutic and remote monitoring system (RMS) designed to drive adherence to human growth hormone therapy. The platform was one of the first digital therapeutics available. In 2010, he became Merck’s Senior Director for Strategy and Operations in Emerging Markets, responsible for articulating go to- market strategies for emerging market countries and sub-regions, as well as defining operating models and driving efficiencies. He led a regional team to analyze major markets in the BRIC countries (Brazil, Russia, India and China), as well as smaller sub-regions, to define the product mix, commercial and operational footprint, and capabilities required to maximize penetration and efficiency.

His last position there was as Head of Commercial Operations, Europe for the biopharma business. As a member of the regional executive team, he led Marketing Excellence, Launch Excellence (preparing oncology and immunooncology product market entry), Sales Effectiveness, Business Intelligence, and Patient Services.

Viewing this span, now including his responsibilities at Admedus, David has covered the field in pharmaceuticals, biopharma and medical device, leading teams in driving go-to-market strategies, most recently as head of the commercial organization at Admedus to achieve more than 60% revenue growth in a single year. He has also developed and implemented market access and contracting strategies, operating models and long-term plans, and has led the global implementation of digital therapeutic and remote monitoring systems. His experience covers a broad spectrum of therapeutic areas, such as oncology, immunooncology, neurodegenerative disease, metabolic disease, and cardiovascular disease. While at Admedus, he has gained new experience in structural heart disease, including congenital defects and valve disease. Having covered that much healthcare, executive and geographic territory, he is perfectly suited for his current assignment as COO. Admedus is the result of a merger between Allied Healthcare Group and bioMD Ltd., formed to create a company with assets in R&D, products in advanced clinical trials ready for commercialization, and a successful sales, marketing and medical device distribution business. Its ADAPT® biomaterial scaffold products for restorative structural heart repair and reconstruction offer superior resistance to calcification.

David says “The potential of this technology is almost beyond measure, as we constantly look to evolve its purpose and application.”

All Admedus ADAPT products are manufactured in, and distributed from, its state-of-the-art bio-manufacturing facility, which has substantial capacity to expand and includes an in-house research and development laboratory. THE VISION: COURAGE, COMMITMENT, CONVERSATION True to his style, David is focused on potential. “We’re always looking for new opportunities to grow, expand and transform our business with a range of exciting development projects underway.”

Admedus is expanding into new dynamic markets, investing in ground-breaking R&D and continuously refining its world-class manufacturing facility and processes. Its first generation products, CardioCel and VascuCel, were recently licensed to LeMaitre Vascular (NASDAQ:LMAT) and are currently being used in more than 135 global centers in US, Europe, Canada, and emerging markets for the repair of complex congenital heart defects.

“In 2020, our focus is on the development of our aortic valve replacement solutions for the treatment of aortic stenosis based on our ADAPT tissue science and unique 3D single-piece valve design. Critically, as younger, lower-risk patients become eligible to receive valve replacement solutions such as TAVR, durability will become the most critical issue to address.”

What has he brought to the company that helps propel them in this direction? A global understanding of how healthcare needs to work.

“It disappointed me that the problem I saw in biopharma exists in the med device space as well. A lot of talk about value and patient focus; in reality, we are far away from putting patients at the center of what we do. In Europe there was a lot of discussion around this, but invariably it would come down to finances and budgets. There was very little development in terms of true value-based agreements or true outcomes-based agreements with the industry. There are a few exceptions, of course, such as certain NHS England’s programs in chronic care. In the U.S., we are making some progress, particularly with the advent of gene-therapy, where payors and manufacturers are bringing real structural change to the system. Overall, however, we are still not seeing revolutionary change towards outcome-driven decision making in the delivery of healthcare.”

“You have to be linked to a value system. At Admedus we can find out what the customer and patient needs are, but if the system doesn’t incentivize us there’s no value.” He sees the territory as a partnership among patients, providers, payors, and manufacturers. “We have to align according to what the other participants are trying to do.”

He cites Admedus’ own patient-focused values as an example. It puts a stake in the ground indicating that the overall focus is on the patient, and everything flows from there. This point of view must shift to the delivery system. “In risk-sharing and pay for performance schemes, manufacturers are already subject to this,” he says. “Margins are cut if we don’t deliver value. But the system delivering care needs to be held to same outcome. In the U.S., for instance, Admedus technology promises that the patient doesn’t have to endure multiple surgeries, because our products are more durable. The value of this can’t be overstated.”

Hospitals get paid by surgeries, according to the cost-containment goals of DRGs. But the system isn’t defined to reward better outcomes, it is geared to lower procurement targets and costs, so the concept of value is not actually driving decision making. “What do I do as a healthcare executive? Stay committed to solving the problem. The first question to answer is always ‘Is this good for the patient?’ We need to ask this not only of ourselves as manufacturers, but to engage all the other participants. How can we accomplish this so we all win – especially the patient?”

David says that med device has some catching up to do in term of patient-centricity in its products and services offerings. “In biopharma there are well-defined pathways to the goal. We asked how we define who the target is, which drug is right for the patient. Sometimes the therapeutic model had to be recalibrated, and consequently fewer patients would be right for it. We saw this in action when I was at Merck, where one of our targeted cancer therapies was discovered to be less beneficial for certain genotypes. We did the right thing, limited our indication, and sales went up. If you do the right thing, we all benefit.”

But he points out that this process is dependent on courage. “At Admedus when we were selling CardioCel directly, we were focused on the repair of complex congenital defects. Despite it being a high specialty procedure space, the market for products was commoditized, and within it we had a high-value and highly differentiated product. To promote that, we had to offer different value propositions for different audiences. There’s little to no room for massive price increases, but differentiation and value that’s properly communicated can still have a major effect on overall sales.”

Bringing new products to market and raising awareness of clinical and outcome benefits costs a little more in the short term, but pays off in the long term, he says. “Some investment from Admedus isn’t going to have an immediate return, but commitment to the space will sustain our success. Again, that takes courage. One of the things that contributes to our long-term view is that we have a seasoned board of healthcare execs who understand the importance of this commitment. We are now focused on bringing a game changing innovation to patients suffering with structural valve degeneration and aortic stenosis with the same focus on patients.”

We asked about the effect Value Analysis Committees are having on med device. “Some VACs are hospital-specific, and some are part of IDNs,” he noted. “Some are very controlling. Depending on the situation, sometimes the physician is very influential, other times not so much. We have to determine our strategy on the basis of atmosphere. We have to come in with the right conversation. That might be about clinical benefit, economic impact, or other factors. The healthcare delivery in the U.S. is currently extremely complex to navigate compared to other systems, and requires a thoughtful approach to how we engage and communicate the value we offer.”

Of course, the healthcare delivery system is moving in the right direction and does have their scorecard and key performance indicators just as we do in the industry; however, it again comes down to the question about how well those are aligned to long-term outcome. “Accountable Care Organizations (ACOs) are emerging in the U.S., for instance. But are we really seeing them implement meaningful systems and metrics to impact treatment algorithms and choice of products which may be more expensive in the short run, but overall lead to a high quality of life and a reduction in follow-on expenditures? “For instance, in congenital heart surgeries, there are numerous treatment factors looked at and measured. What’s the changeover time between procedures, how much time does the patient spend on the pump? Mortality and readmission are tracked for only 30 days. If the patient is readmitted in 90 days, it doesn’t count.”

“The important task is for us to make sure we are telling our story and message about value, which covers a lot of territory. What’s the patient experience, the physician experience? What do we measure about long-term outcome?”

Commenting on the future of their strategy, David said that “The real opportunity for our new partner who is now selling these products into the congenital defect space is to partner with younger generation – residency programs and fellows, to influence their thinking and educate them about new options and treatments.” Companies like Merck, where David last worked, have done this successfully in the areas of multiple sclerosis and fertility, where they sponsored fellows and residents, exposing them to the cutting edge of science. “We sponsored and fostered peer-to-peer educational events as well. The effect of these efforts will resonate for many years.”

With respect to Admedus’ vision, he said “Our focus is on investing in and developing next-generation technologies with world-class partners and acquiring strategic assets to grow product and service offerings. Our unique ability in the tissue engineering space has given us an opportunity to drive a significant inflection point in the treatment of aortic stenosis, and most likely other structural valve disease.

“We are focused on durability, which again is really down to a patient-centric approach to creating more access and better outcomes, while utilizing healthcare budgets more efficiently, and bringing meaningful improvements to healthcare practitioners’ experiences with our products.”