Edwards Lifesciences Exec on How to Innovate in Medtech

Edwards Lifesciences' Stanton Rowe has a unique vantage point on innovation in the medical device world. Now the company’s corporate vice president, advanced technology and chief scientific officer, he was previously the CEO of Percutaneous Valve Technology, a pioneer in the field of percutaneous heart valves. That company was acquired by Edwards, eventually enabling it to be among the first firms to enter the field of transcatheter heart valve therapy. Earlier, Rowe was the vice president of business development for Johnson & Johnson’s interventional systems division, which was responsible for the company’s coronary stent development efforts.

In this Q&A, Rowe define innovation in today's medical device world and speaks to Edwards' approach to product development. The interview also provides a preview of his keynote on February 11 at MD&M West in Anaheim.  

MD+DI: “Innovation” is a term that us used quite a bit these days. How would you define it in general and what, in your opinion, makes a medical device innovative?

Rowe: Innovation involves changing the norm, and, in the medical device world, it means fulfilling an unmet patient or clinician need. In today's environment, medical devices can't be considered innovative if one is iterating "in the middle," meaning there's a small change to an existing device in an attempt to make it new. Innovative devices surpass the middle and are designed to improve patient outcomes or health economics—or, ideally, both. Device innovators must take larger steps in order to prove clinical benefits or cost-effectiveness. Device companies must innovate broadly; considering the procedure, treating patients in emerging markets and how the care will be delivered.

MD+DI: The title of your keynote talk asks whether there is room for innovation in today's medical device industry. Can you briefly summarize your thoughts on that subject? 

Rowe: The current environment within which medical device companies must innovate is very challenging. For example, companies big and small are facing the impact of the medical device tax, while at the same time managing through updated regulations from authorities around the world, a demand for greater evidence to support both the clinical efficacy and cost effectiveness of new devices and the increasing time and cost required to bring new devices to patients. In addition, several key stakeholders, including physicians and payors, are under increasing stress - and this translates into a high pressure situation for device makers. We can no longer iterate for innovation's sake. We must strive to change the norm and, as a result, fundamentally improve patient outcomes or impact health economics - or both. This means taking on more risk in R&D when R&D investments are under pressure. Those companies who do not adapt to this environment will struggle.

MD+DI: At MedTech Cardio in 2012, your colleague Francis Duhay, MD spoke of the increasing need for medical device companies to provide evidence of value for their products. What advice would you give to medical device companies seeking to provide evidence that their products are not only clinically effective but deliver high value as well?

Rowe: This is our new norm, where devices ideally are both clinically effective and positively impact health economics - innovation is still the answer. The innovators that adapt to the changing environment will succeed. We must prioritize development carefully and generate evidence beyond safety — taking into consideration efficacy, cost effectiveness and quality of life. 

MD+DI: Traditionally, a lot of innovation in the medical device sector has come from startups. Now, many startups are struggling to find funding and find it even tougher to reach profitability with new hurdles such as the medical device tax. Will larger device companies be forced to do more innovation and R&D in-house?

Rowe: I believe we will continue to see, and benefit from, the R&D work at both startups and larger device companies' in-house developers. For example, Edwards Lifesciences continues to invest aggressively in R&D, at 15% of sales. We believe this investment in R&D is a critical element to ensuring our long-term success. We make a significant investment in the division at Edwards that I oversee, Advanced Technology. We are exploring new ways to address structural heart disease, as well as new technologies to aid in the treatment of the critically ill. However, as has been evident through Edwards' M&A practices of the last several years, we are open to acquiring or licensing technologies when it complements our internal development efforts or areas of interest. We have a dual approach to R&D — investing significantly in our in-house efforts, while also making strategic acquisitions. This enables us to better address unmet patient needs, and be more competitive.

MD+DI: There has been a lot of buzz around areas such as mobile technology, 3D printing, regenerative medicine, etc. and their potential to greatly improve the practice of medicine by making it smarter, more accessible, less expensive, etc. Which technological disciplines do you think have the most promise for medical device applications?

Rowe: Edwards has always been focused on transforming patient care through innovative technologies with clinical superiority. We look for opportunities to create therapies and technologies to fulfill unmet patient needs. For us, this means innovating in structural heart disease and critical care, working in partnership with clinicians in these fields to provide solutions to improve the treatment of their patients.

We're increasingly focused on developing minimally invasive therapies and technologies in both our heart valve and critical care businesses. We develop very unique, specialized technologies - for example, heart valves that are restorative - and both patients and clinicians would love if we could make our technologies less-invasive or non-invasive.

Our goal is to lead in the space of minimally invasive, small incision surgery - we want to create platforms that allow surgeons to use those procedures in a way that makes the procedure easier and also takes less time. At the same time, we are also seeking ways to continue to provide important patient information to clinicians via our monitoring technology, but in a way that is more comfortable for the patient.

Innovation in manufacturing or rapid prototyping capabilities like 3D printing make the progress of innovation faster and more cost-effective for both large and small device companies. Where we must be cautious is technology looking for a problem to solve. This has never been an effective development strategy.

Innovation must start with a clear understanding of the disease, the patient and physician, and needs to include an understanding of referral and economics.

The greatest risk in R&D remains defining the wrong problem, or not solving the problem adequately.

At Edwards, we frequently focus on less invasive approaches to treating structural heart disease. Patients are happier with less pain and trauma, and less time in the hospital is good for patients and payors.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.