Roulston Research March 8th Medical Devices Conference Call with Former Covidien and Abiomed Executives

March 12, 2013

There’s no denying that the Medical Devices Industry has been growing and changing rapidly over the last 5 to 10 years and with change, comes obstacles and opportunities. Roulston Research recently held their informative medical devices conference call with two key healthcare executives, Jerry Liebrand and Edward Berger, both providing over 25 years of healthcare experience. Jerry Liebrand is currently President at Liebrand Consulting and has served as former Global Vice President of Strategy and Portfolio & Marketing Intelligence at Covidien and is the former VP of Business Development & Product Licensing at GE Healthcare. Edward Berger is the principle and founder of Larchmont Strategic Advisors, and President at Medical Development Group. He is the former VP for Policy, Reimbursement and External Relations at Abiomed. The presenters provided an in-depth analysis of the changing healthcare environment ranging from the ever-changing regulatory system to the current economic landscape in the healthcare industry. One of the importance and recurring theme in the conference call is will healthcare reform (Obamacare) restrict the potential for adoption of innovative medical technologies? The presenters don’t think so, there still remain extraordinary opportunities for innovative medical technologies and it is important to see that the key to success for innovative medical technologies is evolving.

In order for products to be used in a wide spread type of environment, clinical value proposition and to an extent, economic value proposition becomes more vital due to the appeal to the clinical buyer and economic buyer. Furthermore, the regulatory environment is moving towards wanting more clinical value proposition during the approval process. The hurdles for new medical technologies are higher now than they were 5 years ago. The FDA 510K process now seems to be gravitating towards the 510K plus more clinical data when approving medical devices, which is a deviation from their more lax stance on clinical data in the past. When looking at individual companies with excellence performing devices that are likely to remain solid, Thoratec clearly seem to be a sector leader in implementable long-term ventricular assistance, providing a product with an advanced pump that’s early in its commercial lifecycle, however not yet through the process of FDA approval. Abiomed has solidified their strength in the implantable space and is carving out a very strong position in minimally invasive and short-term cardiac support. On an International-Macro level, many companies have come to this conclusion that it is easier to get a product to market in Europe than in the U.S., which is becoming most companies starting point. This however, may not be the case in the future, as Europe continues to adopt the U.S. FDA protocols when approving of medical devices and healthcare related products. China and India are viewed as opportunistic areas, if a company’s strategy is successfully implemented. Companies have found it more beneficial to use the foreign direct investment (FDI) approach vs. exporting when entering these markets. Companies that are covered and not mentioned above include, Covidien, Johnson & Johnson, Stryker Corp, Medtronic, GE Healthcare, Macy’s and more. If you are interested in listening to the podcast from the event or engaging Jerry or Edward in a 1 on 1 discussion please contact

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