Highlights Events Resources Resources Articles 01.10: Medical Device & Diagnostic Industry Magazine Medical Devices Deserve More Respect By Mark Speers, Partner and Managing Director, Susan A. Posner, Vice President, and Jennifer Kim Cutie, MD, Professional Development Manager Should devices be considered earlier in the treatment paradigm? Devices are often reserved for patients who have already failed multiple drug therapies, but in some cases, devices may ultimately provide better long-term outcomes more cost-effectively than drugs. In order to pursue these opportunities, manufacturers must effectively develop technologies that can surmount traditional therapeutic hurdles, including physician perceptions of drugs and devices and the short-term payer outlook. Health Advances Medtech Practice Group shares their insights on the potential paradigm shift that would move devices to an earlier position in the treatment pathway, potentially expanding the market opportunity for devices and the medtech industry. request a reprint. 10.09 Maintaining Attractive Biopharma Returns in the Face of Healthcare Reform — Perspectives from Health Advances and Cowen Healthcare Royalty Partners Contributing Authors: Health Advances: Marie Schiller, Sheela Hegde, Kerry Phillips, and Urvesh Shelat Cowen Healthcare Royalty Partners: Greg Brown M.D., Paul Hadden, and Wendy Liu Healthcare reform is the Obama Administration’s top domestic priority. Although the Administration’s original goal was to have a reform bill passed in October, it now appears that a final vote will not take place before December. The rigorous debates have focused on three key components: access to care, cost of care, and value of care in the US healthcare system. Investors are grappling with how these three components of reform will affect the favorable returns traditionally captured in the biopharma sector – a sector that is already feeling pressure from patent expirations, fewer drug approvals, and growing development costs. Biopharma executives are working hard to influence the path that the government takes and are seeking solutions that will offset both top-line and bottom-line pressure created by cost containment measures. So what can be done by biopharma companies? In addition to reducing costs through traditional means, biopharma will need to change fundamental elements of its business model and adopt new solutions. Examples include participating in follow-on biologics, integrating products as part of larger healthcare solutions, sharing risk with payers, prioritizing personalized therapies, and continuing to work on reducing overall R&D and promotional expenditures. request a copy. 09.09: Medtech Insight Value Proposition is Key to New Product Success in a Cost-Conscious Medtech Market By Susan A. Posner, Jennifer Kim Cutie, MD, and Anna Chen Management teams are well aware of the need to demonstrate compelling economic data, but can a product still be successful without an economic benefit in the increasingly cost-conscious health care marketplace? Overcoming negative economics requires a combination of positive attributes; many compelling advantages like clinical or safety benefits are well-known, but other key attributes may be overlooked. Recognizing all of these potential advantages is crucial for appropriate planning to compile relevant data and position the product accordingly, thereby optimizing product success. Health Advances Medtech Group shares its thoughts and observations on current products that have overcome negative economics, highlighting the keys to their success and lessons learned for emerging products. request a reprint. 03.09: In Vivo Magazine How to Earn the Economic Payback Diagnostics Companies Deserve By Gary Gustavsen and Kristin Pothier For most diagnostics companies, the prospect of premium pricing has been an evasive dream. The health care landscape is peppered with expensive novel drugs priced to underscore their clinical impact on patient care. A similar strategy for pricing novel diagnostics with significant clinical impact makes sense, especially since many of them are driving the decisions to deploy novel drugs in the first place. But logic has only recently translated into reality for most novel diagnostics. The existence of an antiquated CPT code system which bases reimbursement for diagnostics largely upon the cost of their underlying laboratory procedures, rather than on their benefit, made for a slow start. In addition, many diagnostic companies did not fund studies to document their products' ability to affect clinical outcomes. However, strong system economics arguments are becoming more mainstream and payers are beginning to reward companies with reimbursement of their premium priced tests. Rewards are based upon rigorous clinical arguments supporting the diagnostics' benefits to clinical decision-making and compelling economic arguments customized to each major payer. Identifying and documenting these arguments for each product is the key to attaining sustainable premium pricing in diagnostics. request a reprint 12.08: Start-Up Magazine Will Simpler Devices Tap the Largest Diabetes Market? By Marie Schiller, Andrew Funderburk, Sheela Hegde, and Kathryn Strayer-Benton Historically, technological advances to the insulin pump market have concentrated on slow but steady improvements to the pump's functionality, size and design. What the market hasn't yet experienced are dramatic improvements that would embrace the needs of both type 1 and type 2 diabetes patients while keeping costs low. This may be changing as companies expand their focus on developing simpler, lower cost insulin pumps that will benefit a broad spectrum of diabetes patients and providers. Health Advances Diabetes Practice Group shares its thoughts on the push to move insulin pump therapy into the larger type 2 diabetes population and some of the hurdles that will need to be overcome. request a reprint 09.08: MX Magazine Taking the High Road: Building the Right Foundation for a Medtech Product Launch By Mark Speers, Managing Director and Partner, and Susan Posner, Vice President; Health Advances Many companies launch products onto the medtech market concurrent with their initial FDA approvals in an effort to realize revenue as soon as possible. Delaying a market launch may seem counterintuitive, however having the fortitude to delay revenue may lead to far greater returns. Executives must be careful to differentiate between their regulatory and commercialization strategies. Each device company should carefully consider whether it has amassed the critical clinical and/or economic data necessary to catalyze purchase decisions by physicians and payers before launching. The article describes an analytic approach to optimizing the commercialization plan including launch timing. request a reprint 01.08: InVivo Magazine Biomarker Diagnostics: Place Your Bets Wisely By Kristin Pothier and Donna Hochberg; Health Advances Biomarker diagnostics are critical to achieving the promise of personalized medicine. Unfortunately, building a successful business around such tests is difficult, given the complexities associated with both their development and commercialization. Many biomarkers present the risks of drug development and only the profitability of devices. Therefore, molecular diagnostic companies need to think carefully before they choose a "go it alone" strategy. It may make far more sense to forge a partnership with another diagnostic company or a drug developer with the goal of sharing costs, risks and profits. request a reprint Tools Proprietary Diabetes Forecasting Tool For the past 17 years, Health Advances has analyzed the diabetes market and developed sophisticated product forecasts for its clients. Our work has consistently demonstrated that developing accurate product forecasts in diabetes is more complicated than in other therapeutic areas. Specific factors that make this process more challenging include: Prevalence is growing due to increases in both incidence rates and survival rates Age at diagnosis and rate of disease progression are highly variable Mortality is not directly linked to stage of disease Treatment paradigms are shifting Penetration varies by specialty request more information. learn more about Health Advances' focus on Diabetes.

Health Advances All Rights Reserved.