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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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