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Patent Rule Changes: Preparing a Medtech Portfolio
Bookoff |
Earlier this year, the U.S. Patent and Trademark Office (PTO)
proposed several changes to patent practice that could significantly
alter the way in which medical device companies file and prosecute
patent applications. If the final rules closely resemble the proposed
changes—which many industry observers predict they will—medical
device companies that fail to take appropriate action on pending
applications prior to implementation of the new rules may lose
their ability to obtain protection on disclosed inventions.
In this issue's lead story, Les Bookoff, a partner at Finnegan,
Henderson, Farabow, Garrett & Dunner LLP (Washington, DC),
describes PTO's proposed rule changes and their implications for
medical technology manufacturers. He also outlines strategies
that companies should consider when preparing their intellectual
property portfolios for the forthcoming changes.
[ More ]
McClellan to Leave CMS
McClellan |
Telling his staff that it was "a very hard decision," Mark
McClellan, administrator of the Centers for Medicare and Medicaid
Services (CMS; Baltimore), has announced his intention to leave
the agency in early October. He has held the top post at CMS since
March 2004, becoming highly regarded as a skilled and effective
administrator by the device and drug industries, healthcare policy
analysts, advocacy groups, and members of Congress across the
political spectrum. McClellan is seen as a strong advocate for
advanced medical technologies that can demonstrate their
healthcare benefits and cost-effectiveness. His tenure at CMS
was marked by a commitment to streamline the process of coverage,
coding, and payment for innovative devices.
"Mark's leadership at the White House, FDA, and CMS on the most
pressing healthcare issues facing patients will leave a lasting
impact," said Stephen J. Ubl, president and CEO of industry
association AdvaMed (Washington, DC). "His role in the early stages
of the critical path initiative at FDA and the development and
implementation of a new and improved Medicare program with greater
emphasis on prevention and quality of care are important legacies
that he leaves behind. We will miss working with Mark, but we look
forward to his continued leadership on healthcare issues."
[ More ]
FDA Reopens Issue of ID System for Medical Devices
Schultz |
Citing the growing number and increasing complexity of medical
devices, FDA is seeking industry input on the advisability of a
unique device identifier system. The agency mandated a similar
identification system for human drugs and biologics in February
2004. Devices were originally included under the compulsory rule,
but their inclusion was subsequently dropped because of objections
by medical device companies, which asserted that such a requirement
would be difficult to implement across the broad and diverse range
of medical devices and equipment.
FDA's move to resurrect the issue of an identification system for
medical devices follows meetings with various stakeholders and two
commissioned reports. According to Daniel Schultz, MD, director of
FDA's Center for Devices and Radiological Health, "A unique device
identifier system could have broad applications in reducing medical
errors, facilitating device recalls, improving medical device
adverse event reporting, and encouraging cost-effectiveness by
improving delivery and supply chain efficiency."
[ More ]
With Charité on the Rocks, Can ProDisc Succeed?
Viscogliosi |
When Charité gained FDA approval in October 2004 as the first
artificial disk available in the United States, the market forecasts
for the device were quite robust. Sales were projected to reach
$100 million in 2005 and $1 billion by 2010. Yet shortly after
market entry, Charité ran into reimbursement resistance from the
Centers for Medicare and Medicaid Services and private insurers.
Additionally, spine surgeons were slow to embrace the device. The
disk's manufacturer, DePuy Spine Inc. (Raynham, MA), a Johnson &
Johnson company, has acknowledged that adoption of Charité has
fallen far short of initial expectations, with only 6000 implants
in the United States since market entry.
With last month's FDA approval of the ProDisc from Synthes Inc.
(Solothurn, Switzerland), many industry analysts are wondering if
the product will fare any better in the marketplace than Charité.
Anthony G. Viscogliosi, a principal with Viscogliosi Bros. LLC
(New York City), predicts that ProDisc will perform substantially
better than Charité as a result of its "superior design, minimal
invasiveness, extensive surgeon training, and elegant tools, which
ease implantation and consistently yield repeatable results."
Synthes acquired ProDisc in 2003 for $350 million as part of Spine
Solutions Inc., a Viscogliosi Bros. portfolio company. [ More ]
Neurodevices Poised for Significant Growth
Arrow |
According to a report released earlier this month, the number of
patients in the United States with diseases that are potentially
treatable with neurodevices is currently 78 million, or about
28% of the total population. "It's a fragmented market," says
Alexander Arrow, MD, an analyst for Lazard Capital Markets
(New York City) and principal author of the report, titled Medical
Technology for Neurosurgery, Neurology, and Psychiatry. "But it's
one that is beginning to shape the neuro-physician groups that use
these devices—much the same way that early use of arterial balloon
catheters in the 1980s created the interventional cardiology market
that now dominates the cardiovascular space."
According to the report, the global neurodevice market is currently
valued at around $2.3 billion, about 75% of which is in the United
States. The sector is largely driven by devices that have
demonstrated clinical efficacy in treating Parkinson's disease,
movement disorders, epilepsy, brain aneurysms, hydrocephalus, head
trauma, and ischemic strokes, as well as devices employed in
tumor-removing neurosurgery. However, Arrow says he sees significant
future growth potential in neurodevices developed to treat
depression, migraine headache, obesity, and Alzheimer's disease.
Within the next four to seven years, Arrow says that neurodevices
designed to treat chronic anxiety, obesity, bulimia, and
obsessive-compulsive disorder should become available.
[ More ]
FDA to Strengthen Clinical Trials Oversight
Colquhoun |
At the end of June, FDA announced a series of new policy and
regulatory developments intended to strengthen the agency's
oversight and protection of patients in clinical trials and the
integrity of resulting data. Experts in the field agree that the
agency's initiative will have a significant impact on the ways
that medical device manufacturers conduct clinical trials—but
the full implications of the initiative are far from clear.
"The most important aspect of the initiative—which has yet to be
enunciated in a specific guidance document—is the general move
toward increased oversight of medical device clinical trials,"
says Helen Colquhoun, MD, president and CEO of Pleiad Inc.
(Cambridge, MA), a clinical research organization specializing
in medical devices. "There are going to be more inspections of
trial sites, sponsor offices, and clinical research organizations.
This should be of particular concern to medical device
manufacturing executives because many companies still do not fully
comply with the investigational device exemption regulations that
govern clinical trials." [ More ]
Medtronic Plans Marketing Campaign
to
Rebuild ICD Sector
Collins |
At the end of August, Medtronic Inc. (Minneapolis) announced that
it was initiating a nearly $100 million marketing and public
relations campaign to rebuild the market for implantable
cardioverter-defibrillators (ICDs), which has suffered from lower
consumer confidence since a spate of recalls hit the sector last
year. "Candidly, we were surprised by the extent to which the U.S.
ICD market softened during the quarter and particularly at quarter
end, and we are doing everything we can to ensure that this doesn't
happen again," said Medtronic CEO Art Collins during an investor
conference call. For the first quarter of fiscal 2007, Medtronic
reported ICD revenue of $673 million, a decrease of 6% over the
year-ago period.
In the medical device industry, the field of marketing covers a
wide range of activities conducted for an equally wide variety of
purposes. Whether the goal is to build product awareness, announce
the benefits of new technologies, or support industry, medtech
marketing is big news—and big money. For in-depth coverage of
the latest trends in medtech marketing, including the medical
device winners in the 2006 International Awards of Excellence
(In-Awe) competition sponsored by the Medical Marketing Association
(San Francisco), see the September/October issue of MX: Business
Strategies for Medical Technology Executives. [ More ] |
