Medical Devices
Creating and commercializing a cutting-edge medical
device is demanding work. Remaining compliant in theface of ever-increasing regulation makes that job evenmore difficult.
We leverage the vast experience gleaned from guiding
companies of all sizes through the hard-to-navigate
health care environment. We ask the right questions
and explore uncovered possibilities to put your productin the best position for success.
Our team of medical device lawyers, scientists, andregulatory specialists arm you with the knowledge andsecurity you need to address each issue that occurs in
regulatory clearance or approval, post-market
enforcement, patents, financing, manufacturing,distribution, and more.

Representative experience
Obtaining the FDA’s designation of expedited review
status for a novel orthopedic and women’s healthdevice and negotiated favorable review timetables.
Instrumental in shepherding the development, clinicalstudy, and review to achieve FDA approval of a novel
synthetic cartilage implant to treat osteoarthritis in thegreat toe.
Conducting due diligence for investment bank on
medical device startup, uncovering several important
FDA issues that substantially altered the target’svaluation.

Contacts
Randy J. Prebula,
Washington, D.C.

Dr. Jörg Schickert,
MunichJodi Scott,DenverMichael S. Heyl,
Washington, D.C.

Industries
Life Sciences and HealthCare

Advising a U.S.-based national trade association thatprovides educational assistance to medical technology
companies in Chinese medical device reimbursement
rules and policies.
Coordinating the defense of a manufacturer of
implantable class III medical devices against alleged
liability in clinical trials after a voluntary worldwide
product withdrawal.
Assisting a medical device manufacturer withinvestigations by the authorities, criminal
investigations, and civil proceedings arising out of theover-exposure of patients to radiations.
Representing a leading medical device manufacturer ina global recall of one of its products in more than 70
countries.
Instrumental in the initial PMA approval for the firstever device to treat glioblastoma multiforme, and in thesubsequent PMA approval to expand the indication ofthis technology to a broader patient population.
Assisting a client in obtaining the first waiver from theFDA under the Clinical Laboratory Improvement
Amendments (CLIA) for a syphilis screening test.
Helping a major device company draft acomprehensive set of Standard Operating Procedures(SOPs) and developing a program to train regulatory
personnel in these SOPs.
Defending a company during a federal criminal
investigation of alleged violations, and during theclient’s ensuing negotiations of a criminal plea and civil
settlement agreement with the DOJ and HHS’.
Developing policies and procedures to help clientscome into compliance with federal and state clinical
trial disclosure requirements.
Advising a medical device client on its European patent
strategy relating to the launch of its adrenaline
autoinjector product, including proceedings in the EPO
and UK courts relating to a competitor’s patent.

Advising in a global patent litigation strategy in relation
to patents for medical imaging.
A medical device client was about to launch an IPO
when it received an FDA Warning Letter. We evaluatedthe significance and helped draft disclosures to ensurecompliance with SEC requirements.
Assisting a company to reverse Medicare’s national
noncoverage decision and secure reimbursement byobtaining an “inpatient new technology add-on” and a
Medicare Severity Diagnosis Related Group
reclassification.
Representing a trade association for medical device
manufacturers for over the last 12 years on coding,coverage, reimbursement issues; the medical device tax;
and other legislative and policy issues.

Latest thinking and eventsMedia mention
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The American Bar Association’s 33rd National Instituteon Health Care Fraud