Medical Devices

Serving the Medical Device Industry

With new technology being developed every day, health care reform a top priority and expanding growth opportunities for medical device companies, having legal counsel that understands the industry is imperative.

With decades of experience representing medical device companies, attorneys in Saul Ewing’s Medical Device Practice have the practical knowledge and expertise necessary to advise clients on how to succeed in this tough financial and heightened regulatory environment. Our attorneys are prepared to assist you in protecting your intellectual property, acquiring the financing you need to get your medical device to market, navigating the regulatory waters to get your device approved for reimbursement and dealing with any claim that may arise which threatens the financial interest of your company.

Attorneys in the Medical Device Practice represent clients across the spectrum of legal needs, including:

Intellectual Property

• Identify protectable trademarks and register them
• File and prosecute patent applications
• Manage patent and trademark portfolios
• Guide companies through due diligence conducted by potential investors  

Corporate

• Assist companies with forming and structuring medical device companies
• Counsel clients with respect to hiring and incentivizing employees, contractors and board members
• Draft and negotiate contracts with manufacturers, strategic partners and clinical sites
• Assist with angel, venture and/or private equity financing
• In-license and out-license technology  

Regulatory and Compliance

• Prepare and file regulatory approval applications with the FDA
• Assist companies with compliance, including avoiding violation of off-label promotion
• Assist with payment and reimbursement matters

 Litigation

• Defend product liability lawsuits
• Prosecute or defend intellectual property infringement suits
• Prosecute/litigate breach of contract and misappropriation of trade secrets claims
• Counsel medical device manufacturers on risk management  

Saul Ewing Medical Device Roundtable Program

To advance the interests of start-up and growth stage medical device companies in its regional footprint, Saul Ewing has developed its Medical Device Roundtable Program. The monthly roundtables bring together executives from start-up and growth stage medical device and diagnostic companies in an open forum to exchange substantive knowledge and experience on shared topics of interest. To view the topics and dates for the 2012 Medical Device Roundtable Program, please click here.  

Publications and Affiliations

In addition to their legal practices, several of the group's attorneys have edited and contributed to books including Top 20 Food and Drug Cases, 2009 & Cases to Watch, published in 2010 by the Food and Drug Law Institute; Defending a Pharmaceutical, Medical Device, or Biotechnology Client in a Government Investigation: Key Issues for Clients and Attorneys, published in June 2009 by Aspatore Books, and Off-Label Communications: A Guide to Sales and Marketing Compliance, published in August 2008 by The Food and Drug Law Institute. Attorneys also frequently speak at national conferences and symposiums that address trends relevant to the medical device industry. They also active in the industry, serving on the Medical Devices Committee for the Food and Drug Law Institute, Pennsylvania Bio, BioStrategy Partners, Association for the Advancement of Science and the Association of University Technology Managers.

Experience

Intellectual Property

• Counseled healthcare facilities on intellectual property matters, trademark and copyright registration, licensing, copyright infringement, and software and website development contracts
• Counseled a major pharmaceutical company on matters involving criminal trademark litigation
• Defended a neutraceutical company in federal trademark infringement and unfair competition claims

Corporate

• Drafted organizational documents for numerous medical device companies, including stock option plans and scientific advisory board agreements
• Advised medical device company on employment and restrictive covenant matters
• Represented underwriters in public offering involving medical device company
• Counseled NASDAQ-traded medical device and biomaterials company on manufacturing, supply, and development agreements involving various strategic partners

Regulatory and compliance

• Obtained Section 510(k) approvals
• Negotiated against regulatory efforts to have company withdraw medical device
• Counseled various medical device companies on payment and reimbursement issues
• Assisted in obtaining insurance coverage and payment arrangements for proton beam therapy
• Counseled medical device company on compliance program

Litigation

• Defended product liability claims involving medical devices such as fetal monitors, intraocular lenses, cataract and vitreoretinal surgical devices, intrauterine devices, laboratory test equipment, latex products, medical exercise equipment, medical packaging, medical restraints, pedicle screws, piercing guns, silicone implants, and wheel chairs and lifts
• Counseled a multinational pharmaceutical and medical device company on matters concerning advertising, promotion, and complaint-response issues
• Counseled medical device manufacturers on products liability risk management issues