Medical Device

We Know the Business of Medical Devices

At Saul Ewing, we understand that medical devices are different from pharmaceuticals – in everything from study size and design to the effect of user experience on performance to diversity in procurement mechanisms and changing price dynamics. With healthcare reform in flux, regulatory changes creating increased unpredictability, and competition for deals and financing at an all-time high, now more than ever it is important to have legal counsel who understand your company and your industry.

Many of Saul Ewing’s attorneys had careers before they went to law school. We are engineers and scientists, accountants and analysts, bankers and entrepreneurs. As such, we understand the practical realities and industry pressures facing your business.

We counsel medical device clients across the spectrum of size and stage of life:

Start-Ups

• Assist companies with forming and structuring medical device companies
• Identify and protect intellectual property
• Counsel clients with respect to hiring and incentivizing employees, contractors and board members
• Assist with angel, venture and/or private equity financing
• Guide companies through due diligence conducted by potential investors

Growth Stage Companies

• Draft and negotiate contracts with manufacturers, strategic partners and clinical sites
• In-license and out-license technology
• Prepare and file regulatory approval applications with the FDA
• Assist with payment and reimbursement matters

Established Companies

• Assist companies with compliance, including avoiding violation of off-label promotion
• Counsel manufacturers on risk management
• Assist in mergers, acquisitions and divestitures
• Defend product liability lawsuits
• Prosecute or defend intellectual property infringement suits

Supporting the Industry

Saul Ewing is committed to supporting the medical device industry and helping to build out the necessary infrastructure in its regional footprint. The firm is a proud sponsor of AdvaMed 2012. It is also an active participant in statewide trade associations, helping to develop and fund device-specific programming and education. To advance the interests of start-up and growth stage medical device companies, 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.

Publications and Affiliations – Knowledgeable attorneys getting the word out

We literally "wrote the book" on Bringing Your Medical Device to Market, John Reiss, copyright 2001. In addition, several of our attorneys have edited and contributed to books including Analyzing the Laws, Regulations and Policies Affecting FDA-Regulated Products, published in 2011 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 and Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011, published in 2010 and 2011 by the Food and Drug Law Institute.

Experience

• Represented major medical device manufacturer with evaluation and in-licensing of a variety of technologies relating to the spine and general orthopedics
• Represented start-up medical device company in negotiating first license ever granted by one of the top-ranked pediatric hospitals in the nation
• Representing medical device company with extensive Department of Defense grants in licensing wound care technology
• Represented several R&D companies in sponsored research agreements, including licensing agreements, for technologies such as gene therapy, non-narcotic pain relief and devices to assist in abdominal surgery
• Represented established R&D company targeting women's health issues on a variety of licensing and joint venture matters with the World Health Organization, a leading research university and one of the world’s largest consumer health companies
• Represented strategic investor/turn-around specialist in acquisition of assets from medical device company to obtain technology and subsequent initiatives to enhance value of intellectual property through range of licensing, collaboration and development agreements, and subsequent divestiture of business
• Represented early stage medical device company with in-licensing from university, and subsequent out-licensing to international medical device company focused on cancer treatment, radio-surgery and x-ray imaging
• Represented publicly traded manufacturer of analytical instruments in multiple Strategic Alliance Agreements, including collaborative research and licensing agreements, with various pharmaceutical and chemical companies, both domestic and international
• Represent various health care providers in the construction and installation of six of the first proton therapy facilities in the United States
• Represent medical device manufacturer in patent infringement litigation