Healthcare Design and Manufacture of Medical Equipment

Healthcare Design & Manufacture of Medical Equipment

Dickinson Wright seamlessly combines full-service regulatory, transactional, and litigation counsel for medical device developers, manufacturers, wholesalers and other distributors, as well as technology companies newly entering the medical device market. We represent an extensive scope of business entities, from start-ups to mid and large sized companies along with diversified global enterprises. 

 

FDA Regulatory

Our pre- and post-market support through all phases of the FDA regulatory procedures includes tactical compliance activities. In the premarket arena, we advise on regulatory and jurisdictional issues for devices and combination devices and products. We formulate investigational device submissions and prepare and negotiate 510(k) and premarket approval applications.

In a device’s aftermarket phase, we counsel on product modifications, medical device reporting, Quality System Regulation issues, recall, correction, removal and supply chain issues, labeling, advertising and promotion, and import/export issues. This includes Medicare and Medicaid coverage and reimbursement, and device compliance with state distribution and related laws. We prepare responses to FDA Form 483 observations and warning letters. We also represent device companies on all aspects of government sales, contracting and disputes.

 

Intellectual Property

Our IP lawyers commonly formulate and prosecute patent applications, including reexamination, reissue, and interference cases for medical device clients. Through the progress and commercialization of technology, we help clients effectively manage their rights, avoid infringement of third-party rights, and enforce patent rights against others.  This includes negotiating and drafting patent and technology licensing agreements, and enforcing and defending against patent infringement claims. We perform IP audits and due diligence investigations. Our lawyers also render opinions on patentability, infringement, and validity, and coordinate the filing and prosecution of patent applications in the United States and worldwide, particularly in Asia and Europe.

Throughout the product life cycle, the technical insight of our team members with advanced degrees in science and engineering is a significant advantage as they help both innovators and investors assess (and litigate) IP and evaluate R&D and commercial pathways to success.

 
Corporate and Finance

In order to optimize capabilities for research, development, and commercialization of investigational devices and to provide an instrument to share risks and rewards, expertise, and IP, our lawyers structure, negotiate, and implement corporate partnering, financing, merger and acquisition transactions, from early phase research platform deals to manufacturing and other operational agreements and later-stage collaborations. 

Within the medical device arena, the firm focuses on service throughout the product life cycle. The firm’s market-leading corporate, finance, and investment practices, and our strong contacts and presence in the global centers for finance and research, help us craft strategic capitalization solutions that connect companies with venture capital funds, investment and commercial banks, institutional lenders, and other investors. Our depth and scope in this division often involves us in multinational device development, manufacturing, licensing, and related transactions.

In the M&A arena, our lawyers regularly handle transactions involving product acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers, proxy contests, restructurings, leveraged buyouts, and private transactions. Our financing transactions on behalf of device companies, venture capital and private equity firms, and investment banks include senior secured credit facilities, acquisition financings, and refinancing.