The medical device industry is experiencing a paradigm shift, marked by disruptive innovation and a more nuanced legal landscape. From regulatory hurdles to technological breakthroughs, the industry is in constant flux. Morgan Lewis provides legal support that helps medical device companies bring rapidly evolving and life-changing innovations to market. We believe in delivering legal solutions that drive business success forward.
Global Market Access Solutions for Now and the Future
We guide medical device companies through the legal implications of cutting-edge technologies, such as:
- AI and machine learning applications
- Telemedicine and digital health platforms
- Wearable and implantable devices
We guide clients through the web of complex global regulations. Our team's in-depth understanding of regulatory frameworks allows us to develop strategies that streamline approval processes and minimize delays and risk. We advise on:
- FDA approvals—IDEs/HDEs, 510(k)s, PMAs, and combination products
- International market entry
- Post-market surveillance initiatives
We leverage our skills to guide clients through regulatory challenges in a manner that can reduce time-to-market and optimize resource allocation.
Protecting Innovation
We safeguard innovations spanning initial concepts to market-leading technology. We advise on the legalities of IP objectives in alignment with business goals, including:
- Patent portfolio management
- Technology licensing agreements
- IP litigation support
Our legal counsel often results in robust patent portfolios that protect core technologies and establish barriers to entry for competitors.
Driving Business Expansion
We structure deals that drive growth and create value across the medical device ecosystem, including:
- Mergers and acquisitions
- Strategic licensing and other partnerships
- Venture capital and private equity investments
- Innovative financing alternatives
Our comprehensive due diligence expertise and proven ability to negotiate favorable agreement terms safeguard client investments while facilitating business growth. Our transactional advice considers regulatory, IP, commercial, and litigation risks to realize optimal outcomes.
Ensuring Market Resilience
Our litigators defend medical device companies faced with high-stakes litigation. We develop tailored litigation strategies that can lessen business disruptions, safeguard reputations, and preserve market positions in the face of:
- Consumer class actions and product liability claims
- Commercial and competition litigation
- White collar litigation, internal investigations, and governmental or regulatory enforcement actions