New technologies and innovation are promoting a transformation in the medical devices sector, bringing with it numerous benefits to patients across the globe. As the adoption of these new technologies continues to rise, so do its challenges, including radically changing regulatory developments.
We work alongside our clients to help them develop strategies to bring their products to market. We also advise on regulatory aspects of clinical evaluation and studies with devices, interactions with relevant regulatory authorities, legal aspects of materiovigilance and product recalls, and advertising and promotion rules, pricing and reimbursement.
Our global network of lawyers focused on the healthcare and life sciences industry ensures compliance with fast-changing regulations, which are increasingly being shaped by the digitalization of medical devices. With the acceleration of digital health solutions, healthcare and life sciences companies are forced to address the mounting pressures to protect patient data with renewed emphasis as health data is both highly sensitive and extremely valuable as an asset in its own right. In addition to dealing with challenges around doctor/patient confidentiality, companies are also coping with differing national data security standards that intersect with regulatory laws. We help life sciences companies keep up with the rapid pace of change by advising on all aspects of data compliance including analyzing various hurdles related to patient data, which includes data privacy, medical confidentiality and liability. A part of this effort includes reviewing existing policies around patient data protection and how they are being applied, while providing regular internal guidance and training for staff.
We assist our clients with all types of medical devices, including diagnostics and diagnostic systems, infusions, interventional solutions, medical and surgical equipment, medical laboratory equipment, and Software as a Medical Device and combination products across a wide range of legal, regulatory and business strategy issues involved in the development, manufacture, registration, pricing, reimbursement, marketing, sale and distribution of medical devices. Such assistance involves a broad range of practice areas such as merger and acquisitions, licensing, regulatory, employment, intellectual property, product liability, compliance and investigations, antitrust and tax.
We have been involved in some of the biggest transactions in the global medical device space. Our clients turn to us for our extensive experience in negotiating, closing and integrating complex cross-border mergers and acquisitions, licensing and collaboration agreements, venture capital financings, corporate governance, and other commercial arrangements.
We also have an established history of working with medical device companies on high-stakes patent litigation and brand management matters. Many of our patent lawyers have advanced degrees in a wide array of technical disciplines and are experienced in handling patent infringement actions before courts globally. We have a deep understanding of the specific issues and challenges affecting the healthcare and life sciences sector such as preparing and negotiating licensing and other technology transfer agreements for complex technologies in cutting-edge areas, including nanotechnology, genomics and proteomics. Second to none in terms of global strength and depth, our firm can protect and enforce copyright, patent and trademark rights and our lawyers are well placed to help decide next steps when infringing products are detected.
How We Can Help
Explores trends and opportunities in digital health from the perspective of three key players in the ecosystem: healthcare and life sciences organizations, technology companies and investors