Freshfields MedTech Update Q1
As expected, the exponential growth of MedTech has continued in the first quarter of 2022. Although we are seeing heightened focus on increasing access to care, innovators continue to face a patchwork of laws, rules, and norms across the world.
In response, businesses are taking an increasingly global approach to the development and deployment of their MedTech offerings, as evidenced by some of the key trends in Q1 and associated legal considerations.
A More Inclusive Approach to Health – FemTech, Aging in Place and Hospital at Home
Through greater use of MedTech, including telemedicine, wearables and remote monitoring, we are seeing an increased blending of the consumer and clinical worlds. The merger of female-focused virtual care company Nurx with telehealth unicorn Thirty Madison has put FemTech firmly in the spotlight. The early months of 2022 have also brought growing interest in supporting the elderly and their caregivers with additional care at home, with many cutting edge intellectual property and data-driven collaborations underway globally among consumer electronics companies, tech titans and medical device manufacturers.
Continued Growth of Digital Therapeutics in an Uncertain Regulatory Environment
We are seeing an increasing number of digital therapeutics companies working with pharma companies, as well as other established players across a variety of industries, to create digital therapeutics that enable patients to take greater control of their care, e.g., Pear Therapeutics’ agreement with SoftBank to develop a digital therapeutic for sleep/wake disorders for the Japanese market. Entrants in this area face an uncertain regulatory framework across jurisdictions, including in the United States, as the Food and Drug Administration (FDA) recently acknowledged the need to modernize its regulatory pathways for software-as-a-medical-device (SaMD) products. As clinical evidence, increased reimbursement, and market demand continue to support the growth of this field, we expect additional guidance from regulators around the world.
Integrating Robotics into Healthcare
Robots are increasingly being used to assist during surgeries, help patients recover post-surgery, diagnose conditions, and enhance telemedicine. Complex partnerships in this space, including Medtronic’s recently announced contract with Vizient, Inc., are enabling the integration of AI-powered surgical platforms with robotic-assisted surgery systems. Such multi-party digital ecosystems give rise to a variety of considerations, from protection of novel types of data to increasingly nuanced models for allocating risk among manufacturers, hospital systems and other purchasers of robots, and users of the technology.
Our MedTech team
Vinita Kailasanath Partner
Dr. Philipp Dohnke Partner
Giles Pratt Partner
Dr. Christoph Werkmeister Partner
Sharon Malhi Partner
Rod Carlton Partner
Menachem Kaplan Partner
Dr. Michael Ramb Partner
Timothy Harkness Partner