Tamara Mills

Tamara Mills

Role: Invited Speaker
Affiliation: Founder, MTL MedTech Network & Fundamedtech;
Director, Cardiovascular Diagnostics Business – Jubilant

Talk Title: Thinking of commercializing your Mobile Medical Device in the United States? Market Access 101 for Complex Digital Health Products

Abstract: The medical technology industry is one of the most highly regulated and has some of the highest barriers to entry. Novel medical technologies must meet stringent regulatory requirements and generate sufficient evidence for payer coverage in order to attain market authorization and market access. Navigating the complex regulatory environment surrounding innovative digital health and mobile health technologies is often left until too late in the development process, requiring significant re-engineering and often a complete product strategy change. Devising an executable regulatory and market access strategy to ensure future payer coverage and reimbursement upfront is critical articulating your medical technology into a convincing business strategy, accessing funding and ensuring product success. This presentation will provide an overview of what digital health start-ups, engineers, health professionals and entrepreneurs should keep in mind when developing a ‘Mobile Medical Device’ with the US market in mind. 

Bio:

Tamara Mills is founder of the Montreal Medtech network, a community focused on bringing together the scientific and business minds of local medical and health technology development in an effort to support the growth of local innovative MedTech. The network provides a forum for those interested in innovative health tech to see what is happening locally & providing an open collaborative network of passionate experts from various backgrounds to drive MedTech and digital health start-ups forward.

Tamara is also Founder and CEO of Fundamedtech, an incubator that supports health technology start-ups and academic/research groups in accelerating healthcare innovations from concept through to commercialization. Fundamedtech is a novel medical technology start-up incubator in that it specializes in highly regulated mobile medical device, digital health and combination drug products that have the potential to significantly  improve patient outcomes and change the health care paradigm.  While most health technology accelerators and incubators steer clear from ventures pursuing the development of complex medical technologies requiring pre-marketing authorization, the core focus of Fundamedtech.

Tamara has over 10 years of global experience in the development and commercialization of highly regulated, pharmaceutical products, software driven medical devices and combination drug products.