Publication Date: April 2015
Top Reasons to Buy This Medical Device Development Report
Leverage clinical trials to supplement FDA submissions and to enhance marketing messages: Although the FDA only requires clinical trials to support Pre-Market Approval (PMA) submissions, both PMA and pre-510(k) submissions can benefit from clinical data by earning more extensive claims than those submissions without clinical trials. Clinical trials may also satisfy anticipated questions from the FDA, thereby expediting regulatory clearance. This report includes medical device companies’ strategies for successful early commercialization for products launching in the US market, including the percentage of companies using specific regulatory pathways.
Manage commercial board size and responsibility to limit delays and keep communication open: Resourcing commercial boards appropriately, both in terms of adequate numbers as well as the right mix of functions, is crucial for product success. It is necessary to have several groups providing input and sharing information while maintaining the appropriate lines of communication. This report examines commercial board staffing and spending in detail. It also includes data on how different functions can most effectively contribute their expertise and experience to commercial teams.
Look to partnerships and acquisitions to maximize resources during product development and commercialization: Because medical device development and commercialization consume a lot of resources, many device manufacturers look to partnerships and acquisitions to aid a number of processes. Medical device companies can use acquisitions to gain businesses, intellectual property and technology, or any combination thereof. Medical Device Development features data that highlight the prevalence of partnerships and acquisitions for surveyed companies supporting Class 2 and Class 3 products.
Excerpt from Medical Device Development
Medical device manufacturers face a number of challenges — from growing numbers of competitors to attaining the resources needed to support development — moving their products through development and into today’s saturated market. Because the commercial landscape is so competitive, organizations must begin commercialization processes early in the product lifecycle — sometimes as early as concept and prototype development. However, commercialization teams need the human and financial resources — either internal or through partnerships — to support emerging products throughout development.
This report serves as a guide to medical device manufacturers that are undertaking new product planning and early commercialization initiatives for US-based launches. Because each medical device product is different, this study profiles 11 companies’ devices, product support and investments. After presenting these unique approaches to product development and commercialization, this study examines the human and financial resources needed to support these processes. Appropriately resourcing commercialization boards allows teams to better support product launches.