Top Reasons to Read 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.
Key Questions That This Study Answers about Medical Device Development
- What key factors influence medical device commercial investments? How much time and money should be allocated for Class 2 and Class 3 products at each development stage?
- Why is it important to establish a commercial board and a dedicated marketing group early in development?
- How many people should a commercial board have, and what functions should be involved on these boards?
- What kind of competition can a product expect based on novelty, class or therapeutic area?
- Why might it be advantageous to run clinical trials even if they are not required for approval?
- How do partnerships and acquisitions expand company/product support and commercialization capabilities?
- How can medical device executives best prepare for a payer’s demands for health economics data and proof of product value?
|Publication Date||April 2015|
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