Benchmarking US early-stage product management, promotion

Cleveland, Ohio – As medical device manufacturers face increasing competition in a saturated market, companies must begin commercialization early in the product lifecycle.

However, it is a challenge for teams to acquire the appropriate personnel and financial resources – either internally or elsewhere – to adequately support emerging medical devices throughout development.

This report serves as a guide to medical device manufacturers that are undertaking new product planning and early commercialization initiatives for U.S.-based launches. Because each product is different, the study profiles 11 devices, including product support and investments, unique approaches to product development and commercialization, and the human and financial resources needed to support these processes.

From identifying best-fit regulatory pathways to selecting partnerships and acquisitions for optimal product commercialization, Medical Device Development also presents key strategies for maximum product success.

Medical device executives working in a variety of functions, including product management, marketing, strategic management, R&D, new product planning, business development will get the following benefits from this report:

• Profiles of 11 medical device manufacturers and their products, including resources for development and commercialization; competition levels; and product technology
• Data on expected commercial success, including market size versus peak annual sales, market share and competition levels in the US market
• Metrics detailing device product novelty (innovation level) – breakthrough, adjacent, and line extension – as well as the origins of underlying device technologies
• Benchmarks for commercial board staffing across four major product development stages, broken down by device class, company/company size, function and eight key therapeutic areas
• Benchmarks showing commercial board investments and expenditures per development phase and device class
• Strategic guidelines and expert advice on correctly choosing a product’s regulatory pathway, forging partnerships or making acquisitions to support development, and compiling health economics data for product value stories
• A case study on the best-fit regulatory pathway for a diagnostic, highlighting use of Clinical Laboratory Improvement Amendments (CLIA)

Key questions that this study answers

• 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?

Top reasons to read this 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.

Source: Cutting Edge Info