SOURCE: Cutting Edge Information

Cutting Edge Information

May 31, 2016 09:26 ET

Class III Breakthrough Devices' Development Budgets Total 10 Times More Than Class II Devices

RESEARCH TRIANGLE PARK, NC --(Marketwired - May 31, 2016) - The average total commercial investment for a device in development 48 or more months is 10 times greater than the average commercial investment for devices in development for 23 months or less. The increase in budgets is largely due to the lengthy duration of complex Class III device development, according to primary research conducted by business intelligence firm Cutting Edge Information.

"There is a clear association between duration and overall commercial investment," said Victoria Cavicchi, research analyst at Cutting Edge Information. "The only phase with no obvious link between budget and duration is Manufacturing-Ramp up."

In its recent study, Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, a positive correlation is proven between spending and duration of development. In the concept and prototype phase spending increases an average of $75,000 per extra month. In the development and final design phase it increases an average of $410,000 per month. Controlling the duration of development can come with significant savings as lengthy clinical trials or manufacturing delays can add substantial investment costs.

The total commercial investment is directly dependent of approval pathway and product type. Some Class II development line extensions have low investment totals close to one billion dollars, but breakthrough devices in Class III can total more than $10 billion during development. To ease budgetary pressures during development, companies need to organize and minimize development time.

Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, available at http://www.cuttingedgeinfo.com/research/marketing/medical-devices/, explores the resources and best practices necessary to support new product planning and commercialization for US-based medical device launches. This benchmarking study, conducted through primary research, includes:

  • Profiles of 11 medical device firms and their products, highlighting human and financial resources supporting development and commercialization, product development timelines and expected commercial success.
  • Data on anticipated US commercial success, including market size, market share and competition levels.
  • Commercial board staffing benchmarks as well as best practices for integrating stakeholders across multiple firms and communicating throughout the development process.
  • Expert insights on selecting the best regulatory pathways for emerging medical technology products, implementing clinical trials and partnering to support development.

To learn more about Cutting Edge Information's primary benchmarking research on medical device development and commercialization or other life sciences topics, please visit http://www.CuttingEdgeInfo.com.

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