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In Vitro Diagnostics: Development Through Postmarket
Cutting Edge Information, Jan 2008, Pages: 98
Make the most of limited resources by benchmarking IVDs' budgets and staff support for development, marketing, reimbursement and sales.
To achieve commercial success, in vitro diagnostic (IVD) companies must earn the approval of several different groups. Regulators, payer organizations, healthcare providers and laboratory technicians ultimately determine the value of a product -- and how well it will do in the market. For that reason, strategic market-focused product development and effective commercialization are crucial.
Slim margins and tight budgets, however, make it a formidable task to design and promote an IVD with a clear picture of the market. To help teams achieve success in their IVD development and marketing efforts, this report provides high-level data benchmarks in these key areas:
-IVD development investments, timelines and processes
-Marketing organization budgets, structures and staffing
-Reimbursement resource allocations
-Sales force staff headcounts and budgeting
-Postmarket IVD management and monitoring
Sample Content:
(Excerpted from Chapter 2: Diagnostic Product Development)
Duration of Development Stages
It is impossible to present a standard benchmark for the amount of time it takes to develop diagnostics products. While the evolution of some products takes more than 10 years, other IVDs fly through development and hit the market in less than three years.
These large variations are present in the data collected for this study, as shown in Figure 2.4 [data figures appear in complete report, but not online]. Total development time from concept to market launch range from Brand 1’s 15 years to Brand 4’s 14 months. The average development time across surveyed companies is slightly more than four years from concept to launch.
IVD development time depends largely on where companies “jump off” with their new products. While some companies’ products are brand new technologies, other diagnostics are conjugations of existing products and technologies. Usually, developing an entirely new diagnostic requires significantly more time than improving on an existing product line. Engineering, regulatory, and marketing hurdles are all lower for IVD conjugations.
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