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 Taking products that have been commercial successes in research to the clinical diagnostic market requires a new set of business strategies and tactics to be effective. BioScience Business Solutions understands what needs to be done internally to move companies into this business sector quickly. Our experience in regulatory issues, reimbursement, product positioning, and sales operations work to your advantage, reducing the time from market entry to a return on investment.
We can help you in the following areas:
- Understanding the clinical diagnostic market industry with a focus on customer targets, what motivates them to buy, how to introduce new technology for quick acceptance, and the best way to educate them on your company.
- Product regulatory issues-manufacturing requirements, laboratory operations requirements, FDA product approval requirements.
- Legal issues-how to navigate within FDA guidelines and requirements, what Stark guidelines are and requirements, ethical guidelines for proper product introductions.
- Product re-imbursement strategies-payer types and what they require for product validation and use, coding, the contracting process, billing and getting payment, patient billing verses healthcare payer issues.
- How to effectively market your products---product positioning, customer education, database marketing programs that generate sales quickly.
- Sales strategy and implementation---going direct, with partners, or through distribution channels, skill sets and training necessary for an effective sales organization, tactical plan, including the best interface with marketing and business development activities.
Case Study : BioScience Business Solutions was hired by a public genomic microarray company to assess the opportunity of taking their platform and chip products into the clinical diagnostic market sector. We were asked to do an analysis of the market, identify thought leaders and interview them, determine how their products would need to be modified to sell into the market, outline the regulatory and re-imbursement issues, and develop the strategic and tactical plan for the company to maximize market entry. Our report was presented to the senior management team, resulting in a decision to invest resources to pursue clinical diagnostics as a new customer segment.
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