Market Strategy

EC Services: Market Strategy

Plan to Succeed

Commercial success requires a lot more than a cleared product and a good ad campaign. It’s a set of decisions that should drive all other activities.

Market strategy begins with a deep knowledge of the competitive environment, but that’s just the baseline.

A truly effective market strategy is one that puts the needs of providers, patients and payers at the center of key decisions. If those needs aren’t identified and pursued, success will be very difficult to achieve.

Key Considerations

From research to commercialization, a typical IVD project undergoes many thousands of small decisions. Many of these decisions have the potential to significantly expand or limit the commercial value of the product.

Determining the best strategy for a particular product will include addressing a number of questions, such as:

  • Who is our customer? A laboratory? A physician? A patient?

  • How will we demonstrate clinical utility?

  • Is it better to seek approval quickly for a limited indication or invest the time to gain a more expansive claim?

  • How will claims and evidence affect treatment decisions, patient incentives and payer support?

  • What does the competitive landscape look like?

  • What is the historic context? Has this been tried before?

  • How do I develop regulatory and reimbursement strategies that work together?

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Related Information

Regulatory Strategy
Clinical Services
Design Control
Product Development
Quality Systems
Enlightened Compliance Overview

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Glossary Terms

Clinical Utility
In Vitro Diagnostic (IVD)