A strong clinical strategy is essential for bringing safe, effective, and compliant medical devices or IVDs to market. We provide a 5-step Clinical Strategy Roadmap that integrates planning with submission timelines. A Guidance Document that helps you from early development to post-market success.
Step 1: Research the Market
Understanding current medical practice in a specific disease area is essential for the launch of a new device. Researching legacy devices can determine if risks have been mitigated by modern designs or clinical outcomes have shifted in response to new research. Research methods can be focus groups, surveys, or a literature review.
Step 2: Know Your Audience
The user could be a patient and/or a health care provider. The strategy should include an assessment of the ease with which the user interacts with the device and how much of a benefit the patient receives. Regulatory agencies are also important, since the clinical evidence requirements differ globally.
Step 3: Set Marketing and Sales Claims Appropriately
A cross-functional team is essential to establish claims. Knowing claims early on will ensure a successful strategy. Once you know the landscape in which the device will be used, the regulatory agencies involved and user preferences, a clear roadmap can be built using both clinical literature and device data.
Step 4: Design Data Collection Plans
Once the claims are identified and clinical outcomes are set, data collection plans can be designed. This can involve systematic literature reviews, patient or healthcare provider surveys, device registry searches, or clinical investigations, depending on the nature of the claim and regulatory requirements.
Step 5: Implement, Evaluate outcomes, and Present Data
Implementation of data collection plans should keep regulatory submission deadlines in mind. Data collection can be tiered to meet various stages of the regulatory process. Outcomes should be reviewed periodically to ensure all claims are supported. Data should be presented in a scientifically sound manner with clear links to regulatory requirements.
Schedule a Meeting for Expert Guidance
Book your free 30-minute consultation with one of our clinical strategy specialists. We'll review your current approach, identify gaps, and provide initial guidance tailored to your device and regulatory goals.