Assess safety and effectiveness and gather data for registration and market access.
The main objective of clinical development is to evaluate the medical device risk/benefit balance during pivotal clinical studies and hence further substantiate the labeling claims. The product is tested in patient populations, and ideally compared with the therapeutic gold standard or direct competitor.
Health economics data are also gathered, to prepare for demonstrating the product’s value to payers.
Client Goals
Design and conduct clinical studies
Prepare essential documentation (e.g. protocol, Investigator Brochure).
Oversee execution and ensure regulatory compliance of clinical trials.
2. Generate required evidence for regulatory approval & market access (Health Technology Assessment, pricing & reimbursement)
Prepare Pre-Submission for Pivotal Study for the Food and Drug Administration (FDA).
Prepare Investigational Device Exemption (IDE) for the FDA.
Assist in Investigational Review Board selection and approval for US studies.
Challenges
- How to obtain endorsement from regulators and payers on the late-stage clinical development strategy?
- Which clinical endpoints would address both regulators’ and payers’ requirements?
- How to articulate medical device development across multiple geographies?
- How to communicate the product value to different stakeholders?
- What must be done for launch readiness and access?
- Will clinical data be robust enough to support market clearance in international markets?
- How to develop the product value dossier?
Solutions 
