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By Stage of Medical Device Development

Preclinical Development

Concept & Feasibility Analyze prototype and concept design Preclinical Development Evaluation of biocompatibility and safety. Analytical validation Clinical Development Assess safety and effectiveness and gather data for registration and market access           Market Approval Assemble and file an application Commercialization & Post-Market Mitigate risk and remain compliant

Evaluation of biocompatibility and safety. Analytical validation.

Early clinical development is primarily composed of human proof of principle/pilot clinical studies – to confirm feasibility in human, explore patient populations and performance claims. Concomitantly, subsequent clinical trials are outlined and prepared for. The appropriateness of the clinical development plan is confirmed during strategic consultations with regulatory authorities/bodies.

Reimbursement environment analysis is undertaken in order to begin understanding any market access challenges, current perceptions of standard of care, define unmet need and gold standard treatments as well as other treatment alternatives.

Client Goals

Clinical studies

Design and conduct pre-clinical studies

Conduct a scientific literature review.

Anticipate critical clinical differences with similar products.


Design product and establish technical documentation file

Prepare essential documentation (e.g. protocol, Investigator Brochure).

Assemble and submit international Clinical Investigation applications.



Generate required evidence for regulatory approval & market access (Health Technology Assessment - HTA, pricing & reimbursement)

Ensure regulatory compliance of clinical trials.


Stage of development: challenges


  • Where is the best place to conduct the study?
  • What are the HTA evidence requirements?
  • Costs & time to complete the study?
  • What market share can be expected?
  • What will be the market access roadmap and the key stakeholders to address?
  • What are the appropriate funding and supply channels?
  • Does the development plan fit in with regulators’ and HTA’s evidence requirements?
  • When & how to scale-up manufacturing processes?
  • Product Development Design Review?
  • Quality Management System audits?

Our Mission

Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.

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