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By Stage of Medical Device Development

Concept & Feasibility

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

Analyze prototype and concept design.

Early development encompasses fundamental steps such as the definition of the device specifications, foreseen intended use(s) and indication(s) for use, and the gathering of relevant data to support product safety for a feasibility study. A thorough risk analysis is performed to support the product global development plan.

Especially for breakthrough technologies, a dialogue is often initiated with regulatory bodies, on the product development plan and registration strategy. Test benches, animal proof-of-concept studies as well as biocompatibity assessments are conducted, as quality control /manufacturing processes are established.

Client Goals

Market access

Understand the market potential

Identify the regulatory path to the market: define applicable classification and regulatory requirements.

Clinical studies

Design and conduct preclinical studies, analytical and manufacturing process

Define nonclinical evaluation plan based on risk analysis.

Identify appropriate partners for preclinical product testing.

Strategy planning

Set up the overall product development plan

Identify key requirements for analytical methods development and manufacturing processes, regulatory requirements to adapt manufacturing and controls to subsequent stages of development.

Stage of development: challenges


  • Is the primary MoA well defined and supported by sound data?
  • Understanding the market and identifying the right commercial or product strategy.
  • What are product-related risks, applicable regulatory requirements & technical standards?
  • Product classification?
  • Are manufacturing processes sufficiently characterized?
  • How relevant the animal model for the proof of principle study?
  • Which biocompatibility evaluation?
  • Will nonclinical data be valid in international markets to support a first in human pilot study?
  • What is the appropriate NB for registration in Europe? Do I need a 3rd party US reviewer?
  • Needs related to Quality Management System?
  • Need for product Development plan and Design Control?

Our Mission

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

Advance with us

What VCLS Can Do

What VCLS Can Do - Services
  • Analyzes the product’s market potential, regulatory environment, pricing and reimbursement potential
  • Develop a strategy in response to the competitive & reimbursement landscapes
  • Identify the market potential of the product (pricing and reimbursement)
  • Obtain early feedbacks from regulators to best plan the product development
  • Identify applicable GLP, Design Control requirements
  • Support in establishing Quality Management Systems incl. audits

VCLS Expertise