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
Understand the market potential
Identify the regulatory path to the market: define applicable classification and regulatory requirements.
Design and conduct preclinical studies, analytical and manufacturing process
Define nonclinical evaluation plan based on risk analysis.
Identify appropriate partners for preclinical product testing.
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.
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?
Solutions 
