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 medical device global development plan.
Especially for breakthrough technologies, a dialogue is often initiated with regulatory bodies, on the product development plan and registration strategy. Bench tests, animal and proof-of-concept studies as well as biocompatibity assessments are conducted, and quality control /manufacturing processes are established.
Understand the market potential
Identify the regulatory path to market access: define applicable classification and regulatory requirements.
Design and conduct preclinical studies, analytical and manufacturing processes
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.
- Is the primary Mode of Action (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 is the animal model for the proof of principle study?
- Which biocompatibility evaluations are appropriate?
- Will nonclinical data be valid in international markets to support a first in human pilot study?
- What is the appropriate Notified Body (NB) for certification in EU or Approved Body in the UK? Is there a need for a third-party reviewer for the US?
- What are the needs related to Quality Management System at this stage?
- Need for product Development plan and Design Control?