Medical Devices: Preclinical Development
Preclinical development encompasses fundamental steps such as the definition of the device specifications, identification of the Mode of Action (MoA), foreseen intended use(s) and indication(s) for use, and the gathering of relevant data to support product safety for a first-in-human pilot 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-principle studies as well as biocompatibity assessments are conducted, as quality control /manufacturing processes are established.
Key challenges encompass:
- Is the primary mode of action well defined and supported by sound scientific data?
- What are the product-related risks, and applicable regulatory requirements in the targeted markets?
- What are the applicable technical standards?
- Are manufacturing processes sufficiently characterized?
- How relevant is the animal model for the proof of principle study?
- Which biocompatibility evaluation should be conducted?
- Will nonclinical data be valid in the targeted international markets to support a first in human pilot study?
- What is the appropriate Notified Body for registration in Europe? Should/could a third party reviewer be used in the US?
- Understand the product’s market, regulatory environment, and market adoption drivers
- Define the Mode of Action, Intended Use(s) and Indication(s) for use
- Identify the regulatory path to the market: define applicable classification and regulatory requirements
- Outline a high-level development plan, based on product risk analysis
- Identify key requirements for analytical methods development and manufacturing processes, regulatory requirements to adapt manufacturing and controls to subsequent stages of development
- Ensure compliance: SOP writing, and audit
- Define nonclinical evaluation plan based on risk analysis
- Identify appropriate partners for preclinical product testing
- Seek regulators’ advice on preclinical program,
- Input regulator’s opinion and requirements into the global development program, anticipate development obstacles, maximize chances to obtain approval for the product to move along the development timeline