Plan for Manufacturing Early in the Design & Development Process

The modern product development process combines physical and virtual design review approaches. The outcome of material testing for the basic design variant is utilized to calibrate the simulation model in this technique. Calibrated simulation models are used to improve design parameters and assess system performance over the whole design space. At the end of the product development process, selected physical testing is carried out.

In recent years, the process of developing medical devices has gotten increasingly complicated. The introduction of new technological concepts, tighter regulatory standards, and the growing relevance of reimbursement choices for successful device commercialization necessitate meticulous planning and strategy development, coordinated decisions, and consistent, rigorous business procedures. The design and implementation of such processes, which are frequently documented in development models and supporting standard operating procedures, have become critical determinants of device commercialization success. While there may be many models in the device business, no comprehensive development model has been released.

Current model representations provide a new complete development model that encompasses all elements of device development and commercialization, from early idea selection through postmarket surveillance.

The process includes the following five phases:

(1) initiation – opportunity and risk analysis,

(2) formulation – concept and feasibility,

(3) design and development – verification and validation,

(4) final validation – product launch preparation, and

(5) product launch and postlaunch assessment.

The study’s findings suggest that stage-gate processes are the most commonly used development model in the medical device industry. Regulatory supplies such as the Food and Drug Administration’s (FDA’s) Quality Systems Regulation play a significant role in shaping activities and decisions throughout the process. The findings also highlight the critical distinctions between medical device innovation and medication research and development and the present problems connected with the successful development of a rising number of combination products.

References

Pietzsch, Jan B., et al. “Stage-gate process for the development of medical devices.” Journal of Medical Devices 3.2 (2009).