In the feasibility phase, all aspects and options for design should be researched and explored, which will avoid wasting time and spending more money in the back end when problems require “do-overs.”
Here are the five primary risks to mitigate prior to design freeze :
1) Team: Be sure your team has the two most important qualities: Experience and breadth of skill. An inexperienced team will often find themselves deep into product development before problems arise.
2) Materials: A team with narrow experience of materials may not know what materials will produce the best outcome for the patient, or how materials interact with each other. This can create a time bomb waiting to go off well after design freeze.
3) Supply chain: Supply chain issues need to be explored during feasibility. Determining which materials to use in a laboratory is one thing; understanding the availability of materials for manufacturing is another. If the materials needed are not abundantly available, transfer to manufacturing will be difficult if not impossible.
4) Testing: Bench testing, anatomical model testing, early feasibility clinical studies, and accelerated aging testing are all important aspects of the research phase. With extensive testing prior to design freeze, you can address any issues head on, saving time and money later.
5) Documentation: Often organizing documentation is put off until the end, when it becomes a huge catch-up activity – and a huge liability for audit and regulatory requirements. A compliant quality system, implemented at the start of the project, is a must.
Your napkin sketch may seem months away from design freeze, and product approval in the even more distant future, but risk mitigation begins when your project begins. Don’t wait to put the processes in place to make your project plan flow as smoothly as possible.
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