Abhishek Shukla, Supervisor of Technical Program Management at Fictiv, has extensive experience in Imaging and Diagnostic Devices.
Here are his top tips for Med Tech product development:
- Prior to beginning a design, ensure you have an understanding of the List of Applicable standards as per FDA or CE. Identify the ones that closely relate to Hardware Design and Safety in particular.
- Design features to always keep in mind: repeatability, safety (as per required standards), scalability, complexity (assembly, installation, maintenance).
- Focus on long-term design solutions, especially in the case of hardware where the design follows a waterfall development model.
- Keeping a backup design iteration is crucial during the prototyping and testing phases. Hardware, when combined with Software, often presents new challenges to the intended part performance.