Top 5 Reasons Medical Device Projects Succeed
Medical Device Projects Can Be Successful During COVID-19
1) Make Sure User Needs are Complete and Stakeholder Approved
- All successful projects begin with the user in mind
- Involved stakeholders keep everyone focused on the end user
2) Don’t ‘short-change’ Risk Management
- Objective: how to design quality & safety into a medical device product
- There are myriad regulations and directives
- EN ISO 14971:2012
- ISO 13485
- QSR – 21 CFR 820.30
- MDD 93/42/EEC
- ANSI/AAMI/IEC/EN 60601-1-2:2014
- IMDRF
- When should you perform Risk Management?
- Start at the project beginning and continue throughout
- During the initial design of the product, to assure that potential hazards and defects are recognized and designed out
- With each design modification, to revisit the original assumptions and to assure that any changes “do no harm” to the original product
- With each production process change, to ensure that improvements intended by new concepts (lean mfg, etc) are completely thought through prior to implementing them
- After each product recall. Yes, problems occur, even with the most robustly designed products, leading to recalls to remove unsafe products from users hands. When these events occur, a smart company will revisit the risk analysis file to critique whether such hazards may have been foreseen with a rigorous and objective risk management effort
- How do you Perform Risk Management?
- There are myriad approaches but the following should suite more organizations
- Fault tree analysis (FTA), a top-down approach
- Failure modes and effects analysis (FMEA) and failure modes, effects and criticality analysis (FMECA), both bottom-up approaches
- Fault tree analysis (FTA), a top-down approach
- Modified versions of these methods are acceptable according to the standard
- A modified FMECA that employs a three-tiered quantitative scoring system for estimation of hazards and risks for each hazard works best (historically)
- It’s important to find the optimal approach that best fits your organization
- There are myriad approaches but the following should suite more organizations
- Find a knowledgeable, experienced partner to support (and guide) your organization’s process improvement efforts
- Start at the project beginning and continue throughout
3) Common Sense QMS and Related Processes
- Do you know the difference between compliance and intent?
- This critical difference will make or break your project…so it’s important this is fully understood
- Is your Quality Management System ‘harmonized’ across your organization?
- Schedule a call with one of our experts; let’s review your processes to capture usable feedback with recommendations
- The best time to start is now
4) Complete Traceability maintained throughout the Product Lifecycle
- Critical to avoid missteps and maintain allegiance to your quality goals
- We can help you improve your processes, in order to directly improve product quality and shrink time-to-market.
- The two go hand-in-hand
5) Process Improvements driven by Cost-of-Quality Metrics
- Knowing the costs – across the board – of each activity/task/step will allow you to significantly reduce cost of operation, eliminate costly mistakes (rework), and dramatically improve customer satisfaction with your products
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Kelly Powell
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