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
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
Find a knowledgeable, experienced partner to support (and guide) your organization’s process improvement efforts
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.
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
