11 Reasons Why Medical Device Remediation Goes Wrong

In a highly regulated industry like MedTech, remediation is simply a cost of doing business. ​While remediation won’t hit every company, as regulations continue to change and or grow more companies will find themselves in a spot where they need to adapt their processes in order to remain compliant.

In 2021 we wrote about the keys to success, identifying six key areas of focus to help get through remediation and come out on the other end intact and moving forward.
 
As the medical device industry continues to evolve, so must our approach to solving problems we face.  As such, understanding the reasons why a device company may experience failure as they go through remediation is key to learning from others mistakes so we don’t repeat them when it comes our turn.

Why Remediations Go Awry in MedTech

1. Root Cause: failing to fully understand the root cause of the issue and or not adequately addressing all aspects of the problem
2. Prevention: neglecting to update or improve processes to prevent future issues
3. Regulatory Collaboration: insufficient communication and partnering with regulatory agencies
4. Big Picture: focusing on short-term fixes rather than solving the longer-term problem
5. Resources & Time: underestimating the resources and time required for remediation
6. Training: neglecting to train employees on new or improved processes
7. Cross-Functional Impact: not considering potential effects on other departments or products.
8. Stakeholders: not sufficiently involving all relevant stakeholders in the remediation process.
9. End User: Taking shortcuts or making compromises which endanger patient safety.
10. Documentation: lack of adequate documentation, record keeping and associated outcomes
11. Validation: failing to thoroughly validate the effectiveness of the remediation

 
When looking at this list the biggest take-away is the starting point.  Once it has been determined remediation is necessary, whether through regulatory intervention or internal, understanding what occurred to get us there in the first place is critical.  If we misdiagnose the root cause of the problem within our operations our ability to successfully navigate through the rest of remediation is be hampered significantly.  For this reason its wise to spend as much time as possible sorting through the cause and effects of your operation to accurately determine the root cause leading to remediation.  Rushing this process will inevitably cause unnecessary challenges on the back end.

Solving the Problem

The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering. Continue the conversation to learn how we can help.

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