White Papers & Articles

​In most regulated industries remediation is a cost of doing business.  Unfortunately the medical device industry is no different.  While remediation won’t hit every business, the fact of the matter is as regulations continue to change and or grow more companies will find themselves in a spot where they are having to change their processes and procedures in order to remain in compliance.
 
In 2021 we wrote about the keys to success, identifying six (6) key areas of focus to help one get through remediation and come out on the other end still in tact 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 THINGS GO SIDEWAYS
the top 11 reasons why remediation goes wrong for medical device OEMs:
 

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.  Learn more about how we can solve your compliance problems while besting your remediation beast!

Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.