Begin with the End in Mind: This is the second habit Steven Covey lays out in his famous book, The Seven Habits of Highly Effective Sales Leaders.
The reason this habit is so important is that it aligns all tasks, projects, and talent toward a single purpose. This habit also provides a framework to eliminate tasks and projects that will not help accomplish the end goal.
With major regulatory shifts occurring in the medical device industry it is imperative that device manufacturers know exactly which “end” to keep in mind. Falling out of compliance with these new regulations comes with a tough consequence: your device may be pulled from the market.
When it comes to staying compliant with MDSAP, MEDDEV, ISO 13485:2016 or MDR, resources are going to be constrained across the board. Audit times are increasing, Notified Bodies are swamped or are closing, access to talent is becoming more scarce, the timeline is tight, and there is a lot of competition. It is vital that you manage medical device compliance projects as efficiently as possible.
So, Where to Start?
In simple terms, a Gap Analysis is needed. Create a comparison document between the current state of compliance and the required future state of compliance. This analysis will identify which compliance requirements are already being met and which ones the product fails to comply with. This gives a clear “end” to which the team can focus. Anything which does not align with these goals must be eliminated to best maintain efficiency.
Once the Gap Analysis is complete, identify the new regulations to comply with and create a list of changes from the previous regulatory standards. Also consider the regulatory impact changes will have on the product under each particular governing country.
With standards changing in Europe, Canada, Asia, and Australia, there may be overlap in regulations. This may enable reuse of some work for multiple regulatory bodies. Dig into and understand what documentation standards you will need to meet. Streamline this process by compiling a list of clinical trials, testing standards, and post-market surveillance to compare against new requirements.
Connect with your Notified Body.
Some Notified Bodies no longer exist and you may need to find a replacement. If yours is still operating, find out where each of your products are in their queue.
Find the Talent.
Begin identifying the talent and resources needed, and when, for this project. With all the competition for talent, it may take extra time to secure the right people on the best timeline. Both the timeline for available talent as well as placement in the queue for the Notified Bodies will require quality project management skills.
Make sure your project is ready when those resources are allocated to you.
The stakes are high and you have a lot on your plate.
If you are concerned about the upcoming medical device compliancy changes, the time to act is now. A Gap Analysis from the experienced team at Waddell Group will get you pointed in the right direction. We work with companies to perform gap analyses for medical device compliance, help maintain compliance, and manage the projects that spin out of these compliance initiatives.