Regulations – such a burden on the medical device industry. Or are they? I am advocating that companies
Can you see the opportunity or just the burden of regulation? This is just one example from eDHR. Take your pick!
re-frame traceability regulations to see them as opportunities. Whether it’s eDHR or UDI, these requirements are actually proving to have an enormous upside, and not just for patient safety.
What most medical device companies have not yet realized is that the regulators are asking for something that will help your business run better. Perhaps much better. This may be counter-intuitive, particularly for those who thrive on being the put-upon industry leader. You can view it as an unfair burden, needing to pay so much to comply with regulations in each country after the rigors of clinical trials.
Or since you already have to do it to sell your products, you can look for an opportunity. Those who do may find the benefits can be quite significant.
Most companies start by just looking at the savings in moving from paper DHR to electronic device history eDHR records. These savings go beyond the storage costs, into the efficiency and time-savings for personnel in production, quality, and regulatory affairs. In addition, moving from paper to electronic can eliminate many of the errors for which companies get warning letters.
When the company achieves traceability for eDHR by means of a comprehensive manufacturing execution system (MES), even greater benefits can stack up. For example,
Enforcement: These systems ensure process routings and standard operating procedures are followed. They will actually not allow an operator to move the product to the next step if all checks do not pass. This includes appropriate signatures.
Analysis: Having all of the data in an electronic system allows easy analysis of materials, product, process and even operator performance. This can lead to insights for product design and for manufacturing engineers as well as procurement and skills development.
I could go on, but you get the idea. I did discuss more of this in a recent webcast Making Traceability Work for the Business with Rick Gallisa and Jennifer Petrosky of the sponsor Dassault Systèmes. Even more detail is in the white paper Traceability as Opportunity.
While regulations are, technically, a “have-to” if you can take a different view, they can become a “get-to” opportunity to generate beneficial business changes. As always in a situation that seems unpleasant, if you can re-frame it, you may find the view is much nicer.
