Fighting Medical Regulatory Bureaucracy with PDM

MedicaMetrix is a US-based startup in the medical devices industry. It is an industry notorious for chewing up and spitting out small companies like a monster finding bad grapes in a vineyard. Founder-CEO Christopher LaFarge says investors in his industry look for leaders “who will run through brick walls head first” among other attributes. “Somehow, they are going to end up in the market with something that makes money,” no matter what it takes.

One of the frustrations in developing new medical devices is the “alphanumeric soup” of regulatory and compliance agencies. There is the FDA in the US, and an equivalent agency for European Union nations. Each agency wants an incredible amount of documentation, presented their way. While there is some overlap, they both want schematics and circuit board designs, CAD file prints of the product, and all the accompanying documentation generated in word processing, spreadsheets, accounting, and other software presented in a specific way.

A key aspect of the documentation to be presented is a substantial audit trail. Version control must be documented, and document approval milestones recorded. Engineering documentation must be linked to the property regulatory approach. The initial electronic document management (EDM) system acquired by Medicametrix did well managing SOLIDWORKS CAD files, but it had no capacity for all the other file types the company needed. And it could not create audit trails. So LaFarge and his small team were forced to use three-ring binders to assemble the “EU Technical File” and the “FDA Design History File”.

This was all very frustrating to LaFarge: “I have been trying since the beginning of time to make us as much of a paperless company as possible.” Not satisfied with having electronic document management for the CAD files, LaFarge sought an alternative. When he took a look at Synergis Adept, he discovered a product that managed all the documents in an engineering workflow, not just the CAD files. And, unlike competitors, it could link multiple SOLIDWORKS assemblies (which each shared some part files) to related non-CAD documentation.

After installation, it didn’t take MedicaMetrix long to make Adept the system that answered all their needs. “I use [Adept’s] unlinked records essentially as one technical file, then another unlinked record that says design specs.” It then becomes easy to tie them to all the related documents: “I now have a completely virtual technical file. It includes the CAD files, and the audit maintenance. It is tremendously helpful.”

The product will provide doctors a new way to do prostate examinations in a way that should save $1.4 billion in unnecessary costs per year once it is available. Because they don’t have a shipping product yet, LaFarge can’t really calculate the ROI of using Adept, but he is convinced the benefits are substantial. “Adept has a captive market in medical devices, pharmaceuticals, and biotech. Because we have to have a system like Adept. In my opinion, Adept has the market cornered for medical device companies using SolidWorks.”

You read more about how MedicaMetrix uses Synergis Adept in this case study.


 

Randall S. Newton is the principal analyst and managing director at Consilia Vektor, a consulting firm serving the engineering software industry. He has been directly involved in engineering software in a number of roles since 1985. More information is available at https://www.linkedin.com/in/randallnewton.

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