Yes, Model-Based Definition Can Work in Regulated Industries

After a recent blog post I wrote on model-based definition (MBD) on the PTC website, I received the following email:

I am curious to hear your thoughts on MBD in medical devices and other regulated industries. In med device, the print is:

• a legal contract between manufacturer and company
• an inspection document (for first article as well as lot inspection, controlled by AQLs for critical dimensions, as dictated by risk analysis)
• an FDA-auditable design artifact ("design history record")

Its use as a manufacturing and design document is dwarfed by the legal and regulatory aspects.

You mention in passing that MBD is not paperless because such artifacts can be generated from the "technical design package" as needed. In my experience, however, there are still filing cabinets filled with prints that are the legal, if not always practical, "source of truth. My guess is regulatory personnel would be extremely reluctant to adopt MBD for this reason: It's harder for them to control it as source of truth.

These are very common concerns for implementing MBD in regulated industries like medical devices, automotive, aerospace, and manufacturing. Product development organizations may decide to or need to pursue industry certifications like ISO 9001, AS9100, or QS9000. FDA (Food and Drug Administration) compliance is managed by CFR (Code of Federal Regulations) Title 21 Part 820.

My regulatory and audit experience is in aerospace. At Blue Origin, I was the process owner for Design and Development when we achieved AS9100 certification. I have found that the verbiage in many of the standards for industry certification have a certain vague quality about them. (That’s not a bad thing.)

Neither AS9100 or CFR Title 21 Part 820, for example, dictates paper or print copies as the document of record. Maintaining print records has been done traditionally, which leads organizations to have a higher comfort level with it. Having gone through several certification audits myself, I understand why a physical hardcopy feels more reassuring. But I also know auditors will allow you to use and access electronic records during the audit to prove traceability from requirements through validation.

CFR 21 Part 820, AS9100, and other industry certifications are concerned more with how companies establish processes and prove that they follow their own processes. Say what you do and do what you say.

For example, in aerospace, certification on the design side focuses on your processes for developing concepts, performing trade studies, holding design reviews, generating detailed designs, analyzing models, running tests, and conducting validating and verification activities. The standards do not prescribe the mechanisms by which you create and maintain deliverables. They do not dictate that these have to be captured in traditional 2D production drawings or physical hardcopies or stored in cabinets. Instead, they specify that the records of these activities have to be captured in some form and traceable back to the initial design requirements.

If an organization considers moving toward becoming a model-based enterprise (MBE), I recommend Windchill's Compliance and Quality module, which supports FDA requirements (among other industry certifications). Windchill PDMLink’s change management processes for promotion, change requests, and change notices are also compliant with industry certification.

Adopting MBD, especially for organizations that require certification, is a lot about changing attitudes. People must let go of the notions that "the drawing is the contract," or physical signatures are required on a printed-and-scanned document, or that the design, manufacturing, and inspection deliverable must be a traditional 2D production drawing.

Can regulations and industry certifications prevent your organization from adopting MBD? I can tell you from personal experience that the answer is no. But your preconceived notions can.

As long as you implement, adopt, and enforce processes and policies that promote the use of electronic documents as the source of truth, you can implement MBD and achieve medical, aerospace, automotive, and quality certification.