Context (and traceability) is king

During my time as an engineer working at a medical device manufacturing company, we were forced to waste a lot of time.

It sounds dramatic, I know. But because we did not have access to a capable system, it was necessary to manually build traceability records to capture the baseline of every project-related item.

Not only was this a time-consuming practice, it also caused a lot of confusion. Which version of the record was the latest one? Has everything been described? And who has edited my document?

So, we wasted our time because the manual way of building these records led to a lot of errors due to a lack of visibility. And that led to a lot of rework, correcting the mistakes and making sure everything was done right the second time around.

I calculated I spent an average of 15 hours each week on unproductive rework!

We simply lacked the right tools to get the work done in a more efficient manner.

And nothing was more frustrating when the time came for us to obtain approvals for designs to ensure that governing regulations have been met. Let me tell you why…

Required documentation

As you might know, obtaining approvals for medical devices can involve the creation of several documentation sets, all under the review and governance of regulations such as FDA CFR Part 820 and the EU MDR.

Specifically, requirements for quality management, where a manufacturer needs to demonstrate the ability to provide medical devices and related services that consistently meet
customer and applicable regulatory requirements are structured in these sets. For example:

  • The Design History File (DHF)
  • The Device Master Record (DMR)
  • Device History Record (DHR)

These documents describe the entire lifecycle of a device, from concept and stakeholder requirements, to design development, to hand-off to manufacturing, and the history of a specific unit or batch. A best practice is to show the relationships and linkages between stakeholder requirements, design inputs and outputs, and design verification and validation in a traceability matrix.

What we did

What we usually did was gather these documents from various siloed sources at the end of the design phase and incorporated them into several large binders that attempted to describe the documents, decisions, and changes that occurred during the design process. In addition, large spreadsheets were created that again tried to capture traceability in the design intent, process, and results.

The overall problem with this approach was that all design efforts are iterative with many changes and reworks along the way. Capturing the many changes that occur simply
became a maintenance nightmare for the spreadsheet owner. That was me!

What we should have done

We should have had access to a system that allowed us to create as many regulatory structures as we wanted to manage and have them managed in the same way so that they are
automatically created, tracked, and base-lined. Other document structures such as the Technical File could also benefit from being managed in the same way as the DHF and the DMR.

Quite frankly, such capability should be a standard requirement in the medical device industry.

That is why we developed Aras Medical Device. In our solution, you are able to handle these document structures in the same way with the same requirements for change management and traceability and achieve:

  • Accurate project update status
  • Faster documentation retrieval and more assured regulatory compliance by capturing product data as it happens, not as an afterthought
  • Efficient regulatory submission workflow that is future-proofed. Face an audit with confidence knowing that information is held or federated into a single knowledgebase that is readily available
  • Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands.

For more info on Aras Medical Device, be sure to check it out here!