This blog series is jointly based on the expertise of Randy Armstrong, Chief Technology Officer at Velentium, and Jama Software’s experience working with developers of Class II and III medical devices. To download our joint whitepaper on this subject, click here.
To Err Is Human
Everyone makes mistakes. And while medical device developers may be creating some of the most advanced, life-saving technology on the planet, they’re still human.
Due to the critical nature of medical devices, errors must be uncovered before they reach the end user or results could be catastrophic.
Therefore, it’s imperative to have a methodical Design Review process in place when capturing design controls.
Shifting the Mindset
The key to implementing a successful Design Review process during medical device development is creating a culture in which there is no fear of repercussions when defects are uncovered.
An anxiety-free environment makes room for presenters and reviewers to create a positive process to shake out potentially tragic errors.
That’s why it’s important to challenge the belief that mistakes shouldn’t happen and embrace a new perspective. Think: Everyone needs reviews. There are always defects. And understand that the defects are the enemy – not the people doing the work.
Yes, it may be frustrating to have outsiders dissect hours of hard work and find flaws. However, the alternative is far more alarming.
“A defect-free review should not be cause for celebration, but a red flag that something was missed.”
Randy Armstrong, Chief Technology Officer, Velentium
Risk Management and Compliance
Reviews are conducted to find blind spots in design and to identify defects. They are meant to mitigate risks to both the end user and the company itself.
Companies also perform reviews to be compliant with regulations and standards so, when ready, the devices can successfully go to market.
“While often presented as two different things, and most companies think of them as such, risk management and compliance are actually one and the same.”
Randy Armstrong, Chief Technology Officer, Velentium
This, too, may require an organization-wide mindset shift. Remember that regulations and standards were created as a part of the risk management process to ensure proper developmental practices are followed that protect users. They are clinically validated solutions that save time, work, and extra documentation.
The Burden of Reviews
Changing the culture of the review process at any company will not happen overnight. If the tools or processes are cumbersome or overly bureaucratic, even review enthusiasts can become disillusioned.
There are many aspects of the review process that could be affecting attitudes and hindering a complete mindset shift, from inaccurate traceability to insufficient tools.
How defects are identified and then tracked for improvement can be especially tedious.
For instance, a review might uncover ten defects, all of which then need to be
updated. The related documents need to be changed and reviewed again. This can be
a vicious cycle if the process contains a lot of paperwork and requires participants to navigate many different systems or tools.
Using rudimentary documents poses issues at many points of the review process. One such problem is that developers often find themselves spending more time creating and formatting a document than working on the information it is meant to record.
Also, sending documents via email requires a lot of mind-numbing administrative work such as ensuring everyone is reviewing the same, correct version and confirming feedback is tracked from all parties.
Legacy tools us for documentation control or quality management also present many challenges. For example, the context is not always as complete as it is in current technology, which facilitates easy access to information and collaboration. In those cases, a person needs to communicate context to the team. This often requires an extra meeting, scheduling that person’s time — if they are still at the company — and adding more hours to the process overall.
Any of these shortcomings in a review process can add unnecessary stress to an organization. When this occurs, it can be hard for teams to stay motivated about reviews. The result: reviewers go through the Design Review process on autopilot and important defects fall through the cracks.
In our next post,we’ll share the 6 attributes shared by all successful design reviews, as well as how to implement them at your company.