27 Nov How Key Tech Innovates with Quality in Mind
At Key Tech it is our nature to be creative and think differently. This is how we find the solutions to the toughest technical challenges. Innovation is at the heart of the product development work we do. We just understand that this must be done in the context of a quality system defined by ISO 13485.
As a founding partner, VP of Operations, and the head of Quality Assurance, I’ve gleaned a few insights and best practices over the past 20 years as Key Tech has honed its quality process into a lean and effective yet unencumbering framework.
By its nature, a quality system requires definition of all processes that could affect the quality of the product or service that is supplied to a developers’ clients. Those processes frequently create an added burden on the development staff that can reduce productivity. That is especially true when the team is required to develop complex medical devices.
And by design, ISO 13485, the internationally agreed standard for the medical device industry, requires the definition of many complex processes. As they should be, safety and quality “are non-negotiable” in the medical device industry. And now, more than ever, for medical devices “regulatory and safety process requirements are increasingly stringent throughout every step of a product’s life cycle.” 1
Organizations certified to 13485 must demonstrate and ensure management of quality processes and best practices for every medical device they develop, service or deliver. The current ISO 13485 standard, updated in 2016, has an increased emphasis on risk management, and risk-based decision making.2
“Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, gaining the trust of customers and meeting regulatory requirements,” acknowledges ISO.org.
As a medical device design and development organization, Key Tech frequently experiences the challenge of needing to quickly develop without compromising the associated stringent requirements. We work hard to continuously refine and streamline our processes. It takes a dedicated effort to make sure we’re always in compliance with regulatory requirements while still:
- Minimizing the burden on our staff (allowing them to be nimble and creative),
- Supporting our product development processes in as seamless a manner as possible and,
- Enabling us to meet the ever changing and challenging needs of our clients.
Creativity and innovation are at the heart of our product development success. But so is our commitment to quality and compliance with regulatory requirements.
We don’t shy away from asking the challenging technology and human centric design questions. We encourage our staff to think outside the box during early development efforts (unburdening them from regulatory concerns so they can conduct solutions brainstorming in the truest sense). It’s not until later development phases that we implement strict but efficient design controls. We’re able to do this because we continually strive to fully understand the necessary regulatory requirements as well as when and how to implement those requirements efficiently.
Once an idea is de-risked, and moving forward, then switch to design-control development under ISO 13485.
This is one way we free up the innovation, keeping our process open and flexible, pushing back when we need to and where we need to, to not lock into “process” until a device is actually in the development phase.
Downstream criteria, based on risk, depends on client to client needs. At Key Tech, we often work under get-to-market as-quick-as-possible scenarios. We’ve worked hard to keep our quality program from stifling our creativity. And we’ve worked equally as hard at assuring clients our quality systems are top of the line. Any product we develop is going to be fully vetted across quality standards and risk mitigation. And we don’t sacrifice creativity or innovation.
If you go by the letter of ISO 13485 – it can be very burdensome. We have worked deliberately to understand the intent of the standard. This is our secret sauce. We have worked diligently to stay nimble and still satisfy the intent of the standard when developing for a client. Frequently, the need to negotiate with the auditor on what compliance looks like in our interpretation of the intent for any given device, will come up and have to be managed in the least disrupt-able way. Our goal is to be responsive to our client, to costs and deadlines, while managing the quality processes. It’s a real give and take trying to refine our quality processes as we move a development project along.
Yes, you read that right. We interpret the intent of the standards as it applies to each project uniquely.
How it came to be: In the beginning, we would take a close look at the standards, it was ISO 9001 then. We recognized that if we weren’t careful, we’d really be handcuffed. If we developed quality and safety processes that were too burdensome we’d never get anything done. We had to work to the intent of the standard and this became part of our process very early on. Allowing the team members, who are technically sharp and innovative and who are also trained in quality management practices, to develop solutions within this deep expertise environment.
Recognizing in order to stay lean and mean, we had to stay close to the intent.
A consultant highly knowledgeable in the standard worked with us to make us as efficient in our processes as possible. We maintain that level of efficiency along with our commitment to be as responsive to clients’ needs as possible. Cost effective, responsive, and efficient.
ISO 13485 is well defined. It takes a lot of effort to refine it, filter through it, distill it down to something that is about as efficient as you can get. And each project requires us to be constantly refining it. It takes a lot of work and effort to be highly skilled at this, but the trade off in efficiencies, creativity, and compliance make it worth nailing it for our clients, every time.
After 20 years of defining, refining and streamlining our quality processes, Key Tech has achieved a truly remarkable, functional and efficient quality system. Contact us to learn more about our innovative process at firstname.lastname@example.org or 410-385-0200
As Key Tech’s QA Manager, he has successfully developed and maintained Key Tech’s ISO 9001 and 13485 certification. He received an AA in Architectural Technology from the Anne Arundel Community College before completing his BS in Mechanical Engineering Technology from the University of Maryland.