On February 26th, Velentium’s Randy Armstrong joined Lance Black of TMCx, Kevin Coker of Proxima CRO, and Tommy Cooper of Cooper Consulting, on a panel at Greenlight Guru’s True Quality Roadshow in Houston. Armstrong, Black, Coker, and Cooper discussed quality and quality management how-tos and presented thoughts and reactions to the State of Medical Device Product Development & Quality Management Report 2020, which was based on a 500+ participant survey of medical device development professionals with global market interests.
The panel reinforced Velentium’s core messaging on quality & compliance:
- Quality management should be your friend. If quality activities feel like an “extra,” an add-on, a burden, or a mismatch to activities that in fact enhance and assure product quality, it’s a sign that something is wrong. A good QMS is lightweight and scales to match your need. If you’re not sure where to obtain or how to design such a flexible system, please contact us. Quality is our passion -- we’d love to help!
- Regulations don’t have to be scary. They do require time and resources to understand, monitor, and comply with, but the goals of regulators and medical device manufacturers ultimately converge at assuring the safety and efficacy of medical devices. Knowing how to enlist the help of FDA or other bodies for pre-submission review can save time and expense by helping manufacturers prepare for the submission process. Experienced consultants are a first recourse for gaining insight into regulatory expectations that are directly applicable to your device. Your company can assure market access by collaborating with experts.
- Quality isn’t a system: It’s a culture. Ultimately, the success of any company’s quality efforts depends on organization-wide comprehension and buy-in. From the top-down and the bottom-up, every role in the company needs to care about producing quality and proving that they have achieved it. That’s a continuous-improvement process, not a finish line; and we believe the best way to get centered and remain engaged with that process is to weave quality throughout development. Everyone on the team should be trained to recognize the big picture and understand the place of their activities in it.
The panel was hosted at the TMC Innovation Institute in Houston’s Medical Center, and attended by ~90 local professionals. It was followed by a live recording of the Global Medical Device Podcast, which featured Evangeline Loh of Emergo by UL discussing Brexit’s implications for EU MDR.
Velentium was pleased to sponsor & participate in the True Quality Roadshow, an education and networking event designed for forward-looking medical device professionals. We look forward to participating again in San Francisco in June. If you’re in the Bay area, we’d love to connect with you there.