EDITOR'S NOTE: This is the third installment of a three-part blog post series about medical device innovator and startup Braveheart Wearable Life Sensors and how automated quality management and compliance solutions have helped the company take their business to the next level. Read Part 1 here and Part 2 here.
“Aviation is the branch of engineering that is least forgiving of mistakes.” - Freeman Dyson
Having started eight successful business ventures, Steve McCalmont, founder and CEO of BraveHeart Wearable Life Sensors, is well aware of how entrepreneurs are expected to be knowledgeable about their industry and how to identify unmet needs. He also recognizes the value of surrounding himself with people who have the talent and skills to achieve the business’s objectives.
Part 1 of this series on BraveHeart examined how McCalmont launched a startup based on a personal interest in improving the quality of life for people. In Part 2, McCalmont demonstrated an aircraft preflight check to illustrate the importance of quality in product design. Part 3 features members of the BraveHeart team discussing their views about quality and their expectations of how quality is emphasized throughout the Wearable Life Sensor’s product life cycle.
One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Compliance with regulatory standards is not a cursory exercise that can be performed after the product design and development phases are completed. To keep quality and compliance on track with a medical device, quality best practices need to be applied at every phase of product development.
Setbacks due to compliance issues are extremely difficult to recover from. “Incorporating quality early is important,” said Ralph Beck, BraveHeart’s vice president of software engineering. “Putting quality procedures in later can become a multi-year process to get everything in place to become compliant.”
When it comes to enforcing regulatory guidelines, Ted McAleer, BraveHeart’s vice president of business operations, will tell you that agencies make no allowances for company size. “When you look at regulations, they’re not designed for small companies. They are really designed for medium- to large-scale companies that are producing a lot of products,” he said. “But as a small company, we still have those same FDA regulations that we have to fit into.”
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McAleer stressed that if growth and expansion are part of your company’s business model, you need to make sure that your quality and compliance systems are in place so you can scale. That way, when you reach the tipping point in sales and marketing, your compliance processes won’t fail you.
Companies developing regulated products commonly outsource various supply chain tasks. Tara Rogers, supply chain manager, sets the bar high for BraveHeart’s suppliers. “A cornerstone for any company is to focus on quality to make sure you’re going to be a world-class developer of a product you’re going to produce,” she said.
Rogers emphasized that it’s important for all their supplier organizations to maintain the same quality ethics, processes and technologies as BraveHeart. This includes implementing an electronic quality management system (QMS). “Comparatively, companies that use a paper-based system or don’t have a system, or simply say they’re compliant-ish are difficult and costly to work with,” she said.
One of the newest members of the BraveHeart team is Dave Shimkus, vice president of operations. He may be new to the company, but he is deeply rooted in the medical device industry – having over 30 years of experience in operations, quality and regulatory. Throughout his tenure in the industry, Shimkus has recognized the importance of keeping up with the stride of the regulatory environment. But his views on quality go beyond checking boxes. “Regulatory guidelines are an entry point for achieving compliance, but quality is about much more than the regulatory environment,” he said. “Quality is about improving patient experiences and outcomes.”
BraveHeart’s goal for the Wearable Life Sensor is to save a million lives. That goal is ingrained in the company’s culture. A focus on quality is embraced by every member of the BraveHeart team. “You can’t go back,” said McCalmont. “We are on an aggressive schedule. We have to do it right, and we have to do it right the first time.”
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.