“If it ain’t broke, don’t fix it; if it ain’t fixed, don’t fly it.” - Anonymous
Any pilot will likely concur that the most important part of a flight is the preflight check. Achieving a safe flight begins with a careful visual inspection of the airplane. Part 1 of this article series introduced BraveHeart and its medical device: the Wearable Life Sensor™.
In Part 2, Steve McCalmont, BraveHeart founder and CEO, performs an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design phase of developing a medical device.
Prior to ever climbing into the seat of his aircraft, McCalmont completes a preflight procedure using a checklist. This list includes which items must be inspected, how to detect possible issues or defects, and the reasons for checking each item.
“I’m sure before the Wright brothers first took off, Orville or Wilbur had a checklist someplace,” McCalmont said. “That’s how they survived.” He explained that a preflight check involves checking oil and fuel levels and looking for signs of leakage. It also entails walking around the aircraft, making sure there is no visible damage or missing bolts and checking the condition of the wings and tail to ensure all moving parts are secure and functioning properly. It’s important to be thorough with every item on the checklist. Even the slightest deviation in an airplane’s mechanics or functionality can keep the aircraft on the ground.
“You can see that in many industries, following best practice models is incredibly important,” he said. Similar to an airplane, any deviations or shortcomings in quality, safety or efficacy of a medical device can prevent it from achieving compliance and getting on the market.
In regulated industries, such as health care, it takes more than an entrepreneurial vision and business acumen to get a product on the market. A regulated product could be highly sought after, but until every box is checked for quality, safety and efficacy, it is of no value to users. This is where expertise with quality and compliance is a vital element of the business model.
When McCalmont launched his startup to develop the BraveHeart Wearable Life Sensor, he knew the endeavor would involve regulatory pathways to achieve compliance. Even though the Wearable Life Sensor is non-invasive, it is designed as a Class II, clinical-quality medical device. This means a 510(k) submission is required for compliance and market approval. Much of this process involves a substantial amount of data, design specifications, documentation, records, etc. It also includes the ability to track, manage and immediately locate any information. The BraveHeart staff recognizes that meeting these requirements for regulatory compliance means effective quality management is essential to the development process.
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One obstacle startups commonly impose on themselves is to begin their journey without a definitive culture. Taking time to establish an organizational culture helps keep everyone mindful and focused on the company’s vision. Steve McCalmont started BraveHeart as a personal endeavor to enhance the quality of life for people. The fact that he operates in an environment where quality, safety and performance are high priorities makes it easier to foster a culture of quality.
McCalmont is no stranger to adhering to regulations. Much of his time in the air is spent participating in aerobatic flying competitions. The pilots in these events are aware of the risks and agree that it’s a process-oriented activity. “You have to follow best-practice standards in order to stay safe,” he said.
BraveHeart applies that same quality model to its medical device development. “Quality must be embedded in the DNA of the company,” McCalmont said. “The regulatory controls are not there to hamper you, they exist to help you produce a quality device.” The BraveHeart development team recognizes that regulatory standards are valuable, and that it’s important to meet or exceed those standards. Taken further, knowing the product could be used by themselves or family members, quality management is no longer just a checklist of standards.
Given the complexity of medical device regulatory submissions, McCalmont made sure BraveHeart’s business model includes the necessary details for completing the required quality processes within the established timelines. He also acknowledged that using automated technology for quality and compliance management is critical for staying on track with the company’s objectives.
Watch this space for Part 3 in this series, where the BraveHeart team members discuss their perspective of the company’s approach to quality.
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.
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