More than 200 regulators, engineers and executives attended the American Medical Device Summit from Oct. 5 to Oct. 6 in Chicago. Attendees discussed the challenges and opportunities of product development, quality management, commercialization and the regulatory process, according to San Diego-based sales platform company Seismic.
Here are three takeaways from the AMDS, as identified by Seismic.
There's a difference between innovation and invention. "An invention is something new. An innovation is something new that solves real-world problems," said Palani Palaniappan, executive vice president of innovation and development for Tokyo-based Terumo BCT. New medical devices should not just use the latest technology, but also meet physicians' needs. To ensure medical device makers are focusing on innovations, and not inventions, Mr. Palaniappan encourages companies to involve all functional groups early in the brainstorming process.
"Good enough" is not good enough when it comes to healthcare. There are no shortcuts when it comes to developing a safe, high-quality medical device. Every employee who takes part in the creation of a device plays a critical role in ensuring quality, compliance and regulation.
Design a device with humans in mind. Marco Costa, MD, PhD, vice president and chief innovation officer of Cleveland-based University Hospitals, discussed the necessity of considering the human end users — including the physicians, support staff, hospital system, patient and caretaker — when designing a new device. In the early phases of a new device idea, the engineering team should ask themselves questions like "Will physicians find it easy to use?" or "Will it make sense economically for larger systems, along with smaller practices?"
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