Agile Method Deployed in Digital Medical Devices

According to Jennifer Miller, MD, PhD, physician consultant at McKinsey & Co., a patient-centric approach to developing Digital Medical Devices has clinical effects and drives value by encouraging patients to engage in their own treatment. “Design & Product Development Principles for Connected Devices,” a panel discussion moderated by MD&M BIOMEDigital, featured Miller.

Industry experts addressed all aspects of agile product creation during the workshop. They have emphasized the importance of including and understanding the needs and weaknesses of all users in the design of Medical Devices. According to Miller, the first step in this agile product design approach is to frame your problem and design, as well as describe your customer.

“You then build out your user experiences to better understand what the product you’re designing is going to do from beginning to end,” she said. The next step, according to her, is to put together an agile team to design the initial concept, prototype it, and test it with a small group of customers, integrating their feedback to create a minimally viable product, which is then introduced to a larger group of customers to incorporate their feedback to develop a product program.

She said, “Finally, you scale this to live customers.” Protection is a top priority, she said, because Medical Devices defects can result in death. According to Miller, companies must develop a quality control system early in the product life cycle and maintain it throughout. Other factors to consider are regulatory enforcement depending on the specific authorities that would dictate a product, as well as identifying potential cybersecurity threats and incorporating data privacy safeguards.