Rules, regulations and medical design trends for 2018
Designers in all different industries are paying close attention to what's trending and changing in 2018. Rules, regulation and design trends will likely transform, making it critical to be mindful of these changes before developing new and innovative tools and strategies. Medical device designers must follow such regulations and trends to ensure usability and compliance to deliver clinical results for clients.
The medical device development process takes more than creative brainstorming and prototype configuration. Learn how to develop your products to the highest standard with the latest rules, regulations and design trends:
Rules and regulations
Effective medical devices must meet the requirements and comply with regulations by the U.S. Food and Drug Administration. The quality rules for FDA-regulation products, such as foods, drugs and devices, are known as current good manufacturing practices (CGMP's).
As of September 2017, the FDA finalized the guidance that outlined the recommendations on how manufacturers can safely exchange information through medical devices and information systems.
"Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions," Bakul Patel, associate director for digital health in FDA's Center for Devices and Radiological Health, wrote in "Interoperability: FDA's Final Guidance on Smart, Safe, Medical Device Interactions."
This new advisory rule pays close attention to cybersecurity, which can be a controversial topic for medical designers, developers, manufacturers and users.
Medical design trends
According to input from Nancy Van Schooenderwoert of Lean-Agile Partners in The International Software Design for Medical Devices Forum, designers need to invest in cyber security and ever-changing technological aspects to succeed in 2018.
"You can be proactive in both areas by supporting the right skills, agility and autonomy for your teams," she said. "There are many low-cost tools, with no vendor lock-in, that enable high-volume parallel feedback so all your experts can work from a genuine shared understanding for development and operations."
According to Medical Design Trend Update 2018, you need to pay attention to three major factors that are transforming medical tool development: User needs, design and technology.
User – Besides technological advances, usability is the driving force behind product development. Understand how the future of technology will transform the way medical devices are used, and where they are used. Perhaps more medical devices will be used in public places in the future, such as shopping malls, at work or in the comfort of the user's own home.
Design – Consumer familiarity and minimalism are key. Designing a smart touch screen feature makes a product more familiar for users. Simplicity is a design trend that takes the complexity out of usability.
Technology – Automation and miniaturization are important aspects that will emerge in 2018. The use of service robots and support systems are expected surface more often.
Compliance is critical in medical device design. Take notice of these upcoming rules, regulations and design trends throughout the product development process.