The medical device landscape is changing fast in part due to new technology including IoT hardware. These modifications are creating opportunities and challenges for products designers.
New medical devices must be safe, practical and valuable to providers and their patients. At the same time, regulations and ongoing supply shortages create additional challenges for manufacturers.
The right approach is needed for businesses that want to design medical devices effectively. Preparing for the current challenges will enable manufacturers to take full advantage of emerging technology.
Here are some concepts medical device designers should keep in mind as they create products that will be effective, safe and long-lasting.
1. Apply common safety principles
The availability of new tools and advances in technology have made safety more important than ever. Manufacturers face risks but also have technologies and standards that can help guide the design process or improve device safety.
Following best practices for safe device design will help companies create more reliable equipment. Isolating critical functions, double-checking inputs and monitoring outputs can ensure proper and safe performance.
It’s also important that devices are designed to fail safely. Components that break down in a non-recoverable fashion should revert to a safe state. They should also fail loudly, or at least in a way that notifies clinicians and patients. Audible, visible and wireless notifications can be used in combination to ensure problems do not go unnoticed.
Designers should also be familiar with relevant safety standards and the design practices they must implement to keep patients safe. For example, thermal management in medical devices is a patient safety and regulatory concern.
Under the IEC60601-1 standard, medical devices can only become so hot during regular function or an abnormal single fault condition. Machines that operate at too high of a temperature can compromise patient safety and fail to meet key regulatory requirements.
Components like heat pipes and other heat management systems can ensure medical devices do not exceed safe operating temperatures.
Awareness of common hazards and familiarity with best practices for safe design will help companies create medical devices that are as safe as possible.
2. Make materials and component selection a priority
Careful selection of materials and device components is necessary for effective design. Shortages and supply chain disruptions have made it more difficult to source and secure important materials — making the choice of suppliers and manufacturers more critical than ever.
Dimensions, life span, intended use, device capabilities and cost should all inform material selection for a new medical device. A single-use item and an implant may require vastly different materials. The same is true for something that will be frequently exposed to UV light and one that won’t. Familiarity with commonly used types of plastic, metallic biometals like titanium and stainless steel, and other materials will be important.
Device manufacturers should also carefully consider how components are used. Conventional PCBAs are no longer the preferred choice for printed circuit boards in medical devices. Instead, many designers are opting to use surface mount technology (SMT) boards, which are typically sturdier, more resilient to vibration and less costly than PCBAs.
Choice of components can also have a major impact on big-picture design decisions — like the cybersecurity capabilities of a networked medical device. Chip-level security features can help manufacturers create more secure products by building security into individual components. A growing number of manufacturers are also using IoT semiconductors to support secure connectivity for networked devices.
Using advanced components to support critical device functions could help streamline the design of new medical equipment.
Supply chain management is likely to become an increasingly important concern at the organizational level. Diversifying raw materials sources, building strong relationships with suppliers and adopting supply chain management technology can help businesses prepare for ongoing disruptions.
3. Design for connectivity
The market for networked medical devices is growing fast. Smart technology — like wearables, patient monitors and ECG monitors — connects to the internet, allowing it to store or receive important data that can be used in patient treatment. Some devices simply check and store information, while others use data from the cloud to inform their operations. These smart devices may be marketed toward providers or directly to consumers.
These items can help providers collect data more efficiently, allow for shorter hospital stays or faster discharge times, and streamline outpatient monitoring. However, an effective networked device must reliably and securely connect to the internet — otherwise, the device may perform poorly or not at all.
The right design practices can help manufacturers anticipate and manage the challenges that come with medical device networking.
Manufacturers should also prepare for the certification process necessary for connected devices. These items may be subject to FCC and CE regulations when networked. If something uses a cellular network to connect to the internet, it may also be subject to the rules of partner operators.
Designers should also consider the new cybersecurity challenges that can come with networked technology. Patient data collected by a smart medical device needs to be stored, transmitted and analyzed securely — otherwise, the patient’s privacy could be at risk, and the device may not be compliant with health care regulations.
Effective design should consider patient safety and potential cybersecurity concerns that come with connecting a device to the internet. Using cybersecurity guidance from regulatory agencies like the FDA may help streamline this process. Designers can also use emerging best practices for creating secure medical devices to ensure they will keep patient data safe from potential attackers.
Managing new challenges facing medical device designers
Medical device manufacturing usually comes with significant design challenges. Every decision, from dimensions to materials to components, must consider patient needs, safety, functionality and more.
Standards and design best practices can help designers effectively navigate device design challenges. Common safety principles and familiarity with popular materials will be useful when creating products that will be truly helpful for patients.
IoT and smart medical technology are becoming more common, and understanding how connectivity may impact device function and design requirements will be vital going forward.
Emily Newton is a technical writer and the Editor-in-Chief of Revolutionized. She researches and writes about how technology is changing the industrial sector.