The Consumerization of Healthcare: A New Landscape for Medical Device Design  

Consumers increasingly expect all technology to be as seamless and convenient as their smartphones and voice-enabled smart speakers. This consumer-driven device ubiquity has migrated to the healthcare industry. The combination of high consumer expectations and rapidly advancing technologies is pushing the boundaries of medical device design.

What strategies can medical device manufacturers employ to meet the growing demand for high-performance, user-friendly devices? Is it possible for consumers to effectively manage their own healthcare monitoring and other tasks traditionally handled by professionals?

With consumer medical devices becoming more and more prevalent, patients are taking an increasingly active role in managing their health.

More Control Over Personal Health Data

Patients are seeking greater access to their medical data and want it made available in an easy-to-use format. However, this leads to a critical design requirement for home-based or wearable medical devices: robust security and privacy of consumer data. Engineers must focus on strong encryption, access controls and user authentication from the outset of the product design phase. 

To achieve this, devices must be designed to use either cloud-based storage solutions or secure, on-device storage to collect and store data, while also providing information in an intuitive format with a clear and customizable user interface (UI). 

Convenience Across a Spectrum of Conditions

Advances in remote monitoring and miniaturization have enabled patients to manage chronic conditions from home. Designers must consider user safety in uncontrolled environments, plan for potential user errors and provide clear warning/error messages when devices aren’t being properly operated by users. The easier a device is to use, the more satisfied consumers will be with their experiences.

From blood pressure monitors with Bluetooth connectivity to at-home sleep apnea testing kits with built-in oximeters, it seems the potential for consumer medical devices is unlimited. However, this growth introduces several design challenges for manufacturers.

As medical devices become more accessible, it’s imperative to create devices that are safe and effective for users with diverse backgrounds and technical competencies. Unlike a hospital setting with trained professionals, these devices will be entrusted to patients who may not have medical knowledge or device expertise. This significantly increases the risk of user error, potentially leading to inaccurate readings or adverse effects. To mitigate these risks, designers must prioritize user-centered design principles. Clear and concise instructions, both written and visual, are crucial. This includes comprehensive user manuals, intuitive in-app tutorials and easy-to-follow video guides. By minimizing the potential for misinterpretation, manufacturers can empower patients to use their devices safely and effectively, promoting confidence and accuracy in managing their health.

In the controlled environment of a healthcare facility, there are immediate intervention protocols in place if complications occur. At home, patients may struggle to react appropriately in critical situations. Device manufacturers can use product features to improve user safety, such as telehealth features or remote monitoring. This would allow patients to connect with healthcare professionals for real-time assistance while using their devices, all from the comfort of their homes. A device equipped with remote data monitoring can report data to a patient’s healthcare team for review and could facilitate timely intervention by trained professionals during potential emergencies. By focusing on innovative and user-friendly features, manufacturers can develop medical devices that are intuitive, easy to use, safe and effective for a diverse set of users.

The shift toward the “empowered patient” model will rely on simple, yet effective devices. However, engineers can improve design by focusing on trends across the broader scope of consumer electronic devices.

Miniaturization

Traditional medical devices are often bulky and cumbersome. Advancements in miniaturization have enabled more compact, discreet devices such as continuous glucose monitors (CGMs), smartwatches and more. By optimizing component selection with parts like miniaturized sensors and low-power electronics, devices can achieve a smaller footprint.

Ruggedization

Durability is a basic requirement for personal medical technology devices. Like smartphones that must survive a fall or a splash of water, these devices will need to withstand a variety of environmental conditions. This requires selecting high-quality, impact-resistant materials for device casing and components. Personal medical devices must be subjected to rigorous testing for extreme temperatures, shock and vibration, EMI, humidity and exposure from dust, dirt and chemicals. Cleaning the device is also an important design consideration since certain household cleaners containing harsh chemicals (like isopropyl alcohol or bleach) can break down some plastics commonly used in electronics. All these factors are critical for ensuring the long-term functionality of a device.

Connectivity

The future (and present) of healthcare is data driven. The next generation of consumer devices will need seamless data management and remote monitoring capabilities. This requires robust connectivity solutions. With a keen eye on battery optimization, consumer medical devices will be able to reliably transmit data without draining the battery. By leveraging open-source APIs, these devices can integrate with popular health apps consumers already use. Regardless, the data needs to be secure, with robust encryption protocols and strict communication standards. 

Personal medical device manufacturers face a constant tug-of-war: bringing innovative solutions to market quickly while navigating the lengthy and rigorous FDA, EMA, MHRA and PMDA (among others) approval process. Fortunately, manufacturers can adopt some sound strategies to keep things moving forward.

Proactive engagement with regulatory agencies during the design phase can help identify potential regulatory hurdles. By doing so, manufacturers can also avoid costly late-stage design changes. Engaging with regulators and implementing robust design control processes to ensure devices meet all safety and performance requirements will greatly reduce the risk of device failure or recall.

One bright spot is that when device manufacturers use proven technologies, timelines for new product approval can be shortened. By leveraging these tried-and-true components, manufacturers can focus on developing intuitive user interfaces and functionalities, ultimately reducing the risks and expediting time-to-market for their new consumer medical devices.

While manufacturers balance consumer demands with regulatory requirements, Molex is uniquely positioned to provide the components that bring these devices to life. Expertise in miniaturization allows Molex to provide essential high-performance interconnect components already proven in devices like smartphones and smartwatches. Molex’s ruggedized components meet the need for durable devices that can withstand wear and tear in a home setting. 

Molex brings deep experience and expertise to collaborate with medical device manufacturers. Additionally, Phillips Medisize, a Molex company, brings over six decades of expertise working with leading MedTech companies, specializing in complex medical cable assemblies with high-performance interconnects, custom high-density, high-speed medical connectors, and plastic injection molding and assembly.  This combined expertise enables us to propel the creation of next-generation healthcare technology.