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Solving the Challenges of Miniaturized Medical Devices


By Brett Landrum
Vice President, Global Innovation & Design at Phillips-Medisize

In the past few years, consumer demand for fitness apps has led to an explosion of new health-monitoring applications. Smartphones, smart watches and hand-held gadgets can now measure everything from blood oxygen level and respiratory rate to heart rate and rhythm, sleep quality and wrist temperature. Nearly 30% of U.S. adults are now using some type of wearable medical device, according to the National Institutes of Health.

While these devices are fun and informative, they aren’t designed or manufactured to meet medical standards, and can’t be relied on for diagnostic accuracy. But the movement has inspired medical-grade device makers to strive to minimize the footprint of their own patient-monitoring devices — the kind doctors can prescribe to help patients manage their care and medication. Making these devices and implants smaller, less obtrusive and easier to manage increases compliance and allows patients to live a more normal life. It also helps inform clinicians in making treatment decisions.

Smaller, More Comfortable and More Effective

Remote patient monitoring devices can be used for conditions including heart disease, chronic obstructive pulmonary disease, asthma, diabetes, and sleep apnea – just to name a few. As populations age, more people are experiencing these chronic conditions, and personalized, remote management can help cut down on doctor visits and hospital stays.

But the devices are only useful if patients agree to wear them. Early devices were cumbersome and complicated. Heart monitors, for example, contained electrodes that spanned the entire chest and had to be spaced just so. Even then, signal transmission was often spotty.

Miniaturizing heart monitors and other devices allows patients to wear them unobtrusively as they go through their daily lives. Many can now be worn during sports activities and even in the shower. Some, such as swallowable “pill cameras” that record images of the gastrointestinal tract, can replace uncomfortable and time-consuming clinical procedures.

Others make home procedures easier, more comfortable and more effective. For example, continuous glucose monitors measure the blood glucose levels of diabetics every 10 seconds with a sensor placed just below the skin, reducing the need for painful finger pricks. Constant monitoring provides early warning of danger signals, prompting patients to take quick action to avoid a heart attack or stroke if their glucose level goes too low or too high.

For conditions such as allergies and asthma, drug injectors with tiny sensors can ensure flawless delivery. For example, the Phillips-Medisize Aria smart autoinjector provides audible sounds to inform users about injection progression, ensuring a correct dose every time. Sensor technology can also monitor drug expiration dates and warn patients and physicians as they draw near.

Miniaturized devices and sensors can collectively gather and integrate an enormous amount of information, fostering a holistic approach to health. Thanks to advances in circuitry and sensor design, a single sensor can now monitor several bodily functions. Placed in different body locations, sensors can also communicate with one another, giving both patients and their physicians a better overall view of physical condition.

Miniaturization Helps Minimize Waste

In addition to providing comfort and convenience, miniaturized medical devices help address another consumer concern: promoting environmental sustainability. Healthcare is one of the most carbon-intensive industry sectors, accounting for 4.4% of global net greenhouse gas emissions and toxic air pollutants, according to a research paper published by the Journal of Health Services Research & Policy.

Smaller devices use less material, making them more energy-efficient to produce and ultimately resulting in less waste. Manufacturers are also using more rechargeable and recyclable electronics and designing drug injectors with fewer single-use components to diminish the waste generated by traditional devices.

Managing Design and Regulatory Challenges

Miniaturized medical devices offer many advantages to patients and clinicians but designing and producing them is a complex endeavor that requires expertise in several fields.

Small-sized electronics must be designed with enough power to reliably collect and relay high volumes of information while fitting into tight and irregular spaces.

Manufacturers must use biocompatible materials that are soft enough to provide the comfort patients expect while also withstanding sweat, bumps, drops and moisture. Skillful use of precision injection molding — and a lot of trial and error — can help them achieve the right balance of flexibility and durability.

Devices must also be easy for the average person to operate, regardless of technical competency. And they must follow strict rules to always keep patient data private and secure at all times.

Implants and devices that offer a diagnosis or dispense drugs are subject to much greater regulatory scrutiny. Manufacturers must provide studies demonstrating use, effectiveness and success rates. In some cases, they must undertake full clinical trials to gain approval, a process that can take up to 10 years.

Continuity from Design Through Manufacturing and Assembly

The manufacturing of miniaturized devices containing microelectronics entails specialized processes, including different material handling techniques and technology to ensure precision alignment, which can be tough to execute when parts are sometimes too small to see with the human eye. Machinery must be adjusted to handle components without damaging them while also packaging them without generating static from plastic enclosures.

To produce devices at scale, manufacturers need to develop custom procedures to replace manual assembly with automation. Small, printed circuit boards may require multiple x-ray and software tests, as well as visual inspection.

Using the most effective processes for fabrication and assembly often involves tweaking the original product design. For that reason, it is important for designers to work with manufacturing experts from the start, so that teams can share their expertise at every stage as products evolve from initial plans to final production.

A One-Stop Shop for Miniaturized Device Expertise

Unlike other medical device makers, Phillips-Medisize, a Molex company, has an extensive range of experts with years of experience in every phase of designing, manufacturing, assembling, and testing high-performance, miniaturized medical products. That means fabrication and assembly considerations can be incorporated into designs from day one. This allows device manufacturers to work with the same team of experts throughout the process, eliminating frustrations, rework, delays, and cost overruns and, ultimately, deliver products to market ahead of competitors.

To learn more about how Phillips-Medisize experts can help bring your medical products to life, visit our website.

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