February 02, 2018

Overcoming the Challenges of Designing Connected Health Care Devices

By Special Guest
Gian Bonanome, Senior director, business development, Intelligent Product Solutions

With a new breed of Internet of Things medical devices that make personal health care easy and reliable, the potential in this space is tremendous. And we are just starting to see some of the results of what is possible.

At the same time, designing connected health care devices has its share of challenges. One of those challenges is that the FDA has strict design testing requirements, and a long review process. With this in mind, engineers and designers must ensure that product doesn’t become obsolete by the time it finishes the FDA process, which can take months or even years.

Case in Point
One area already showing great potential is at-home medication adherence. That’s because prescription drug adherence is a big problem in the U.S It costs the health care system hundreds of millions of dollars per year, as health complications can develop for patients who don’t follow their doctors’ orders.

So startup AdhereTech came up with an idea to remedy that problem. It’s a wireless pill bottle that alerts patients when they have to take their meds. And it keeps track of their usage and dosage.

AdhereTech approached our product design firm to help design and develop a second-generation smart pill bottle that reminds patients to take their medication. The AdhereTech IoT pill bottle, now being used by thousands of patients, presented many design challenges. The lessons we learned from this initial undertaking can help guide others with similar projects for connected medical devices.

We were contracted to provide a full range of design services for the new product from prototype through manufacturing, including mechanical, electrical, and industrial design. The company wanted to take a major step forward from its first generation pill bottle to the second generation. The pill bottle needed to see some big changes – primarily to make it more attractive, user friendly, and suitable to be manufactured. 

The company’s strategic vision for the new pill bottle was to increase adherence and reduce the costs associated with missed or haphazard dosage. We started by designing the product to connect to a cloud service wirelessly, collecting regular usage data and ensuring that patients are taking pills when they are supposed to.

The newly-designed AdhereTech smart pill bottle is now internet connected and can alert patients when it’s time to take their medicine, either through a call or text, or via a blinking light directly in the bottle. It also has a wireless CDMA chip that sends a small amount of data, measuring when the bottle was opened and how many pills were taken.

Our firm’s product design expertise − in particular, our background and experience designing wireless products − helped us to create the right balance and approach. We viewed the project as essentially a pill bottle with the insides of a cell phone. We were tasked with meeting the fundamental design goals − to build the product to work globally and be manufactured at scale − while also tackling the usability design goals to improve the look and feel of the device, greatly extend the battery life, and ensure day-to-day durability. 

Key design challenges for the AdhereTech pill bottle included:

  • Battery Life: As part of the design process, we worked to create a power- efficient design with more than six months of battery life. This challenge was critical for the new pill bottle, as we needed to make sure the battery stayed charged for the duration of the patient’s prescription. The first-generation bottles only held a charge of about 45 days, so the pharmacists would have to swap them out for a newly charged bottle every month when the patient picked up refills.
  • Ease of Use: Since we knew many seniors would be using the new pill bottle, a key design goal for us was ease of use. The challenge was to design a patient-friendly bottle that was actually packed with dense electronics. To make sure it would be simple and worry-free to use, we designed it so that it doesn’t require the patient to connect to the internet, plug it in to charge it, or download any software – all of that is done automatically.
  • Regulatory Testing and Requirements: In addition to the pill bottle product design, we were responsible for facilitating the preliminary regulatory reviews and shepherded the design through FCC regulatory testing. This step is another important part of any IoT product design effort. Regulatory requirements and required certifications must be factored into the design. Because they are connected, IoT products must be tested for radiated emissions and susceptibility. Additionally, cellular carrier testing must be performed.

In the end, the use of IoT design principles helped the new AdhereTech pill bottle become a big success. Currently used by many top pharmaceutical companies and hospitals, these innovative smart bottles have been shown to improve medication adherence by an average of 20 percent. The results are helping curb lost sales for pharmaceutical companies, and more importantly, reducing patients’ risk of having recurring health problems.

About the author: Gian Bonanome is senior director of business development at Intelligent Product Solutions (www.intelligentproduct.solutions).

Edited by Ken Briodagh

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