Wearable medical devices face a number of challenges and certification to battery life. Low power operation allows these devices operate for longer periods of time. There are many ways to do this, including efficient memory utilization. One technology that can prove beneficial to wearable medical devices is ferroelectric RAM (FRAM).
A company that has heavily researched and ultimately applied FRAM is Cypress Semiconductor. I talked with Doug Mitchell, Product Marketing Engineer MPS at Cypress, about the technology and how the company is taking advantage of it.
Doug Mitchell, Product Marketing Engineer, Cypress Semiconductor
Why are medical wearables getting so much attention? What advantage will they provide patients/doctors?
Medical wearables are becoming increasingly popular because they can provide a wide range of functions, including both passive and active devices. Active devices such as heart pacemakers, neuromodulators, and infusion pumps offer direct therapies, continuously providing treatments like medicine or electrical stimulation in tightly controlled doses. Passive devices monitor various functions or conditions for diagnosis and can uplink data for healthcare providers to evaluate and act upon.
However, it’s important to realize that the technology for these devices is still in the early stages of development. I would say it’s akin to the early stages of cellphone technology, when these devices were big, heavy, and prohibitively expensive for most people. So, while medical instruments have yet to reach their full potential, we see them reaching mass adoption in the near future. To help ensure this happens, Cypress is working closely with partners to help make the technology more aggressive and self-sufficient to meet patients’ requirements.
Once these devices enter into mainstream usage and more people begin to wear them, the widespread use of these devices will give researchers a large pool of data. And the ensuing “big data” resources will allow for deeper, broader analysis for better understanding, and ultimately, better prevention and treatment of illnesses.
What’s the potential risk of using these devices?
Device failure is the biggest risk involved. If the device is highly relied on for its efficacy and fails, then there may be catastrophic results, especially for the active devices that administer a therapy to the patient.
There’s also the risk that patients will become too reliant on the device, without the proper healthcare provider supervision or guidance. Notifications on the devices to consult a healthcare professional for a second opinion can be helpful. However, as these devices become more reliable and self-diagnosing tools become more accurate, the risk of medical professionals getting cut out of the equation increases.
Aside from a life-and-death type failure, the biggest risk is to privacy. While the amount of data that will become available with wider usage of medical devices will help change what the medical community can do in terms of diagnostics and treatments, data security is a very hot topic at the moment.
However, people are highly aware of and working toward mitigating the risk of exposing sensitive data, and the technology is becoming more and more capable of protecting the data. Data encryption and storage is possible today, but it’s a matter of making sure the product developers are implementing these measures. Consumers need to begin pushing back on the developing companies to pressure them to include those protections.
Our team at Cypress is working on a next-gen update to our FRAM fail-safe storage solutions to build data-protection features into the memory itself, which we hope will encourage product developers and designers to incorporate secure features natively into their devices. Stay tuned for more on this in the near future.
What’s been the biggest (or one of the biggest) roadblocks to continued advancement/improvement of medical wearables?
One of the biggest roadblocks is that active devices require long, expensive certifications to meet regulatory requirements. Regulations vary by country, but the U.S. tends to be very conservative in giving approvals with devices needing to be approved by the FDA. It’s hard to say how long it takes to get a device approved, but generally, the more revolutionary the device, the longer approval will take.
In addition, design challenges, such as efficacy, quality, size, patient experience, and costs, require specialized solutions when compared to traditional consumer or industrial product developments. When a consumer IoT device, like a smart thermometer, fails, the impact to the end user is fairly small. However, if a medical device fails—and especially an active device—the impact has the potential to be far more serious. To address these challenges, it’s necessary to go to extreme optimizations when designing these devices, such as custom integrated circuits, packaging, and architectures, in order to provide the best solutions.
Why is Cypress well-positioned to help take the industry to the next level?
Cypress has developed a culture of becoming a technology partner with companies looking for long-term support with high-value products. This is different from being a commodity product supplier with routine products and processes.
Cypress has implemented design techniques across product families that deliver efficient solutions purpose-built for demanding applications. We’re ensuring compliance with the most stringent quality and reliability requirements in the industry while supporting product features that meet designers’ requirements.
For instance, our latest family of PSoC microcontrollers offers high levels of feature integration (processor, memory, connectivity) with the lowest power consumption in the industry. Low power consumption is especially important for implantable devices, as it minimizes the number of surgeries needed to replace a device that has run out of power.
As it specifically relates to the storage aspect, how is FRAM fitting the medical wearable bill better than other nonvolatile memories?
FRAMs provide a variety of benefits compared to other nonvolatile memories, depending on what each product developer values. Perhaps they’re seeking a smaller form factor, or a lower power consumption—it varies by designer, but they’re able to improve upon their designs with other memories by using FRAM. For example, our data-logging FRAM memories support the highest reliability (infinite write cycles and no data-at-risk) with the lowest operating modes and power consumption and smallest form factor of any memory technology offered for these kinds of applications.
Are there any examples of a device doing something with FRAM that it would have been harder to do with a different type of storage?
Absolutely. We’re not yet authorized to publicize these, but we’re designing into implantable devices (neuromodulators and cardiac monitors) specifically for the features called out earlier. The traditional memory solution would be EEPROM. We’re able to improve the reliability due to our infinite write endurance and extend battery life because of our lower power consumption. Additionally, with these features, the designers can afford to add more memory, which supports more data recording and more complex algorithms.
Doug Mitchell is a Product Marketing Engineer MPS at Cypress Semiconductor, where he focuses on product definition, market analysis, and business-plan development for memory technologies. He has over 35 years of experience leading technology, marketing, and business development.