By Sean Fenske, Editor-in-Chief
Medical device wearables were heralded as a significant trend in healthcare. Lackluster patient compliance (primarily with wrist-worn fitness tracker style devices) have resulted in unmet expectations. New approaches in the design and development of medical wearables, however, has renewed significant interest in these monitoring technologies.
One of the primary examples of a success story is the continuous glucose monitor (CGM). These devices offer an array of benefits to users (primarily those with diabetes) to gain insights on their condition through trends and long-term data, rather than single data points captured at a given point in time. The comprehensive nature of continuous monitoring offers a much clearer picture of a patient’s condition.
To further explain the benefits of CGM devices, as well as medical wearables on the whole, Sara Zuelke, MedTech Marketing Manager at Phillips-Medisize, has set aside time to participate in the following Q&A. Her responses form a FAQ-style presentation that should provide further explanation on key considerations stakeholders should know.
Sean Fenske: What is a continuous glucose monitor?
Sara Zuelke: A CGM is a device that measures glucose levels over time. Unlike conventional blood glucose monitors (BGMs)—which measure one specific glucose level “snapshot”—CGMs measure these levels progressively and continuously. This gives patients and their medical providers a clearer picture of important trends, including intervals when glucose is in a healthy range.
A wearable CGM collects data around the clock and consists of three key parts: a sensor, a transmitter, and a receiver.
Glucose monitors that work in conjunction with insulin pumps are known as integrated CGM systems. These systems can adjust or pause insulin delivery in direct response to real-time glucose level changes.
Fenske: When were CGMs first introduced?
Zuelke: The American Diabetes Association indicates the concept of continuous glucose monitoring was first publicly introduced in 1999, when the U.S. Food and Drug Administration (FDA) approved the first glucose data-aggregating device. Original models operated by collecting readings over a period of time, which were then downloaded for professional review in a healthcare setting. Many older-model CGMs required patients to collect a blood sample via fingerstick. Even certain early models branded as “noninvasive” caused skin irritation at the measurement site due to the electrode placement necessary for gathering data.
Fenske: Have specific factors recently prompted a greater focus on CGMs in the diabetes community?
Zuelke: Yes, advocacy and acceptance are on the rise for many diagnostic wearable devices, including CGMs. A growing number of patients, doctors, and other healthcare professionals feel CGMs enhance convenience, comfort, measurement accuracy, and awareness. As a result, CGMs have gradually become the gold standard of patient care in glucose monitoring because they’re:
Fenske: How is CGM device technology advancing?
Zuelke: Due to increasing awareness of CGM capabilities and advantages, several new and improved wearable medical devices for tracking diabetes are expected to become available within the next five years. Increased patient and provider demand is coinciding with recent advances in technology. Accordingly, future offerings will likely be characterized by improved device connectivity, longer wear time, enhanced accuracy, reduced invasiveness, more convenient insertion/application, and lower cost.
Fenske: Which key design attributes can help CGMs gain widespread acceptance as a mass-produced wearable medical device?
Zuelke: Six key qualities can help CGMs achieve widespread acceptance among today’s patients and providers.
Fenske: What are the primary challenges associated with developing a new CGM device?
Zuelke: CGMs often appear simple on the outside thanks to their patient-friendly design, but that unassuming exterior reflects a complex set of design considerations. Since creating an effective wearable device means making components smaller, those ultra-compact form factors still need to incorporate highly reliable sensors, connectors, antennas, and more.
As a result, power management and battery life often rank among the most challenging technical issues for CGM design engineers. Device power consumption tends to dictate almost every other CGM design consideration—including size, shape, connectivity, and component selection.
Manufacturers looking to maximize the cost-versus-quality equation must also carefully consider patient usability expectations. These include sourcing certified biocompatible materials and designing for a non-medical home environment that demands user-friendly functionality.
Fenske: Why is Phillips-Medisize uniquely suited to address these challenges?
Zuelke: Today’s miniaturized CGMs are comprised of a myriad of materials and technologies that need to enable easy, dependable operation without advanced medical training. These complex designs require innovative engineering and production expertise across an array of disciplines.
Phillips-Medisize has been collaborating with global healthcare companies for more than 60 years—delivering safe and effective solutions that help people live healthier, more fulfilling lives. Our design, development, manufacturing, and in-house production expertise reflects our specialized industry awareness. Yet, we’ve also gained unique problem-solving skills from tackling decades’ worth of issues in highly regulated markets. These comprehensive capabilities make us particularly well-suited to address even the toughest development challenges with a variety of proven design-for-manufacturing (DFM) and design-for-assembly (DFA) techniques. Our dedicated team adheres to best practices, helping to create and customize:
As an affiliate of Molex and part of Koch Industries, Phillips-Medisize is commercially positioned across the world to provide complete production solutions with vertical integration.
Fenske: Looking beyond CGMs and into the wider diagnostic wearables market, what insights can you offer?
Zuelke: The latest Molex global survey, conducted in collaboration with Avnet, explores “Diagnostic Wearables: The Future of Medical Monitoring.” Design engineering stakeholders provide an intriguing glimpse into how this emerging industry segment is evolving. Key findings include the following:
Fenske: If my readers have additional questions about CGMs and other wearable medical devices not addressed here, who can they contact?
Zuelke: Anyone with questions should visit phillipsmedisize.com for the latest industry updates, engineering insights, and customized recommendations. We’re here to provide expert support for all your product design, development, and manufacturing needs.
Medical device wearables were heralded as a significant trend in healthcare. Lackluster patient compliance (primarily with wrist-worn fitness tracker style devices) have resulted in unmet expectations. New approaches in the design and development of medical wearables, however, has renewed significant interest in these monitoring technologies.
One of the primary examples of a success story is the continuous glucose monitor (CGM). These devices offer an array of benefits to users (primarily those with diabetes) to gain insights on their condition through trends and long-term data, rather than single data points captured at a given point in time. The comprehensive nature of continuous monitoring offers a much clearer picture of a patient’s condition.
To further explain the benefits of CGM devices, as well as medical wearables on the whole, Sara Zuelke, MedTech Marketing Manager at Phillips-Medisize, has set aside time to participate in the following Q&A. Her responses form a FAQ-style presentation that should provide further explanation on key considerations stakeholders should know.
Sean Fenske: What is a continuous glucose monitor?
Sara Zuelke: A CGM is a device that measures glucose levels over time. Unlike conventional blood glucose monitors (BGMs)—which measure one specific glucose level “snapshot”—CGMs measure these levels progressively and continuously. This gives patients and their medical providers a clearer picture of important trends, including intervals when glucose is in a healthy range.
A wearable CGM collects data around the clock and consists of three key parts: a sensor, a transmitter, and a receiver.
- People living with diabetes wear tiny sensors day and night to make more informed choices regarding treatment. These sensors are usually inserted just under the skin and measure interstitial glucose levels (i.e., glucose found in the fluid between cells).
- The transmitter wirelessly sends glucose readings from the sensor to a receiving device where the data can be viewed.
- The receiver—usually a handheld device, such as a smartphone—intercepts these readings and displays them.
Glucose monitors that work in conjunction with insulin pumps are known as integrated CGM systems. These systems can adjust or pause insulin delivery in direct response to real-time glucose level changes.
Fenske: When were CGMs first introduced?
Zuelke: The American Diabetes Association indicates the concept of continuous glucose monitoring was first publicly introduced in 1999, when the U.S. Food and Drug Administration (FDA) approved the first glucose data-aggregating device. Original models operated by collecting readings over a period of time, which were then downloaded for professional review in a healthcare setting. Many older-model CGMs required patients to collect a blood sample via fingerstick. Even certain early models branded as “noninvasive” caused skin irritation at the measurement site due to the electrode placement necessary for gathering data.
Fenske: Have specific factors recently prompted a greater focus on CGMs in the diabetes community?
Zuelke: Yes, advocacy and acceptance are on the rise for many diagnostic wearable devices, including CGMs. A growing number of patients, doctors, and other healthcare professionals feel CGMs enhance convenience, comfort, measurement accuracy, and awareness. As a result, CGMs have gradually become the gold standard of patient care in glucose monitoring because they’re:
- Convenient and easy-to-use
- Capable of providing automated, accurate glucose readings with alerts for highs and lows
- A more personalized care approach for diabetes management
- A dependable way to significantly reduce the need for unpleasant fingersticks
Fenske: How is CGM device technology advancing?
Zuelke: Due to increasing awareness of CGM capabilities and advantages, several new and improved wearable medical devices for tracking diabetes are expected to become available within the next five years. Increased patient and provider demand is coinciding with recent advances in technology. Accordingly, future offerings will likely be characterized by improved device connectivity, longer wear time, enhanced accuracy, reduced invasiveness, more convenient insertion/application, and lower cost.
Fenske: Which key design attributes can help CGMs gain widespread acceptance as a mass-produced wearable medical device?
Zuelke: Six key qualities can help CGMs achieve widespread acceptance among today’s patients and providers.
- Durability—The wearable device must be sturdy enough to withstand daily knocks and bumps without instrumentation damage or adverse data impacts. Tight seals are also imperative to help the device endure moisture and debris exposure.
- Size and Weight—Where possible, miniaturized forms of electronics, antennas, and microprocessors should replace standard-sized components to reduce overall weight and bulk for the wearer.
- Usability—The application and use must be straightforward enough for non-medical professionals of all ages to operate.
- Biocompatibility—Established industry regulations dictate materials contacting a patient’s skin, ingested, or delivered intravenously must be made from approved non-toxic elements to maximize safety while minimizing potential irritation or harm.
- Compatibility and Compliance—Medical data system hardware needs to generate a robust signal that’s fully compatible with specialized software systems aligned to strict HIPAA privacy regulations.
- Reliability—Power sources need to meet minimum thresholds for reliable patient usability and connectivity.
Fenske: What are the primary challenges associated with developing a new CGM device?
Zuelke: CGMs often appear simple on the outside thanks to their patient-friendly design, but that unassuming exterior reflects a complex set of design considerations. Since creating an effective wearable device means making components smaller, those ultra-compact form factors still need to incorporate highly reliable sensors, connectors, antennas, and more.
As a result, power management and battery life often rank among the most challenging technical issues for CGM design engineers. Device power consumption tends to dictate almost every other CGM design consideration—including size, shape, connectivity, and component selection.
Manufacturers looking to maximize the cost-versus-quality equation must also carefully consider patient usability expectations. These include sourcing certified biocompatible materials and designing for a non-medical home environment that demands user-friendly functionality.
Fenske: Why is Phillips-Medisize uniquely suited to address these challenges?
Zuelke: Today’s miniaturized CGMs are comprised of a myriad of materials and technologies that need to enable easy, dependable operation without advanced medical training. These complex designs require innovative engineering and production expertise across an array of disciplines.
Phillips-Medisize has been collaborating with global healthcare companies for more than 60 years—delivering safe and effective solutions that help people live healthier, more fulfilling lives. Our design, development, manufacturing, and in-house production expertise reflects our specialized industry awareness. Yet, we’ve also gained unique problem-solving skills from tackling decades’ worth of issues in highly regulated markets. These comprehensive capabilities make us particularly well-suited to address even the toughest development challenges with a variety of proven design-for-manufacturing (DFM) and design-for-assembly (DFA) techniques. Our dedicated team adheres to best practices, helping to create and customize:
- Multi-shot molded housings that provide watertight seals
- Micro-molded internal components
- Selective plating solutions
- Custom-printed electronics
- Miniaturized interconnects
As an affiliate of Molex and part of Koch Industries, Phillips-Medisize is commercially positioned across the world to provide complete production solutions with vertical integration.
Fenske: Looking beyond CGMs and into the wider diagnostic wearables market, what insights can you offer?
Zuelke: The latest Molex global survey, conducted in collaboration with Avnet, explores “Diagnostic Wearables: The Future of Medical Monitoring.” Design engineering stakeholders provide an intriguing glimpse into how this emerging industry segment is evolving. Key findings include the following:
- 61% of respondents feel patients and consumers are the biggest advocates of diagnostic wearables.
- 47% of respondents feel doctors and medical professionals are promoting increased use of these devices.
- Adoption barriers cited most frequently among respondents include the need for medical-use regulatory approval, along with the need for better data from existing fitness and wellness trackers.
- Respondents say the top five diagnostic wearable design challenges include cost, durability, power, miniaturization, and data capture.
- Respondents predict, with sufficient time and innovation, energy harvesting may eventually power diagnostic wearables.
Fenske: If my readers have additional questions about CGMs and other wearable medical devices not addressed here, who can they contact?
Zuelke: Anyone with questions should visit phillipsmedisize.com for the latest industry updates, engineering insights, and customized recommendations. We’re here to provide expert support for all your product design, development, and manufacturing needs.