In this month’s “Roundtable Q&A,” industry leaders provide insights on medical electronics topics, including the design impact of consumer electronics, obstacles to success with taking a product from wired to wireless, and the value of making devices “smart.”

Question 1: How are consumer electronics impacting the design of electronic medical devices?

Seamus Grady
Senior Vice President, Medical Division, Sanmina-SCI

One of the most significant growth segments in the medical industry are devices used for patient managed care. These include a number of handheld medical devices that patients utilize to monitor their health and fitness. Another trend is the increased use of “telehealth” technology to link patients to healthcare providers using wireless or wired communication technology. Combining telehealth technology and personal-use devices for monitoring and communicating medical information has already shown significant potential for improved health benefits and reducing visits to a clinic or expensive hospital admissions.

The consumer electronics device that shares the majority of the core technologies that are making their way into medical devices is the mobile phone. At the core of a mobile phone is the RF technology that allows you to communicate wirelessly, a user interface consisting of a display and often a touchscreen, low power electronics for extended battery life, Bluetooth connectivity, and GPS. These same technologies are foundational for handheld medical devices enabled with remote access telehealth capability. In addition to driving the technological features needed by modern handheld medical devices, the mobile phone market has also driven down the cost of these core technologies.

Another aspect of medical devices that is just now coming to the forefront is patient compliance. This refers to being able to verify a patient is actually using a medical device or being able to verify they are taking medication as prescribed. We are seeing nearly 50% of new medical devices being developed have a requirement to embed telehealth functionality in the device to facilitate demonstration of compliance. We also see a significant push toward using technology to monitor medication compliance.

Dr. Juergen Schilz
Director Product Management—Detection, Excelitas Technologies

The current direction of consumer electronics is toward the need for more computing power, better and smarter displays, and the ability to communicate wirelessly with a host or within an RF network. All these advances are making inroads into medical devices. There is, however, a time lag of about two years between a medical design and market adoption. With the typical long product lifetime of medical designs, an important characteristic of a consumer electronic item must be its availability over a long time period, typically more than 10 years.

Consumer electronic items are typically found only in the periphery of a medical design (i.e., the user interface). The measurement or data acquisition part (whether a radiation detector or an optoelectronics component) still needs to be specifically adapted and qualified for the medical application only. There is very little to be taken from consumer electronics here. As such, there is and always will be a dedicated development effort for the core items of medical equipment.

Bill Tormey
Electrical Engineering Manager, Ximedica

Continuous improvements in battery, microcontroller, capacitor, display, and sensing technologies are having huge impacts. Increased capacity in compact batteries with various package styles enable smaller devices that weigh less, with improved operational run times. FLASH capacitors and powerful low-cost microcontrollers spur wearable defibrillators, which monitor patients’ hearts 24/7 and provide immediate therapy in life threatening circumstances like sudden cardiac arrest. Now, very affordable color touch screens enable user friendly interfaces in products at reasonable costs. MEMS sensors (accelerometers from the car industry) capture acceleration data in the computation of compression depth and rate during cardiopulmonary resuscitation (CPR), enabling feedback to caregivers.

Question 2: What is the greatest obstacle to traditionally wired devices going wireless?

SG: There are two primary challenges to the broad deployment of wireless communications for medical devices. The first is the concern for privacy. Any time you store and transmit patient data, and this data can be associated with a particular individual, you must ensure the information is protected from inappropriate or malicious use. The second challenge is communications and data format standardization and interoperability. Currently, there are no widely accepted standard data formats and communication that have been adopted by the medical device industry.

JS: The greatest technical obstacle is that there is still no mainstream standard for a wireless device, and with the long lifetime of a medical device, the risk to design it with an RF-interface in which its standard may change within the next 10 years is high. As such, there are very few medical companies designing core medical measurement equipment with an integrated wireless node.

Another obstacle is the tough qualification process a wireless design for medical applications must undergo to make sure that there is no interference with important life-saving hospital equipment. Wireless may, however, be possible for home medical devices, such as a blood pressure sensor or an infrared (IR) fever thermometer.

BT: There’s no industry-standard wireless solution. Yesterday, Sony’s Betamax and JVC’s VHS battled to dominate the videotape format arena. Today, Zigbee and Bluetooth battle for the top spot in wireless applications. Differences like power consumption, data rates, or longer range may make the choice easier. Protecting patient information over wireless networks is another concern. Preventing loss of hundreds of electronic devices unintentionally leaving hospitals with patients is one more. That’s why product features (like RFID), which assist with locating and tracking devices, is another key selling point with hospital decision makers.

Question 3: What is the value of medical devices becoming “smarter” via electronics?

SG: The main concerns with healthcare are safety, efficacy, and in the practical world—cost. Medical devices can be made very safe using “smart” electronics. In a similar fashion, medical devices can become more effective using “smart” electronics, including advanced sensor technologies and very accurate and controlled treatments. Controlling the cost of medical care is perhaps the area where smart medical devices can have the most significant benefit to society as a whole. The population of the earth continues to increase, the average life span continues to increase, and, unfortunately, the lifetime cost for healthcare is also continuing to increase. We believe it is only through the application of cost-effective technology that can meet the needs of a growing population at a manageable cost.

JS: Smarter medical devices mean having more computing power and intelligent evaluation of results. Network integration of devices in hospitals or a doctor’s office allows access to large databases and facilitates diagnosis.

Faster image processing, as needed for imaging devices, is advancing quickly. For example, in home medical use, it may become possible for a remote doctor consultancy using home medical equipment and, perhaps, a computer or smart phone for transmitting images.

BT: As medical devices become smarter with sophisticated electronics, patients and caregivers benefit from more user friendly interfaces. By reducing user errors, these advances result in better, safer care for patients. Also, patients’ vital health information can be collected, transmitted, and analyzed in ambulances en route to hospitals before arrival. Doctors and nurses can then prepare for procedures, tests, blood transfusions, etc, before patients are admitted. Heart patients can go home with peace of mind, wearing electronic devices that detect SCA and provide life-saving defibrillation pulses within 30 seconds of an occurrence—much faster than waiting for an EMT to arrive.

Question 4: Any thoughts/comments on medical electronics you’d like to share with medical device manufacturers?

SG: The three most exciting growth areas for medical devices are:

  • Personal use “consumer” medical devices
  • Telehealth technology for linking patients to healthcare providers
  • Compliance

The three questions posed either directly or indirectly touch on each of these areas. One additional obstacle in the path of enabling and empowering patients is the current model for payment and reimbursement for medical devices and the monitoring of patients remotely. Healthcare providers and insurance providers need to agree on a new model before we will see wide deployment of these exciting new technologies.

JS: Even though core measurement equipment will always be specialized, it makes sense to pursue the definition of hardware interfaces and its protocols between electronic building blocks. This would at least facilitate testing and integration procedures and aid a faster qualification to market.