Michael Barbella, Managing Editor02.03.16
Göran Gustafsson has long pondered the relationship between cars and the human body. It’s not the cause and effect type of correlation, however, that gets his mind racing, nor is it the love-hate affiliation many people have with their vehicles.
No, Gustafsson puzzles over the body’s lack of an automotive-like communications system that could flag and diagnose disease at its earliest stage. Modern-day cars are equipped with cutting-edge sensors and sophisticated computer systems that notify drivers of problems while they are still easy to fix, yet the body—which operates those vehicles—is left to sputter and suffer in seclusion.
It’s an injustice Gustafsson and his fellow engineers aim to change through the creation of a natural early warning system—an internal “check engine” light, of sorts, for the body. Gustafsson and his team at Swedish electronics firm Acreo, with help from researchers at Linköping University, have designed topical and implantable sensors as well as an anatomical “intranet” (called BioCom Lab) that links all the gear while keeping the biological/physiological data generated private.
Achieving corporeal connectivity is quite the challenge, though. Circuits must be shrunk significantly, electronics must be flexible and stretchable (the body, after all, is privy to bending, stretching and swelling), and the devices themselves must be able to function alongside tissue rather act in isolation like pacemakers and other electronic fixtures already used internally. Also, non-stop monitoring and treatment devices require new, innovative power sources as well as new methods of data transmission.
One approach to smaller, more flexible electronics involves the use of ions and electrons as charge carriers. Science has shown that cells communicate with each other using ion currents at different frequencies; thus, organic electronics theoretically can use both ions and electrons as charge carriers, making them ideal transducers between biology and electronics.
Acreo engineers, Linköping University researchers and Karolinska Institute clinicians validated that theory with the development of an implantable (electronic) drug delivery device to treat neuropathic pain. The tool was designed simultaneously as an electronic circuit (a resistor network) and as a delivery mechanism, matching a specific geometry, according to Acreo.
The two teams constructed the device from conducting polymers to convert electronic pulses into biological signals, in the form of ionic and molecular fluxes. Scientists implanted the instrument onto the spinal cord of rats, and after two days, delivered pain medication through the device directly to the affected area. The rodents experienced a significant decrease in pain with low doses and no visible side effects, researchers noted last spring in a Science Advances article.
“This demonstration of organic biolelectronics-based therapy in awake animals illustrates a viable alternative to existing pain treatments, paving the way for future implantable bioelectronic therapeutics,” the authors wrote.
Future treatment options, in fact, are already taking shape. Researchers worldwide have begun developing tiny, wearable or implantable sensors designed to harvest reams of physiological and biological data that potentially could transform healthcare. Scientists in Japan and Austria, for example, have created sensor-laden flexible circuits that are one-fifth the thickness of plastic kitchen wrap and one-thirtieth the weight of a piece of paper. This “electronic skin” reportedly can flex with elbow or knee joints and provide readouts on temperature, moisture, pulse and oxygen concentration in the blood.
Stanford University engineers, meanwhile, are fine-tuning the skin-worn pressure sensors they built for cardiac patients. The sensors’ design—involving microscopic rubber pyramids sandwiched between two films—changes the flow of electric current, making them ideal for pulmonary pressure analyses. Researchers believe the device could be used to warn of impending heart attacks.
The scientists at Massachusetts Institute of Technology (MIT), on the other hand, are looking deeper into the body with their electronic sensor research, developing carbon-nanotube devices to monitor nitric oxide in blood—an inflammatory marker indicative of infection or, in some cases, cancer. The MIT team also is currently working to expand the sensors’ capabilities to track glucose and cortisol levels, the latter of which could be useful for monitoring anxiety and post-traumatic stress disorders.
George Malliaras is targeting epilepsy and Parkinson’s disease with the organic electrochemical transistors (OECTs) he created with colleagues from the bioelectronics department at École Nationale Supérieure des Mines de Saint-Étienne (France). The OECTs could replace metallic electrodes and be used to track electrical patterns in the brains of epileptics or Parkinson’s disease patients.
Malliaras’ transistors are made from a thin polymer film that responds to chemical signals—i.e., the flow of ions that generate electrical patterns. The movement of ions in and out of the channel creates a measurable change in the transistor, making them better than conventional electrodes, Malliaras claims. He expects a less-invasive version of the OECTs to be ready for market relatively soon.
With OECTs and other cutting-edge sensor technology in the works, innovators like Malliaras increasingly will depend on electronics manufacturing services (EMS) providers to help turn their visions into marketable products. Consequently, EMS companies must be duly qualified, proficient not only in electronics design and assembly, but also in cost containment, risk management, testing, volume forecasting, supplier collaboration, automation, and robotics.
In short, they must be a jack-of-all trades.
“If you don’t have the capabilities to take a product from ideation to end-of-life, you’re going to become a less viable partner,” noted Dave Busch, vice president of Medical, NEO Technology Solutions, at NEO Tech, a Chatsworth, Calif.-based supplier of electronic engineering and manufacturing services for the medical, defense/aerospace and industrial markets. “CMs [contract manufacturers] who really want to be in the medical device space must have design capabilities as well as disposable and box-build capabilities. The distinction between the OEM and CM is getting more fuzzy as contract manufacturers do more and more of the work in the product development process. This has been happening for a long time but it’s accelerating now. As medical device OEMs rationalize their supply bases and the number of suppliers they want to deal with, they’re going to look for companies that do the whole thing. They don’t want to find a development house that can do product development, and then get someone to do prototypes, and then another outside party to do disposables and maybe a consulting group that is good at FDA submissions and certifications. OEMs don’t have time for that. They want one throat to choke.”
OEMs also want that throat to be versed in device interoperability and the Internet of Things (IoT), as the lines between traditional medicine and digital health continue to blur. Most, if not all, medical products are now (and even retroactively) designed to connect to and communicate with other healthcare and/or consumer devices.
Smart inhaler firm Propeller Health, for instance, received FDA approval last spring to sell its app and sensor with certain GlaxoSmithKline dry powder and Boehringer Ingelheim spray inhalers for asthma and chronic obstructive pulmonary disease (COPD). The technology previously was approved for COPD patients who use pressurized metered-dose inhalers.
Propeller’s digital health platform is available over Apple and Android smartphones, as well as on tablets and personal computers.
The system uses a sensor attached to an inhaler to track medication use and frequency, while the app provides personalized feedback based on the data collected. It might, for example, notify patients of missed doses, or alert doctors to sudden spikes in rescue inhaler use.
A new feature permitted by last year’s FDA clearance is the use of audio and visual medication dosage reminders, but Propeller is still working to perfect this kind of tracking technology.
One of the most promising—and potentially revolutionary—digital health add-ons comes from Redwood City, Calif.-based Proteus Digital Health, which is working with Japanese drugmaker Otsuka Pharmaceutical Co. Ltd. to market a new drug-sensor-app system designed to improve medication compliance. Proteus’ system can detect when a pill is swallowed and also collect physiological data like rest, body angle, and activity patterns, according to the company.
“I think you’re going to see more applications that help people better communicate with their doctors on health issues they might not normally be as thorough in communicating about,” said Susan Mucha, president and founder of El Paso, Texas-based Powell-Mucha Consulting Inc., a management consultancy focused on the EMS industry. “In some instances, communications-enabled devices can let people do doctor-supervised diagnostic tests or monitoring at home instead having to check into a clinic or hospital, which saves on healthcare costs. Or, it simply makes it easier for consumers to control their devices. For instance, my hearing aid can connect with my iPhone. I can sit in a noisy restaurant and if I’m having trouble hearing someone, I can pull out my iPhone and change the direction my hearing aid focuses on, cancelling out most of the background noise. No one needs to know that I’m adjusting my hearing aids. And when I visit the audiologist he downloads information from my hearing aids on the type of noise environments I’m in frequently and the control setting changes I’ve made, and fine tunes the programming. This trend toward greater connectivity will continue and is good for the EMS market because it increases the value that many contract manufacturers can add.”
“There’s a need for greater connectivity among medical devices and consumer devices,” she continued. “It used to be that medical devices had unique controls and limited ability to interface with other devices but now there’s more of an interest in more universal connectivity among devices and with apps. So EMS companies need to not only be good at the medical side of the equation, they also should have some understanding of communication and connectivity with consumer devices.”
Specifically, EMS companies should be wise to basic interfaces like Bluetooth, USB, Zigbee (for low-power LAN sensor technology), RFID, Bluetooth Low Energy, Z-wave and IPv6 as well as open hard-ware platforms (ARM architecture) and standards such as 6LoWPAN, Weightless, and 802.11 that support IoT communication and networking technologies.
EMS provider Freescale Semiconductor Inc. incorporated both 802.11 and Bluetooth connectivity technology into a line of Radical-7 SET pulse oximeters from Masimo Corporation to help patients stay continuously connected to clinicians.
Similarly, French firm Bewell Connect, a subsidiary of Visiomed Group S.A., has integrated Bluetooth technology into many of its health/wellness products, including MyThermo, a no-contact thermometer that monitors body temperature fluctuations; MyTensio, a wireless blood pressure cuff; and MyOxy, an app to help patients measure and control oxygen saturation levels.
“We are seeing an increased use of RF [radio frequency] technologies in medical products for data collection aggregation and sharing,” noted Chris Eldred, president/CEO of TeligentEMS, a Havana, Fla.-based full-service EMS provider. “Products can contain WiFi, Bluetooth, near-field communication, or other communications technologies and they all need to interconnect.”
And they must do so flawlessly, as the slightest disruption—even a tenth of a second (100 milliseconds)—can stop the continuous flow of data. Thus, EMS firms striving for long-term OEM partnerships must be capable of testing devices on various levels, from basic flying probe assays to more complex in-circuit board assembly analyses and full functional tests.
Testing prowess alone, however, is unlikely to sway customers. OEMs also expect their EMS cohorts to be schooled in the complicated maze of regulations governing medical electronics assessments, including International Electrotechnical Commission
standards (IEC 60601-1 and IEC 60601-1-2, in particular) and Federal Communications Commission requirements.
Consumer market experience can be helpful in this area, considering the medical device industry has integrated many consumer RF standards with guidelines such as Wireless Medical Telemetry Service, MedRadio, and Medical Body Area Network (MBAN). Design verification and functional test strategies for devices like body sensors are similar to those already implemented for numerous mass-market products.
The MBAN protocol, for example, requires significantly less power than Bluetooth, ZigBee or WiFi, and works on a regulated frequency band, thereby preventing the sensors from interfering with other equipment. While it is relatively new to the medical device sector, MBAN test strategies are similar to those undertaken by companies in other industries testing in the 2.4 GHz spectrum.
“The more you can do for the OEMs the more business they’re likely to give you,” Busch said. “It’s becoming table stakes. It used to be, five to six years ago, having product development in-house was a differentiator—there were not a lot of companies that provided the service. Now, most of the contract manufacturers to medical device companies do.”
Not all provide exemplary service, though. Most have learned to be proficient at the basics: quality management, design for manufacturability, cost containment, and speed-to-market. But the standouts go beyond the call of duty to provide customized solutions for their OEM partners, industry experts note.
SigmaTron International Inc., for instance, is working to certify its Suzhou, China, facility to ISO 13485 standards this year to help its customers capitalize on the Middle Kingdom’s growing medtech market, expected to become the world’s second-largest by 2020. Business intelligence firm Espicom expects China’s medical device sector to grow 7.4 percent annually over the next three years to reach $24.6 billion.
SigmaTron also is considering pursuing China State Food and Drug Administration registration, as more of its partners embrace a domestic manufacturing and marketing (i.e., “build in China/sell in China”) business model.
“We are seeing more customers focus on a strategic approach to regional outsourcing. For example, some of our customers are starting to split production among our U.S. facilities for proximity to their operations or migrate margin-sensitive product to our Mexican or China facilities,” explained Gary Fairhead, SigmaTron president/CEO. The full-service EMS provider has a network of manufacturing facilities in the United States, Mexico, China and Vietnam.
“Depending on the interest in domestic build for the China medical market, we may also pursue China FDA registration...” Fairhead added.
Also working in SigmaTron’s favor is its ability to help customers with Conflict Minerals-related data collection. The company’s Green Compliance Service Center in Asia actively surveys suppliers to determine whether any Conflict Minerals (columbite-tantalite [coltan]; cassiterite [tin]; gold; wolframite [tungsten]; or their derivatives) used to make product components were procured from “covered countries” such as Angola, Burundi and Rwanda.
The service center team gathers data and/or certifications from suppliers for various bureaucratic information disclosure requirements, including RoHS (Restriction of Hazardous Substances), RoHS II, and REACH (Europe’s Registration, Evaluation, Authorization and Restriction of Chemicals), as well as for customer-specific material tracking requests.
Though it is exempted from converting its supply chain to “Conflict Free” sources for four years, SigmaTron nevertheless is working to achieve the designation for its supplied products by May 31. The feat is likely to add value to the company’s professional relationships and give it an edge over competitors.
SMTC Corporation differentiates itself from rivals in a distinct manner—by seeking outside expertise in medical product design.
“A lot of firms do design in-house, but we have chosen a different path when it comes to medical product design,” notes Josh Chien, senior vice president of Worldwide Sales and Marketing at SMTC Corporation, a San Jose, Calif.-based EMS provider. “We have chosen to find best-in-class partners that design medical devices. In our ecosystem partnership, that’s how we differentiate ourselves. What we find is that there are many companies that are experts in designing medical devices and this is their main area of product design focus. These companies have decades of experience in developing medical devices and this is their core competency. We like to find those kinds of best-in-class companies to support our ecosystem and complement our Value Engineering services as a complete solution provider. Sometimes design firms that are involved with a lot of different products and technologies don’t stay focused on the medical industry as much as they should. We feel that medical devices products are different and deserve the expertise of a design firm’s full focus. One of the things that companies need to do more of is understand how to connect the design and idea phases to the manufacturing phase; this is where we can create the biggest impact for our customers.”
EMS companies that lack SigmaTron’s Asian market presence or SMTC’s medical design focus can still gain favor with OEMs by helping them conquer the world of electromagnetic interference. The explosive growth of wireless technology (and devices) over the last decade has subjected medical products to a constant barrage of electrical interference. The culprits are everywhere: in hospitals (MRI machines, defibrillators, diathermy therapy); in ambulances (radios); in homes (microwaves, cell phones, iPods, MP3 players); and in public (mobile products, security equipment, anti-theft devices).
The adoption of RF wireless technology in and around medical devices is particularly concerning because the environments in which these products are used generally contain numerous sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another.
EMS providers are perhaps best suited to troubleshoot communications issues. They are virtual masters of electromagnetic compatibility testing, helping their partners avoid potentially catastrophic problems through strategic product design.
Baltimore, Md.-based Key Tech Inc., for example, designed a consumable medical device last year that featured a disposable part embedded with a memory chip. The company’s engineers used shielding to protect the chip from outside electrical interference, and minimize its impact on other devices.
“It helps if a contractor has some design understanding of issues that can interfere with communications. Not all medical device manufacturers or design firms that specialize in medical products are expert at the communications equation,” Mucha explained. “This is an area where an EMS companies with expertise in communications can add value because they see the issues that arise from poor design on a regular basis. For instance, if a board is designed in a way where there is a lot of electrical noise in it, that can interfere with communication. A contractor that understands communication design and testing best practices is in a better position to tell the customer early in the process what the [interference] issue potentially is and support the redesign effort.”
* * * *
It has taken merely a dozen or so years—the blink of a generational eye, really—for wireless technology to transform the healthcare industry. Devices like smartphones and tablets increasingly are replacing conventional monitoring and recording equipment, allowing patients to undergo full consultations in the privacy of their own homes. Advancements in telecommunication, connectivity and medicine are helping healthcare become a truly mobile delivery system, freeing it from the confines of hospital walls and integrating it with user-friendly, accessible devices.
EMS providers are at the core of this metamorphic shift with their command of miniature electronics and their ability to keep their customers on the leading edge of mHealth innovation. To remain in their partners’ good graces, though, EMS companies must be versatile and capable of adapting to changing market needs as well as customer demands. As SigmaTron’s Fairhead noted: “There is a huge amount of opportunity in the medical device connectivity and mobile health sector, and much of it comes from companies finding new ways to adapt technology into products. In this environment of innovation, the challenge is figuring out which of these new products is sustainable and a good fit for the long term.”
No, Gustafsson puzzles over the body’s lack of an automotive-like communications system that could flag and diagnose disease at its earliest stage. Modern-day cars are equipped with cutting-edge sensors and sophisticated computer systems that notify drivers of problems while they are still easy to fix, yet the body—which operates those vehicles—is left to sputter and suffer in seclusion.
It’s an injustice Gustafsson and his fellow engineers aim to change through the creation of a natural early warning system—an internal “check engine” light, of sorts, for the body. Gustafsson and his team at Swedish electronics firm Acreo, with help from researchers at Linköping University, have designed topical and implantable sensors as well as an anatomical “intranet” (called BioCom Lab) that links all the gear while keeping the biological/physiological data generated private.
Achieving corporeal connectivity is quite the challenge, though. Circuits must be shrunk significantly, electronics must be flexible and stretchable (the body, after all, is privy to bending, stretching and swelling), and the devices themselves must be able to function alongside tissue rather act in isolation like pacemakers and other electronic fixtures already used internally. Also, non-stop monitoring and treatment devices require new, innovative power sources as well as new methods of data transmission.
One approach to smaller, more flexible electronics involves the use of ions and electrons as charge carriers. Science has shown that cells communicate with each other using ion currents at different frequencies; thus, organic electronics theoretically can use both ions and electrons as charge carriers, making them ideal transducers between biology and electronics.
Acreo engineers, Linköping University researchers and Karolinska Institute clinicians validated that theory with the development of an implantable (electronic) drug delivery device to treat neuropathic pain. The tool was designed simultaneously as an electronic circuit (a resistor network) and as a delivery mechanism, matching a specific geometry, according to Acreo.
The two teams constructed the device from conducting polymers to convert electronic pulses into biological signals, in the form of ionic and molecular fluxes. Scientists implanted the instrument onto the spinal cord of rats, and after two days, delivered pain medication through the device directly to the affected area. The rodents experienced a significant decrease in pain with low doses and no visible side effects, researchers noted last spring in a Science Advances article.
“This demonstration of organic biolelectronics-based therapy in awake animals illustrates a viable alternative to existing pain treatments, paving the way for future implantable bioelectronic therapeutics,” the authors wrote.
Future treatment options, in fact, are already taking shape. Researchers worldwide have begun developing tiny, wearable or implantable sensors designed to harvest reams of physiological and biological data that potentially could transform healthcare. Scientists in Japan and Austria, for example, have created sensor-laden flexible circuits that are one-fifth the thickness of plastic kitchen wrap and one-thirtieth the weight of a piece of paper. This “electronic skin” reportedly can flex with elbow or knee joints and provide readouts on temperature, moisture, pulse and oxygen concentration in the blood.
Stanford University engineers, meanwhile, are fine-tuning the skin-worn pressure sensors they built for cardiac patients. The sensors’ design—involving microscopic rubber pyramids sandwiched between two films—changes the flow of electric current, making them ideal for pulmonary pressure analyses. Researchers believe the device could be used to warn of impending heart attacks.
The scientists at Massachusetts Institute of Technology (MIT), on the other hand, are looking deeper into the body with their electronic sensor research, developing carbon-nanotube devices to monitor nitric oxide in blood—an inflammatory marker indicative of infection or, in some cases, cancer. The MIT team also is currently working to expand the sensors’ capabilities to track glucose and cortisol levels, the latter of which could be useful for monitoring anxiety and post-traumatic stress disorders.
George Malliaras is targeting epilepsy and Parkinson’s disease with the organic electrochemical transistors (OECTs) he created with colleagues from the bioelectronics department at École Nationale Supérieure des Mines de Saint-Étienne (France). The OECTs could replace metallic electrodes and be used to track electrical patterns in the brains of epileptics or Parkinson’s disease patients.
Malliaras’ transistors are made from a thin polymer film that responds to chemical signals—i.e., the flow of ions that generate electrical patterns. The movement of ions in and out of the channel creates a measurable change in the transistor, making them better than conventional electrodes, Malliaras claims. He expects a less-invasive version of the OECTs to be ready for market relatively soon.
With OECTs and other cutting-edge sensor technology in the works, innovators like Malliaras increasingly will depend on electronics manufacturing services (EMS) providers to help turn their visions into marketable products. Consequently, EMS companies must be duly qualified, proficient not only in electronics design and assembly, but also in cost containment, risk management, testing, volume forecasting, supplier collaboration, automation, and robotics.
In short, they must be a jack-of-all trades.
“If you don’t have the capabilities to take a product from ideation to end-of-life, you’re going to become a less viable partner,” noted Dave Busch, vice president of Medical, NEO Technology Solutions, at NEO Tech, a Chatsworth, Calif.-based supplier of electronic engineering and manufacturing services for the medical, defense/aerospace and industrial markets. “CMs [contract manufacturers] who really want to be in the medical device space must have design capabilities as well as disposable and box-build capabilities. The distinction between the OEM and CM is getting more fuzzy as contract manufacturers do more and more of the work in the product development process. This has been happening for a long time but it’s accelerating now. As medical device OEMs rationalize their supply bases and the number of suppliers they want to deal with, they’re going to look for companies that do the whole thing. They don’t want to find a development house that can do product development, and then get someone to do prototypes, and then another outside party to do disposables and maybe a consulting group that is good at FDA submissions and certifications. OEMs don’t have time for that. They want one throat to choke.”
OEMs also want that throat to be versed in device interoperability and the Internet of Things (IoT), as the lines between traditional medicine and digital health continue to blur. Most, if not all, medical products are now (and even retroactively) designed to connect to and communicate with other healthcare and/or consumer devices.
Smart inhaler firm Propeller Health, for instance, received FDA approval last spring to sell its app and sensor with certain GlaxoSmithKline dry powder and Boehringer Ingelheim spray inhalers for asthma and chronic obstructive pulmonary disease (COPD). The technology previously was approved for COPD patients who use pressurized metered-dose inhalers.
Propeller’s digital health platform is available over Apple and Android smartphones, as well as on tablets and personal computers.
The system uses a sensor attached to an inhaler to track medication use and frequency, while the app provides personalized feedback based on the data collected. It might, for example, notify patients of missed doses, or alert doctors to sudden spikes in rescue inhaler use.
A new feature permitted by last year’s FDA clearance is the use of audio and visual medication dosage reminders, but Propeller is still working to perfect this kind of tracking technology.
One of the most promising—and potentially revolutionary—digital health add-ons comes from Redwood City, Calif.-based Proteus Digital Health, which is working with Japanese drugmaker Otsuka Pharmaceutical Co. Ltd. to market a new drug-sensor-app system designed to improve medication compliance. Proteus’ system can detect when a pill is swallowed and also collect physiological data like rest, body angle, and activity patterns, according to the company.
“I think you’re going to see more applications that help people better communicate with their doctors on health issues they might not normally be as thorough in communicating about,” said Susan Mucha, president and founder of El Paso, Texas-based Powell-Mucha Consulting Inc., a management consultancy focused on the EMS industry. “In some instances, communications-enabled devices can let people do doctor-supervised diagnostic tests or monitoring at home instead having to check into a clinic or hospital, which saves on healthcare costs. Or, it simply makes it easier for consumers to control their devices. For instance, my hearing aid can connect with my iPhone. I can sit in a noisy restaurant and if I’m having trouble hearing someone, I can pull out my iPhone and change the direction my hearing aid focuses on, cancelling out most of the background noise. No one needs to know that I’m adjusting my hearing aids. And when I visit the audiologist he downloads information from my hearing aids on the type of noise environments I’m in frequently and the control setting changes I’ve made, and fine tunes the programming. This trend toward greater connectivity will continue and is good for the EMS market because it increases the value that many contract manufacturers can add.”
“There’s a need for greater connectivity among medical devices and consumer devices,” she continued. “It used to be that medical devices had unique controls and limited ability to interface with other devices but now there’s more of an interest in more universal connectivity among devices and with apps. So EMS companies need to not only be good at the medical side of the equation, they also should have some understanding of communication and connectivity with consumer devices.”
Specifically, EMS companies should be wise to basic interfaces like Bluetooth, USB, Zigbee (for low-power LAN sensor technology), RFID, Bluetooth Low Energy, Z-wave and IPv6 as well as open hard-ware platforms (ARM architecture) and standards such as 6LoWPAN, Weightless, and 802.11 that support IoT communication and networking technologies.
EMS provider Freescale Semiconductor Inc. incorporated both 802.11 and Bluetooth connectivity technology into a line of Radical-7 SET pulse oximeters from Masimo Corporation to help patients stay continuously connected to clinicians.
Similarly, French firm Bewell Connect, a subsidiary of Visiomed Group S.A., has integrated Bluetooth technology into many of its health/wellness products, including MyThermo, a no-contact thermometer that monitors body temperature fluctuations; MyTensio, a wireless blood pressure cuff; and MyOxy, an app to help patients measure and control oxygen saturation levels.
“We are seeing an increased use of RF [radio frequency] technologies in medical products for data collection aggregation and sharing,” noted Chris Eldred, president/CEO of TeligentEMS, a Havana, Fla.-based full-service EMS provider. “Products can contain WiFi, Bluetooth, near-field communication, or other communications technologies and they all need to interconnect.”
And they must do so flawlessly, as the slightest disruption—even a tenth of a second (100 milliseconds)—can stop the continuous flow of data. Thus, EMS firms striving for long-term OEM partnerships must be capable of testing devices on various levels, from basic flying probe assays to more complex in-circuit board assembly analyses and full functional tests.
Testing prowess alone, however, is unlikely to sway customers. OEMs also expect their EMS cohorts to be schooled in the complicated maze of regulations governing medical electronics assessments, including International Electrotechnical Commission
standards (IEC 60601-1 and IEC 60601-1-2, in particular) and Federal Communications Commission requirements.
Consumer market experience can be helpful in this area, considering the medical device industry has integrated many consumer RF standards with guidelines such as Wireless Medical Telemetry Service, MedRadio, and Medical Body Area Network (MBAN). Design verification and functional test strategies for devices like body sensors are similar to those already implemented for numerous mass-market products.
The MBAN protocol, for example, requires significantly less power than Bluetooth, ZigBee or WiFi, and works on a regulated frequency band, thereby preventing the sensors from interfering with other equipment. While it is relatively new to the medical device sector, MBAN test strategies are similar to those undertaken by companies in other industries testing in the 2.4 GHz spectrum.
“The more you can do for the OEMs the more business they’re likely to give you,” Busch said. “It’s becoming table stakes. It used to be, five to six years ago, having product development in-house was a differentiator—there were not a lot of companies that provided the service. Now, most of the contract manufacturers to medical device companies do.”
Not all provide exemplary service, though. Most have learned to be proficient at the basics: quality management, design for manufacturability, cost containment, and speed-to-market. But the standouts go beyond the call of duty to provide customized solutions for their OEM partners, industry experts note.
SigmaTron International Inc., for instance, is working to certify its Suzhou, China, facility to ISO 13485 standards this year to help its customers capitalize on the Middle Kingdom’s growing medtech market, expected to become the world’s second-largest by 2020. Business intelligence firm Espicom expects China’s medical device sector to grow 7.4 percent annually over the next three years to reach $24.6 billion.
SigmaTron also is considering pursuing China State Food and Drug Administration registration, as more of its partners embrace a domestic manufacturing and marketing (i.e., “build in China/sell in China”) business model.
“We are seeing more customers focus on a strategic approach to regional outsourcing. For example, some of our customers are starting to split production among our U.S. facilities for proximity to their operations or migrate margin-sensitive product to our Mexican or China facilities,” explained Gary Fairhead, SigmaTron president/CEO. The full-service EMS provider has a network of manufacturing facilities in the United States, Mexico, China and Vietnam.
“Depending on the interest in domestic build for the China medical market, we may also pursue China FDA registration...” Fairhead added.
Also working in SigmaTron’s favor is its ability to help customers with Conflict Minerals-related data collection. The company’s Green Compliance Service Center in Asia actively surveys suppliers to determine whether any Conflict Minerals (columbite-tantalite [coltan]; cassiterite [tin]; gold; wolframite [tungsten]; or their derivatives) used to make product components were procured from “covered countries” such as Angola, Burundi and Rwanda.
The service center team gathers data and/or certifications from suppliers for various bureaucratic information disclosure requirements, including RoHS (Restriction of Hazardous Substances), RoHS II, and REACH (Europe’s Registration, Evaluation, Authorization and Restriction of Chemicals), as well as for customer-specific material tracking requests.
Though it is exempted from converting its supply chain to “Conflict Free” sources for four years, SigmaTron nevertheless is working to achieve the designation for its supplied products by May 31. The feat is likely to add value to the company’s professional relationships and give it an edge over competitors.
SMTC Corporation differentiates itself from rivals in a distinct manner—by seeking outside expertise in medical product design.
“A lot of firms do design in-house, but we have chosen a different path when it comes to medical product design,” notes Josh Chien, senior vice president of Worldwide Sales and Marketing at SMTC Corporation, a San Jose, Calif.-based EMS provider. “We have chosen to find best-in-class partners that design medical devices. In our ecosystem partnership, that’s how we differentiate ourselves. What we find is that there are many companies that are experts in designing medical devices and this is their main area of product design focus. These companies have decades of experience in developing medical devices and this is their core competency. We like to find those kinds of best-in-class companies to support our ecosystem and complement our Value Engineering services as a complete solution provider. Sometimes design firms that are involved with a lot of different products and technologies don’t stay focused on the medical industry as much as they should. We feel that medical devices products are different and deserve the expertise of a design firm’s full focus. One of the things that companies need to do more of is understand how to connect the design and idea phases to the manufacturing phase; this is where we can create the biggest impact for our customers.”
EMS companies that lack SigmaTron’s Asian market presence or SMTC’s medical design focus can still gain favor with OEMs by helping them conquer the world of electromagnetic interference. The explosive growth of wireless technology (and devices) over the last decade has subjected medical products to a constant barrage of electrical interference. The culprits are everywhere: in hospitals (MRI machines, defibrillators, diathermy therapy); in ambulances (radios); in homes (microwaves, cell phones, iPods, MP3 players); and in public (mobile products, security equipment, anti-theft devices).
The adoption of RF wireless technology in and around medical devices is particularly concerning because the environments in which these products are used generally contain numerous sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another.
EMS providers are perhaps best suited to troubleshoot communications issues. They are virtual masters of electromagnetic compatibility testing, helping their partners avoid potentially catastrophic problems through strategic product design.
Baltimore, Md.-based Key Tech Inc., for example, designed a consumable medical device last year that featured a disposable part embedded with a memory chip. The company’s engineers used shielding to protect the chip from outside electrical interference, and minimize its impact on other devices.
“It helps if a contractor has some design understanding of issues that can interfere with communications. Not all medical device manufacturers or design firms that specialize in medical products are expert at the communications equation,” Mucha explained. “This is an area where an EMS companies with expertise in communications can add value because they see the issues that arise from poor design on a regular basis. For instance, if a board is designed in a way where there is a lot of electrical noise in it, that can interfere with communication. A contractor that understands communication design and testing best practices is in a better position to tell the customer early in the process what the [interference] issue potentially is and support the redesign effort.”
* * * *
It has taken merely a dozen or so years—the blink of a generational eye, really—for wireless technology to transform the healthcare industry. Devices like smartphones and tablets increasingly are replacing conventional monitoring and recording equipment, allowing patients to undergo full consultations in the privacy of their own homes. Advancements in telecommunication, connectivity and medicine are helping healthcare become a truly mobile delivery system, freeing it from the confines of hospital walls and integrating it with user-friendly, accessible devices.
EMS providers are at the core of this metamorphic shift with their command of miniature electronics and their ability to keep their customers on the leading edge of mHealth innovation. To remain in their partners’ good graces, though, EMS companies must be versatile and capable of adapting to changing market needs as well as customer demands. As SigmaTron’s Fairhead noted: “There is a huge amount of opportunity in the medical device connectivity and mobile health sector, and much of it comes from companies finding new ways to adapt technology into products. In this environment of innovation, the challenge is figuring out which of these new products is sustainable and a good fit for the long term.”
