Though a rise in obesity has been linked to the rise in diabetes, one of the most important factors that contribute to an increase in diabetes is genetics. Heredity plays an important part in determining who is likely to develop type 1 diabetes, the type most commonly found in children, and which used to be known as insulin-dependent or juvenile-onset diabetes. Diabetes is more prevalent in the older population, that is, those aged over 65. However, 215,000 Americans younger than age 20 have diabetes.
With a rise not only in overall cases but also cases among the young, Tandem Diabetes Care Inc.’s t:slim pump comes at an ideal time. According to a recent study by Common Sense Media, in 2011 43 percent of children under the age of 8 had access to a smartphone in their homes; just two years later in 2013, that percentage increased to a whopping 63 percent.1 With that many young children becoming savvy to, familiar with and perhaps even dependent on the smartphone platform, t:slim offers an attractive option to diabetes sufferers who need to continuously monitor their insulin.
The device looks just like a smartphone. It has a touch screen and is compact so it can fit into a pocket. The San Diego, Calif.-based company even markets the device as “familiar,” referring to the American population’s comfort around smart mobile devices: “The t:slim pump incorporates familiar, proven technologies such as a built-in rechargeable battery, and an integrated micro-USB port for convenient charging and fast data transfer speeds,” according to the company’s website. The small device also is touted to deliver insulin in the tiniest doses available.
Girish Wable, technical project manager for St. Petersburg, Fla.-based Jabil Inc., told Medical Product Outsourcing that wearable
devices such as t:slim are “exploding” in the electronic medical device market, which is in line with the trend toward more home-use devices. In addition to wearables, “smartphone-like data communicators for all body mounted or home use devices like monitoring systems and drug delivery pumps,” of which the t:slim also is an example, are on the rise.
“Integration of electronics in passive devices has seen a big increase in the last year with everything from glasses to wristwatches,” Wable went on to say. “With an increasing trend towards miniaturization, integrating functionality through cross technology pollination is becoming a key ingredient of innovation. EMS (electronic manufacturing services) can leverage from the experience gained through the manufacturing of smart electronics and adapt it for medical device integration. The emergence of wearable electronics for daily consumer use promises a great vision for medical devices. As these devices become ubiquitous they have the ability to propel health monitoring and awareness beyond human comprehension. Wearable devices can help feed a huge amount of data into intelligent analytics, making it possible for prognostic and strategic medical care while minimizing the need for tactical and reactive treatments. It is also exciting to see small and medium enterprises that have had years of experience and diversified engineering capabilities in their respective fields of printed circuit board assembly work together to make the integration happen.”
MICROMO , too, a Clearwater, Fla.-based DC motor company, sees in its business the trend towards miniaturization.
“We see this miniaturization trend continuing with our OEM customers’ requirements,” Micromo engineering staff told MPO. “We see the need for smaller motors for such products as surgical and diagnostic tools.”
Although a perfect example of the continuing trend toward miniaturization, t:slim also provides an ideal example of why miniaturization to infinity will not be the prime focus of electronics manufacturing for medical devices. As Apple Inc. showed with its ubiquitous i-products (the iPhone, the iPod, the iPad and so on), the trend to “small” can reverse. The tablet technology featured in the iPad came after the smaller iPhone as the market started to call for a better viewing interface for playing games, for instance, or watching movies.
“While the trend towards miniaturization is very much continuing to emerge, there is also some dialogue happening on ‘right sizing’ of devices,” said Wable. “Products don’t have to be smaller and smaller, but could be just small enough. In some cases, in fact, the sizes have been growing in order to deliver more functionality over miniaturization, e.g. larger screens for smartphones.”
However, Wable went on to say, there is no denying that for certain components, miniaturization is the name of the game. This requires electronics manufacturing service providers such as Jabil to remain capable of handling smaller and smaller components.
For instance, Rohm Corporation makes a chip resistor—a passive component used to create and maintain a known safe current within electrical components—that measures just 0.3 by 0.15 mm, and offers a purported dimensional accuracy of plus or minus 5
microns (a micron is one millionth of a meter). A higher dimensional accuracy reportedly contributes to a reduction of stiction errors in the packaging process.
“We continue to see our customers wanting smaller overall packages for portability,” said Jim Thompson, director of engineering at Safari Circuits Inc., an Otsego, Mich.-based electronics development and manufacturing services company. “We have customers integrating the latest low power Bluetooth technology into their products, including medical devices. These are products that will utilize Bluetooth technology for communications with smart applications. This requires designing electronic devices with smaller footprints for these applications.”
“Consumer devices tend to drive component footprint sizes and packaging trends because they are built in the highest volumes,” explained Rajesh B. Upadhyaya, executive vice president of West Coast operations for Elk Grove Village, Ill.-headquartered EMS provider SigmaTron International Inc. “Consumers like wearable products and that has been driving miniaturization. This aligns well with some of the cost pressures found in healthcare right now, because smaller, wearable devices can make it easier for patients to wear a diagnostic monitoring device at home vs. staying in a hospital for that monitoring process. And more intelligence can now go in smaller devices such as inhalers and hearing aids, enabling doctors to evaluate the way patients use these devices based on what the device reports vs. what the patient remembers doing.”
Indeed, Smartinhaler, a subsidiary of Franklin, Ohio-based respiratory disease management company Nexus6 Ltd., makes inhalers for asthmatic patients that contain wireless sensing devices. They track medication usage, provide audiovisual reminders if patients forget to use their inhalers, and automatically send the data to the “cloud.” Similar to the t:slim, the Smartinhalers feature screens that prompt patients when to take their medication, and patients can upload and review usage on a smartphone, tablet or computer.
“Three-D printing has received some significant press and additive manufacturing has made the most amount of progress in terms of commercial availability of solutions,” said Jabil’s Wable. “The EMS industry has rapidly adopted this trend and has begun to offer services and initiate standards work in this space. Portable 3-D printing and infrastructure of embedded electronics including integration on the component side has gained significant momentum over the last year.”
Jabil was one of the early adopters of additive manufacturing for electronic components, having used the technique to prototype products for about 15 years. Now, Jabil Mechanical Engineering Manager Gregory Jantsch told USA Today, Jabil uses a 3-D printer for “almost anything we touch, from medical equipment to semiconductor equipment.” Jantsch reported that most design review meetings at Jabil revolve around prototypes produced on a 3-D printer that costs about $45,000. “For engineers and designers, there’s no substitute for a part you can touch or hold in your hands.”
There’s no escaping 3-D printing—it seems to be everywhere we look lately. This is because several key patents on the technology expired or are expiring, leaving the technology open for wide adoption. Just last year, two major patents on 3-D printing technology expired, and this year, 11 are on the chopping block. Last October, a patent on thermal stereolithography expired, a method for providing 3-D objects through the principles of stereolithography using flowable materials. Then in December, a patent held by Israeli 3-D printing company Stratasys Ltd. expired. This patent is for a method for producing 3-D objects using a computer-generated specification of a solid object to interweave the planning and building phases of production on a slice-by-slice basis. Because the method does not require an explicit evaluation of the entire shell of the object at the outset, it ostensibly reduces the total time required to generate a finished part.
The founder of Stratasys, Scott Crump, invented one of the 3-D printing methods that the company still sells today: fused deposition modeling (FDM). The 3-D printers that run on FDM technology build parts layer-by-layer by heating thermoplastic material to a semi-liquid state and extruding it according to computer-controlled paths.
“Three-D printing hasn’t even begun to blow up yet,” Jason Hundley, president and CEO of Huntsville, Ala.-based Zero Point Frontiers Corporation, told MPO. His company 3-D printed a mechanical hand for a young girl with symbrachydactyly—she was born without one of her hands. “We do a lot of technology studies, and we’re only seeing the tip of the iceberg. The reason you’re seeing 3-D printing in the media today is because the patents that expired on plastic extrusion has allowed, for the first time in history, 3-D printing devices to come to market that cost less than $5,000. And that just happened in the last year to 18 months.”
We’re Not Done Talking About Regulation
Although it may seem as if the Affordable Care Act (ACA) has been discussed ad nauseam, the medical device industry is not yet at the point where it can stop. After all, the medical device tax has only been in effect for a year, and while companies lay off employees and nip and tuck their operating costs where they can to offset the cost of the tax, there has not yet been a disastrous effect on the industry either in the OEM or CMO side. As American Academy of Orthopaedic Surgeons’ William M. Mihalko, M.D., Ph.D., told MPO, it is much too soon to identify any meaningful effects of the medical device tax or the ACA as whole—which also means the industry will be feeling and examining effects for years yet. But, the current political climate certainly has put companies on edge in terms of making sure they maintain their profit margins.
“The biggest impact we see is with increased FDA regulation and concerns over device taxes,” said Micromo engineering staff. “Start-up device companies have real concerns about sustaining business and investing in innovation with new taxes and regulation. Larger OEMs can weather the effects of any device tax and will likely be affected only by product to market delays with more regulation. There is a lot of difference of opinion in the market on the perceived and real results of the ACA.”
“Healthcare providers are under cost pressure and that means that medical device manufacturers and their supply base are also under cost pressure,” said SigmaTron’s Upadhyaya. “Quality can’t be cut. The challenge becomes finding ways to take cost out of the process without cutting quality. We use a combination of strategies to do that which include: strong front-end engineering support to eliminate manufacturing inefficiencies; a global purchasing team that identifies cost-competitive high quality materials options; and a systems strategy that minimizes manual information processing activity while providing real-time visibility into the areas that management and technical teams need to monitor. We also offer customers the ability to migrate product to lower-cost labor regions in Mexico and Asia. As an example, customers using our Tijuana (Mexico) facility often see total costs competitive with China, while maintaining logistics simplicity since products shipped from our facility are normally in the United States by the next day.”
Whether the dreaded tax will have any lasting detrimental effects on the medical device industry or not, it is certain that the electronic device and component market has a strong market position going forward. According to the latest Market Research report on medical electronics, the medical electronics market is expected to reach $372.4 billion by 2018 primarily supported by the application sectors monitoring and surgical systems, imaging systems, diagnostics and medical therapeutics. Globally, medical therapeutics and imaging systems together account for approximately 52.9 percent of the market and are expected to support the medical electronics industry going forward. The report found that the highest rate of growth—17.2 percent—is anticipated from the Asia-Pacific region during the report’s analysis period of 2011-2018. Last year, China’s medical electronics market experienced a double-digit-rate expansion driven by demand for equipment in a country increasingly beset by “first world-type ailments,” according to a China Electronics Supply Chain topical report from IHS Inc. Monitoring and surgical systems account for the largest share of the global market, driving an annual growth rate of 13.4 percent. Imaging systems are promising to be the fastest growing application with a forecast growth rate of approximately 16.9 percent annually by 2018. The report delves into how, along with the fast growth and rapid advancement in technology related to healthcare industry, medical electronics expectations have increased innovatively for large numbers of incurable diseases.
Reports show that success in the medical electronics market is a matter of identifying key growth sectors and keeping abreast of where the most need lies. Ultimately, the market is wide open and full of electronics-savvy patients, and physicians and regulators eager for smarter devices. As long as industry keeps up with the type of market demand, they will not want for demand itself.
- “Zero to Eight: Children’s Media Use in America 2013.” www.commonsensemedia.org/research/zero-to-eight-childrens-media-use-in-america-2013