For many years, Bluetooth wireless technology has been relegated to the world of hands-free mobile headsets. However, this wireless protocol has found a new home in miniature integrated medical devices. These devices can be worn, carried or even swallowed by patients. Some novel wireless medical devices that have emerged in recent years include bandanas that record epilepsy-related brain waves, body bands that monitor a patient's cardiovascular health and underwear that monitor a patient's vital signs. All of these technologies are made possible by Bluetooth wireless technology.

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When combined with a tablet or mobile phone, Bluetooth-powered medical devices can provide both medical body area monitoring and remote patient monitoring. With these new networks, physicians and heathcare providers can achieve an always-connected health care delivery environment. However, challenges await those who want to use this unique technology. In part, medical device manufacturers must work with programmers to create software that supports these types of devices. In many cases, manufacturers will be required to use software developers from different domains to ensure reliability and ease-of-use for their wireless Bluetooth medical devices. Next-generation medical devices are self-managing, self-documenting, portable, adaptable and multifunctional. Many of these features are made possible due to advances in data storage and processing. In the past, many medical devices were limited due to their hardware. However, wireless medical devices can use the cloud to "outsource" analysis of patient biometric data. For example, imagine a Bluetooth-enabled blood pressure monitoring system. In the past, this type of device could provide one-off readings to a patient. While the device could potentially store a number of previous blood pressure readings, patients would have few ways to analyze their biometric data and incorporate it into a broad overview of their health. With Bluetooth-enabled devices, a wireless blood pressure cuff could send data to a cloud-based patient health profile. By combining blood pressure readings with other biometric data like weight, blood lipid profiles, heart rate, body fat percentage and more, patients can effective ways to improve their overall health and wellness. High blood pressure is often linked to obesity, a sedentary lifestyle and excessive consumption of sodium. As of now, there are a variety of mobile applications for Android and Apple devices that allow users to record the foods they consume during the day. For the most part, these applications are designed to monitor a person's calorie consumption. With a Bluetooth-enabled blood pressure cuff and a smartphone-based food diary, patients could see how their consumption of sodium impacts their blood pressure over time. When patients input data on the food they consume, a cloud database could track the amount of sodium associated with those foods. Based on this, patients would have an effective way to reduce their blood pressure while staying accountable to themselves and to their physicians. There are hundreds of different electronic sensing devices that could incorporate Bluetooth chips. By digitizing patient biometric storage and retrieval, companies can find new ways to improve patient health and quality of life.

Europe is an attractive home for many medical device startups. While the United States medical device market is very large, medtech companies face a significant number of regulatory hurdles when bringing new products to the U.S. market. Because of this, many medical device manufacturers commercialize their product in Europe before coming to the United States. In a MedCity article, several industry leaders offered valuable advice for young entrepreneurs hoping to take on the European market. "Don't invest in all markets at once," says Kevin Sidow, CEO of MoxiMed. As a startup, many companies are strapped for cash. Instead of battling with FDA regulators, Sidow recommends pursuing CE Mark approval first. Armed with post-European-commercialization clinical data, companies are in a better position to get their medical device cleared or approved by FDA regulators. MoxiMed pursued European milestones first due to several unique nuances of the German market. Since Germany has a long-standing history of tibial osteotomies, the country was the perfect starting point for some of MoxiMed's devices. While Moximed is based in California, the company also maintains offices in Switzerland. "Set up relationships between key surgeons first before you begin to hire people or go to third party suppliers or agents," notes Sidow. It's also important to understand organizational differences. "Different pricing, different healthcare systems, different languages-as a smaller company that can be quite a headache," states Barry Russell, CEO of NeoSurgical. Europe isn't a single country with uniform laws. While many countries in Europe are bound together by the European Union, it's essential for startups to have the human resources and information needed to navigate these different systems. Finally, medical device startups shouldn't blindly try to win favor with European regulators before taking on the United States. While the CE Mark system may be more reasonable, it's essential to look at the fine details of a medical device and a company. CE Mark approval isn't always easier. In some cases, an FDA 510(K) clearance is easier than a CE Mark path due to classification differences.

On Tuesday, Johnson & Johnson stated that three of its China-based managers would start reporting to a local chairman. The company hopes this restructuring will improve oversight and boost sales. Over the past few months, pharmaceutical companies and others in the Chinese medtech industry have been in the limelight. GlaxoSmithKline, a British drug manufacturer, received significant scrutiny from Chinese regulators over bribery allegations. J&J stated that its global consumer business chairman, Jesse Wu, would be the next chairman of J&J's China segment. Wu will report directly to CEO and chairman Alex Gorsky. As of now, all three of the company's Chinese divisions have reported to separate managers based in the United States. While each of the divisions will still maintain autonomy when it comes to making business decisions, each president and general manager based in China will now report directly to Wu. Wu's old position will be filled by Lynn Pendergrass, a senior vice president of Hewlett-Packard in the Americas. Pendergrass will take over as leader of the Johnson & Johnson's global consumer business. "Now it is all segmented like the rest of the world," noted a spokesperson for the company. "You report through steps to the worldwide chairman of your unit." In total, Wu will be in charge of 9,000 China-based employees. J&J's Chinese operations pulled in $2.5 billion in revenue in 2012.

This glass implant can trigger bone growth.

Scientists at Missouri S&T have developed porous strong glass scaffolds that cause bone generation. The scaffolds are "strong enough to repair large structural bone defects" resulting from severe injuries or cancer], according to lead researcher Len Rahaman. In addition, the material can be customized to make it resist infection by, for instnace, incorporating silver into the scaffolds.

Developed using robocasting technology, the material has been shown capable of standing up to the stresses similar to those subjected to the bones in the legs.

The researchers have tested the materials in rats. In those experiments, the scaffold proved capable of quickly joining to skulls and promoting substantial bone growth in a six-week time frame. The research is documented in Acta Biomaterialia. The researchers are now testing the material in the rats leg bones.

A new color-changing syringe design could save millions of lives every year. In many cases, deaths or injuries resulting from the use of syringes are caused by poor sterilization.

In total, approximately 1.3 million people around the world die every year due to unsafe injections and the reuse of syringes. According to the World Health Organization, approximately two-fifths of all injections are administered with used needles that haven't been sterilized. This is estimated to cause 5% of HIV cases and 30% of hepatitis B/C cases.

At the University of Huddersfield, researchers developed a new type of "behavior-changing syringe" that could warn patients if a needle was unsafe.

"The difficulty for patients is that it is impossible to determine a visual difference between a used syringe that has been washed and a sterile syringe removed from its packaging," notes Dr. David Swann, a researcher who worked on the project. "Instigating a colour change would explicitly expose the risk and could indicate prior use without doubt."

To make the technology viable in developing nations, it was essential to keep the cost as low as possible. In part, researchers took inspiration from the food industry. By using inks that reacted in the presence of carbon dioxide, patients and physicians in developing countries can tell if a needle is used. Once a needle is removed from its nitrogen-filled packaging, the color of the syringe will change within one minute.

To reduce the risk of tampering, the piston of the syringe is designed to break if someone attempts to replace it. Researchers estimate that the syringe will cost only a little more than traditional disposable syringes.

Medical device recalls ticked up in the second quarter of 2013. Image from Stericycle ExpertRECALL.

Medical device recalls at a five-quarter high and dealing with them has become increasingly complex as a result of globalization. "The number of recalls that had a global component were up, which really speaks to the challenges of a global supply chain," says Mike Rozembajgier, vice president of recalls for Stericycle ExpertRECALL.

In the second quarter of 2013, medical device recalls ticked up 30% over the previous quarter. Nevertheless, the total number of units recalled globally dipped--by 50% in that quarter. 

In addition to the number of recalls that affected units both in the U.S. and abroad, the global supply chain is complicating matters in that many medical devices contain components developed outside of the country. "How medical device companies go about minimizing the ensuing complexity goes back to their internal quality programs, their ability to conduct appropriate audits of their facilities, and having an appropriate recall in place to manage the logistics in a timely fashion," says Rozembajgier. Medical device companies need to make sure that they are transparent in the manner in which they communicate and that they have the appropriate logistical plan in place to manage the flow of product back to a central source so it can be removed from the marketplace."

Depending on the target demographic involved, medical device companies could consider using social media to help get the message out about the recall, Rozembajgier says. "If it is a device that has broad-based distribution or one that has an over-the-counter unit, they could use that route to help get message out in a format that is clear and concise." The pharmaceutical industry has used this tactic successfully, but social media has not been widely adopted for this purpose by medtech companies.

For more on recalls:

• This Month in Recalls: August 2013
• You're Hit with a Medical Device Recall--Now What?

Here, we recap the seven most popular items posted to Qmed in the month of August. 1. The most popular item was posted towards the end of the month. Titled "Which U.S. State Is Best for Medical Device Companies?" the article drew from the opinions of medical device professionals on LinkedIn supplementing it with MPMN's own research on the subject, which we have performed for a decade. 2. The second-most popular item was a recap of summer layoffs in the medical device sector. That article was titled "Which Medtech Firms Had the Most Layoffs This Summer?" 3. Next in line is an article on three medical device companies that are faring well so far in 2013. The list includes some surprising picks, like Mako Surgical whose stock had languished since April of this year, when it began a stead upward trajectory. 4. The fourth-most popular item was a story on rising engineering salaries, which now average over six figures. (In case you were wondering, the average medtech engineer's salary is $103,512 with a $10,240 bonus.) 5. Readers were interested in a lawsuit in which a federal judge ordered Zimmer to pay $228 million to Stryker as part of a patent infringement case. 6. Earlier in the month, we recounted how The New York Times blamed orthopedic device makers for rising hip implant costs in the United States. In their corporate blog, Biomet's CEO weighed in on the issue, faulting the Times' article for its inaccuracy. 7. Readers seem to always be interested in the subject of medical device recalls, so it comes as little surprise that a recap of August recalls proved popular.

Spinal health is an often overlooked by healthy patients. Until there is a problem, many people take their spine for granted. However, both disease and aging can lead to spinal deformations. While a deformed spine may not be straight, finding a solution involves much more than simply straightening the spine.

A sagittal imbalance is caused when the back loses its characteristic S-shape. This shape allows the human skeleton to resist the downward force of gravity. However, this S-shape can change due to bad posture, ill health or the inexorable march of time.

According to Professor Le Huec, chairman of the Bordeaux University Hospital Orthopaedic Department, the slopes and tilts of the back are based on a delicate equilibrium of different forces.

"Fish don't have lordosis. We see inappropriate kyphosis in humans causing imbalances in the forces involved in maintaining the erect position," he notes.

Each week, this French surgeon performs several operations with the goal of restoring the natural balance found in a patient's back. By forming a triangular part of a patient's spinal structure and adding screws and rods, he can restore the natural curvature of the spine. This technique, pioneered by Le Huec and others, has made great strides over the past decade.

One procedure, dubbed a Smith-Peterson Osteotomy (SPO), is only designed to change the posterior arch of a patient's vertebrae. However, this operation may involve the removal and resharing of a small part of a patient's vertebrae. In this technique, dubbed Pedicle Subtraction Osteotomy, a vertebra section is reshaped from rectangular to triangular.

"It is a long surgery, with an average loss of 1.5-2 litres of blood in the literature and potential complications has historically been very high, including infection, post-operative pain and muscle pain," Le Huec notes. "But 90% of patients say they are very happy because they lose their back pain and recover a normal life."

As patient populations age, the number of kyphotic patients increases. Almost all patients experience this type of degeneration after 60 years, according to Le Huec. However, anatomy is usually able to compensate for this change in four-fifths of patients.

Approximately 15 years ago, the French surgeon saw increasing numbers of patients with a flat back, the opposite condition. Oddly enough, this issue was due to a surgical procedure that had long been considered a success. During the 1980s, many physicians around the world pioneered new spinal surgery techniques. In particular, physicians learned treatment techniques for patients whose vertebrate had fused, hunching them forward.

As surgeons began using screw-based implants, bone fused much more easily in a desired position. However, physicians at the time did not respect a patient's natural spinal anatomy. In Le Huec's words, "In fact they were creating flat backs due to the position of the patient on the operating table. The majority of patients are in hypolordotic position on various frames during surgery."

Le Huec's latest contribution to the medical device arena is dubbed the ReDuX Plier. This device is designed for osteotomies in sagittal imbalanced patients. In particular, the device is indicated for patients suffering from pedicle subtraction osteotomy. Since current tools didn't work very well for patients suffering from these conditions, Le Huec worked with engineers to create a new instrument, giving patients greater control.

The ReDuX Plier is designed to connect directly to implants. The device helps protect the front of a patient's vertebrae from collapse in a unique way. By dissipating stress onto the bone screws by driving the kinematic of the closure (while a progressive correction is applied), the device allows for a highly-controlled procedure. The device was released on the market in June of this year.

Over the past 20 years, cell phones have evolved from bulky, lunchbox-sized systems into invaluable communication devices. Since most modern Apple and Android devices contain integrated GPS systems, cameras, Bluetooth, wireless connectivity, accelerometers and more, they can be used to gather and transmit a wide variety of patient biometrics. According to some industry analysts, the global mobile health market is slated to hit $26 billion in the next four years.

According to one survey, over half of smartphone owners use their device to research health-related information. In response to this, the mobile app market has exploded over the last few years. In total, programmers have created almost 100,000 mobile apps for personal fitness and health. The top 10 mobile health apps generate an estimated four million free downloads every day. In addition, these apps are estimated to generate approximately 300,000 paid purchased every day.

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But the majority of health-related mobile technologies make no attempt to compete directly with traditional medical devices. There are exceptions, like the AliveCor heart monitor and the iBGStar blood glucose meter, which have been cleared by FDA. Products like that, however, have yet to become mainstream. "You need to use these technologies in mainstream medical practice in order to gather the experience -- the insight and the data -- that is necessary to establish the product and to establish clinical value," said AliveCor interim CEO in an interview with MobiHealthNews.

Meanwhile, the consumer mobile health segment is on track to go mainstream. In the next four years, analysts predict that half of all smartphone users will have downloaded mobile apps for personal health and fitness. As of now, weight loss apps reign supreme with an estimated 50 million downloads. In second place, exercise-related apps command 26.5 million downloads. Other mobile health apps with millions of downloads include women's health, sleep / meditation, pregnancy and tools / instruments. Other health-related apps are estimated to account for 18 million downloads in total.
While mobile health apps are used by people of all ages, the average age of a mobile health app user is 35. Out of these users, approximately 54% are male and 85% use social media. While Android may command the largest number of users, iPhone owners make up 33% of the total mobile health market.

In many cases, mobile health app users are already participate in the traditional healthcare system. In total, 76% of mobile health app users are estimated to take a prescription medication. In addition, approximately one-third of mobile health app users are caregivers for a dependent.

While the mobile health market shows strong popularity with patients, physicians are also utilizing these new technologies. In total, four-fifths of physicians use medical apps for their smartphones. An estimated 93% of physicians believe that mobile healthcare apps can be successfully used to improve a patient's health. In some cases, physicians (40%) believe that mobile health technologies can be used to reduce the number of times a patient visits a doctor's office. On top of this, 93% of physicians believe that having a mobile health app for Emergency Health is valuable.

For now, however, only 25% of physicians use mobile health technologies for patient care. While many physicians are willing to embrace mobile technologies, adoption rates are still lagging behind demand. For the right entrepreneur, the mobile health market could be a goldmine. Time will tell, however, to what extent the field is capable of disrupting the traditional healthcare industry.

ACA is Spurring Innovation and Creating Unlikely Alliances Health accelerators have mushroomed nationwide all with the intention of encouraging entrepreneurs eager to disrupt the siloed healthcare marketplace. Verizon, a telecom company, has now a FDA-cleared wireless home health app that can connect to biometric devices to provide remote patient monitoring. Medtronic, known more for being a device manufacturer of ICDs and pacemakers, just made a surprising move by buying a disease management company.

  

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Learn more about how Obamacare is affecting next-generation medical technologies in a conference session at MEDevice San Diego, on September 26, 2013.