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Articles from 2014 In May


Dean Kamen Doesn't Rest

As an inventor, Kamen holds more than 440 U.S. and foreign patents, many of them for innovative medical devices. He was responsible for the first wearable infusion pump and the first wearable insulin pump for diabetics. Some of the many devices he’s worked on include the HomeChoice peritoneal dialysis system, the Hydroflex surgical irrigation pump, the Crown stent, which he developed for Johnson & Johnson, the iBOT mobility device (an all-terain wheelchair that climbs stairs), and the famous Segway Human Transporter. He founded his first medical device company, pump manufacturer and marketer AutoSyringe Inc., in 1976. At age 30 he sold AutoSyringe to Baxter Healthcare and founded DEKA soon after to develop its own inventions and conduct R&D for corporate clients.

A veteran uses DEKA's prosthetic arm. 
“I've never gone to work for a company, but in the end it was the right decision for me” he says. He likes taking his own lead and credits much of it for a distaste for authority that started at home. His mother, Evelyn, was a schoolteacher, and his father, Jack, was an illustrator who worked for EC Comics in the 50s, illustrating famed horror comics like Tales from the Crypt. If you look up the artistic renderings for the Segway patent, those are Jack Kamen's work.
 
“I've never gotten a paycheck because, frankly, as a young kid, at 5 years old, I didn't like my parents telling me what to do. I didn't like teachers telling me what to do. I couldn't imagine getting a job and thinking that because somebody's paying me they get to tell me what to do,” Kamen says.
 
“I figured if I started a business I could make things and if nobody wants them the Darwinian system of capitalism will win and I will fail and have to try something else. On the other hand, I assumed if I could create fair value I would be able to make things on my own terms, of my own design, offer them to the world, and let history decide whether I was crazy or not.” Kamen says that for him things like letter grades, or requirements from a boss or company have always felt arbitrary–something that doesn't create or indicate real value. “I would rather go out and try on my own and if I fail at least I blame myself. If I succeed, I succeed on my own and that to me is the challenge that's the excitement of life.”
 
Coming from most people this might soudn like a platitude, but you can tell from the nonchalance in his voice that Kamen means it. There's a fearlessness his approach that makes you feel like there's nothing he believes is out of his reach. In fact, you have to reach into the staples of science fiction to find the only technology that Kamen would like to create but believes will be out of reach in his lifetime–time travel. 
 
“I'd love to develop a time machine, and I mean a real H.G. Wells, Jules Verne classic science fiction time machine. You sit in it, the lights flash, you pick a date, and you pop up and talk to Albert Einstein or Archimedes or Galileo. Or you go forward 100 years to see how those people ended up addressing all the problems that we were stymied by.”
 
Kamen say he would love to be able to talk to the greats of the past and see the reality of the future. And, as he goes off to his next appointment, a more practical and personal use for a time machine becomes apparent that maybe even the superstar inventor hasn't considered. “I don't give all of [my projects] as much attention as they deserve and need,” he says when asked about balancing his workload.
 
There are only so many hours in a day after all.  
 
Dean Kamen will be awarded a Lifetime Achievement award at the 2014 MDEA Awards as part of MD&M East, June 11, 2014
 
 
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Dean Kamen Doesn't Rest

DEKA's "Luke" prosthetic arm. 
For Kamen the worthwhile projects aren't necessarily the juiciest from a business or profit standpoint. “It takes 12 to 15 years to educate a kid, so FIRST is not likely to attract the business community or the venture capital community the way a new product might,” he says as an example.
 
Thinking this way means embracing a philosophy that looks at money as something needed to reach the real end goal–freedom. “Profit is about giving you the resources to be free to do what you want to do–to work on projects like water and power and give resources to FIRST and other programs that are not likely to be able to sustain themselves based on capitalism and the profit motive," he says.
 
It also means choosing projects carefully in a world where there's no shortage of big problems to tackle, particularity in the medical space. Technology, particularly in the consumer space, moves with incremental change. If you want to sell more smartphones, cars, or personal computers, often all you need are a few new bells and whistles. Aesthetic changes and marginal improvements have kept more than one company's products stocking store shelves.
 
But incremental change won't drive medtech forward, Kamen says the technologies DEKA develops need to be the kind that will affect real change and disruption. “By process of elimination I think what we do most is avoid getting involved in incremental changes to existing technologies or working on some consumer product that maybe you could make some money with, but who cares in the end,” he says. “The threshold for us is we will work on a project if there is a really big need, if it'll improve quality of life for people, and if we can succeed in raising the bar.
 
“If we can come up with a different approach to a problem, and that approach requires engineering expertise that we think exists inside DEKA, and there's a reasonable chance that we can make a major breakthrough, we'll try it. Water, power, prosthetic devices, artificial organs, drug delivery systems, we work on them because if we succeed they make a big difference.”
 
He sounds rueful when talking about receiving a lifetime achievement award at this stage in his career. "I like to think I'm just getting going, doing more, and working harder all the time,” he says. “I hope [the MDEA Lifetime Achievement Award] does not turn out to be the pinnacle of the work being done by anybody here at DEKA. I hope it just incentivizes us to do more and better work in the future."
 
So what medical technologies get Kamen most excited right now? “I think right now it's a lot about sensor technology because computation has become virtually free. You can get incredibly high performance microprocessors that consume incredibly small amounts of power into very small packages that don’t cost much money. And similarly you can get gigabytes of memory on a small chip at a low cost.” Kamen believes that senors are the missing piece that will allow today's powerful processors to gather important, real-world data for effective outcomes. “There are a lot of base technologies being developed in sensors and in energy that are going to make medical products substantially more capable in the near future.
 
“I also think materials technology is moving pretty quickly in the medical space,” he continues. “It's allowing more tools to address problems, whether they are implantable, drug compatibility, biocompatibility, or weight and structure.”
 
Dean Kamen will be awarded a Lifetime Achievement award at the 2014 MDEA Awards as part of MD&M East, June 11, 2014
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Dean Kamen Doesn't Rest

Dean Kamen Doesn't Rest

Dean Kamen doesn't sleep much. It's seven in the morning right now–he got home after midnight the previous night after getting off a plane from Colorado after spending all day in meetings with universities and the National Renewable Energy Technology Lab for one of his many ongoing projects. He'll spend the rest of the day making up for lost time. At 7:00am the 63-year-old's voice has an energy to it most of us don't muster until around 10 or 11. He is reported to own two jets, two helicopters, and a private island, his schedule of meetings and speaking engagements sounds like something you'd hear from your favorite band on tour. It's perhaps fitting for a man who has been very outspoken that we should celebrate our scientists, engineers, and inventors as much as we do celebrities, entertainers, and athletes. “We're not creating enough innovators,” he told an audience at SXSW 2014. It's the reason Kamen founded his organization For Inspiration and Recognition of Science and Technology (FIRST) 25 years ago to get elementary through high school-age students interested in science and technology.This year over 300,000 young people worldwide, ages 6-18, will participate in FIRST's annual robotics competition.

Dean Kamen 
"You have teenagers thinking they're going to make millions as NBA stars when that's not realistic for even one percent of them. Becoming a scientist or engineer is,” Kamen is quoted as saying on the Web site of DEKA Research and Development, the New Hampshire-based company he founded in 1982. Since its founding DEKA (as in DEan KAmen) has ballooned to an organization of 500 employees – all of whom specialize in technology, design, or development.
 
In May, FDA approved one of DEKA's biggest projects, the “Luke” (named after Skywalker) prosthetic arm developed in conjunction with the Defense Advanced Research Projects Agency (DARPA) – the Department of Defense's big R&D wing. Designed with disabled veterans in mind, the DEKA Arm mimics the human arm in size, weight, and range of motion. It coverts electrical signals from muscles into movement and is designed to give people with upper extremity amputations the ability to complete complex tasks. A video released by DARPA shows an elderly vet easily moving eggs from one cartoon to another with the Luke arm. 
 
“The good news is [the DEKA Arm] was approved,” Kamen says, “But the real heroes of the story are not DEKA, it's the soldiers who need these things and also DARPA because they showed up many years ago and said, 'We've got to do this.' ”
 
When DARPA initially approached them about the project, Kamen and his team told them up front that no for-profit business would invest the amount of time and money needed to bring something like the Luke arm from conception to final product. “The market is very very small and we hope it stays that way,” Kamen explains. “And it's almost inconceivable that anyone would put in the time, effort, and energy to develop the internal expertise to go out and build and support these things clinically.”
 
DARPA's response was that it didn't care. “They told us these young soldiers deserve this and they've hung in with us for six, seven years,” Kamen says. DARPA even helped with the FDA approval process. “I think any story of that technology that doesn't' include the extraordinary support of DARPA is missing the point.”
 
With more and more innovations coming from smaller companies and startups Kamen believes there is a lot of potential in partnerships with larger companies or with large research organizations like DARPA. “The technologies move so quickly in so many areas that developing a core technology isn't the big barrier it used to be,” he says. “But the little guys typically don't have the financial resources to go from a conception, to a design, to a prototype, to clinical trails–which, in particular, are very expensive. So I think there's a huge opportunity for DARPA in this case and smaller companies.”

Dean Kamen Discusses Developing a Prosthetic Arm for Wounded Veterans 
 
 
 
Page: 1 | 2 | 3 
 
-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com
 
 

Smith & Nephew Completes ArthroCare Takeover

Arthrocare
ArthroCare's Coblation technology (Courtesy of ArthroCare)

London-based Smith & Nephew, which has lately had the financial markets in a tizzy over rumors of an impending takeover by Stryker Corp., has announced that it has completed its own takeover, of ArthroCare Corp. (Austin, TX).

The deal, originally announced in early February, gains Smith & Nephew a highly complementary sports medicine portfolio for a purchase price of $48.25 per share, which translates into a total of about $1.5 billion. For that price, Smith & Nephew will gain ArthroCare's patented Coblation technology, a radio frequency technique that dissolves target tissue with minimal damage to surrounding healthy tissue. This provides surgeons with an alternative to Smith & Nephew's strong mechanical blade portfolio.

And speaking of synergies, Smith & Nephew is a major player in hip and knee replacements while one of ArthroCare's specialties is shoulders and other soft-tissue surgeries. And although ArthroCare has good market penetration in the States, Smith & Nephew is strongest in international markets. For the sales teams of the newly combined company, an expanded product portfolio will lead to increased cross-selling opportunities.

Additionally, ArthroCare has an ear, nose, and throat (ENT) business that will provide new growth opportunities, including  the ability to expand this business into Smith & Nephew's global markets.and the potential to utilize the combined company's technological expertise to develop the product range further.

Of course, everyone is optimistic on their wedding day. Olivier Bohuon, CEO of Smith & Nephew, said, "The acquisition of ArthroCare is a compelling transaction that accelerates our strategy to rebalance Smith & Nephew towards our higher growth segments.  Its technology and highly complementary products will significantly strengthen our portfolio, and we will use our global footprint to drive substantial new revenue growth. We are pleased to welcome ArthroCare's employees to Smith & Nephew and look forward to the further development and expansion of our combined business."

Still, we wonder if the thought of this acquisition and soon-to-happen assimilation might have been one of the reasons that Kevin Lobo, Stryker's CEO, decided to hold off a bit on making an offer. After all, both at the dinner table and at the boardroom table, too much gobbling too quickly can lead to indigestion.

Stephen Levy is a contributor to Qmed and MPMN.

Samsung Launches Consumer-Focused Health Platform

Samsung has beaten Apple to the punch by announcing that it will debut a consumer-focused platform that includes a health-tracking smartwatch known as the Simband. The smartwatch can potentially be used to track everything from ECG to blood pressure and respiration. An onboard accelerometer can track activity. While the company did not release a firm date for the launch of the Simband, it promised it would hit the market before the end of the year.

A cloud-based platform known as SAMI will analyze the data, sharing conclusions with consumers. SAMI, which is an acronym for Samsung Architecture for Multimodal Interactions, can also accept data from non-Samsung devices. Owned by patients, the secured data can be shared with clinicians.

To refine the clinical applications of the technology, Samsung has established a partnership with clinicians at the University of California, San Francisco.

Cnet covered Samsung's announcement of the SAMI platform.

"As far as I know, Samsung's platform is the first with the size and market clout to try and bridge the gap between wearables and care delivery for market segments that would benefit (in health terms) from wearables," said T. Drew Smith, senior business consulting analyst at Kaiser Permanente in the Medical Devices Group on LinkedIn.

The Simband device will be powered by a "shuttle battery," which can be charged while the device is worn.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

The Simband is not Samsung's first foray into the health-tracking space. The company had previously introduced the Gear Fit and the S-Health software apps that are compatible with its Galaxy mobile devices.

The Korean tech giant has also announced a $50 million investment fund dubbed the Samsung Digital Health Challenge to spur innovation in the digital health space.

Medtech Engineer Admits to Stealing Trade Secrets

An engineer who formerly worked for Becton, Dickinson and Co. (BD; Franklin Lakes, NJ) and C.R. Bard Inc. (Murray Hill, NJ) has admitted to stealing trade secrets from the two global medical technology companies, U.S. Attorney Paul J. Fishman announced.

According to a press release from the US Attorney's Office, District of New Jersey, Ketankumar Maniar, 37, aka "Ketan Maniar," pleaded guilty before U.S. District Judge Joel A. Pisano in Trenton (NJ) federal court to two counts of theft and attempted theft of trade secrets for his own economic benefit. Maniar, an Indian national, has been in custody since his arrest on June 3, 2013.

Acting on search warrants, special agents of the FBI arrested Maniar in June at a hotel in Ramsey, NJ, disrupting his apparent plan to take the trade secrets he'd stolen back to India. The agents seized, among other things, at least one hard drive containing Bard and BD trade secrets.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

Court documents say that from November 2004 until his resignation in January 2011, Maniar worked as an engineer at Bard's Salt Lake City facility and was responsible for developing molding processes and specifications for catheters, ports and other medical products. From February 2012 until his resignation on May 24, 2013, Maniar worked as a staff engineer at BD's Franklin Lakes headquarters, where he helped manufacture pre-fillable syringes and pen injectors. 

Through his work at Bard and BD, Maniar was able to steal secret information related to the companies' products, including Bard's development of the first implantable port used for power injection of pharmaceutical drugs throughout the body. Maniar also had access to secret information related to a self-administered disposable pen injector still under development by BD and not yet available for commercial sale. 

In May 2013, while still employed by BD, the FBI says that Maniar downloaded approximately 8000 files containing, among other things, highly valuable BD trade secret information related to the pen in development. The materials Maniar downloaded essentially comprised a tool kit for mass producing the pen injector.

Most of Maniar's download activity occurred during the weeks leading up to his resignation, and he also downloaded BD files from home after he had called in sick to work. He forwarded numerous files containing confidential information from his work email accounts at Bard and BD to his personal email accounts, and also copied numerous files from his work computers onto multiple storage devices, including external hard drives and thumb drives.

Each count of theft of trade secrets for personal gain is punishable by up to a maximum penalty of 10 years in prison and a fine of up to $250,000. Sentencing is currently scheduled for Sept. 23, 2014.

Stephen Levy  is a contributor to Qmed and MPMN.

Vascular Robotics Firm Aims to Make Coronary Interventions Safer For Patients & Physicians

Vascular Robotics Firm Aims to Make Coronary Interventions Safer For Patients & Physicians

The CorPath Control Console inside the Interventional Cockpit in A Cath Lab

The interventional cardiology market in the U.S. is on a downward trend due to a combination of factors such as concerns regarding overuse of stenting and high cost for these procedures.

Still, a vascular robotics company with an approved product hopes that hospitals will choose its robotic surgical system to conduct angioplasty and percutaneous coronary interventions in the U.S. in the future.

Corindus, founded in Israel and based in Waltham, Massachusetts, has developed the CorPath Vascular Robotics System which aims to provide a safer, better alternative to the manual angioplasty and PCI procedures. Better in terms of clinical outcomes for the patient and safer for the interventional cardiologist who is exposed to harmful radiation during the procedure.

In the traditional cardiac catheterization lab, the interventional cardiologist wears heavy leaded garb to limit their exposure to harmful radiation, explained Corindus CEO David Handler in a recent interview. Every so often, the cardiologist who is bent over the patient has to look up at X-Ray imaging machines that are several feet away to see the anatomy of the patient and then manipulate the guidewires, balloons, meshes and stents manually.

Often what happens is that the physician is unable to accurately know the length of the lesion that needs stenting, and ends up choosing a stent that is too short. That requires another expensive stent - made by the likes of Abbott, Medtronic and Boston Scientific - to be deployed. The problem is that Medicare and private payors reimburse providers on a per lesion basis irrespective of whether one or two stents were used to treat it.

The Interventional Cockpit and Control Console

The CorPath Vascular Robotics System addresses both the problems currently being faced in the cath lab, Handler said. One it prevents the need to have cardiologists and other hospital staff wear heavy, joint-straining lead garb to protect from radiation exposure. And second, the system aids in knowing the exact lesion measurement, so that physicians are not having to guess lesion length that often can lead to wrong stent choices.

How is that possible?

In the first instance, the CorPath System has the cardiologist seated at a cockpit on wheels that contains the control console to manipulate the robotic surgical evice. The cockpit also houses screens through which he or she can get real time images of the anatomy being treated. The cockpit has lead glass and lead-lined walls and as such the cardiologist sitting in it to perform the robot-assisted intervention is protected from radiation exposure.

At the same time, cables connect the cockpit and console to the robotic drive that is at the end of an arm mounted on the patient’s bed rail. The drive contains a disposable, sterile cassette in which the cath lab technician can load the equipment needed for the angioplasty or coronary intervention including the guidewire and the stent.

The drive is constructed such that it is compatible with all manufacturers’ stents and guidewires, Handler said.

Seated at the cockpit, the cardiologist can use the two joysticks to control the robotic drive and using the imaging right in front of him to see when he has reached the beginning of the lesion. At that point of time, he can press a button to let the system know that the lesion has begun.  

The CorPath Bedside Unit and Robotic Drive

The robotic system can keep track of how far the lesion stretches as the physician manipulates the drive and the guidewire.

“The way we do that it that our system is measuring the movement of the guidewire, the balloons and the stents in sub-milimeter accuracy and it reads that out on the screen so that the doctors can see exactly how far they are moving,” Handler explained. “So the system can be used just like a trip odometer in your car to track how far it is from the beginning of a lesion to the end of a lesion.”

Once the X-ray image in front of them shows that they have reached the end of a lesion, they can press another button to have a readout of the lesion size. That helps to determine the length and type of stent that they should choose.

Using more than one stent to treat a lesion, which happens not unfrequently, is not considered clincially ideal. Thus the ability to know the lesion measurement that guides the choice of the stent size, cannot be underestimated, Handler said.

“Overlapping stents are not necessarily the ideal clinical treatment for the patient,” he said. “[On the other hand] if one stent chosen is too long and they deploy it, it can end up blocking a side branch because the coronary artery is like a tree - there are big branches and there are small branches.”

The CorPath system thereby helps to address the issue of lesion measurement accuracy.

“If they are able to use fewer stents and accurately treat the patients, it’s better for the patient and better for hospital economics,” he said, given that hospitals get reimbursed for the number of lesions they treat and not how many stents or other equipmnt were used. 

A clinical trial testing the CorPath has shown that the system reduces the amount of contrast dye needed to provide a continuous image of the anatomy when compared with traditional, manual treatment procedures, Handler noted.

“The measurement capability allows doctors to do the lesion assessment in a predictable way. You don’t need to be puffing the dye as often,” Handler explained “The control of the device gives them extra predictability in the navigation through the coronary artery which again reduces the times they need to puffing contrast.”

For these reasons, Handler believes that hospital administrators will be open to installing the CorPath Vascular Robotics Systems in their cath labs. He added that compared to other surgical robotics systems that can cost any where from $800,000 to about $2 million, the CorPath costs less than $500,000. Each disposable cassette costs $800.

So far 20 systems have been sold to many different types of hospitals like those in big cities, to academic centers to community hospitals. And unlike new systems that require special construction in the cath lab, CorPath is fairly easy to install.

“Our system doesn’t require any construction, so the installation is very easy to facilitate in the hospital, which is part of the whole economics story," Handler said.

[Images Credit: Corindus Inc.]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

J&J, Bausch & Lomb Fined Millions over China Price Fixing

China may finally be getting serious about cleaning up corruption, at least where big foreign-owned companies are concerned, as Johnson & Johnson (JNJ), Bausch & Lomb, and others have just found out to the tune of a combined total of over $3 million in fines..

The latest crackdown, in a country long known for bribery and other corrupt practices, is over alleged price fixing in the contact and eyeglass lens markets. Other companies involved in the investigation include Essilor International SA, Nikon Corp., and Carl Zeiss Meditec AG.

In a statement on its website, the Chinese National Development and Reform Commission (NDRC) said the companies had ordered their dealers to set the price of lenses strictly in accordance with a "suggested level," and also made resellers hold similar promotions at the same time in order to maintain pricing consistency.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

This comes just weeks after Mark Reilly, the former head of GlaxoSmithKline's China operations, was charged with graft. As reported on our sister publication European Medical Device Technology (EMDT), Reilly is accused of systematically bribing doctors and other hospital staff to boost the company's drug sales and, if convicted, he could face from three years to life imprisonment.

And it remains to be seen what effect, if any, this fine will have on JNJ's business in China, of which eyeglasses and contact lenses are only a part. We recently described the company's impressive overall year-on-year increase of 18 percent, to a $1.4 billion sales total in 2013.

But, according to Reuters, following the 10-month investigation of GlaxoSmithKline, that company's in-country revenues plunged 61 percent in the third quarter of 2013 and were still down by 20 percent in the first quarter of this year, from a year earlier. Official Chinese media have said that the firm may have suffered "irreparable damage" in the Chinese market.

The Reuters report continues, saying that its "legal sources and one source with direct knowledge of the GSK investigation said China's authorities might still try to charge the company itself, which could potentially put GSK's business licenses to operate in China at risk."

This is not the first time that Johnson & Johnson has been accused of bribery. Recent headlines related to the firm include:

Many other U.S. multinationals have also had troubles in recent years as well.  

Stephen Levy is a contributor to Qmed and MPMN.

Bluetooth and You

By Horst Merkle and Errett Kroeter

IMS Research suggests that the market for wireless patient-monitoring equipment is expected to grow to $9.3 billion by the end of 2014. Most experts agree that the catalyst for this growth is the number of people living with chronic diseases. The number of Americans living with chronic illnesses is expected to climb to 157 million by 2020, according to a paper published in Health Affairs titled “Confronting the Growing Burden of Chronic Disease: Can the U.S. Health Care Workforce Do the Job?”

Pulse oximeters are among the medical devices that can communicate wirelessly using Bluetooth technology.

As more people face chronic illnesses, medical device manufacturers operating in a vast, untapped healthcare ecosystem are tasked with developing technologies that improve patients’ lives. One technology for achieving this end is Bluetooth, a wireless technology standard for exchanging data over short distances from fixed and mobile devices. Bluetooth creates personal area networks with high levels of security. Suitable for use in health-monitoring devices, a more advanced version of Bluetooth—Bluetooth Smart—is a simple and secure connectivity solution that offers both power efficiency and a flexible application development framework.

During manufacturing, thoughtful consideration should be given to Bluetooth implementations in order to deliver successful products and optimize opportunities. Consequently, manufacturers should give careful consideration to such issues as power consumption, ease of use, security, and privacy, enabling them to lay the foundation for long-term gains benefiting both patients and company stakeholders.

Power Consumption

Lithium ion AAA batteries can be an attractive option when powering such wireless devices as glucose meters and pulse oximeters. However, while they are inexpensive and readily available, such batteries are bulky, resulting in medical devices with large footprints and rendering them inconvenient for daily use. In contrast, coin cell batteries such as those used in Bluetooth Smart devices are very small. And because Bluetooth Smart devices use less energy than devices using other connectivity systems, they last longer and are more compact and less obtrusive.

Security and Safety Issues

The increasing use of wireless connectivity technologies in the medical device industry raises a range of security and safety issues. Bluetooth technology uses 128-bit Advanced Encryption Standard (AES) encryption. Established by the National Institute of Standards and Technology (NIST), this standard protects data during transmission from one device to another. While no wireless technology is completely immune from attack, AES is among the most secure technologies available today.

Adding to the complexity of complying with standards and managing security concerns is the fact that there is no harmonized approach to privacy worldwide. Thus, while medical devices in the United States must comply with the Health Insurance Portability and Accountability Act (HIPAA), Europe has its own set of privacy and security regulations. In 2012, the European Commission unveiled a draft of the European General Data Protection Regulation, which will supersede the Data Protection Directive. In addition, privacy laws may limit what types of personal data can be stored and what types can be used for analytics. Medical device manufacturers that offer products for the global market need to maintain a flexible set of protocols and a system that reaches the appropriate balance between privacy and device utility.

Pairing and Ease of Use

Pairing a Bluetooth-enabled device with a hub generally involves two concerns: making pairing easy for the user and supporting a multidevice environment. For example, when a patient at a doctor’s office downloads data from a device onto the physician’s computer, both the patient and the device manufacturer face myriad challenges. With several other patients in the waiting room—and even more in a hospital setting—several Bluetooth-enabled devices and hubs are likely to be engaged, overwhelming users and nurses. Thus, manufacturers must follow guidelines and standards for multidevice environments that support secure, reliable, and simple pairing—in the home, office, or hospital.

In medical device environments, manufacturers must also consider the special challenges involved in sharing sensitive medical information. The good news is that because of the use of adaptive frequency hopping and Secure Simple Pairing (SSP), Bluetooth technology is more reliable and more secure than other technologies. SSP provides multiple association models, depending on the security requirements of the device and user interface capabilities. Manufacturers can also choose to add additional security layers on top of Bluetooth Smart technology.
 

Horst Merkle is the director of diabetes management systems and diabetes care at Indianapolis–based Roche Diagnostics Corp. He is responsible for the initiation, definition, and development of key components of the company’s diabetes management solutions product portfolio, focusing on interoperability/connectivity, standardization, and mobile- and cloud-based applications. Merkle is a member of the Continua Health Alliance board of directors. He has also served on the executive committee of the Connectivity Industry Consortium, which developed the accredited POCT-1 standard for point-of-care systems interoperability. He has bachelor’s degrees in organic chemistry and business administration. Reach him at horst.merckle@roche.com.
 

Errett Kroeter is director of industry and brand marketing at the Kirkland, WA–based Bluetooth Specialist Interest Group (Bluetooth SIG), a body that oversees the development of Bluetooth standards and the licensing of Bluetooth technologies and trademarks to manufacturers. With more than 20 years of experience in business-to-business technology marketing, he is responsible for the worldwide branding strategy for Bluetooth. He has also led global marketing initiatives in such companies as Gateway and IBM Software. Kroeter received a master’s degree in business administration from the University of Colorado. Reach him at and ekroeter@bluetooth.com.

Stryker Could Buy Smith & Nephew Later, Not Sooner

The latest round in the spine, hip, and knee segment's M&A dance has ended with Stryker Corp. admitting that it has its eye on Smith & Nephew plc but isn't ready to pop the question yet.

Meanwhile, Zimmer Holdings Inc. and Biomet Inc. are, after their big April announcement, sitting quietly in the corner and planning the merger that will create the company that will take over the No. 2 spot in orthopedic devices from Stryker.

Bloomberg reports that Kevin Lobo, Stryker's CEO, said that his $31 billion company has been evaluating the purchase of London-based Smith & Nephew, worth about $15 billion, which would expand its share of the market for hip and knee replacements. While the deal is on hold for now, Lobo told Fox Business, the company could move forward with the acquisition at a later date.

When news of Stryker's interest was published in London's Financial Times, the spike in the share price of Smith & Nephew was enough to draw the interest of the UK's Takeover Panel, which is the regulatory body that oversees such matters.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

"We were evaluating this as a potential transaction," Lobo said. "But based on the price spike in Smith & Nephew, the Takeover Panel called us and we have to make this public statement." After Smith & Nephew's share price jumped nearly 18 percent, Stryker had to make an offer within 28 days or wait six months under UK takeover rules, unless Smith & Nephew's board recommends the deal. If that should happen, the waiting period could be shortened to three months, RBC analyst Glenn Novarro told Bloomberg.

"Zimmer pulled the trigger on one of the two likely takeover candidates, and that somewhat forces Stryker's hand," Mark Landy, an analyst at Summer Street Research in Boston, told Bloomberg in a phone interview. Stryker must be "analyzing the competition from a larger Zimmer, the potential impact of that on its business and what is the right step for them going forward. Stryker is a logical acquirer for Smith & Nephew, which is a good asset that would bring a lot of diversification."

Also speaking on the phone with Bloomberg, Lisa Bedell Clive, a London-based analyst at Sanford C. Bernstein & Co., reportedly said, "The Zimmer-Biomet announcement really changed the game." She continued, "Zimmer has consulted enough antitrust lawyers that they think they can complete the Biomet transaction. That potentially paves the way for Stryker to do the same."

Even after Stryker's denial that it was planning a bid, London traders said the return of takeover speculation would continue to support S&N shares. "There have been bid rumors in Smith & Nephew for ages ... People are buying on the back of that," Mark Ward, head of execution trading at Sanlam Securities, told Reuters.

Still, all this jockeying is just for the right to call themselves Number 2. The top spot is, apparently unassailably, reserved for Johnson & Johnson.

Stephen Levy is a contributor to Qmed and MPMN.