MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Herrmann Ultrasonics Releases Ultrasonic Punching and Welding Machine (MD&M West Exhibitor)

An ultrasonic punching and weld-sealing machine has been designed to save medical device manufacturers material and steps in the production of plastic components with integrated filter membranes. Supplied as a manual workstation or integrated into an automation line, the HiQ MPW modular system can punch and weld at the same time. In a single step, the unit transports the membrane by conveyor, punches the membrane contour, and welds the membrane onto the part in a weld cycle time of less than 2 seconds. Downstream optical quality control is not needed because the system has its own vacuum monitor to check whether the membrane is correctly punched and positioned. The machine control features gentle conveyor transport with a splice check to minimize other sources of error and thus production downtime.

Bartlett, IL

Herrman Ultrasonics will be exhibiting at MD&M West in Booth #3235

Indian Stent Makers Give Boston Sci, Medtronic, and Abbott a Run for Their Money

Multinational stent manufacturers like Boston Scientific, Abbott and Medtronic face new competition from a growing number of Indian stent manufacturers. According to a new report in Daily News & Analysis, a news publication based in Mumbai, Indian companies like Meril Life Sciences may cut into sales of established stent manufacturers. Meril Life Sciences is an Indian stent manufacturer that produces more than 60,000 stents every year. As of now, more than half of these stents are exported to South Africa and Germany. However, Meril Life Sciences plans to expand into emerging markets around the world. This includes parts of the Middle East, Asia, Eastern Europe and Latin America. In many emerging markets, lax regulatory standards make entry barriers low for new stent manufacturers. As of now, established brand-name manufacturers can't provide stents at the same low price as their Indian rivals. Meril states that its international sales are growing at a rate of 40 percent every year. In addition, Meril notes that many international markets view Indian stent manufacturers in a positive light; quality and safety issues are not a huge concern for emerging-market purchasers of these Indian stents. References www.dnaindia.com/money/report_stent-firms-find-pulse-overseas-too_1788627

Filter Vents from Donaldson Company (MD&M West Exhibitor)

A company provides filter vents made with proprietary Tetratex expanded-PTFE membranes for a variety of medical device applications, such as devices requiring acoustic and protective vents, drainage bags, IV-administration sets, ostomy bags, urine bags, and device packaging. The vents are hydrophobic, toxicity-tested to USP Class VI standards, clean and nonshedding, chemically inert, and thermally stable. They feature high particulate and bacterial removal rates and high rates of airflow, and are designed to minimize extractables. Oleophobic and acoustically transparent materials are optionally available. Equipped with design and filtration-material expertise, the manufacturer offers custom systems that are easily integrated into the customer’s device or application.

Minneapolis

Donaldson Company will be exhibiting at MD&M West in Booth #974

Conductive Compounds' Conductive Pad-Printing Ink (MD&M West Exhibitor)

Silver conductive ink for pad-printing high-definition fine-line traces in hard-to-print areas of electronic medical devices is offered to give design engineers flexibility in creating circuits. AG-1074 ink is designed to print well in recessed areas of hard-plastic device substrates and on raised surfaces, by contrast with screen printing and other conventional printing processes that cannot access contoured surfaces. Solvents can be adjusted for compatibility with specific substrates or medical-grade silicone pads, and the ink enables design engineers to incorporate electronic circuit traces into molded parts more easily.

Hudson, NH

Conductive Compounds Inc. will be exhibiting at MD&M West in Booth #1447

Russia Introduces New Medtech Regulations

According to information from the Roszdravnadzor, the Russian healthcare agency, new regulations for medical devices are currently being implemented in the country. Some of the new medical device regulations became active on January 1st, 2013. However, details of the new regulations aren't fully available yet. The Emergo Group, a medical device consultancy, provided an early analysis of the new regulations. According to information posted on a company blog, the new regulations impact conformity assessment, quality and safety issues and medical device vigilance processes. As of now, new regulations on importation, adverse event handling and medical device classification have been approved. Overall, the new regulations may indicate a more challenging atmosphere for medical device companies. Instead of playing a direct regulatory role, the Roszdravnadzor will defer decisions to expert reviewers. In addition, the new regulations indicate there may not be established timelines for medical and clinical testing; this could lead to multiyear approval delays for medical devices. In addition, changes have been made in medical device registration fees. Emergo Group (http://emergogroup.com) posted a summary of new regulatory processes. A copy of the text from their Web site is available below: 1. Applicant must obtain an import permit for samples submitted for testing by Roszdravnadzor. 2. Applicant must establish agreements with laboratories for any necessary technical and toxicological testing of its device. 3. Applicant must submit documentation including test reports to Roszdravnadzor. 4. Roszdravnadzor authorizes expert review of the applicant's submission. 5. Expert reviewers determine whether additional clinical testing of device is necessary and provides list of hospitals where such tests should occur. 6. Roszdravnadzor informs applicant whether clinical tests are required. 7. Applicant must set up agreements with hospitals where clinical testing will take place. 8. Applicant provides clinical testing results to Roszdravnadzor. 9. Roszdravnadzor then sends applicant's clinical test results out for expert review. 10. Expert reviewers notify Roszdravnadzor whether clinical test results are acceptable, provide a report of the test review to regulators, and inform Roszdravnadzor whether the device in question can be registered. 11. Roszdravnadzor issues either a Registration Certificate to applicant based on a positive expert review or a refusal based on a negative review. References http://roszdravnadzor.ru/main/oficial/22972 (text only available in Russian) www.emergogroup.com/blog/2012/11/major-changes-russian-medical-device-regulations-planned-2013

CES 2013: Medical Device Roundup

The 2013 Consumer Electronics Show wraps up today, but this year showed no shortage of new products and innovations in medical technology – especially in the areas of mobile/digital health and safety. If there's one trend to take from the news coming from this year's CES it's that healthcare is expanding out of the hospitals and doctor's offices and into the rest of our lives.

In addition to a Digital Health Summit focused on the latest trends in digital technology affecting healthcare, CES 2013 saw a good number of new medical device products being unveiled. Some are aiming to carve out a niche in already crowded markets (i.e. wearable sensors and monitors) while others are looking to take on new challenges.
 
Here's a roundup of some of the products that could be on everyone's mind (and our bodies) in 2013:
 
 

The HealthSpot Station

Those weight scales and blood pressure machines you've seen at your local CVS could be in for a major upgrade. The HealthSpot Telehealth System is a walk-in kiosk that will provide patients with immediate access to diagnosis and treatment. Once you enter the 8 x 5-foot private kiosk, you'll be linked with board-certified doctors via HD video conferencing. The HealthSpot Station will also feature several digital interactive medical devices including a scale, thermometer, dermascope, otoscope, stethoscope, and pulse oximeter to assist doctors with rapid, on-the-spot diagnosis. Each HealthSpot will be accompanied by an accredited medical assistant and is designed to fit into everyday locations from retail stores to pharmacies in addition to doctor's offices, nursing homes, and anywhere a patient might take advantage of the purported convenience. HealthSpot is expected to roll out in early 2013. Pilots are currently being conducted in Ohio.



 



Masimo iSpO2

As an addition to the ongoing trend of medical devices that attach to the iPhone, Masimo has unveiled the iSpO2, a consumer pulse oximeter to noninvasively measure blood oxygenation, pulse rate, and perfusion index that also connects with your iPhone, iPad, or iPod Touch. Users simply slip the device onto their finger and their vital stats will appear onscreen. The iSpO2 app provides immediate access to your data history – allowing you to view measurements, graphs, and trending over time – with the ability to export data history for use with text editing and spreadsheet programs. The device is currently available and retails for $250.

 
 

RP-VITA Remote Presence Robot

At this year's Digital Health Summit, InTouch Health presented its RP-VITA Remote Presence Robot, which has just received FDA 510(k) clearance. The first of its kind, the RP-VITA is a robot designed to facilitate remote doctor-to-patient consultations. FDA clearance allows it to be used for active patient monitoring in pre-operative, peri-operative and post-surgical settings, including cardiovascular, neurological, prenatal, psychological and critical care assessments and examinations.The robot features an iPad interface and is capable of being linked with other hospital machinery (such as ultrasound machines) for data transmission and recording patient interactions.


 

BodyMedia CORE 2

BodyMedia has introduced a prototype for another entry into the steadily overcrowding market for wearable monitoring devices, the CORE 2. In addition to the standard features like heartrate monitoring and smartphone and tablet connectivity, BodyMedia promises this activity tracker/armband will be the smallest product of its kind yet and arguably the most fashionable – offering interchangeable jewelry like faceplates, straps, and cuffs. BodyMedia envisions the CORE 2 as part of a total body monitoring package that will include a free mobile app, online activity manager, and personalized feedback with a “BodyMedia FIT Coach.” BodyMedia's body monitoring technology is also the only system of its kind that is a FDA-registered medical device.

Philips Lifeline GoSafe

Royal Philips Electronics has added a mobile component to its Lifeline system for senior citizens. The GoSafe is a mobile personal emergency response system that features fall detection capabilities along with tracking technologies and cellular voice communication. Similar to the existing Philips Lifeline service, users wear the GoSafe button around their neck as a pendant at all times, both inside and outside the home. In the event of an emergency, the user can push the button to initiate a call for help to the Lifeline Response Center or, if a fall is detected, the GoSafe's AutoAlert feature can automatically place a call for emergency assistance.

TelCare BGM

Telcare, in collaboration with Verizon and Qualcomm, has developed a wireless blood glucose meter – the Telcare BGM – that has been certified to operate on Verizon's nationwide cellular network. The Telcare BGM is also the first medical device to utilize Qualcomm’s new Internet of Everything module. By integrating Telcare’s FDA-cleared blood glucose meter and cloud server to the Verizon network, people with diabetes, their families, and their health professionals will now be able to integrate real-time measurement of blood glucose levels with other physiologic parameters, such as weight and blood pressure. No word yet on the level of Verizon plan that will be required of users.

 

- Chris Wiltz is the Associate Editor of MD+DI

 
Related Links:
 
 

Medical Device Manufacturers of the Year, 2012

 
 
 

Medtech Innovation Doesn’t Have to Be Expensive

Medtech Innovation Doesn’t Have to Be Expensive

In the medical device industry, it is often assumed that groundbreaking product designs involve substantial investments in R&D and technology. That’s not necessarily the case, says Stacey Chang, associate partner and director of IDEO's health and wellness practice.

Creativity has more to do with understanding a problem than deploying new sets of technologies. Image from Flickr
 

MD&M West Workshop to Target Medtech Creativity

Stacey Chang, joined by his IDEO colleagues Brian Mason and Jesse Fourt, will lead an interactive workshop at MD&M West on February 11 in Anaheim that will illustrate these principles. The workshop also will provide several examples of their approach to innovation as well as some case studies that illustrate how breakthrough products can be relatively inexpensive to develop. “We can give some examples of some really breakthrough ideas that were inexpensive,” Chang says.

Innovation has more to do with recognizing “what the real need is” rather than deploying new sets of technologies. “Even when you are designing with your existing technology you can actually subtly shift the way you design in order to address the need better,” he says.

Most device companies do traditional market research, Chang says. For instance, ”they do time-and-motion studies, talk to key opinion leaders to see what their thoughts are,” he explains. But there are a lot of different ways you can get at new ideas that don’t involve those traditional methods. “Key opinion leaders (KOLs) aren’t always the best people to talk with because generally they are the most practiced and the most capable; the issues that your average practitioner has, they don’t necessarily have,” Chang explains. “You are not actually solving the needs of the population you are going to sell to if you are only deriving your product specs from the KOLs.”

Device companies also should make sure they thoroughly consider the “human need” of the end user, Chang advises. “The way most medical device companies go about determining specs is actually pretty rigid and defined by regulatory constraints. Some device companies don’t [allow] a lot of time to focus on the human need, which is not always captured in the specs.”

Chang acknowledges the substantial differences in product development in the medical device space and the broader technology industry. “The consumer space, which includes products like the iPhone, is all about making the consumer happy. In healthcare, the most important thing might be saving the patient’s life,” he says. “That being said, when you design a product well, it makes it easier for the physician not to make a mistake, which is a big deal.”

Another barrier to innovation in the medical device environment is the lure of the consumer space for startups. “Because there are so many hurdles: regulatory, the difficulties of running trials, and so forth, it really raises the hurdles for entrepreneurs,” Chang says. “If I am an entrepreneur and I want to do something really creative, I could move over to the consumer space, where there are low hurdles and the chances for success are high, and I’ll know I’ll spend less time spinning through all of the challenges of patent and regulatory kind of stuff,”

Chang muses that a consortium of people might be able to get together to come up with a set of tools that makes it as easy to innovate in the healthcare space as it is in the consumer space. “How do we get the broader ecosystem to lower those barriers so it is equally enticing to save a life as it is to make a cool iPhone app?” Chang asks. “Healthcare is where a lot of money is going to be spent in the next ten years and I think it is not a matter of if but when someone figures out how to develop those platforms. You look at companies like Qualcomm Life, Alere Connect, those are some of the people who are thinking about building platforms with which you can at least do digital innovation in healthcare,” he says. “I think we have to figure how we can extend that notion much more broadly across the entire healthcare space including devices, services, protocols, and things like that so the risk profile is a lot lower.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

Related Content:

Top 10 Device Challenges for Hospitals in 2013 Podcast

Title: Top Device-related Challenges for Hospitals in 2013

Join Heather Thompson, Mary Logan, and Ken Maddock in a frank and illuminating discussion of the key device-related problems that hospitals are facing today. What can device makers do to alleviate the new burdens hospitals face, such as cybersecurity, alarm management, and the bandwidth issues created by BYOD (bring your own device). 

Host:

  • Heather Thompson, Editor in Chief, MD&DI

Guests:

Duration: 37 minutes

Topics: Heather, Mary, and Ken discuss the top device-related challenges for hospitals in 2013, as reported in a study conducted by the AAMI.

Top concerns include:

  • Managing Devices and Systems on the IT Network – complexities in device networking
  • Alarm Management – is FDA to blame?
  • Maintenance of Infusion Pumps – better maintenance contracts versus planned obsolescence route
  • Cybersecurity – something the industry knows it needs to do but doesn't want to talk about
  • Preventive Maintenance Strategies – manufacturers and service community need to understand how they can help each other
  • Medical Device Incidence Reporting and Investigation – not just a data issue
  • Medical Devices brought in by Patients – concerns about introducing a device from an uncontrolled environment into a controlled environment

Download the Podcast 

Stryker Announces New Global Initiative

Stryker, a medical device manufacturer based in Kalamazoo, Michigan, announced that it will place a higher emphasis on markets outside the United States. At the JP Morgan Healthcare Conference, Stryker CEO and president Kevin Logo detailed the new plans for the company. According to information released at the San Francisco conference, Stryker will overhaul its European and emerging-markets business. It has made several significant changes in its management and structure oversees. According to Lobos, it could take several quarters for changes to be reflected in the company's finances. However, he stated that the European market was a "key plank" in Stryker's global market initiative. Emerging markets currently represent six percent of Stryker's sales. In emerging markets where the company has an existing footprint, Stryker has seen 20 percent growth. However, the company feels that there are many existing emerging-markets where a larger footprint would enhance sales. In ending remarks, Lobo stated, "Globalization's an enormous opportunity for Stryker, we clearly have room to grow outside the U.S." He continued, "The U.S. is still representative of 65% of our total sales. That is a ratio that hasn't changed in about 10 years." References http://www.stryker.com/en-us/corporate/pressnews/index.htm

Dexcom’s CEO: FDA’s Fast Approval of the G4 CGM Was Unprecedented

The G4 CGM from Dexcom (above) looks similar to an earlier generation of Apple's iPod (below). 

It is fitting, in more ways than one, to compare the firm’s technology to GPS systems. In addition to helping diabetics navigate changes in their blood glucose levels, the company’s Gen 4 Platinum also reflects the trend of consumerization in the medical device space. The Gen 4 Platinum itself looks more like an iPod than a GPS system. The company recently announced a partnership with Tandem Diabetes Care, which also has a product, the t:slim insulin pump, that bears a resemblance to an Apple product.

Much of Gregg’s talk focused on the Gen 4, which debuted in October 2012 after having been approved by FDA in six months. “That is unheard of in this regulatory environment,” he said.

The device is 20% more accurate overall than its predecessor, the 7 Plus (for a look inside that device, see: “Inside the Dexcom Seven Plus Continuous Glucose Monitoring System”), which will help diabetics better navigate the “delicate balance between hypoglycemia and hyperglycemia,” Gregg explained. “Hyperglycemia contributes to the microvascular complications associated with diabetes: cardiovascular disease, increase in blindness, kidney failure, and nerve degeneration,” he said. “On an acute basis, hypoglycemia is even more dangerous [leading to] cognitive impairment, loss of consciousness, and potential death.”

In general, CGM can also help reduce the costs of treating diabetes, which, in the United States, exceeds $170 billion annually. “On average, a hospitalization for hypoglycemia costs $17,000,” adding that “CGM can reduce hypoglycemia by 50%.”

MD&M West to Feature Keynote From Tandem Diabetes Care CEO

Kim Blickenstaff, president and CEO of Tandem Diabetes Care will deliver a keynote titled "Innovation with ears: Designing a consumer-friendly medical device" at  MD&M West on February 12 in Anaheim. 

At present, only a handful of firms have CGM products on the market. In the United States, Medtronic and DexCom are the only players. Dexcom has working to expand its operations outside of the United States. “Today, 90% of our revenue is derived from the U.S. market,” Gregg acknowledged. “We now operate in 22 countries. As we expand beyond our shores, we will expand that to an additional 11 countries.”

The company plans on introducing a variety of new products in 2013 and 2014. “In late 2014 to 2015, we’ll introduce smartphone technology that we are currently working on,” Gregg said.

“Mobile health is at our doorstep,” he said. “And we are leading activities with FDA looking at Class III medical devices, the risk and mitigations of those risks in order to achieve wireless capability.”

The company is also involved in the artificial pancreas project, which integrates a continuous glucose sensor and insulin pump, and an algorithm, which serves as a brain for the device.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz