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Digital Health Companies Exhibit at CES: Will You?

Digital Health Companies Exhibit at CES: Will You?

Attendance at the 2013 CES topped 150,000, according to the CEA.

It has been a week since the 2013 Consumer Electronics Show (CES) wrapped up in Las Vegas, and the Consumer Electronics Association (CEA), which puts on the annual technology trade show, has already released the dates (January 7–10, 2014) for next year’s event. Is your medical device company planning to attend? 

This year’s show featured 221 exhibitors in the digital health and fitness category, an increase of nearly 30 percent over 2012, according to the CEA. Exhibitors in the Digital Health Summit at the 2013 CES ranged from giants like Qualcomm, whose chairman and CEO Paul Jacobs delivered the preshow keynote, and Sony Electronics, which has made a recent push to enter the medical device space, to smaller players such as NeuroSky, a maker of mobile brainwave-reading devices.

“Digital health companies exhibit at CES to showcase new products before the more than 5000 media at the show and more than 150,000 industry professionals from around the world who attend CES to make deals, network, and see the future,” says Tara Dunion, senior director of communications for CEA and the International CES.

Masimo launched its first consumer device, the iSpO2 pulse oximeter, at the 2013 CES.

Among this year’s digital health exhibitors was Masimo Corp. (Irvine, CA), which attended the show for the first time to launch its iSpO2, a pulse oximeter that can be used with the iPhone, iPad, and iPod touch. The product, which is available on Amazon.com, is the company’s first consumer device.

“Our core business is in selling medical equipment to medical offices, hospitals, and doctors,” says Dana Banks, director of corporate communications, PR, and media relations for Masimo. “To then launch a consumer product, we really needed the right show, the right place, and the right buzz. We captured all of that at CES.”

Banks says the company wanted to generate media buzz around the iSpO2 and chose CES for its debut because it’s the most well attended consumer electronics event. 

“It went very well,” Banks says. “We saw a lot of excitement for the product—a lot of interest from consumer standpoint and also from the buyer standpoint, in terms of tech buyers for stores.”

Though the iSpO2 is aimed at the consumer market—athletes, fitness and sports buffs, pilots, quantified selfers, and consumer technology enthusiasts—Masimo plans to launch a medical-grade version for clinicians once it's cleared by FDA. The company’s exhibit at CES also helped build buzz for that product. Mehmet Oz, a cardiopathic surgeon known for his best-selling books and daytime television show, took notice of the product at the event.

“We talked to him about this product, and he said, ‘I can’t wait to get my hands on it and start using it,’” Banks says.

Jamie Hartford is the managing editor of MD+DI

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This Week in Devices [ 1/18/13]: Can NYC Become a Medical Device Hub?

NYC makes a play to become a hub for medical device startups. NuVasive Sued. Stryker wants to expand into China with purchase of Trauson. Hackers can steal patient data from medical devices.

Can New York City Become a Medical Device Hub?

New York City is stepping up its efforts to become an attractive locale for medical device and life science technology startups. Though many companies are based in NYC, findings show that investment is leaving the NY area and traveling as far as San Francisco. Now universities and public/private partnerships are devising plans to attract medical entrepreneurs to the area. [Xconomy]

Stryker Moves to Acquire Trauson

In efforts to expand in the Chinese orthopedic market Stryker Corp. announced this week that it will make a voluntary general offer to purchase Hong Kong-based Trauson Holdings Co Ltd for $764 million in cash. Trauson is the leading trauma manufacturer in China and a major competitor in the spine segment. In a press statement, Kevin Lobo, president and CEO of Stryker, says, "The acquisition of a leading player in the Chinese trauma and spine market underscores our commitment to strengthening our presence globally. With its research and development expertise, manufacturing capabilities, and strength of its distribution network, Trauson is a compelling opportunity for Stryker to drive growth in China and other emerging markets for years to come." [Stryker]
 

NuVasive Sued for Breach of Contract

Andrew Cappuccino, M.D., a renowned orthopedic surgeon, noted as the orthopedic surgeon for the Buffalo Bills, has filed a lawsuit accusing NuVasive Inc. of breach of contract. Cappuccino charges NuVasive with failure to pay a $660,000 "milestone payment" tied to FDA approval of a medical device used for cervical disc replacement. The device, the PCM, was developed by Cervitech, a company in which Dr. Cappuccino was a prime investor and which was acquired by NuVasive. The case is ongoing. [PR Newswire]
 
Image via SC Magazine

Medical Device Hack Reveals Patient Data

It's getting to a point where it'd be more surprising to find a medical device that wasn't vulnerable to hackers. Researchers have recently found vulnerabilities in two popular medical management platforms that could give malicious hackers access to patient data and records. The companies involved have disputed claims of these exploits. [SC Magazine]

 
 

What Happens When Nanotechnology Goes 3D?

A neon pump proposed by K. Eric Drexler and Ralph Merkle in 1995. 

A universal joint proposed by  K. Eric Drexler and Ralph Merkle in 1992.

It's not surprising that many medical device applications of nanotechnology have been limited to drug delivery and implants; most applications of nanotechnology at large have been 1D or 2D--despite countless predictions of complex implantable nanobots that would travel through our blood stream à la Fantastic Voyage. In the relatively near future, however, 3D structures could become commonplace and, as that happens, the medical (and nonmedical) applications of nanotechnology will greatly expand.

Theoretical examples of what such structures would a pump made of neon atoms and a universal joint (both shown here on the right), which were proposed by molecular nanotech pioneers Eric Drexler, PhD and Ralph Merkle, PhD. Molecular filters that use a rotor to draw in a solution while grabbing a target molecule is another basic application that could have a host of medical applications. In addition, this technology could potentially be used to filter carbon dioxide out of the atmosphere while simultaneously harvesting carbon as a raw material for commercial use. Such a breakthrough, however, is likely decades away. A molecular sorting motor could also be engineered to run in reverse, enabling it to be used as a microfluidic concentration gradient generator. Another potential application of molecular manufacturing is the creation of nano-robotic arms that wield molecular tools.

While the field of molecular manufacturing has tremendous potential, it is difficult to precisely estimate how far away it is from widespread use. The Institute for Molecular Manufacturing estimates that molecular manufacturing could mature within a decade.

In any event, commercializing the technology would require a concerted effort among researchers. Ralph Merkle has compared the situation to Kennedy's push to put a man on the moon, which required both a substantial investment in resources as well as focus and collaboration. "At this point, I would say that [having such a micromanufacturing initiative] is more important than any of the technological issues that are floating around," Merkle said last year while speaking at the Singularity University at Moffett Field, CA.

The chairman of the Institute for Molecular Manufacturing, Neil Jacobstein, has predicted that the technology will "transform our relationship to molecules and matter as thoroughly as the computer changed our relationship to bits and information." In any case, it should be an interesting field to watch: along with fields like 3D printing technology and synthetic biology.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

University of Michigan Offering First Course on Medical Device Security

 The University of Michigan (UMich; Ann Arbor, MI) is now about a week into its course offering – Medical Device Security – the first college-level course of its kind to tackle the subject matter. Taught by professor Kevin Fu, whose research background extends into medical devices, healthcare, and computer science, the course is designed to give students concepts and skills they will need to create safer and more trustworthy software-based medical devices.

For Fu the demand for the course was demonstrated not just in major news headlines covering medical device security, but in the overall tone of the industry. “Manufacturers and regulators bemoan the difficulties of hiring medical device engineers with backgrounds in computer security. Such graduates are hard to find, but I intend to change that.”
 
Prof. Kevin Fu
He says though it is often discussed, medical device security doesn't become an action item. “There's a lot of talk, a lot of handwringing, but I saw very few constructive things going forward,” Fu says. “My intent isn't to make this an exclusive course. Ultimately, I'd like to see other universities and manufacturers teaching their own version in-house.”
 
The course is divided into major sections covering computer and systems engineering, human factors, and regulatory policy. “It's a computer security course, but security in isolation doesn't have a whole lot of meaning so I teach in the context of the other properties that are common to the medical device manufacturing space like safety, effectiveness, and dependability,” Fu says. The course also features a heavy emphasis on writing (prose not computer code) with students presenting essays that make factual, technical arguments on various device security issues. The goal is to produce engineers who can clearly convey their ideas to management.
 
Still early into the semester, Fu says it's too early to say whether the course will become a regular offering. “I'm optimistic it will be offered regularly. But this is an experiment to see how things go. Every class has ended late because the discussion, not from me but from the students, just keeps going. So I'm optimistic because the students are very engaged and inquisitive about these kinds of problems.”
 
With device manufacturers already expressing interest in the course and corresponding materials (some have even offered to send guest speakers to the class), Fu has ongoing plans to replicate the course for universities and manufacturers. This May he'll be replicating a version of the course in Ann Arbor for the manufacturing community. Those interested are also able to view the course syllabus and download a coursepack.
 
-Chris Wiltz is the Associate Editor of MD+DI

FDA-Industry Consortium to Speed Device Reviews

“MDIC will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations,” an FDA release says. MDIC will “bolster the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilized to better and more efficiently evaluate new devices,” it says. 

The collaboration will provide an “enormous contribution in promoting the broad regulatory science needs of the medical device community,” FDA commissioner Margaret Hamburg said on a media call. Regulatory science has been underfunded in the medical device area, and the agency and industry look to MDIC as a new model needed to help meet general regulatory science needs, she said. It will create a safe haven to foster pre-competitive collaborative research, and the group will make sure findings enter the public domain. Regulatory tools from the collaboration “will be validated and qualified such that we know that the result that come out of them are strong enough to make regulatory decisions,” added CDRH director Jeff Shuren.

Asked about MDIC’s priorities, LifeScience Alley president Dale Wahlstrom told the media that the collaboration would likely help improve communication between developers and reviewers because there often exists a lack of understanding about science and engineering principles. One of the first things out of the process should be a shared understanding of technical submission questions and standardized test methods, he said. 

Shuren said the collaboration will also lead to better computer models for devices that use brain electrodes. He said one of the challenges has been that the electrodes can corrode and animal models are limited. An artificial brain is under development that will allow a better understanding of electrode durability which will lead to better designed devices, he said.

 More Washington Wrap-Up

CDRH Answers Slowness Critics on Patient Blog

CDRH Says It has Improved Its Processes. Do you Agree?

 

DHS Launches Initiative to Improve Medical Device Security

Researchers discovered serious vulnerabilities in two medical management platforms that are used for generating patients reports and managing surgeries. The vulnerabilities lead to an elevated response from the United States Food & Drug Administration and the Department of Homeland Security. According to information from Secure Business Intelligence, an Australian news service, the vulnerabilities gave security researchers remote root access to the impacted systems. When an individual has root access to a device, he or she can control most of its functions. With the root exploit for the Philips' platform management system, hackers could potentially steal patient records and other private healthcare information. The exploit also gave researchers the ability to remotely control medical devices that are connected to the Philips platform. Any connected device that communicates via the HL7 standard could potentially be controlled by hackers. Due to the severity of the exploits, both the DHS and the FDA took action. Both government groups urged Philips to fix the exploit immediately. However, Philips may have ignored initial warnings. According to Billy Rios and Terry McCorkle, the security researchers who discovered the exploit, private attempts by the researchers to warn Philips about the exploits were ignored. In response, the researchers shared information about the exploit with the FDA and the DHS. Two days after information about the exploit was released, Marty Edwards, the control system director at the DHS, announced that the government agency would handle all future information on medical device security vulnerabilities. A smaller exploit was also discovered in a patient monitoring tool by SpaceLabs ICS-Xprezz. The platform, designed for use with the Apple iOS, could give hackers access to restricted parts of a corporate network. References www.healthcare.philips.com/au_en/products/cath_lab_exp/xper_info_mgt

A Digital Human for Medical Device Designers

Device makers may soon have a new tool in their design and prototyping process, thanks to BioDigital Systems (New York City). The company has developed an animation and visualization system that provides a 3-D view of the human body so detailed that it can be used to model a device or implant and its function within the human anatomy.

In an effort focused on developing the first noninvasive robotic ablation treatment for such cardiac arrhythmias as atrial fibrillation and ventricular tachycardia, BioDigital is working with Medtronic on a project dubbed CyberHeart. "The CyberHeart was one of our very early projects where we took real human data and were able to resurface it and attach real motion data to 3-D models," remarks company cofounder Aaron Oliker. "The outcome was the representation of a very realistic beating virtual heart."

Such realistic renditions of organs are created by culling and integrating data from a variety of sources. To create the CyberHeart, for example, the initial heart data were taken from the National Institutes of Health's Visible Human Project. The initial model was then augmented using data from such sources as CT and MRI scans. "Essentially, through various real data sources, we built out the entire human body," Oliker says. "Now we have 5000 peer-reviewed models of male and female anatomy that we distribute online through biodigitalhuman.com, an online tool offering detailed 3-D views of the human body that enables users to add and remove layers and conditions.

"If you're dealing with an implant, it's very difficult to have a three-dimensional reference," Oliker notes. "Because if you're just dealing with CT or MRI data, you're dissecting just one part of the body; you're not looking at all of the other structures that surround that part of the body." Thus, CyberHeart enables a much more holistic view of any particular structure.

The advantage of this system is that it allows device makers to look deeper into the body and see things that might not necessarily appear on scans. BioDigital also offers a service in which it can lay a virtual rendition of a device into a virtual body to demonstrate how the device would be positioned and how it could affect surrounding structures. The company can even render the entire implant process from beginning to end.

"The value added for a device manufacturer, or even an installer, is that you can really understand what the process is and can take yourself through it and demonstrate it," Oliker comments. "We can take real data and manipulate them to show error pathways. If you have enough data, we can show possible pathways that you could never demonstrate in live surgery."

While BioDigital's goal is to make its tools as accessible as possible, its technologies are meant to complement existing medical device design methods, including cadaver dissection. "Interacting with the human body and cadaver dissection is essential," Oliker says. "But it's expensive, and there are all sorts of legal issues associated with it. Moreover, dissected cadavers do not always look like the real thing." CyberHeart and other BioDigital tools are designed to augment dissections. But if dissections are not an option, these tools are the next best thing, Oliker adds.

Aaron Oliker will be speaking at MD&M West on Tuesday, February 12. His talk, "Motion Capture for the Heart: A Close Look at the CyberHeart Design Project at Medtronic," will show attendees how BioDigital creates its simulations and how real data were gathered for the CyberHeart project. He will also present examples of the BioDigital Human technology and demonstrate the work the company has performed in conjunction with Medtronic, Stryker, and other medical device manufacturers,

Surface-Treatment Process Prepares Balloons for Drugs, Flexible Electronics

A balloon postprocessing technique from Interface Catheter Solutions produces a textured surface (left). In contrast, balloons that have not undergone the process have smooth surfaces (right).

While coronary stents--both the bare metal and drug eluting varieties--have revolutionized the field of interventional cardiology, they are not without drawbacks. In response, medical device manufacturers are either working to improve stent designs or developing alternative technologies, such as drug-eluting or electronics-laden balloons. One such manufacturer is Interface Catheter Solutions (Laguna Niguel, CA), which offers drug-eluting balloons that could prove useful in treating stenosed arterial vessels and in-stent restenosis.

Supporting the development of drug-eluting balloons, the company has developed a surface-texturing technology that facilitates the process of coating balloons with a drug. Normally, the surface of such balloons is smooth, making them difficult to coat, explains Mark Geiger, vice president of sales and marketing at Interface Catheter Solutions. The traditional method of overcoming this challenge is to coat the balloon with a polymer, which serves as a primer before it is 'painted' with a drug layer. In contrast, the company has developed a balloon with a textured surface that avoids the need for this coating. After producing the balloon, the company applies its surface-treatment process to create a textured surface, increasing the surface area and improving the ability of a drug to bond to the balloon.

While it remains to be seen which technology--drug-eluting balloons or balloons equipped with electronics--will ultimately have a bigger impact on interventional cardiology, the field of flexible electronics is gaining steam. "With the advent of companies like MC10, the use of the balloon, which is such a familiar platform, could really be extended by using them in conjunction with electronics," Geiger comments. "The two applications that have risen to the top in those discussions are renal denervation (RDN) and atrial fibrillation."

For treating atrial fibrillation, balloons with mounted electronics can be used to both sense and ablate tissue. RDN, on the other hand, appears to be an effective method for treating hypertension in patients that are not responsive to drug therapy. Highlighting the importance of RDN, Geiger notes that both Medtronic and Boston Scientific have acquired companies that focus on renal denervation technologies. Based on Interface Catheter's surface-modified balloons, for example, Boston Scientific's Vessix Vascular Inc. provides balloon-based RDN systems with embedded flexible electrodes that can perform renal denervation procedures in 30 seconds per artery.

Although balloons are not used universally to perform RDN, a growing number of firms have become interested in balloon-based technologies with electronics mounted onto them, according to Geiger. "These types of technologies are different from each other, but they all use a balloon with some sort of electronics mounted on it," he says. "It is really the convergence of the unmet clinical need, the familiar platform in balloon technology, and the advent of flexible electronics that have really allowed this to be realized."

Medtech Industry Analyst to Perform Teardown Analysis at MD&M West

Curious about which parts are inside an Animas Ping insulin pump? The device will the subject of a live teardown at the MD&M West conference on February 12 in Anaheim, CA, which will shed insight into the inner workings of the device as well as the insulin pump market and relevant intellectual property considerations. The teardown will be performed by Bill Betten, medical technology director at UBM TechInsights, who previously has led a number of medical device product development efforts.

The components of the Animas Ping insulin pump from UBM TechInsights' teardown.

On February 13, Betten will provide teardown analysis of the iPad Mini and the Google Nexus 7, which will shed insight on their design. Although tablets are not medical devices per se, they are being used for a growing number of medical applications and proven to be popular among physicians.

Betten also will provide teardown analysis of another Apple product, the iPhone 5, on February 14, along with the Samsung Galaxy S3, which is now the most popular handset on the market.

Additionally on February 14, Betten will give a presentation titled "When Worlds Collide: When Consumerization Meets Medical Device Technology." Although the intersection between the two has been growing in recent years, the design philosophies found in the two industries remain much different.

Device Tax, ACA Top PWC's 2013 Top Healthcare Issues List

The Affordable Care Act (ACA) takes its place as the major shaper of 2013 in Pricewaterhouse Cooper’s Health Research Institute’s (HRI) top 10 health industry issues (scroll to the bottom of this article for full list). With 2014 as a significant deadline for changes in the industry due to expanded health coverage, 2013 will be a year to prepare for what is to come.

“The medical device industry has a real opportunity to explore its relevance,” Todd Evans, director on the Health Industry Advisory for Pricewaterhouse Cooper, said. “We have a sizable expansion of the population that’s to be treated coming online. There may be the potential in the growing pie for everyone to benefit, including medical device makers.”

Although the top 10 concerns are diverse and influence a range of stakeholders in the healthcare industry, certain items will particularly affect medical device companies. Firms should should take heed and shape their strategies.

The medical device excise tax has been the subject of intense focus for a few years now. According to HRI, medical device companies should no longer wait for a chance at repeal—the tax is here to stay. Evans believes that medical device companies will have to work harder and perform better to get good results and prevent volatility and disruption in the supply chains. “The executive teams across the industry [should] consider this a chance to restructure the company in a more efficient way to perform at those levels,” he said.

In addition, it’s time to determine who will pay for the tax. PWC believes that passing the tax onto the consumer is not an option, but the report suggests that medical device suppliers could be tapped to take on the cost of the tax. The report notes that the tax poses a threat to smaller companies, which they may owe more in taxes than they can generate in profits. Larger device firms may be able to expand their portfolios by acquiring those smaller companies. The report suggests that ultimately, the device tax could be a boon for the industry, in that it could help spearhead new innovation and make operational recalibration possible.

The transition of hospitals looking to reduce costs will have a tremendous effect on the industry, as hospitals adjust purchasing habits. With 40% of consumers not seeking treatment due to the expense, hospitals will be scrambling to lower costs, which, according to Evans, includes procedures that extend beyond the walls of the hospital to make sure there are fewer cases of 30-day readmission. Hospitals have started with some minimal retooling, but PWC says it’s only the beginning. General cost management will be the most important decision for these facilities, and companies who can provide better outcomes at better cost will be at an advantage.

Comparative effectiveness and value analysis is changing the game for many medical device companies. Their success will not depend on the physicians using their products but on the insurers and large institutions that are willing to cover it. The HRI report references a recent example from Memorial Sloan-Kettering Cancer Center, where the center refused to pay for a colon cancer drug, citing a different drug that cost less and was just as effective. The result was that the company slashed its prices to the same as the competing drug two months after the release of the drug. In terms of medical devices, Evans sees that medical device companies can charge a premium price, but they should have the data to back up evidence that it will be worth the cost. “If there’s no outcome, there’s no income,” he said. “It can be an economic outcome, a clinical outcome, or a quality of life income, but any of those can lead to the other two.”

Finally, population health management is going to be a huge issue, as more companies will be taking it on in partnerships in order to share responsibility for working to prevent medical issues before they happen. PWC expects population health management to require major investments over the next several years, with no determined date of finish, and there will be a lot of trial and error to get effective systems in place. A strong technology base is vital for these collaborations, and systems should have the capabilities to support analytics and strong web data.

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HRI's Top Health Issues for 2013
  1. States will be determining how do deal with insurance exchanges, including whether to expand Medicaid and how to regulate the industry. Information technology (IT) will be a major challenge, and many states are overhauling the infrastructure of Medicaid eligibility systems.
  2. Consumers are starting to be able to take charge of how they spend their healthcare money, which is changing how medical companies will market their wares. The methods are now more retail-based in theory, and insurance companies are benefitting from nontraditional marketing.
  3. The excise tax will increase government revenue, but manufactures have to determine who will take on the cost. The tax is anticipated to help develop new innovations, as well as drive consolidation in the industry.
  4. Dual eligibles, or people who qualify for both Medicare and Medicaid, will begin to increase, and the cost of care is rising quickly. States must turn to managed care companies to help coordinate care and technology companies to support home-based care.
  5. Doctors and nurses are beginning to use their own devices, which brings questions of protecting patients’ information through the wifi networks of hospitals. Many hospitals will have to figure out how to regulate mobile device usage for its workers as well as for patients.
  6. Cost reduction for hospitals is being driven by multiple factors, not just ACA. Labor productivity and supply cost reductions are only the beginning of the cuts; look for hospitals to launch full transformation efforts in how they deliver care.
  7. Consumer ratings are having a higher impact on hospitals and insurers, with insurers being able to receive $3 billion in bonuses for quality reviews. However, hospitals may have $850 million held back as a result of the federal government’s value payment program.
  8. Insurance companies and larger providers will have more say in payment decisions than physicians. Medical device companies and pharmaceutical companies will now have to appeal to them.
  9. Employers are rethinking their roles in providing insurance to their employees, possibly resorting to private or state exchanges. Consumers will have to reconsider their place in their healthcare process, as employers may no longer have as much say.
  10. Population health management is more important that ever. Look out for partnerships to form with companies to share responsibility for patient outcomes and satisfaction as well as data collection and analysis. Population IT health infrastructures will also be built.