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Ahead of His Time: Part III

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New Opportunities

AliveCor devicesAmidst all of the hoopla, Albert received multiple offers for funding from venture firms who had caught wind of the iPhone ECG from Albert’s viral video. “The company that had turned us down also came here and begged, they asked, could we execute the agreement?” Albert says. “To which we said, are you freakin’ kidding me?”

Today, more than 160 companies and distributors from around the world contact Albert expressing interesting in the technology. And 10s of thousands of people wanted to buy one.

“So that became an odyssey. Because this was just a hobby—it was not planned to be a product, let alone a company!”

Soon thereafter, Satchwell had set up a website for the product. “It was very crude but at least you could register your e-mail.” he said. “We’ve since had thousands of registrations.”

A Unique Reimbursement Strategy

With the goal of raising cash for their fledgling business, the AliveCor founders set off looking for funding. “And raising money is always an issue. Especially in a completely new product area,” he says. “The first thing every venture guy asked me was ‘what is your reimbursement strategy?’ And I tell them, ‘um, your wallet. You are going to buy it. It is going to cost you $99 in the Apple store. Or AT&T, Verizon, or Sprint, or Best Buy.’”

“Will anybody do that?” the venture guys typically ask.

“And I say, ‘well, we are going to find out.’” Albert says. “But people have done surveys. Actually, IBM had gone out and done a big survey that found if it costs less than $100, people will consider buying a new health-monitoring product,” he says.

There are a number of mHealth devices out there that fit that price structure. “There is the Zeo, and the Lark, and FitBit, and all of these things, and they all try to be at $99.” In contrast to those products, however, Albert’s device is a medical product. “Those are kind of fitness or health devices.”

The two clinical studies performed on the iPhone ECG have resulted in three abstracts, one of which was submitted to American Cardiology and two were submitted to the Heart Rhythm Society.

“We compared it to state-of-the-art GE 12-lead ECG machines,” he said, “and we have phenomenal data. And this is as good a single lead ECG as has ever been built,” he says. “It’s absolutely better than the event recorders that people have made in the past,” he says. “And it’s an order of magnitude cheaper.”

Regulatory Matters

“It’s absolutely better than the event recorders that people have made in the past. And it’s an order of magnitude cheaper.”

Albert is filing two 510(k)s for the device. “One of them will be prescriptive—for physicians. The other will be for consumers,” Albert says. “What is unique about our product is that this product it is just as useful in the hands of a physician as it is in the hands of a patient.”

The AliveCor team has finished three clinical trials and is is filing two 510(k)s. The company expects the CE Mark to be granted for the device in early 2012.

In addition, in February 2011, the Alivecor team discovered that FDA had come up with a brand new category, which is why they are filing a second 510(k). The FDA category specifies a single lead over-the-counter ECG. “It’s a brand new category. And they talk about a battery-powered plastic case. Metal electrodes. Liquid crystal display,” Albert says. “I think they made it for me.”

Early Promise

Eric Topol, MD, chief academic officer at Scripps Health, used the device to diagnose a myocardial infarction while on a plane. In November 2011, he was on a plane flying from Dulles to San Diego. About 30 minutes into the flight, the flight crew asked over the intercom whether there were any physicians on board. A passenger was having chest pain and was sweating. Topol put his iPhone ECG on the guy’s chest. “And he had the absolute diagnostic notion that he was having an acute heart attack—big time,” Albert says.

RhythmStatXL
Mobile computing technology has grown exponentially since Albert worked to develop the RhythmStat XL portable ECG device, shown here in a brochure.

“Eric said, ‘this guy is having a heart attack. You need to land this plane.’ They actually landed the plane somewhere in the vicinity of Cincinnati,” he says. The patient had a stent implanted and survived the ordeal.

That’s just one example of the anecdotes supporting the benefits of the device that have emerged from people who have been testing the device. More objective information comes from the team’s clinical studies. The AliveCor team did studies in comparing the single lead ECG to a 12-lead ECG. “The accuracy of the data is absolutely the same,” Albert says.

Because of the high resolution of the data, the device can be used to diagnose whether a pacemaker is working. “Today, ambulatory monitors have a very difficult time with pacemakers. Because the pacing spikes become very small—2 milliseconds wide,” Albert says. “Most ambulatory recorders record at a 128 to 256 samples–per-second at 8-bit resolution. This means every 8 milliseconds. So what happens if you get one sample every 8 milliseconds? If there is a 2-millisecond pacemaker pulse, you’ll never see it.” The iPhone ECG samples at 44 KHz at 24-bit resolution, which is the same rate as CD-quality audio.

Support

Francis Collins
Francis Collins, MD, PhD, chief of the National Institutes of Health and Human Genome Project leader, demonstrates the iPhone ECG on NDTV, an Indian station.

Albert is delighted to have enthusiastic support from respected people such as Leslie Saxon, Eric Topol, and Francis Collins, MD, PhD, the chief of the National Institutes of Health. Recently, Collins appeared on Indian TV demonstrating the technology. “He’s probably the premier scientist in the United States,” Albert says. “I couldn’t afford to get Francis Collins, Leslie Saxon, or Eric Topol to use, demonstrate, and essentially talk about how good our product is. So I feel very blessed.”

“Over the last 25 years, I have built more and more sophisticated medical devices and this is the simplest, smallest, and cheapest thing I have ever done. I am confident that it will have by far the biggest impact, which is satisfying, I can tell you. We have saved people’s lives with this already.”

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Ahead of His Time: Part II

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Enter the iPhone

Part of the problem in finding support for the mobile ECG device was the limitation of the mobile technology available at the time. “And then the world changed,” Albert says. Apple had introduced the original iPhone, which caught their attention. But they were especially impressed when the iPhone 3G debuted in 2008.

 
 What a different the iPhone makes: Above is a picture of the RhythmStat XL (along with an original caption from a product brochure). Below is, obviously, the iPhone ECG.

Albert continued to think about the idea and, in 2009, built a prototype for an ECG using the Mophie rechargable case as a platform for it. They took apart the 1500-mAmp battery of the Mophie device and integrated it with single lead ECG technology.

“This might work, I thought,” says Albert. Satchwell was skeptical, but offered his help to work on the electronics and write software to support the technology.

“So we made this prototype and it was lousy, but it kind of worked sometimes,” Albert says. And it was able to upload ECG data to the Web.

In April 2010, Albert showed the technology as a proof of concept to a number of companies. He was hoping they would be interested in the device because of its potential to monitor atrial fibrillation, which is a major cause of strokes and affects between three and four million people in the United States.

A large medical device company Albert presented to had conducted focus group studies in several U.S. cities, asking cardiologists if they would find a mobile ECG for patients as useful. “And they said, the data was absolutely clear, no one wants this.’”

At the time, Albert found this news discouraging. But he now invokes Steve Jobs to explain why focus group data isn’t always reliable. When a reporter asked Jobs about the iPad market research, he replied that no research had been done. “It's not the customer's job to know what they want,” he said. Albert often uses that anecdote to his own thoughts on focus group data.

A Nice Chunk of Money

In April 2010, Albert got a call from a rapidly growing, venture capital-backed company active in the cardiac monitoring space. The firm had contacted Satchwell and was interested in iPhone-based ECG technology.

Albert went to visit the firm and brought his prototype. “When I got down there, they put a slide up on the wall and it showed their concept of an iPhone in a case with electrodes on the bottom of it. And they showed a picture of our prototype. And they said ‘great minds think alike.’”

Bruce Satchwell
Albert and Bruce Satchwell (shown above) have long had similar thinking when it comes to mobile ECG technology.

About six months later, the firm paid Albert and Satchwell “a nice chunk of money” for an option to buy the business. “During that summer, we got the terms done, negotiated, [and] they paid us the option money,” he says.” “It was a nice little pay day. But no venture capitalist would have written home about it.”

In the meantime, Albert and Satchwell were making significant progress advancing the technology.

However, the firm that paid an option for the technology began complaining and claiming that the IP behind the technology was poor. “But, in actuality, our IP is very, very good,” Albert says. “I have 33 issued patents. I have done this before. They were essentially trying to negotiate with us by claiming that.”

“Turns out they that the company had been thrown into turmoil.” he says. “We didn’t know that. And so they could not—they were not allowed by their board—to exercise their options. So we got to keep the money.”

Albert and Satchwell took the money and went to a company named IDT in China in October 2010 with the goal of getting help to make a better prototype. IDT, the OEM arm of Oregon Scientific, makes products such as heart rate monitors and pedometers for companies that include Timex, Adidas, Nike, and Omron. “I had a relationship with IDT dating back several years, so I knew their quality and their senior management,” Albert says. “They had FDA 510(k) experience, and they would build the prototypes without upfront payment.”

iCard ECG
Albert holds the AliveCor iCard ECG brings the functionality of the iPhone ECG to a range of devices.

“And on December 14 last year (my 56th birthday), I received a box with 15 prototypes—snap-ons for the iPhone 4,” Albert recounts. “They worked beautifully,” he says. “So then, I was pretty excited. I sent Bruce [Satchwell] a couple. And he was excited.”

Albert decided to bring the prototypes to the Consumer Electronics Show held in January 2011 in Las Vegas.

The Fateful YouTube Video

At this point, Albert filmed the video described earlier. “And I sent the video to two people because they told me they were not going to be at CES. Two companies,” he says. “I just happened to upload it to my LinkedIn account. And I had about 600 LinkedIn connections. I had 20 Twitter connections and 100 Facebook friends. But I happened to click the box that said ‘go to Twitter’,” he says. “That changed my life.”

“So at 11:00 a.m. on December 30, 2010, I clicked upload,” he says. The video’s popularity exploded with the help of social media. A flood of messages were sent to Albert’s e-mail. Satchwell called from Australia saying “David, have you seen what is going on? Watch the statistics, mate, it is crazy!”

The video had 200,000 views by April 2011. It now has had 337,000 at the end of December 2011.

The above image, pulled from YouTube's statistics, shows the number of views of Albert's video demonstrating the iPhone ECG.

People such as cardiologist and genetics researcher Eric Topol, MD and Leslie Saxon, MD, a professor at the Keck School of Medicine of the University of Southern California, soon caught wind of the technology. The technology fits with Saxon’s mission of, as she puts it, bringing “a little bit of pop culture to medicine and a little bit of medicine to pop culture.” Saxon invited Albert to come to her annual Body Computing conference in Los Angeles, an event dedicated to wireless technology used to monitor health. Saxon also asked if it would be possible to order 100 units of the prototype to use under a clinical trial.

Albert also took the technology to the University of Oklahoma in the cardiology division, where he formerly had worked, with the interest in doing a clinical trial.

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Ahead of His Time

Ahead of His Time

PAGE 1 OF 3

David AlbertLast year, the life of David Albert, MD, was changed significantly—by a YouTube video he had uploaded with the help of his youngest son. Albert, who was formerly the chief clinical scientist of cardiology at GE Healthcare, had just filmed a video demonstrating a prototype of an iPhone electrocardiogram (ECG) device he had developed in his spare time. Earlier that year, a focus group study found that no one would want such a device. But Albert was reticent to give up on a vision he had about 15 years ago of putting an ECG in the pocket of physicians and patients. The technology could be used to immediately determine cardiac rhythm and diagnose potentially life-threatening heart problems. Albert was planning on going to the Consumer Electronics Show (CES) show in Las Vegas and the video he had just uploaded was meant to be a preview of the technology for just a few people. Without giving it much thought, he clicked a box when uploading the video that promoted the video on his LinkedIn and Twitter accounts. He also included his private e-mail address in the video.

And the video (embedded below) went viral. It was viewed more than 100,000 times in two days. “It was nuts,” Albert says. “I went to CES and I had gotten called by Good Morning America, Fox and Friends, and CNN—and I was on all of the shows,” he says. “We had the unofficial hit of CES2011.”

Apple also noticed, too, and later invited him to their headquarters to explain how the technology works. A number of companies contacted Albert, as did venture capitalists wanting to fund the technology.

The technology, which hasn’t yet been cleared by FDA, got the attention of FDA as well. While at the show, Mitchell Shein called Albert. Shein, who is the Chief of the Pacing and Defibrillator Branch of the agency’s Division of Cardiovascular and Respiratory Devices at the Office of Device Evaluation, asked “Dave, what are you doing?” Albert says. “I said ‘Mitch, this is all an accident. You guys at the FDA have got to understand. I know what the rules are. I could never have anticipated this,” he says.

History

Albert had been interested in medical applications of handheld computing since the technology was in its infancy. In 1990, Albert had licensed ECG technology to Hewlett Packard’s cardiology group, which is now owned by Philips. One of the engineers from Hewlett Packard showed Albert a prototype of something called the HP 95LX—the first palm top computer. “From that time on, I became fascinated with the notion and the potential use of mobile technology in healthcare,” Albert says.

Albert, pictured here in 1999, has been working on mobile applications of ECG technology since mobile computing was in its infancy.

Later, Albert purchased a Psion 3A, which at the time was the state-of-the-art handheld computer. While using the device, he wondered if the technology could be used as a platform for an ECG.

Albert ran the idea by his business partner Aviv El Idrizi. “And he said something like ‘That is crazy. That is ridiculous. You’ve been drinking again,” he says. “And I said ‘no, no, I think we can make this work.’”

Albert and his partner worked on developing the technology that would turn a palm top computer into an ECG viewing device. The product was called Rhythm-Stat XL. It could receive a signal from a small recorder directly or through a phone and that phone could be wired or wireless, displaying an ECG. They eventually got a 510(k) for the device.

The Next Step

Albert, who is based in Oklahoma City, received a visit from Bruce Satchwell, who was then vice president of engineering for a small medical technology company called Micromedical based in Australia. Satchwell was a friend of Albert’s with expertise working with low-power ECG devices. Satchwell’s company sold small battery-powered ECG devices all over the world. During his visit, Satchwell had brought along an HP Palm Top device with ECG functionality to show to Albert. It became apparent that the two men had similar thinking.

Albert and Satchwell worked with Kim Barnett, a software engineer to file a U.S. patent. The patent—number 5,735,285—was granted on April 7, 1998. “That patent is now actually used in a lot of patent litigation because it talked about wireless transmission of ECGs in handheld devices. It has blown up patents from a number of other people.”

This image was pulled from the patent that was filed for the technology. The patent was issued in 1998.

A few years later, in 2002, Albert, who was then working for GE’s cardiology branch, was visiting Seattle. Satchwell happened to also be in the area and was working on developing a Bluetooth ECG monitor. Albert showed the concept at GE but everyone said, “‘Well, you know, we just aren’t that interested in that because it doesn’t fit into our product plans.’” I wasn’t going to argue with them at the time,” Albert recounts. “And I tried to push a few other wireless things. And what I had learned, and it took about a year for me to figure out, is that large companies have little interest in jumping into risk of any kind.”

In 2004, Albert decided to leave GE to, once again, become an entrepreneur—eventually going on to form AliveCor, the company now commercializing the iPhone ECG. In 2007 he decided to partner with Satchwell to advance the Bluetooth ECG technology Satchwell was working on at a company he launched called Alive Technologies. The technology was used in research by companies and government agencies around the world. “It used Bluetooth and could speak to a variety of phones at the time to send real-time ECG data back to a server to the Web. That was pretty revolutionary at the time.”

Satchwell flew over to find support for the technology. “We made a series of investor presentations, including in Dallas and Oklahoma City,” Albert says. In all, they showed the technology to about 25 investors, including several venture funds with little interest on their part.

Part 1 | 2 | 3 

   

Albert will be speaking at the MedTech Cardio 2012 conference (Oct. 30 – 31, 2012 in Minneapolis) on the consumerization of cardiovascular devices and applications of wireless connectivity for medical technology. Visit www.medtechcardio.com to learn more.

Top 10 Medical Device Hazards for 2012

Tubing misconnections are among the top 10 most hazardous medical device technologies for 2012, according to ECRI Institute.

As 2011 drew to a close, we were again bombarded with a barrage of newspaper articles, Web sites, TV shows, and radio programs touting the best this and the greatest that. But now, the ECRI Institute (Plymouth Meeting, PA) has taken hyperbole to a new level, publishing a report highlighting the medical device world's "Top 10 Technology Hazards for 2012."

The institute's list of hazards includes a range of medical devices and related technologies that offer countless benefits and numerous risks, including alarm hazards, exposure hazards from radiation therapy and CT, drug-delivery errors involving the use of infusion pumps, cross-contamination associated with the use of flexible endoscopes, inattention to change management for medical device connectivity, enteral feeding misconnections, surgical fires, needlesticks and other sharps injuries, anesthesia hazards resulting from incomplete preuse inspection, and poor usability of home-use medical devices. Dangerous though they are, most of these hazards can be avoided, according to the institute. But it takes work.

The institute prepares a new list annually based on the following factors:

  • How harmful is the hazard? Can it kill or seriously injure a patient?
  • How likely is it to occur? Does it happen often, or only very rarely?
  • How widespread is it? If it occurs, is it likely to affect a great many people, or will its effects be contained?
  • Is it a high-profile problem? Has it been reported in the media, and is a facility likely to be under pressure to deal with it quickly and conspicuously?

While emphasizing hazards caused by the improper use of medical devices by healthcare personnel, the report is a must-read for manufacturers of medical devices as well because it focuses attention on the need to design devices with the aim of reducing the incidence of user errors. For example, while infusion pump safety has improved over the years, preventable errors, including misprogramming steps, still occur. Addressing this issue, FDA issued a white paper in April 2010 highlighting the need to improve infusion pump technology. By understanding the technology-related problems that arise in hospitals and clinics, designers and manufacturers of medical device can contribute to improving healthcare outcomes, and the ECRI report can contribute to this knowledge base.

Another case in point is enteral feeding tube misconnections. Such misconnections usually occur when nutrients intended for the GI tract are inadvertently delivered elsewhere in the body or when inappropriate fluids such as IV solutions are inadvertently delivered to the GI tract. The first hazard is the more critical one because it can result in death, usually as a result of embolus or sepsis.

In 2005, a voluntary standard was introduced to reduce the risk of misconnecting enteral administration sets to unintended medical lines that employ a female luer connection. However, this standard has done little to prevent misconnections, in part because it is voluntary and does not prohibit the use of adapters that can be used to connect lines that are not meant to be connected.

To address the dangers associated with enteral misconnections, FDA wrote a letter in July 2010 urging manufacturers to implement color-coding safeguards and to build "designed incompatibility" into their products to help reduce or prevent misconnections. Currently, the International Organization for Standardization is working on a standardized enteral connector that will eventually have to undergo bench and clinical testing. As in the case of infusion pumps, the ECRI report could aid manufacturers in developing new connection technologies that help reduce the incidence of dangerous misconnections. Providers of medical device connectors, such as Value Plastics Inc., are already beginning to develop such technologies.

ECRI Institute's "Top 10 Technology Hazards for 2012" is directed primarily at medical practitioners and hospital administrators, but it also provides manufacturers with valuable insight into how they can design and build medical device technologies with greater benefits and fewer risks. --Bob Michaels

FDA Is Now Blogging

Just before Christmas, FDA debuted a new blog named "FDA Voice." The inaugral post was written by FDA administrator Margaret Hamburg, who explained that she hoped the forum would "give insights on some of the most pressing public health issues of the day." The intended readership of the blog includes consumers, patients, medical professionals, scientists, researchers, as well as industry professionals.

The second post was from Jeffrey Shuren, MD, (who recently spoke at Life Science Alley extolling the virtues of regulatory science), who seeks to address the agency's reputation for being unclear in its communication with the device industry.

Based on input from industry professionals, the agency has announced new plans to improve its 510(k) premarket program. To that end, FDA will release three guidance documents. As the blog post explains:

One outlines the process for appealing CDRH decisions. The second explains how product codes should be developed and used. And the third helps clarify how FDA decides whether a device is “substantially equivalent” to a legally-marketed device under the 510(k) program.

Contrary to the Institute of Medicine's advice to do away with 510(k) premarket notification, the new guidance seeks to make "the existing regulatory framework more transparent and predictable."  

—Brian Buntz

Lubricant Research Could Lead to Improved Metal-on-Metal Implant Alloys

If you're among the many Americans that have metal-on-metal implants, you have a vested interest in knowing what's under the hood, so to speak. According to a study funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (Bethesda, MD), what's under the hood of metal-on-metal hip implants is graphitic carbon lubricant.

Metal-on-metal implants were developed as a substitute for combination metal- and-polyethylene implants, which were used almost exclusively before the 1990s but tended to deteriorate over time. The problem is that metal-on-metal implants are also not without problems. Some metal-on-metal systems have not performed well, says Joshua J. Jacobs, lead investigator and chair of the department of orthopedic surgery at Rush University Medical Center (Chicago). "Problematic devices have tended to release more metal debris through wear and corrosion than devices that have performed well. This debris can cause a local tissue response involving the bone, ligaments, tendons, and muscles around the hip." The study was initiated in an effort to stop erosion between the metal surfaces of hip implants.

Earlier research by team members Alfons Fischer, professor of materials science and engineering at the University of Duisburg-Essen (Germany), and Markus Wimmer, associate professor of orthopedic surgery at Rush, had already revealed that a lubricating layer forms on metallic joints as a result of friction. To better understand this layer and improve artificial joints, the scientists relied on the science of tribology, which studies friction, lubrication, and wear.

"There is good reason to believe that those layers form a barrier to wear and corrosion on the surfaces of these implants, so it certainly would behoove us to understand the nature of these tribological reaction layers--what they are made of, how they form, etc.--so that we may be able to use this information to design metal-on-metal bearings going forward that are far less susceptible to corrosion and wear," Wimmer notes.

While the researchers knew little about the layer, they assumed that it consisted of proteins in the body that entered the joint and somehow adhered to the implant surface--in other words, that it was similar to the lubrication present in natural joints. However, they discovered that the layer actually consists at least in part of graphitic carbon, a solid lubricant used in industrial applications. Knowing that the lubrication is graphitic carbon could enable scientists to manipulate the system to produce graphitic surfaces. "We now have a target for how we can improve the performance of these devices," Fischer says. Wimmer adds, "Nowadays we can design new alloys to go in racing cars, so we should be able to do this for implants that go into human beings."

The researchers' next task is to relate their findings with clinical outcomes by examining the surfaces of retrieved devices and correlating their observations with the reasons why the implants were removed. They also hope to learn how cells are affected if the graphite flakes off.

"This finding opens new avenues of investigation to help scientists understand how joint implants function and to develop strategies to make them function better," remarks NIAMS director Stephen I. Katz. "The results of such research could have important implications for several hundred thousand Americans who undergo hip replacement each year--as well as those who could benefit from the procedure but have been advised by their doctors to delay surgery until they are older."

FDA’s Jeffrey Shuren on How Regulatory Science Could Reduce Cost and Time to Market

Jeffrey ShurenIn early December 2011, CDRH director Jeffrey Shuren, MD gave a keynote presentation at the LifeScience Alley Conference in Minneapolis titled "Regulatory Science—Reducing the Cost and Time to Market Through Scientific Innovations." Bill Betten, senior technical advisor of UBM TechInsights shares his notes from the presentation here:

  • In addition to acknowledging Minnesota’s long history of medical device development and large number of medical companies located in the state, one of Shuren’s purposes in attending the conference was to announce that a Memo of Understanding (MOU) had been signed between CDRH and Life Science Alley. The MOU formalizes interactions that had been occurring between LifeScience Alley and CDRH for more than a year regarding the advancement of regulatory science. The MOU recognizes that CDRH and LifeScience Alley, which represents the industrial and academic medical technology community sectors, have shared interests in further developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality, and performance of medical devices. It also forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives among the FDA, LifeScience Alley, the University of Minnesota, the medical device community and eventually other partners across the country.
     
  • This MOU was focused around regulatory science. An interesting definition of it was provided and provides a stark contrast to the criticism that the FDA has been under. The definition said that regulatory science provides the tools, standards, and approaches needed to evaluate the safety, effectiveness, performance, and quality of medical products. It was also suggested that this benefits patients by speeding the rate of important technologies reaching market and reducing time and resources needed for device development, assessment, and review. The definition is hard to argue with. However, the impact of the FDA on these issues was the subject of much of the rest of the talk.
     
  • Much of Shuren’s presentation related to the issues related to the FDA’s pace of regulatory approvals, a topic about which much has been written recently so I won’t dwell on it at this time. However, as a former VP of Engineering for a medical device company, I can say that even relatively routine 30-day submissions were frustrating, often with questions coming back from the FDA examiner on day 29. In addition, training and knowledge of the examiners with regard to the subjects they were being asked to review were often an issue as many of the questions were not representative of someone with a knowledge of the particular space. Shuren has been on the defensive on these issues for some time.
     
  • Shuren did discuss relative funding issues, contrasting spending on basic R&D by the government and industry with that on basic regulatory and engineering issues. He pointed out that, from 1990–2008, federal spending for applied R&D had dropped from about 40% to 20% of the total, with industry basically filling in by growing to almost 80% of the total during that time. He also commented that the U.S. government contribution to R&D had stayed relatively flat as a percentage of economic output while a number of countries (notably Japan, South Korea, and China) are increasing theirs. However, percentages can be deceiving as the U.S. economic output is larger than those countries so total overall spend is more. Finally, from a financial investment perspective, he pointed out that in fiscal year 2011 NIH invested $30 billion in research, while the FDA investment in regulatory science was $15 million, accentuating a previous call made for additional resources to address some of the issues associated with device reviews and approvals.
     
  • Shuren did have recommendations for addressing some of the concerns, most of which tie back to the MOU. These included establishing a public-private partnership between industry, the FDA, and academia; working on projects where there is shared interest; implementing a governance structure; sharing human and financial resources; and validating tools, standards, approaches developed. There was substantial focus on the issues associated with the last point on validation and development of tools, with a suggestion that by standardizing and defining approaches to product development and testing, that perhaps time to market could be accelerated. There was also some brief suggestion of perhaps a set of tests that could be passed (perhaps a certification?) that could be used as a basis for decision making by the FDA.


General Reaction to the Presentation

I first met Shuren a couple of years ago at an FDA-sponsored meeting on device interoperability shortly after he was appointed to the Director’s role. He seemed to say all of the right things. However, it has now been a couple of years since then and the FDA is under even more fire from industry with regard to product approvals. Perhaps it is a case of good vision with poor operational execution, which plays to the resource issue. However, many device companies have been vocal about these issues and we are now seeing products introduced overseas well before the United States, in some cases years before introduction here. While product safety is indeed important, it is clear that the system today is not working well. When a product development team worries more about the two R’s (regulatory and reimbursement) than the technical issues, it isn’t a healthy product development environment and threatens our competitiveness. Perhaps Shuren’s call for greater engagement with industry will work. At the very least it may be an attempt to quiet the FDA’s harshest critics by engaging them as part of the solution. Only time will tell, but it can’t be allowed to get worse if U.S. medical device companies expect to continue to be world leaders. Finally, one challenge that I will watch with interest, particularly with regard to presentation from Leslie Saxon, MD earlier [during the conference] on mobile devices and health care, will be how the FDA addresses the rapid proliferation of mobile devices and the convergence between consumer and medical. This was not explicitly addressed during his talk nor during the Q&A.

—Bill Betten