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Articles from 2012 In May

Will Doctors Become Obsolete?

Will Doctors Become Obsolete?

As a recent article from the Economist points out, the demand for health care is rising faster than the supply of doctors. Titled "Squeezing out the doctor," the article points out that technology is increasingly stepping in to perform tasks once performed by physicians. In addition, patients are empowering themselves and taking a greater role in their own healthcare. 

In any event, the question of what role physicians will play in the future has been receiving a lot of attention of late. I've gathered what I think are some of the more interesting musings on the subject below and have bolded and italicized some of the key points. 

Bryan Vartabedian

Pediatric gastroenterologist and social media expert Bryan Vartabedian:

What [doctors] once did with our eyes, hands and ears is being replaced by diagnostic widgets. Social and technological forces are conspiring to make the traditional role of the doctor irrelevant

Peter Diamandis

X PRIZE Foundation Chairman and CEO Peter Diamandis, MD:  

We also don’t have enough doctors to handle our needs. It is projected by 2020 that we will be short 91,000 doctors in the United States. And there is no way we can possibly educate that many physicians. And then, on top of that, even if we could, a human doctor just can’t cut it in today’s technological world. At best, a doctor is a gateway to subspecialists or technology tests. 

I think that, in the short term, human intuition remains a very powerful tool. But I think that ultimately, technology will displace even that.

 Don Jones

VP of Global Strategy & Market Development at Qualcomm Life Don Jones:

And patients are giving up on the notion that physicians are absolute authorities. Most people now want to see doctors as advisors.  

He had this to say about how the Qualcomm Tricorder X PRIZE could empower patients by enabling them to diagnose themselves:

We want to arm the consumer to self-diagnose. This is about disarming doctors.

Eric Topol, MD 

 Eric Topol, MD, author of "The Creative Destruction of Medicine" and  Professor of Translational Genomics at Scripps believes that Watson should play a key role in medicine but that computers will never be able to replicate the wisdome of an experienced physician:  

Watson can comb through two million pages of content in three seconds. I don’t know any physician who can do that. If you have a challenging patient and you don’t know what is going on, why wouldn’t you access a supercomputer?

I think [clinical use of Watson] is going to become commonplace. Right now, it is only at a few cancer centers and Wellpoint, but tomorrow, it will be used across the board. That will be an expectation—that you would consult a supercomputer to look at all of the data up to the moment and you couldn’t possibly do that before. You didn’t have the time or the capability. There is just an absurd amount of information to try to process. No human being can do that in an acceptable unit of time.

But, go back to that physician who has got years of wisdom, savviness, experience, clinical judgment—that is something that Watson will never be able to replicate. Qualities like those are what separates the digital age and the true medical profession.  

Satava, MD 

Richard M. Satava, MD, Professor, Department of Surgery University of Washington wonders whether the growing use of surgical robotics mirrors the use of unmanned aerial vehivles by the military. Will surgeons go the way of the fighter pilot?

Until the year 2002 fighter pilots, like surgeons, were the peak of performance. Then came the [unmanned aerial vehicles], such as the Predator [...]. Initially it was used for surveillance, then for hunter-seeker missions, and now for full combat. The military is fully committed to replacing all fighter aircraft with [unmanned aerial vehicles] by the year 2025, and there is even a new Air Force school for Remote Pilot Training (pilots that never get into an aircraft but remotely control a UAV) – is there a lesson here for surgeons

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

MD&M East 2012 Report—Fertile Ground for Invention

by Joe Pustka

Historians of science and academics studying creativity tell us that many “novel” ideas and breakthroughs that have changed the world have really come about when the discoveries of one field “cross-pollinate” into the field of ideas in another.

That might not have been the driver but it may well be the result of UBM Canon bundling several industry shows into one hall. The medical device industry shared space with innovators in plastics, packaging, and other fields.

We certainly felt it at the USON Innovative Systems booth while at MD&M East. We had a lot of traffic this year—perhaps because the show was busy or perhaps also because we had an attention-grabbing moving robotic arm leak testing station in our display. We enjoyed meeting a medley of visitors, some from well beyond the device industry—everything from egg processors to a brake manufacturer, mixed in with medical device industry personnel who wear many hats.

I also got the impression that there was more innovation-sniffing going on because most of the attendees seemed to be traveling in groups instead of solo strollers, as is often the case. When I go to a show as an attendee instead of as an exhibitor, I’m usually on a mission with a certain number of calls to make. Yes, there were those conversations too. From where I stood though, most people coming to the show and to our booth were company decision makers making a determined effort to take in as much as they could.

That and our healthy lead count—I think MD&M East was a sign that we are seeing more unfreezing in the industry than even from half a year ago.

Putska (pictured on the left) is a medical device leak testing technical support manager for Uson, which first developed high accuracy leak testing methods for NASA, and since 1963 has specialized in leak detection, leak testing, and non-destructive testing for the medical device and medical packaging industries, among others. Putska works with medical device companies throughout North and Central America and has worked with Uson in various technical capacities since 1980.

Wall Street Journal: Device Tax Puts Innovation on Par with Cigarettes, Gas

Yesterday's Wall St. Journal featured an un-bylined opinion piece on the subject of the device tax. "Improvised Explosive Device Tax ," is strongly worded. The peice includes the excise tax as part of the "Taxmageddon," of 2013, also comprising the Bush-Obama tax cuts that end around the same time.

My favorite paragraph, however, is this:

For the first time ever the Internal Revenue Service is not writing rules that will treat some of medicine's most inventive and complex products the same way it does gas, cigarettes, liquor and wine, guns, airline tickets, and tires. Those are the commodities on which the political class normally attaches excise taxes, and the appeal is that the levies are hidden in higher prices, rather than listed separately like a sales tax. this is somewhat awkward for a law that claims to aspire to make health care more affordable."

The hard copy of the article also contains an amusing, if telling, error. In quoting Senator Al Franken (D-MN) the paper assigns the democrat to the Great State of Medtronic, rather than to Minnesota.

Whether we are in a corporation-run government, I'll leave to the science fiction writers. In the meantime, I'll say that teh device tax will be on everyone's mind this week as congress debates the repeal of the tax. 

Heather Thompson is editor-in-chief of MD+DI. She regularly read scifi with plot points surrounding the corporate takeover of nations.

Latest Headlines on the Device Tax:

Will the Medical Device Tax Force You to the Unemployment Line? | A Medical Device Podcast with Cook Group Chairman, Stephen Ferguson

Congress to Take Up Medical Device Tax Repeal After Memorial Day Weekend

Affordable Care Act Is Good for Business, Says California Council

Women in Medtech: Nancy Singer

Nancy Singer is president of Compliance-Alliance, LLC. She is also a tireless regulatory advocate, warning medtech firms of the dangers lurking in e-mails, post-it notes, and other seemingly benign documents. Singer teaches a course on these dangerous documents and has talked about it with MD+DI. She is also a long-time member of MD+DI's editorial advisory board.

Nancy SingerMD+DI: How did you get your start in the medical device and technology industry?

My first job was as a prosecutor for the U.S Department of Justice where I performed litigation for the Food and Drug Administration. My next job was to defend drug and device companies who were being prosecuted. Today I teach companies how to comply with FDA requirements.

MD+DI:  What important challenges does the medtech industry face in the next 5 years?

In the next five years medtech companies will face increased government regulation, higher user fees, more taxes, and increased labor costs. These factors will impede companies from producing cost-effective, innovative, safe and effective medical device technology. I predict that companies will continue to open more facilities in other countries, and they will focus on selling their products to new markets outside of the United States.

MD+DI:  How can more women get involved in the medtech industry?

Women are highly represented in the quality, regulatory, legal and sales professions. We need to encourage women to concentrate in the science and engineering professions. We also need to groom more women for positions in upper management, so, when they are qualified, they can be selected to actively lead companies as the president or CEO or participate in the management of companies by being on the board of directors. As more women are given the opportunity to serve in these roles and are successful, other companies will provide similar opportunities to women.

MD+DI:  Are there barriers for women in medtech?

A barrier for women is a perception that women, during their child bearing years, will drop out of the work place to raise children and the investment in that individual will be wasted. As more women refrain from having children or successfully combine the roles of raising children with being a dedicated dependable professional, more women will get the opportunity be in these leadership positions.

MD+DI: What advice for women would you give for pursuing a medtech career?

Get as much formal education as possible. Attend seminars and stay current in the profession. Get an understanding of finance, engineering, accounting, marketing and sales. Become an effective communicator. Cultivate an image of being a competent, reliable, and cooperative professional who solves problems with grace under pressure. Volunteer for high visibility projects. Continue to meet people inside and outside of the company. Take chances and conquer the fear of the unknown. Get a mentor and be a mentor. Have a passion for your current job or find a job for which you have a passion. And most importantly, have a good time. Remember that life is short and time is precious.

Prescription for Change: Medical Devices Increasingly Replace Drugs

Drug use could soon be tapering off in the healthcare industry as medical devices increasingly replace pharmaceutical therapies to treat a variety of conditions. But what kinds of opportunities lie ahead for medical device makers, and what does this emerging trend mean for Big Pharma?

A blog post over at the Wall Street Journal earlier this week, written by Gregory J. Millman of Dow Jones Banking Intelligence, took an interesting look at a rising trend in which medical devices are replacing the use of traditional drug therapies in certain applications and how it's changing the life sciences sector. In particular, the post highlights two venture capital firms, Morganthaler Ventures and Advanced Technology Ventures, that are specifically seeking out medical device investment opportunities that have the potential to supplant drug use.

For example, the companies invested back in 2003 in Ardian Inc., which developed a minimally invasive method for performing renal denervation (RDN) to control hypertension that offers the added benefit of demonstrated success of RDN on patients resistant to drug therapy. Ardian was eventually acquired by Medtronic.

The lucrative potential of these drug-replacing medical devices can be understandably alluring for venture capital firms. But while this focused investing strategy is interesting on its own merit, there's also a hook to expand exit possibilities: These innovative medical devices not only attract medtech power players, they are also beginning to attract pharmaceutical companies.  "One of the last three bidders [on Ardian] was a large pharmaceutical company without any medical device presence," Hank Plain, partner, Morgenthaler Ventures, told the WSJ. "Because the therapy had the potential to replace drugs, pharmaceutical companies bid."

That's a fascinating development. We've seen the early signals of this drug-to-device shift at the American College of Cardiology's scientific meeting last year, for instance, at which drugs took a noticeable backseat to discussion of innovative minimally invasive procedures and medical device advertising dominated the scene. Furthermore, the promise of medical devices to treat Alzheimer's patients has generated excitement and hope for the devastating disease.

But this is certainly an interesting twist to the medical device story as pharmaceutical companies adapt to survive when new blockbuster drugs are elusive. So, will pharmaceutical companies with no existing medical device ties take the plunge into the market? Or is this a rare occurrence? While the future of innovative, drug-replacing medical devices is exciting and bursting with opportunities, the trend could seemingly also serve to spur more competitors to enter the market. It will be interesting to see how this trend truly unfolds.

What do you think about this emerging trend? Let us know in the comments section below. Also, catch up on this drug-device trend in MPMN's archives, "Are Medical Devices the New Drugs?" and "Could Light-Based Alzheimer's Devices Be 'The Next Big Thing?'" --Shana Leonard

FDA Pilot Program Will Streamline Process and Benefit Consumers, OEMs, even the FDA Itself


The program is open to foreign and domestic medical device manufacturers previously audited under one of the regulatory systems in the framework of the regulations of the founding members of the Global Harmonization Task Force (GHTF), which includes Canada, the European Union, Australia, and Japan.

Under the pilot program, effective June 5, 2012, manufacturers will be able to proactively report to the FDA with particulars of quality management systems, demonstrating their willingness to work transparently with the FDA. FDA will “use the audit results in their risk assessment to determine whether that establishment can be removed from FDA’s routine work plan for one year.” Astute establishments will only submit these voluntary reports to FDA if the audit report will not cause FDA any reason for concern. The program will certainly streamline the process significantly, eliminating costly and time-consuming duplication of inspection and audits throughout the year and disruption of business operations.

Companies that have successful compliance history, with few if any, minor deficiencies and no major observations will be well-positioned for the pilot program. With some firms subsequently removed from inspections schedules for one year, the FDA will be able to focus on more critical areas of concern within its mandate – namely the higher-risk areas within the industry.

At the same time, OEMs will now also have a better opportunity to push or encourage suppliers to go in this direction, providing OEMs greater control over, and confidence in, their supply chain players. So OEMs will no doubt see this as a positive development for their supplier partnerships. Patients and consumers should also expect to see benefits in terms of medical device safety as FDA gains what they refer to as more ‘person days’ to tighten its focus on higher-risk companies. 

Contract design and manufacturing firms – particularly those that have not really had a platform to demonstrate compliance without an actual FDA inspection - will also see advantages. The pilot program gives such firms, particularly smaller ones, a greater ability to show their wares, so to speak, and demonstrate their compliance and quality assurance in the face of ongoing competition from the larger and more resource-rich players. Finally, the pilot program also stands to give the FDA itself helpful new insights into the compliance process. How? While the FDA will be removing companies from its inspection schedule for 12 months, it will also be gaining new perspectives into the certification process, as it will now be reviewing reports from the various GHTF assessment bodies themselves. The FDA, by reviewing those third-party reports firsthand, can expect to gain an appreciation for the audit framework of these GHTF members. The pilot program is a welcome and positive development for the industry on several fronts and it will be interesting to see how it unfolds in the weeks and months ahead. Stay tuned!

Duarte-Lonnroth is director of quality, regulatory affairs for Celestica HealthTech (Toronto, ON, Canada).

New Medical Technology Research Organization Formed

A new contract research organization has taken root. Agility Clinical Inc. (Carlsbad, CA) will focus on providing customized clinical research and consulting services to small and virtual biotechnology, specialty pharma, medical device, and diagnostic companies.

"Agility's mission is to provide services to small and virtual biopharma companies, with a focus on treatments or diagnoses for children and orphan diseases," remarks David F. Hale, chairman and CEO of Hale BioPharma Ventures LLC. "While Agility will provide traditional CRO services, companies may also choose from a menu of services that addresses their specific needs. The executive management team is comprised of individuals with strong experience in all phases and functional areas of clinical trials."

Read more here:

Emerging Trends in Medical Device Outsourcing and Their Impact on Your Business

Join Qmed, MD+DI, MPMN, and a host of industry experts on June 14, 2012, for "Trends in Medical Device Contract Manufacturing," a free virtual event that addresses some of the key benefits, challenges, and trends in outsourcing medical device design and development and how they can impact your business. A keynote presentation on "The New Medical Device Landscape: Adapt or Fade Away," by Venkat Rajan, Industry Manager, Medical Devices, at Frost & Sullivan, will be followed by conference sessions focused on such areas as outsourcing to China, medical device miniaturization, and design trends.

Touching on such hot topics as the medical device tax and healthcare reform, the keynote presentation will illuminate how new business models and other healthcare cost-containment pressures are prompting companies to rethink their long-term strategies and approach to product development. It will also examine the potential effects of these factors and their impact on the medical device supply chain.

In addition to the keynote, the event will feature three educational conference sessions. The first, "Design Trends in Outsourcing Innovation," will explore the challenges, benefits, and risks associated with outsourcing medical device R&D and design services. Experts in industrial design and R&D will present on best practices for partnering with design companies in order to produce innovative, next-generation medical devices.

Another session, "Medical Device Miniaturization: The Quest for the Incredible Shrinking Parts," will delve into the industry-wide trend of medical device and feature miniaturization, particularly for minimally invasive applications. Featuring presentations from experts in medical device micromolding, micromachining, and microextrusion, the session aims to provide medical device professionals with advice on working with these tiny yet complex parts.

The final session of the day, "Sourcing Suppliers in China," will feature a lively roundtable discussion with a panel of industry experts on the polarizing topic of outsourcing medical device manufacturing to China. Participants will debate such topics as quality concerns and both the pitfalls and advantages of doing business in China.

Conference sessions will be complemented by interactive chat sessions on medical device packaging and testing. Furthermore, a virtual exhibit hall will house booths of contract manufacturers that serve the medical device industry, complete with chat capabilities, data downloading, and prizes. Sponsored by Lumenous Device Technologies, Fluortek Inc., Microspec, and Minnetronix, the event is free to medical device professionals. Make sure to register now for this exciting event!

Drug Injection, Without a Needle

 Image via MITnews

In the late 19th century, Hendrick Lorentz, a Dutch physicist, described what later became known as the Lorentz force. Essentially, a charged particle can be accelerated by moving it through an electric and magnetic field. Today, researchers at MIT are applying the same principle to medical device innovation.

They have developed a device that uses the Lorentz force to inject tiny, high pressure jets of medicine directly through the skin at near sonic speeds. Though it sounds intense, the procedure is purportedly less painful than a traditional needle injection and less invasive, using a nozzle no wider than a mosquito's nose (think how often you feel it when a mosquito bites you).
Furthermore, by controlling the degree of charge, this new device allows doctors to control the rate and amount of injection depending on the depth and amount of drug needed. This gives the new device a big advantage over previously developed jet injectors which offer a “bang or nothing” release that can only inject the same amount of a drug to the same depth.
Watch as Ian Hunter and Catherine Hogan of MIT's BioInstrumentation Lab and Department of Mechanical Engineering further explain the device.  
 -Chris Wiltz is the assistant editor at MD+DI

What is Germany’s Secret? How the World Can Learn from a Thriving Medtech Industry

What is Germany’s Secret? How the World Can Learn from a Thriving Medtech Industry

Germany is Europe’s largest market for medical device manufacturing. In fact, its global share of medical technology exports is 14.6%, second only to the United States. Germany is significantly ahead of Japan, which comes in third with a 5.5% share of the worldwide market. An estimated 65% of medical technologies made in Germany are exported, with the largest single market being the United States. According to Germany Trade & Invest, the country’s foreign trade and inward investment promotion agency, Germany’s healthcare industry represents 11.6% of gross domestic product (GDP) and €278.3 billion in annual revenues, which is a larger share than the automotive industry. Medical devices generated €20 billion in revenues in Germany in 2010, representing year-over-year growth of nearly 10%. Exports made up the largest share of revenue, growing 12% to €12.8 billion. Furthermore, the European Patent Office (EPO) documents that most of 2009, 2010, and 2011 patent approvals were in medical devices.
General Conditions
“The general conditions for developing and bringing to market innovative medical technologies are excellent in Germany,” says Joachim M. Schmitt, managing director and board member of BVMed, the German Medical Technology Association. Schmitt says that the environment is ideal for bringing new medical products and processes to market in Germany because of the large number of well-educated doctors, researchers, and engineers, as well as the high standard of clinical research. “We possess of a large knowledge pool in the area of medical device technology through university hospitals and numerous centers of excellence,” Schmitt says. Furthermore, the proximity to leading machine and packaging manufacturers, high quality and technical standards, and dependable delivery service works to Germany’s advantage.
In its 2011/2012 industry report, BVMed cites the healthcare industry as the largest employer in Germany with 5.4 million employees. Almost one in seven jobs in Germany can be found in the healthcare industry. Since 2000, the number of employees in the healthcare system has increased by more than 12%. A 2010 forecast on behalf of the German Federal Ministry of Economics anticipates an additional 2 million people will be working in the healthcare industry by 2030. The report also states that job prospects in the German medtech industry are excellent for engineers and medical technicians, as 96% of companies currently have vacant positions. As a result, the demand for engineers is expected to rise even further.
Germany’s Secret Sauce
In the medtech world, what can the United States and the rest of the world learn from Germany? First of all, it is important to understand that Germany has a long history of small- and medium-sized clusters of firms, which often specialize in niche areas of manufacturing. “While a significant portion of the U.S. market strength lies in large companies, the German key to success is that most of the medical devices are medium-sized producing companies,” says Urs Schneider, MD, PhD, head of the Department of Orthopaedics and Systems in Motion at the Fraunhofer Institute Manufacturing Engineering and Automation (Stuttgart, Germany). He stresses that Germany has strong research structures within its companies, excellent funding for medium-sized enterprises and research institutes such as Fraunhofer that are focused on supporting the industry on its risky path to new product solutions.
According to Schmitt, Germany holds an advantage as the largest domestic market for medical products in Europe. It has a well-functioning infrastructure, a central location in the heart of Europe with short distances to the most important European markets, an excellent transport connection, and a high security of supply.
Market Launch­­––the United States vs. Germany
When considering the time it takes to bring to market a medical device, there is an enormous difference between the United States and Germany. According to a 2010 Stanford University (California) study titled "FDA Impact on U.S. Medical Technology Innovation," for a PMA-type product, the time span from the initial con­tact with the regulatory authority until market launch was 54 months in the United States and just 11 months in Europe. On average, a market launch in Europe can be realized three years earlier, with significantly lower costs. Further studies conducted last year by Boston Consulting Group and PricewaterhouseCoopers confirm that many medtech innovations are first made avail­able in Europe and then later in the United States. This is due to a bureaucratic FDA approval system that prevents an early market access—but without the system leading to a higher number of reported incidents in Europe than in the United States.
Device makers and industry associations agree. “The advantages of the German market include the much shorter market approval times and the excellent and lower-priced clinical research,” says Schmitt. “In Germany, it costs approximately €8 to 10 million to bring to market a new medical device technology. In the United States, costs are much higher at around USD $80 million.”
However, FDA disagrees with device manufacturers that see Europe as a model for product approvals. In late April, the Star Tribune quoted a recent internal FDA report: "Unsafe and ineffective devices approved in the EU that were not approved in the United States," it stated, indicting a European system that American medical device manufacturers have held up as a model for getting lifesaving devices to market faster. It comes as Congress debates reauthorization of the Medical Device User Fee Act. However, the device industry contends that FDA's slow approval of high-risk devices drives U.S. businesses overseas, costing the country high-paying jobs. Furthermore, the U.S. regulatory environment has become more stringent, which hampers profit and is forcing some companies to shift operations overseas.
Although many of the elements that work well in Germany are part of a traditional culture that would be difficult to transplant from one country to another, the world can learn from the German model of highly educated professionals, a strong R&D structure within companies, and a funding environment that supports medtech development.
Yvonne Klöpping is associate editor of European Medical Device Technology.