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.

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

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.

MD+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.
 

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

Duarte-Lonnroth

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).

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."

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!

Image via MITnews

In the late 19^th 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.