Guest blog: Optimizing process management in medical device manufacturing

by Guest Contributor May 15th, 2012

An interview William J. Bergen, President & Chief Executive Officer, MicroGroup, which will be participating in the marcus evans Medical Device Manufacturing Summit Spring 2012. In this interview, Bergen focuses on efficient process management.

Medical device manufacturing executives are currently challenged with getting products to market faster; however, with increased FDA regulatory requirements and validations, they must ensure that the manufacturing processes are robust, says Bergen. Here he provides some perspectives on product development and globalization in the medical device sector.  

How can medical device manufacturing industry executives shorten time to market?

WilliamJBergen_web

William J. Bergen

The big challenge for all medical device industry executives is time to market and the ability to move quickly, with high-quality goods, from the prototype through the commercialization phase. It is essential that devices are both effective for patients and cost effective. Efficient process management is also crucial when discussing time to market. Medical device industry executives must evaluate and control process risks through quality planning and production control systems. This will allow them to develop new products rapidly and meet the ever-increasing requirements of the marketplace and the various regulatory bodies.

When speeding up their approaches, what do executives often miss out?

With the increased FDA and other regulatory requirements and validations, they must ensure that the manufacturing process is robust and repeatable. Therefore, effective communication with all parties at each stage of production is crucial along with selecting the “best fit” materials and production techniques.

What does it take to prosper in today’s competitive marketplace?

They key is in delivering the product performance needed, at the price the market requires. This involves having the necessary engineering talent and machine sophistication to handle the requirements, without over-designing and over-engineering the parts.  By having a very keen focus and the appropriate equipment to incorporate design for manufacturability into all aspects of the product design phase, executives will be able to understand the optimization continuum between costs, tolerances and manufacturing capabilities.

What does the future hold for medical device executives?

Healthcare expenditures are rising globally but under increasing cost scrutiny, creating an enormous opportunity in the globalization of the medical device sector. Many US products are being re-adapted to meet the needs of patients in Europe, Latin America, and Asia. To accomplish this, medical device industry executives must optimize engineering design and manufacturing to drive the performance of specific patient needs, and set the correct price according to marketplace demands.

About the Medical Device Manufacturing Summit Spring 2012

Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on investments and technologies heading overseas, keeping up with the global emerging regulatory systems, and staying at the forefront of the industry. Medical Design is a media partner for the event. For more information email info@marcusevanscy.com or visit the event Web site.  Please note that the Summit is a closed business event and the number of participants strictly limited.

About MicroGroup

For over 40 years, MicroGroup has focused on using speed and precision to rapidly deliver the highest quality metal components and assemblies to its customers. Both of its facilities have world-class capabilities and equipment, combined with excellent quality systems. A particular strength is the breadth of the company’s in-house capabilities which when combined with an extensive inventory of raw material enables the company to rapidly deliver parts while maintaining the quality control and cost effectiveness. 

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AdvaMed to IRS: dated excise tax structure won’t work for medical device industry

by Sherrie Conroy May 8th, 2012

While AdvaMed remains committed to advocating for the repeal of the medical device excise tax (MDET), the association is also devoting time and energy to making sure that if implemented, the tax is as palatable as possible. In a press conference today, AdvaMed’s asssistant counsel, Andrew Van Hout, reviewed the group’s third set of comments submitted to the  Treasury Department. AdvaMed submitted two sets of comments prior to the release of the proposed rule.

AdvaMed says that as an excise tax, the MDET is subject to decades old IRS precedent ill-suited for this dynamic industry. “In these comments, we largely focus on our

Andrew Van Haute

Andrew Van Haute

industry as certainly a unique industry to having an excise tax imposed on it,” said Van Haute. “With an innovation cycle that is different from other industries that are taxed under this sort of regime, very complex distribution chains and multiple transaction types. With that in mind, we focused these comments in four specific areas.”

AdvaMed outlined the four key areas as follows:

• First, under excise tax law, certain “uses” of products are considered taxable even though the product is not sold. As this policy is applied to our industry, this means even beneficial, no charge “uses” would be subject to the MDET, such as demonstration or evaluation devices, surgical instruments loaned for implant procedures, and even charitable donations of products for medical missions. Our comment letter addresses each category of these beneficial uses, explaining industry practices, patient benefits, and regulatory structures in place to guide these arrangements, and we urge the IRS to clarify that these “uses” are not taxable. In the absence of such guidance, device companies will be forced to evaluate whether these uses, having significant patient and societal benefit, remain viable.

• Next, we ask IRS to depart from existing tax authorities concerning rebates. The proposed rules require a company to pay the MDET on the full sale price of a device, even if there is a rebate in place that will subsequently lower the price (the company would then make a later adjustment to take the rebate into account). Existing Treasury regulations explain that rebates are difficult to anticipate and shouldn’t be counted until they are actually paid. This may be true in other industries, but rebates in the device industry are highly regulated and always made pursuant to a contractual agreement –this makes them much easier to account for at the outset to ensure that a company does not overpay the tax. An application of existing law would add administrability burdens and cash flow challenges to companies already burdened with significant MEDT implementation expense.

• Further, we urge IRS to allow flexibility on “constructive pricing.” These are highly complex rules intended to ensure that an excise tax is paid on a price derived through an assumed standardized transaction structure, which might not exist for all device products. Especially in the first year or two of the tax, it will be extraordinarily difficult for device companies to comply with these rules—partly because of the complexities of our distribution chains.

• Last, the proposed regulations take an encouraging view of which devices should be exempt from the tax because they are generally purchased by the public at retail. IRS’ approach avoiding the creation of a rigid list of exempt devices is consistent with our earlier recommendations. IRS’ newly proposed framework sets out a non-exclusive series of factors that determine whether a particular type of device is exempt from the tax, subject to a catchall safe harbor. Overall, this is a good solution, but it is important for the IRS to clarify that its set of factors cannot be applied by agents in the field as a rigid “checklist” – and, for this reason, we seek clear field instructions. Further, we recommend tailored revisions to the multifactor test, including:

  • We suggest IRS remove one factor from the analysis – affordability – given complexities in assessing affordability in the context of patient specific public and private insurance circumstances.
  • We suggest that IRS recognize Internet sales as a factor reflective of retail status, and hence, exemption.
  • We offer a definition of “of a type” based on FDA principles and providing flexibility for companies to furnish relevant documents on the point.
  • We suggest IRS modify a reference to Class III devices to align with the statutory history; and
  • We provide a technical suggestion to revise the safe harbor for capped rental equipment where title transfers to the end user.

AdvaMed’s May 3, 2012, 22-page comment letter offers additional recommendations based on the proposed regulations. The group says these recomendations address “some of the most problematic issues—most extending from an application of dated excise tax precedent designed for different industries in earlier eras.”

Van Haute said that the IRS will hold public hearing on May 16. “We have given notice that we would like the opportunity to submit testimony to make clear our points and concerns. Following that there is no guarantee as to when the IRS will release a final regulation. Once the final rule is in place, companies will have a bit more certainty in knowing exactly what the tax will cover and what it won’t, said Van Haute.” The tax will go into effect January 1, 2013.

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Chairman of medical device summits shares views on medical innnovation and product development

by Guest Contributor May 7th, 2012

An interview with: Donald DeLauder, Executive Director-Corporate Innovation, Bayer Radiology and Interventional, a business of Bayer Healthcare.

“Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable,” says Donald DeLauder, Executive Director – Corporate Innovation, Bayer Radiology and Interventional. They must spend more time on developing their products, he adds.

Donald DeLauderThe chairman at the upcoming marcus evans Medical Device Manufacturing Summit Spring 2012 and Medical Device R&D Summit Spring 2012, DeLauder shares his views on product development and the complex regulatory environment.

How can executives in this industry ensure that their products are reimbursable?

Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable. This means that companies are spending time and money on developing products that go nowhere. It is crucial to take the time to get the data right and understand the reimbursement path. Although they aim to get to market faster, there is much more to it than simply developing the technology. Unfortunately, very little has been done in terms of improving the research and development (R&D) process. Product data management tools, for example, help organize information, but they have also allowed processes to become more complex and inefficient.

What are the regulatory concerns that medical device industry executives are currently facing? How can they be prepared for what lies ahead?

Over the past 20 years, the industry has evolved immensely; however, there are complex challenges with regulations. Gaining 510(k) approvals is becoming a difficult task, and is driving companies away from the US market. The industry is troubled with the difficult economic environment, and very few venture capitalists are investing in early stage opportunities. There is not enough capital to fund the increased requirements in the regulatory space for early stage companies. It is a tough environment, and medical device executives must spend time trying to improve R&D, launch, and commercialization processes.

With globalization being a major trend in the industry, what does it take to prosper in today’s competitive marketplace?

The US market is facing intense competition from countries that are producing sophisticated medical devices at lower costs, and of the same, or at least sufficient, quality. Although emerging markets are not typically direct competition, they do hold large opportunities due to the phenomenal growth rates of up to 15 per cent, which is tremendous compared to the US, Europe, and Japan. Organizations must change their mindset and become more connective. If they want to be successful in emerging markets, they probably have to do it by developing products in those markets.

What is your outlook for the future?

Medical device industry executives will begin to see more interaction between devices, which provide opportunities and complicates development and approval. Generally, digital technologies keep getting faster and cheaper, and from a mechanical perspective there will be more miniaturization. Manufacturers must stay focused on the clinical environment and their customers’ needs. It is crucial for them to spend more time in the clinical environment, learning rather than selling, as devices have got to become more effective for better patient outcomes.

The marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends, and breakthrough innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. For more information please send an email to info@marcusevanscy.com or visit the event Web sites at Medical Device Manufacturing Summit Spring 2012 and Medical Device R&D Summit Spring 2012. Medical Design is a media partner for the event.

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Patients who don’t feel a thing are part of Cleveland Clinic training facitlity

by Joe Jancsurak May 3rd, 2012

Robotic “patients” that bleed, give feedback, have heartbeats, and can simulate hundreds of different medical conditions and situations, are part of the The Cleveleand Clinic’s newly opened, 10,000-sq- ft addition to its now 59,000-sq-ft  Multidisciplinary Simulation Center.  

The center includes an intensive care unit and a fully functioning operating room designed to replicate the operating rooms found elsewhere in the hospital, complete with all of the same equipment and capabilities. It  also includes two debriefing rooms, where teams can play back video from their session and talk about their communication challenges and clinical lessons after the simulation. Co-developed by physicians and nurses along with the leadership of the Clinic’s Education Institute, the new space also allows for consistent training of all staff and an environment where new medical personnel can refine their skills before caring for patients at the bedside. The center also was designed with strong collaboration with Cleveland Clinic’s Quality & Patient Safety Institute, the goal of which is to connect training to real-life issues at the forefront of patient safety.

Training at the center will be available to Cleveland Clinic’s healthcare professionals, including nurses and allied health professionals. Courses will consist of three components: team-based sessions (simulated surgery using technologically advanced mannequins); procedure-based sessions (practicing basic skills, such as suturing, at a virtual station); and clinical examinations. More information is available at http://simcenter.clevelandclinic.org/.

Kudos to the Cleveland Clinic on this important training hub.

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Vital sign of the future? Smart phone technology could replace cumbersome ECG sensors and wires

by Sherrie Conroy May 3rd, 2012

An interdisciplinary team of engineers at the University of Arkansas has developed a smart phone–based wireless health-monitoring system that gathers critical patient information, regardless of the patient’s location, and communicates that information in real time to a physician, hospital, or the patient, according to a press release issued by the university.

The system includes a series of nanostructured, textile sensors integrated into a conventional sports bra for women and a vest for men.

The system includes a series of nanostructured, textile sensors integrated into a conventional sports bra for women and a vest for men.

The system includes a series of nanostructured, textile sensors integrated into a conventional sports bra for women and a vest for men. A lightweight and wireless module snaps onto the garments. The sensors communicate with system software that relies on a smart phone to collect information, compress it, and send it over a variety of wireless networks.

“Our e-bra enables continuous, real-time monitoring to identify any pathophysiological changes,” says Vijay Varadan, distinguished professor of electrical engineering, in the release. “It is a platform on which various sensors for cardiac-health monitoring are integrated into the fabric. The garment collects and transmits vital health signals to any desired location in the world.”

The system monitors blood pressure, body temperature, respiratory rate, oxygen consumption, some neural activity, and all of the readings provided by a conventional electrocardiograph (ECG), including the ability to display inverted T waves, which indicate the onset of cardiac arrest. The system does not require a cuff or any extra accessories to measure blood pressure and could therefore replace conventional blood-pressure monitors. It could also replace the cumbersome combination of ECG sensors and wires attached to patients while they walk on treadmills.

The sensors, which are smaller than a dime, include gold nanowires, as well as flexible, conducting textile nanosensors. The sensors are made of arrays of gold nano-electrodes fabricated on a flexible substrate. The textile sensors are woven into the bra material. These sensors do not require conventional sticky electrodes or the use of gel.

Electrical signals and other physiological data gathered by the sensors are sent to the snap-on wireless module, the contents of which are housed in a plastic box that is slightly smaller than a ring box. As the critical wireless component, the module is essentially a low-powered laptop computer that includes an amplifier, an antenna, a printed circuit board, a microprocessor, a Bluetooth module, a battery, and various sensors. The size of the module depends heavily on power consumption and minimum battery size. Varadan says that anticipated battery and Bluetooth upgrades will allow the researchers to build a smaller–1.5 in. long, 0.75 in. wide and 0.25 in. deep–lighter, and flexible module that will replace the rigid box.

Data from the sensors stream to commercially available cell phones and handheld devices, which the researchers say expands the use of the system beyond healthcare. By carrying a cell phone, for example, athletes can monitor other metrics, such as number of calories burned during a workout, in addition to the data gathered for cardiac monitoring. To render clean data, the software includes filtering algorithms to mitigate problems due to motion of the handheld device during exercise.

Whether on a computer or cell phone, the software is set up so that users can view all data on one screen or window, or they can view each measurement on its own unique window. The software also includes a global positioning system that tracks the exact latitude and longitude of the patient or athlete. The geographic information is transferred to a cloud cluster and stored in a secured database that doctors or other healthcare personnel can access to view location of the patient as well as historic or real-time ECG data. The system can also be programmed to send emergency messages, via voice or text messaging, if it detects extreme or abnormal conditions.

Varadan has not yet published findings on the e-bra, but results on the system, which he calls an e-Nanoflex Sensor System, were published in the Journal of Nanotechnology in Engineering and Medicine. Varadan is editor of the journal. The research is supported by the Global Institute for Nanotechnology in Engineering and Medicine.

Varadan holds the College of Engineering’s Twenty-First Century Endowed Chair in Nano- and Bio-Technologies and Medicine and the college’s Chair in Microelectronics and High Density Electronics. He is director of the High Density Electronics Center and the Center for Wireless Nano-, Bio- and Info-Tech Sensors and Systems, which is funded by the National Science Foundation. Varadan is also a professor of neurosurgery in the College of Medicine at the University of Arkansas for Medical Sciences in Little Rock, AR.

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Guest blog: Time for Your Production Line’s Annual Checkup?

by Guest Contributor May 3rd, 2012

Joe Pustka

Joe Pustka

 

By Joe Pustka, USON  Medical Device Leak Testing Technical Support Manager

A yearly checkup for a production line? That’s exactly what this leak testing doc prescribes, and here’s why.

Medical device manufacturing operations are growing, and production lines are being stretched beyond their capacity. Systems that were once optimized for a certain throughput may now be limping. However today’s powerful processors translate into a faster tipping point for any highly automated assembly line where re-tooling with more up-to-date processing power or data networking capabilities has potential for rapid return-on-investment.

That’s true for any NDT instrumentation as well. While there’s an enormous incentive in the device industry to stick with leak detectors that have gone through thorough validation for regulatory compliance, there comes a time when it is worth the trouble to trade up to newer leak detection equipment. For example, leak testers capable of eight  concurrent tests or having multipressure range capability can provide improved throughput. Those are best-match leak detectors for some applications, while others are better served by bench-top models of leak detectors capable of multiple asynchronous leak tests. 

The decision of whether or not to upgrade can be made simpler by manufacturers that provide no-cost consultations. Device manufacturers that don’t avail themselves of such services are doomed to never know what they don’t know.

 

 

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GE Healthcare to use Covidien technology in five-year deal

by Sherrie Conroy May 3rd, 2012

Covidien and GE Healthcare, which are both known for patient development of monitoring and respiratory care devices, have announced a five-year, global collaboration to incorporate Covidien measurement technologies into GE Healthcare patient monitors. Covidien is clearly in a growth mode. This follows on the company’s recent acquisitionof Oridion Systems to build on its respiratory care applications.

“GE Healthcare is committed to making a broad range of parameter measurements available on our powerful monitoring technology, including GE’s own SpO2 technology,” says Matthias Weber, general manager, monitoring solutions at GE Healthcare. “Leveraging our 100-year history of designing life-critical devices, we are focused on delivering innovative clinical measurement technology. Such advances have the potential to support improved care, quality, and patient safety.”

According to a release, the Nellcor Respiratory Function portfolio, which includes Nellcor pulse oximetry with OxiMax Technology, and the BIS Brain Monitoring system, are now available on many GE Healthcare patient monitors. This includes the CARESCAPE Monitor B850 and CARESCAPE Monitor B650, which combine GE Healthcare’s cardiac and anesthesiology heritage.

The companies say that the collaboration reflects GE Healthcare’s commitment to maintain an open monitoring architecture, bringing together streams of patient data and making it usable for clinicians at the point of care. For instance, the CARESCAPE Monitor B850 now provides access to Covidien measurements, bidirectional information flows between the monitor and hospital information systems, such as electronic medical records, and electrocardiogram measurements without requiring a separate monitor. Integrated clinical information can provide valuable information for physicians, helping guide their decisions and enhance efficiency of care.

“The advanced parameter portfolio from Covidien, coupled with GE Healthcare’s patient monitors, supports clinicians in detecting subtle but critical variations in a patient’s status,” says Robert J. White, President of Covidien Respiratory and Monitoring Solutions. “By delivering the full picture of a patient’s physiological status, patient safety and positive outcomes can be advanced.”

The collaboration leverages the Covidien portfolio of patient monitoring technologies, including:

  • Nellcor pulse oximetry with OxiMax Technology, a cardiac-based pulse oximetry platform, which accurately monitors patients at all acuity levels and in challenging conditions. The Nellcor pulse oximetry solution from Covidien offers SpO2, pulse rate, and respiration rate in a single sensor design.  
  • INVOS Cerebral/Somatic Oximetry, which monitors site-specific oxygen levels to optimize end-organ perfusion and help protect against devastating major organ morbidity and neurological injury.
  • BIS Brain Monitoring, which measures the effects of anesthetics and sedatives on the brain.

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New coatings offer improved properties, overcome challenges

by Sherrie Conroy May 2nd, 2012

New coatings are available to solve some old problems, including processibility and biocompatibility, as well as one that can be stored and transported under a wider array of conditions than previously available coatings. Biocoat, Inc, maker of lubricious HYDAK hydrophilic coatings, introduced the new hydrophilic coatings for medical devices.

HydroSleek2, which succeeds the original HydroSleek lubricious coating, offers the improved processing and biocompatibility. Josh Simon, senior product managerat Biocoat, says the company’s HydroSleek Kit allows the HydroSleek coating to be stored and transported under more conditions than before. Simon says the coatings are based on high molecular weight hyaluronic acid (HA), which has applications among a range of fields including ophthalmology, urology, cardiology, endoscopy, and neurovascular. Simon notes that the HydroSleek coatings have “overcome the trade-off between lubricity and durability seen in cross-linked coatings. Additionally, HydroSleek involves a heat-cure process so both ID and OD may be coated without the concerns surrounding UV curing.”

For more details, visit the Hydrophilic Coatings blog.

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InHealth awards grants two grants to study impact of medical technologies on preventing, reducing HAIs

by Sherrie Conroy May 1st, 2012

The Institute for Health Technology Studies (InHealth) has awarded two grants totaling more than $440,000 to research teams at Massachusetts General Hospital (MGH) and the Mount Sinai School of Medicine, according to a press release from the institute. The grants will support studies of the role and impact of innovative medical technologies in reducing the economic, human, and clinical consequences of healthcare-associated infections (HAIs).

HAIs have been linked to substantial increases in morbidity and mortality as well as prolonged hospitalizations and increased readmission rates. The US Department of Health and Human Services estimates that HAIs lead to preventable healthcare expenditures totaling between $28 billion and $33 billion annually, and recently announced its National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination.

“Healthcare-associated infections are widely recognized as a serious and costly threat to public health, but the contribution of advanced medical technologies in HAI intervention has not been thoroughly explored,” said Charles M. Fleischman, interim executive director of InHealth. “We are very pleased to support two new studies that will fill this gap in knowledge and inform policymakers and clinicians as they tackle this issue.”

Chuck Fleischman

Chuck Fleischman

MGH will receive $229,597 for its study, “Novel Methods to Evaluate Infection Control Strategies: Projecting the Clinical and Economic Outcomes of Rapid Molecular Diagnostics for Vancomycin-Resistant Enterococcus (VRE).” The researchers will study the clinical, operational, and economic value of rapid molecular diagnostics for preventing and controlling VRE, an organism resistant to the antibiotic vancomycin and a common cause of infections acquired in the hospital setting. The study will pioneer the application of computer simulation techniques to model patient flow in the hospital and examine how alternative infection control strategies may improve both clinical and economic outcomes.

The research team will be led by coprincipal investigators Rochelle P. Walensky, MD, MPH, codirector of the Medical Practice Evaluation Center at MGH, a practicing infectious disease physician at MGH and Brigham and Women’s Hospital, and an associate professor of medicine at Harvard Medical School; and David C. Hooper, MD, associate director of the Division of Infectious Diseases and director of the Infection Control Unit at MGH, and a professor of medicine at Harvard Medical School. The research team includes coinvestigator Erica S. Shenoy, MD, PhD, a clinical and research fellow in infectious diseases at MGH and a clinical fellow in medicine at Harvard Medical School. Shenoy is trained as both an infectious disease physician and a health economist.

“This generous grant from InHealth will allow us to determine which new methodological approaches can most effectively and efficiently advance the field of infection prevention,” said Walensky. “Our goal is to provide data that will enable leaders to make more-informed decisions regarding the integration of rapid molecular diagnostics into clinical practice.”

In a separate grant, researchers at the Mount Sinai School of Medicine will receive $213,278 for their study, “Clinical and Economic Impact of Hospital-Acquired Infections in Cardiac Surgery: Planning Cost-Effective Prevention Strategies.” Focusing on HAIs following cardiothoracic surgery, the researchers will assess the costs arising from different types of infections, and create benchmarks to assess novel interventions. Such infections constitute the most common noncardiac complication after cardiac surgery, and are associated with substantial morbidity, mortality, prolonged hospitalizations, and higher readmission rates. The study will utilize data from the National Institutes of Health-funded cardiothoracic surgical trials network, whose data coordinating center is located at Mount Sinai’s International Center for Health Outcomes and Innovation Research (InCHOIR).

The Mount Sinai team will be led by principal investigator Giampaolo Greco, PhD, MPH, an assistant professor in the Department of Health Evidence and Policy at the Mount Sinai School of Medicine. Other team members from the Mount Sinai Department of Health Evidence and Policy include Emilia Bagiella, PhD, a professor in the Center for Biostatistics; Helena L. Chang, MS, senior biostatistician; and Michael J. Weglinski, MBA, senior programmer and analyst.

“Healthcare-associated infections following cardiac surgery take a significant toll on patients and the healthcare system,” said Greco. “Through our InHealth grant, we will identify the real costs and economic impact of HAIs after surgery, and identify best practices that can be adopted to reduce them.”

The two research teams were among a number of applicants responding to InHealth’s request for proposals on “The Impact of Advanced Medical Technologies on the Control of Healthcare-Associated Infections,” which was issued in November 2011. Grantees were selected after review by an independent panel of experts that included clinicians, academics, and medical technology professionals. The selected grants support InHealth’s research mission to conduct studies of the impact of medical technologies on the healthcare system, on the economy, and on major policy issues that affect the industry and its ability to provide innovative and effective therapies to patients. More information about the grants is available from the InHealth web site.

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LinkedIn group creates online petition to kill device tax

by Sherrie Conroy April 24th, 2012

A new Web site has sprung up to gather signatures to petition the repeal of the medical device tax. Created by the LinkedIn Medical Devices Group, the “No 2.3%” Web site is a grassroots effort that needs 23,465 signatures by July 18. (As of April 24, it had 1535 signatures.) The signatures will be sent to the Senate.

Petition_sizedThe petition, which can be shared via Twitter, Facebook, LinkedIn, Google+, includes articles detailing the effect of the device tax, as well as videos, including one that features Rep. Erik Paulsen (R-MN) calling the tax “ill conceived” and noting that the the tax will kill 43,000 jobs over the next several years.

The online petition includes a letter that 400 US medical device CEOs sent in July 2011 letter to both branches of Congress. The letter highlights the effects of the tax, including its impact on jobs: “The tax will stifle innovation and cost thousands of high-paying jobs. It will increase the effective tax rate for many medical technology companies, thereby reducing financial resources that should be used for R&D, clinical trials and investments in manufacturing. The impact will be especially hard on smaller companies whose innovations are not immediately profitable.”

It will be interesting to see whether the group can gather so many signatures in such a short time. It’s the first time that I’ve seen such an effort come from the ranks of industry rather than from industry organizations such as AdvaMed and MDMA.

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