Op Ed: When the U.S. Medical Device Industry Wins, America Wins

The U.S. has been the global leader in medical device development for decades. It boosts the overall economy, reduces the foreign trade deficit, and provides jobs and products that enhance and save lives. 

Baiju R. Shah, president and CEO, BioEnterprise
However, in recent years, regulatory uncertainty at FDA has begun to hinder industry’s growth. These uncertainties have driven up costs and could drive away medical technology innovation and jobs, hampering America’s economic recovery and future prosperity, as well as the health of its citizens.
 
For the United States to keep its world leadership in medical devices—a key driver of our economy and quality of life—it must restore an appropriate regulatory balance that fosters innovation in addition to ensuring product safety.
 

World Leader in Medical Devices

 
In 2008, the U.S. medical device industry shipped $136 billion worth of medical devices, from simple contact lenses to implantable neurostimulators, according to a 2010 report by The Lewin Group. That year, the industry employed 422,778 workers (researchers, biomedical engineers, manufacturing technicians and salespeople, to name a few) who earned a collective $24.6 billion in income at an average of $58,000 per worker.<
 
The industry has benefitted from consistent demand for new medical innovations that is fueled by better understanding of diseases and improved underlying technologies. And as foreign countries become wealthier, their citizens have added to this demand through their desire for improved medical devices to increase the quality and longevity of their lives.
 

Challenges to Medical Innovation in the United States

While the fundamentals to drive global industry growth are strong, the U.S. medical device industry is faced with a new challenge in regulatory uncertainty regarding the approval of new medical devices. Depending upon the nature of the medical device, the development costs can range from $10 million and a few years to upwards of $75 million and a decade of development due to required technology and clinical studies. Stumbling along an unclear regulatory path can adds millions more and years of time to the path of these devices. 
 
These costs and time to market have increased recently. In part, the additional time has been due to low staffing levels at the FDA, an issue that will be seemingly addressed through the higher user fees that have been agreed to by the industry. However, increased staffing alone will not cure the uncertain nature of the regulatory pathways for medical devices. This is the primary challenge to maintaining U.S. leadership in the medical device industry.
 

Less Spending on Development Means Fewer Devices

The regulatory uncertainty has already resulted in fewer investments for medical device innovations. Investors are increasingly wary of investing in medical devices prior to regulatory approval. At the recent JP Morgan Global Healthcare Conference, venture investors we met with consistently asked of new companies, “Is their device in the market today?” The current consensus is to shy away from investing in companies that have unknowable regulatory risks ahead of them. 
 
Venture capital investments in medical devices fell for the third straight year in 2010, down 37% to $2.3 billion from $3.7 billion in 2007. “The current situation has undermined the ability of venture capital firms to achieve a favorable return on their investments and to raise funds to support the next generation of innovative biotechnology and medical device companies,” investor Sharon Stevenson, managing director of Okapi Venture Capital LLC, told a House subcommittee in September 2011. Investors are more likely to put their money in devices already in the market. So while investments in medical devices increased a modest 19 percent in 2011, most of that money went to a handful of mature companies, according to an Ernst & Young report.
 
In response, U.S. device developers have had to seek smaller, gap funding sources to continue to advance their innovations—a grant here, a Defense Department contract there, some angel and seed money on top. These can be complemented in states such as Ohio, where BioEnterprise is based, that have dedicated seed funds, tax credits, grants, and accelerators to support emerging medical technology companies. But most states and regions lack these resources and bootstrapping is insufficient for truly breakthrough, innovative devices.
 

U.S. Global Competitiveness at Risk

The difficult regulatory environment for medical device innovators in the United States has led them to begin developing and testing their devices overseas.
 
“I am deeply concerned that we are in jeopardy of losing the U.S. leadership position in medical technology innovation as a result of the current regulatory environment at FDA,” medical device inventor and job-creator Dr. Josh Makower told the U.S. Senate’s Health Subcommittee in February 2011. “Over the past several years, it has been increasingly difficult, more time-consuming, more costly and less predictable to navigate the FDA approval process. As a result, investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products.”
 
Eventually, this foreign investment could cost America its medical device leadership. China, for one, is investing enormous resources to develop its medical technology capabilities as a consumer of healthcare and as a producer of medical devices, and not surprisingly, U.S. companies are announcing new R&D facilities to be located there.
 

Restore the Regulatory Balance

 
The medical device industry is one of only a few U.S. industries that has a positive trade surplus, meaning the country exports more than it imports. If we give up our lead in medical devices, we give up this industry’s trade surplus and add to our nation’s trade deficit.
 
Historically, the United States has encouraged the advances of medical technologies by creating an environment in which entrepreneurs and investors could safely and profitably bring innovative products to market. An uncertain regulatory pathway for new devices is making it less favorable to develop devices in the United States than in other countries. Regulatory clarity at FDA that restores a pro-innovation environment will enable America to retain its leadership in this industry, enabling the sector to continue to supply jobs and medical innovations for Americans. The President and Congress must focus on creating a regulatory environment that encourages innovation to continue America's global leadership in medical devices.
 
+++++++++++++++
Baiju R. Shah is President and CEO and a Founder of BioEnterprise. He focuses on BioEnterprise's strategic initiatives as well as counseling clients on business and financial matters. Prior to BioEnterprise, Shah was with McKinsey & Company, where he played a leading role in the Growth and Business Building practice.  Shah is on the Board of Directors of Invacare and on the Midwest Regional Advisory Board of RBS Citizens/Charter One.  In the community, Shah is Chair of Global Cleveland and serves on the boards of Great Lakes Science Center, Saint Luke's Foundation, and United Way of Greater Cleveland. Shah received a J.D. from Harvard and his B.A. from Yale. 

Op Ed: When the U.S. Medical Device Industry Wins, America Wins

Baiju R. Shah, president and CEO, BioEnterprise
However, in recent years, regulatory uncertainty at FDA has begun to hinder industry’s growth. These uncertainties have driven up costs and could drive away medical technology innovation and jobs, hampering America’s economic recovery and future prosperity, as well as the health of its citizens.
 
For the United States to keep its world leadership in medical devices—a key driver of our economy and quality of life—it must restore an appropriate regulatory balance that fosters innovation in addition to ensuring product safety.
 

World Leader in Medical Devices

In 2008, the U.S. medical device industry shipped $136 billion worth of medical devices, from simple contact lenses to implantable neurostimulators, according to a 2010 report by The Lewin Group. That year, the industry employed 422,778 workers (researchers, biomedical engineers, manufacturing technicians and salespeople, to name a few) who earned a collective $24.6 billion in income at an average of $58,000 per worker.
 
The industry has benefitted from consistent demand for new medical innovations that is fueled by better understanding of diseases and improved underlying technologies. And as foreign countries become wealthier, their citizens have added to this demand through their desire for improved medical devices to increase the quality and longevity of their lives.
 

Challenges to Medical Innovation in the United States

While the fundamentals to drive global industry growth are strong, the U.S. medical device industry is faced with a new challenge in regulatory uncertainty regarding the approval of new medical devices. Depending upon the nature of the medical device, the development costs can range from $10 million and a few years to upwards of $75 million and a decade of development due to required technology and clinical studies. Stumbling along an unclear regulatory path can adds millions more and years of time to the path of these devices. 
 
These costs and time to market have increased recently. In part, the additional time has been due to low staffing levels at the FDA, an issue that will be seemingly addressed through the higher user fees that have been agreed to by the industry. However, increased staffing alone will not cure the uncertain nature of the regulatory pathways for medical devices. This is the primary challenge to maintaining U.S. leadership in the medical device industry.
 

Less Spending on Development Means Fewer Devices

The regulatory uncertainty has already resulted in fewer investments for medical device innovations. Investors are increasingly wary of investing in medical devices prior to regulatory approval. At the recent JP Morgan Global Healthcare Conference, venture investors we met with consistently asked of new companies, “Is their device in the market today?” The current consensus is to shy away from investing in companies that have unknowable regulatory risks ahead of them. 
 
Venture capital investments in medical devices fell for the third straight year in 2010, down 37% to $2.3 billion from $3.7 billion in 2007. “The current situation has undermined the ability of venture capital firms to achieve a favorable return on their investments and to raise funds to support the next generation of innovative biotechnology and medical device companies,” investor Sharon Stevenson, managing director of Okapi Venture Capital LLC, told a House subcommittee in September 2011. Investors are more likely to put their money in devices already in the market. So while investments in medical devices increased a modest 19 percent in 2011, most of that money went to a handful of mature companies, according to an Ernst & Young report.
 
In response, U.S. device developers have had to seek smaller, gap funding sources to continue to advance their innovations—a grant here, a Defense Department contract there, some angel and seed money on top. These can be complemented in states such as Ohio, where BioEnterprise is based, that have dedicated seed funds, tax credits, grants, and accelerators to support emerging medical technology companies. But most states and regions lack these resources and bootstrapping is insufficient for truly breakthrough, innovative devices.
 

U.S. Global Competitiveness at Risk

The difficult regulatory environment for medical device innovators in the United States has led them to begin developing and testing their devices overseas.
 
“I am deeply concerned that we are in jeopardy of losing the U.S. leadership position in medical technology innovation as a result of the current regulatory environment at FDA,” medical device inventor and job-creator Dr. Josh Makower told the U.S. Senate’s Health Subcommittee in February 2011. “Over the past several years, it has been increasingly difficult, more time-consuming, more costly and less predictable to navigate the FDA approval process. As a result, investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products.”
 
Eventually, this foreign investment could cost America its medical device leadership. China, for one, is investing enormous resources to develop its medical technology capabilities as a consumer of healthcare and as a producer of medical devices, and not surprisingly, U.S. companies are announcing new R&D facilities to be located there.
 

Restore the Regulatory Balance

The medical device industry is one of only a few U.S. industries that has a positive trade surplus, meaning the country exports more than it imports. If we give up our lead in medical devices, we give up this industry’s trade surplus and add to our nation’s trade deficit.
 
Historically, the United States has encouraged the advances of medical technologies by creating an environment in which entrepreneurs and investors could safely and profitably bring innovative products to market. An uncertain regulatory pathway for new devices is making it less favorable to develop devices in the United States than in other countries. Regulatory clarity at FDA that restores a pro-innovation environment will enable America to retain its leadership in this industry, enabling the sector to continue to supply jobs and medical innovations for Americans. The President and Congress must focus on creating a regulatory environment that encourages innovation to continue America's global leadership in medical devices.
 
+++++++++++++++
Baiju R. Shah is President and CEO and a Founder of BioEnterprise. He focuses on BioEnterprise's strategic initiatives as well as counseling clients on business and financial matters. Prior to BioEnterprise, Shah was with McKinsey & Company, where he played a leading role in the Growth and Business Building practice.  Shah is on the Board of Directors of Invacare and on the Midwest Regional Advisory Board of RBS Citizens/Charter One.  In the community, Shah is Chair of Global Cleveland and serves on the boards of Great Lakes Science Center, Saint Luke's Foundation, and United Way of Greater Cleveland. Shah received a J.D. from Harvard and his B.A. from Yale.  

Top Designers Tackle Market Needs First | Medical Device Podcast

Edward G. Chekan, MD, FACS
Craig D. Friedman, MD, FACS
 
 
 
 
Stuart Karten
Stephen B. Wilcox, PhD, FIDSA

A definition of innovation could be solving a problem. Taking it a step further, you could say it means responding to the needs of marketplace. And most people agree that the needs of a medtech marketplace are moving targets.

The Medical Design Excellence Awards finalists exemplify the design genius that can come out of a tough challenge. Hospitals have been saying they need less expensive, and more portable designs. And this year, finalists delivered, said several judges of the MDEA program.

In this medical design roundtable, Ed Checkan, Craig Friedman, Stuart Karten, and Steve Wilcox discuss the design challenges and opportunities facing medical device companies.

Listen to Design Experts Roundtable podcast.

More On the Medical Design Excellence Awards

Four Trends from the 2012 Medical Design Excellence Awards

2012 MDEA Finalists Slideshow

TEDMED Update: Why the Future of Medical Electronics Is Flexible

We take it as a matter of fact that technological devices generally get more powerful and less expensive over time. And, over the years, it has become apparent that electronic devices can radically change countless facets of our lives—from picking out music to finding out how to get from point A to B.

But even the latest electronic devices are essentially “smaller versions of the rigid bricks they have always been,” said David Icke, CEO of conformal electronics maker MC10, speaking at TEDMED on April 11 in Washington, DC. “They are solid, boxy, and often uncomfortable to use.”

David Icke at TEDMED 2012

These drawbacks also apply to medical electronics, Icke pointed out. Home-monitoring devices can be cumbersome to lug around. And, in the hospital, electronic devices require that patients be tethered to them with wires and sensors.

A more graphic example can be found in the case of epileptics whose seizures are not controlled by drugs. One method of treating these patients is to connect the brain directly to computers, which monitor the the patients to identify the source of their seizures. To accomplish that, doctors saw open the cranium and manually connect electrodes to the brain’s surface. They then keep the patients in the hospital for roughly one week to ten days to monitor their brains.

“There has to be a better way,” Icke said. Flexible electronics capable of monitoring the brain could be placed through a narrow burr hole in the skull. From there, they could expand like a parachute, eventually settling on the surface of the brain. This approach would not only be less traumatic but more effective as well.

Icke mentioned a whole host of other medical and health applications for flexible electronics. Patches with flexible sensors could be used to monitor everyone from infants to athletes. In addition, flexible sensors could provide the foundation for a human–computer interface that links prosthetics directly to the brain.

The sensors could be a boon for the field of cardiology as well. To monitor heart patients, an implantable version of such a patch could be deployed through the femoral artery through the vasculature to be placed in the beating heart. Data from the sensor could be relayed wirelessly to smart phones.

This example of a flexible electronic circuit hints at the possibilities of such electronics to accommodate warping.
This example of a flexible electronic circuit hints at the possibilities of such electronics to accommodate warping.

The technology could be used in smart catheters to give physicians a better understanding of “what is happening at the far end of the catheter.” Doing so can be used to improve the placement of stents and artificial heart valves.

Icke’s company, MC10, will begin shipping its first consumer products this year for sports monitoring. Skin-mounted wellness and health products will follow thereafter. The company will introduce medical applications of the bendable electronics after that. Icke expressed interest in working with “partners in the medical device space that have that expertise in going through the regulatory process as fast as they can.”

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

Supreme Court Ruling in Prometheus Patent Case Could Be a Landmark

A recent Supreme Court decision to strike down two patents issued to a medical diagnostics maker could have important repercussions for the life sciences industry. 
 
On March 20, 2012, the Supreme Court unanimously ruled to invalidate a pair of patents covering a method for using blood tests to determine drug dosage that were issued to Prometheus Laboratories. The Mayo Clinic had challenged the patents’ validity. In Mayo Collaborative Services v. Prometheus Laboratories Inc., the Court found that the patents are based on a law of nature and, as such, are not patentable.
 
Many professionals in the biotech, pharma, and medical diagnostics industries fear that the Prometheus ruling could mean that numerous patents in those sectors could be overturned. (Image from Flickr user walknboston.)
Many in the biotech, pharma, and medical diagnostics fields have taken issue with the ruling because it could mean that numerous patents in those sectors could be overturned.
 
“The Prometheus decision is a big pronouncement from the Supreme Court on patent eligibility, and the ruling will have a direct impact on diagnostics, genomics, and personalized medicine patents,” explains David Dykeman, a registered patent attorney and shareholder at Greenberg Traurig (Boston).
 
Less than a week after the ruling, on March 26, the Supreme Court remanded another patent case, Association for Molecular Pathology v. Myriad Genetics, to the Court of Appeals for the Federal Circuit, which previously issued a ruling supporting the patentability of DNA and genes linked to a high risk of breast and ovarian cancer.
 
More recently, Prometheus was invoked in SmartGene Inc. v. Advanced Biological Laboratories S.A., a case related to two diagnostic test patents. Judge Beryl Howell of the District of Columbia dismissed the claims of two patents from Advanced Biological Laboratories S.A., marking the first time the Prometheus decision has been used to invalidate diagnostic method patents.
 
The Prometheus ruling follows a 2010 decision by the court to deny the eligibility of a patent covering a method of hedging risk in commodities trading. In 1997, Bernard L. Bilski and Rand Warsaw filed a U.S. patent application that described a series of steps designed to hedge against risk in the energy industry. The United States Patent and Trademark Office (USPTO) dismissed the application, with a patent examiner explaining that it “merely manipulates [an] abstract idea and solves a purely mathematical problem without any limitation to a practical application, therefore, the invention is not directed to the technological arts.”
 
While laws of nature, physical phenomena, and abstract ideas are, in themselves, not patentable, Bilski argued that the business method for hedging risks is patentable because it represents “an application of a law of nature or mathematical formula.” The case made its way to the Court of Appeals for the Federal Circuit, which ruled against Bilski, explaining that in order to receive patent protection, an invention must be associated with a particular machine or transform an article into a different state. This principle, known as the “machine or transformation” test, also applies to the patentability of products used in medical diagnostics and personalized medicine.
 
Bilski appealed the case to the Supreme Court, which, in Bilski v. Kappos, issued a splintered opinion denying the eligibility of the Bilski patent in 2010. The Supreme Court also held that the “machine or transformation” test is a “useful and important clue, an investigative tool, for determining whether some claimed inventions are processes.” The Court, however, explained that the test is not the sole criterion for patent eligibility of a process.
 
In general, federal district courts and the Court of Appeals of the Federal Circuit have chosen not to interpret Bilski broadly and have not make substantial changes to their decisions regarding business method and software patent claims. Although Bilski updated the criteria for patent eligibility, the ruling wasn’t as effective as the Supreme Court likely hoped in shedding light on what constitutes patentability, Dykeman says.
 
The court’s unanimous ruling in Prometheus puts some of the uncertainty to rest. The opinion did not, however, precisely explain what level of detail is necessary in order to obtain a diagnostic test patent. 
 
“A big question mark still hangs over diagnostic and personalized medicine patents,” Dykeman says. “If the lower courts apply the Prometheus decision broadly, it will likely mean more patents will be found invalid. If the lower courts read it narrowly, we may get better guidelines about the types of diagnostic patents that are patentable.”

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

Modeling Future Robots on the Sea Lamprey

Researchers in the UK and the United States are modeling a disease-detecting microrobot on the sea lamprey. (Photo courtesy of Great Lakes Fishery Commission)

A tiny prototype robot--dubbed 'Cyberplasm'--is being developed by scientists in the UK and United States. Funded by the Engineering and Physical Sciences Research Council in the UK and the U.S. National Science Foundation (NSF), the device is being designed to mimic key functions of the sea lamprey, a creature found primarily in the Atlantic Ocean. The researchers hope that by basing their device on the sea lamprey, it will be extremely sensitive and responsive to the environment into which it is placed. If successful, the robot could eventually be used to swim through the human body to detect diseases.

The scientists are modeling their robot on the sea lamprey because it has a very primitive nervous system that is easier to mimic than more sophisticated nervous systems. And because it can swim, the sea lamprey was considered by the researchers to be the best candidate on which to model Cyberplasm.

Based on advanced microelectronics and biomimetics, Cyberplasm will have an electronic nervous system, 'eye' and 'nose' sensors derived from mammalian cells, and artificial muscles that use glucose as an energy source to propel it. The scientists' goal is to engineer and integrate robot components that respond to light and chemicals, as do biological systems. Once it is developed, the prototype will be less than 1 cm long, although future versions could potentially be less than 1 mm long or even built on the nanoscale.

Cyberplasm's sensors are being developed to respond to external stimuli by converting them into electronic impulses that are sent to an electronic 'brain' equipped with sophisticated microchips. This brain will then send electronic messages to artificial muscles telling them how to contract and relax, enabling the robot to undulate its way through the body. These systems will also be able to collect and store data on the chemical composition of the robot's surroundings.

In addition to detecting diseases, Cyberplasm could find use in advanced prosthetics. In such applications, living muscle tissue might be engineered to contract and relax in response to stimulation from light waves or electronic signals.

"Nothing matches a living creature's natural ability to see and smell its environment and therefore to collect data on what's going on around it," remarks Newcastle University bioengineer Daniel Frankel, who is leading the UK-based work. The researchers are developing and testing Cyberplasm's individual components, hoping to proceed to the assembly stage within a couple of years. "We believe Cyberplasm could start being used in real-world situations within five years," Frankel adds.

Finalists Selected for 2012 Medical Design Excellence Awards

Medical Device and Diagnostic Industry (MD+DI) announced the finalists in the 2012 Medical Design Excellence Awards (MDEA) competition in its April print issue. The award ceremony, which will take place on May 23, will also honor Thomas Fogarty with the 2012 MDEA Lifetime Achievement Award. Holding 150 patents on surgical instruments, Fogarty invented the Aneurx stent graft, now a Medtronic-branded product. He has also published roughly 180 scientific articles and textbook chapters on topics of general and cardiovascular surgery. The lifetime achievement award will be presented by Dean Kamen, an inventor, entrepreneur, and advocate for science and technology.

MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes--engineers, scientists, designers, and clinicians--who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-finalist and winning entries excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.

A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, clinical practice, diagnostics, human factors, industrial design, manufacturing, and medicine. The 2012 MDEA Jury selected 41 finalists in 10 medical product categories. The finalist products and manufacturers (alphabetical by cateory) are:

CRITICAL-CARE AND EMERGENCY MEDICINE PRODUCTS

  • CARDIOHELP System for circulatory and pulmonary support. Manufactured by MAQUET Medical Systems USA (Wayne, NJ). Entry submitted by WCG (New York, NY).
  • endOclear wiper device for the cleaning and visualization of endotracheal tubes. Manufactured by EndOclear LLC (San Ramon, CA). Entry submitted by Innovative Design LLC (Danvill, CA).
  • The Freedom portable driver. Manufactured and submitted by SynCardia Systems Inc. (Tucson, AZ).
  • King Vision video laryngoscope. Manufactured and submitted by King Systems (Noblesville, IN).
  • LS-1 "suitcase" intensive care unit. Manufactured and submitted by Integrated Medical Systems Inc. (Signal Hill, CA).
  • ProSim 4 Vital Signs Simulator. Manufactured and submitted by Fluke Biomedical (Everett, WA).


DENTAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

  • 3-D Click Guide kit for dental implants. Manufactured and submitted by Idondivi Inc. LLC (San Francisco, CA).
  • Elevance Dental Chair with Cantilever Forward design. Manufactured by Midmark Corp. (Versailles, OH). Entry submitted by Design Central Inc. (Columbus, OH).
  • Identafi Oral Cancer Screening Device. Manufactured by DentalEZ Inc. (Malvern, PA). Entry submitted by M3 Design (Round Rock, TX).
  • Waterlase iPlus All Tissue Laser. Manufactured and submitted by Biolase Technology Inc. (Irvine, CA).


FINISHED PACKAGING

  • Scotchbond Universal Adhesive dropper vial. Manufactured and submitted by 3M Deutschland GmbH, 3M ESPE Division (Seefeld, Germany).


GENERAL HOSPITAL DEVICES AND THERAPEUTIC PRODUCTS

  • Combitide Starhaler for asthma and COPD. Manufactured by Sun Pharmaceutical Industries Ltd. (Mumbai, India). Entry submitted by Cambridge Consultants Ltd. (Cambridge, United Kingdom).
  • Edelvaiss Multiline paradigm-shifting manifold and I.V. line. Manufactured and submitted by Doran International (Toussieu, France).
  • Safepole I.V. pole. Manufactured by SafePole LLC (Los Angeles, CA). Entry submitted by TEAMS Design (Chicago, IL).
  • TissuGlu Surgical Adhesive. Manufactured and submitted by Cohera Medical Inc. (Pittsburgh, PA).
  • TOBI Podhaler dry powder inhaler device with PulmoSphere technology. Manufactured and submitted by Novartis Pharmaceuticals Corp. (San Carlos, CA). TOBI Podhaler is not approved in the USA.
  • Vasculaire Compression System. Manufactured and submitted by Venous Health Systems (Portola Valley, CA).


IMPLANT AND TISSUE-REPLACEMENT PRODUCTS

  • ConforMIS iTotal CR Knee Replacement System. Manufactured by ConforMIS Inc. (Burlington, MA). Entry submitted by Racepoint Group (Waltham, MA).
  • GORE Hybrid Vascular Graft. Manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ).
  • KAMRA Corneal Inlay. Manufactured and submitted by AcuFocus Inc. (Irvine, CA).


IN VITRO DIAGNOSTICS

  • Myla microbiology middleware system. Manufactured and submitted by bioMerieux Inc. (Durham, NC).
  • Simplexa Direct and Simplexa Universal Direct assay kits. Manufactured and submitted by Focus Diagnostics (Cypress, CA).
  • SnapPath 1000 biomarker testing system. Manufactured by BioMarker Strategies (Baltimore, MD). Entry submitted by HS Design Inc. (Gladstone, NJ).


OVER-THE-COUNTER AND SELF-CARE PRODUCTS

  • New prefilled insulin injection pen. Manufactured by Novo Nordisk A/S (Hillerod, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, United Kingdom).
  • Vibrance Kegel Device. Manufactured and submitted by Bioinfinity (M) Sdn Bhd (Kuala Lumpur, Malaysia).


RADIOLOGICAL AND ELECTROMECHANICAL DEVICES

  • BodyTom portable, full body, multi-slice CT scanner. Manufactured and submitted by NeuroLogica Corp. (Danvers, MA).
  • Carestream CS 7600 imaging plate system. Manufactured and submitted by Carestream Health Inc. (Rochester, NY).
  • DermScope imaging accessory for the iPhone. Manufactured by Canfield Scientific Inc. (Fairfield, NJ). Entry submitted by HS Design Inc. (Gladstone, NJ).
  • NOMAD Pro handheld x-ray system. Manufactured by Aribex Inc. (Orem, UT). Entry submitted by IQMS (Paso Robles, CA).
  • Planmed Verity extremity scanner. Manufactured and submitted by Planmed Oy (Helsinki, Finland).


REHABILITATION AND ASSISTIVE-TECHNOLOGY PRODUCTS

  • BiOM Ankle prosthetic device. Manufactured and submitted by iWalk Inc. (Bedford, MA).
  • Breathe NIOV Ventilation System. Manufactured and submitted by Breathe Technologies Inc. (Irvine, CA).
  • Neptune sound processor. Manufactured by Advanced Bionics LLC (Vlencia, CA). Entry submitted by Product Creation Studio (Seattle, WA).
  • Niagara Foot field-adjustable prosthetic device. Manufactured and submitted by Niagara Prosthetics and Orthotics International Ltd. (Fonthill, ON, Canada).
  • RT600 Functional Electrical Stimulation (FES) stepper ergometer featuring SAGE smart stimulation system. Manufactured and submitted by Restorative Therapies Inc. (Baltimore, MD).
  • SIM (Smart Incontinence Management). Manufactured and submitted by Simavita Pty. Ltd. (North Sydney, Australia).


SURGICAL EQUIPMENT, INSTRUMENTS, AND SUPPLIES

  • The ActiViews CT-Guide navigation system. Manufactured and submitted by ActiViews Inc. (Wakefield, MA).
  • Alair Catheter for Bronchial Thermoplasty procedures. Manufactured by Asthmatx (Sunnyvale, CA). Entry submitted by Bridge Design (San Francisco, CA).
  • Catalys Precision Laser System. Manufactured and submitted by OptiMedica Corp. (Santa Clara, CA).
  • EndoSerter Corneal Endothelial Delivery Instrument. Manufactured by Ocular Systems Inc. (Winston-Salem, NC). Entry submitted by Cathtek (Winston Salem, NC).
  • FMwand Ferromagnetic Surgical System. Manufactured and submitted by Domain Surgical (Salt Lake City, UT).

The 2012 MDEA-finalists, and their suppliers, will be honored for their innovative contributions to the medical device industry.
Up to one Bronze, one Silver, and one Gold-winning product will be announced in each category. One Gold-winning product will be awarded "Best-in-Show."

Medtech in China: Transitioning from the World’s Workshop to Innovation Hub

“You can't do R&D offshore from a distance,” writes Venkatesh Narayanamurti, founding dean of Harvard's School of Engineering and Applied Sciences and director of the Science, Technology and Public Policy Program at Harvard Kennedy School's Belfer Center for Science and International Affairs. “The ‘look-see-do’ of innovation depends on close ties to the manufacturing process. Proximity to manufacturing is the key to other higher-value activities—design, engineering, and R&D,” Narayanamurti notes in an opinion piece published in the March 26 edition of the Los Angeles Times. Narayanamurti wants to draw attention to the fact that sending manufacturing jobs offshore ultimately leads to exiling innovation. He’s right, but seen from China’s perspective, that’s not something to bemoan.

Chinese medical device manufacturers are moving up the value chain. The Chinese government is encouraging entrepreneurs to embrace an innovation mindset rather than simply acting as the world’s factory. Industry observers see China making tremendous progress in a very short span of time. A recent report published by PwC,PwC’s Medical Technology Innovation Scorecard, laid out this dynamic.
 
The report’s authors note, in regards to medtech innovation, the United States, Germany, France, the United Kingdom, Israel, and Japan will begin to lose ground to other countries during the next decade. They write that Brazil, Russia, India, and China will increasingly pick up the slack, adding that China is firmly positioned as the leader of the pack and will continue to outpace other countries and reach near parity with the developed nations of Europe by 2020.
 
It is becoming increasingly clear that the Chinese economy and its indigenous medical device industry is at the threshold of seismic change, as an emphasis on R&D and a willingness to embrace a sophisticated international business strategy take hold among Chinese medical device manufacturers. Mindray, Shantou Institute of Ultrasonic Instruments Company, Ltd., and Time Medical Systems are three China-based medical device manufacturers that are setting the tone for an industry in transition.
 
 
Mindray
Headquartered in Shenzhen, China, Mindray has become the largest medical equipment manufacturer in China. Since its founding in 1991, Mindray has been single-minded in its focus on the development and manufacture of medical equipment. Patient monitoring systems (representing 45.3% of revenue), clinical testing, and reagents (24.2%), and digital medical imaging (24.6%) are the company’s three major business areas. Mindray went public on the New York Stock Exchange in 2006. It is currently valued at U.S. $3 billion, which makes it the leader of all public medical device companies in China.
 
Mindray has staked out a midrange position for its products. Its devices compare favorably with systems from Philips and GE in terms of quality, but come with an obvious cost incentive. That competitive advantage disappears domestically, where Mindray’s equipment is 10% to 20% more expensive than competing products. Mindray excels, however, in branding, maintenance and R&D, and its sales network extends to more than 100 countries.
 
Mindray typically invests 10% of its annual revenue in R&D. This strategy has paid off handsomely not only in the marketplace but also in prestige: the company received a 2011 Medical Design Excellence Award for its V Series patient monitoring system. Mindray is the first Chinese company to win an MDEA trophy.
 
 
Shantou Institute of Ultrasonic Instruments Company, Ltd (SIUI)
SIUI manufactures ultrasound and digital medical imaging systems, nondestructive testing products and transducers. Founded in 1978, SIUI has maintained rapid growth and typically invests more than 15% of revenue in R&D. Breakthrough products include elastography systems, and 4-D transvaginal probes that wirelessly transmit ultrasound images from an SIUI device to iPads and iPhones. The app is available for download at the Apple store.
 
Headquartered in Shantou in southeast China, SIUI is recognized for its R&D-centered approach. Company engineers are avid learners, emulating global best practices and combining in-house and cooperative R&D in the service of mastering its core technology. SIUI has established research centers in the United States and regularly works with universities and world-class high-tech companies.
 
 
Time Medical Systems
Founded in 2006, Time Medical Systems is a pioneer in the development of high-temperature superconducting (HTS) coil technology for use in clinical MRI scanners. HTS coils improve the signal-to-noise ratio primarily through the use of more-efficient RF coil materials and design methods.
 
Company CEO Ma Qiyuan has been outspoken about the need to ramp up indigenous innovation. He has called on the Chinese government to assist device manufacturers to boost their R&D efforts for the design and production of high-end medical devices. China must champion national brands, says Qiyuan, adding that hospitals and other purchasing organizations should give priority to domestically produced medical equipment during the procurement process.
Time Medical Systems has offices in Shanghai, Beijing, and Hong Kong as well as in Singapore and San Diego, CA.
 
Helen Zhang is Associate Editor, China Medical Device Manufacturer
 
Norbert Sparrow is Editor in Chief, China Medical Device Manufacturer and European Medical Device Technology

Peeling Back the Layers of Coextruded Medical Tubing

When it comes to medical tubing for catheters, IV products, drug-delivery devices, and other applications, it's not just what's on the inside that counts. In fact, a material's properties are often equally as important to the outer diameter (OD) of the tube as they are to the inner diameter (ID) in terms of achieving superlative performance. Consisting of configurations that feature different materials for the inside and outside layers of the tube, coextruded medical tubing offers the advantage of IDs and ODs optimized with the functional characteristics best suited for a given medical device application. As a result, multilayer medical tubing can be produced to accommodate the increasingly complex needs of the industry by ultimately offering the best of both worlds.

Multiple Layers, Multiple Functions

Raumedic coextruded tubing

Coextrusion enables the development of medical tubing designs with different materials and, thus, functional characteristics for the OD and ID.

Because it offers the ability to produce a tube with its ID and OD optimized for their respective environments and functions, coextrusion offers advantages to manifold medical device applications. Chief among these applications, however, are guide catheters through which a physician must pass guidewires or probes to deliver stents or other medical devices to the proper destination in the body for treatment.

A lubricious ID is imperative for such medical tubes in order to facilitate device delivery, according to Don Centell, vice president of engineering, thermoplastics division, at medical extrusion specialist Vesta Inc. (Corona, CA). However, the tube may only require a thin-wall material with lubricious properties for contact purposes. Pairing that thin-wall, lubricious ID material with an implant-grade OD material that offers kink resistance to navigate the tortuous anatomy of the body can yield an ideal tube design for delivery devices, Centell notes.

Coextrusion is also the processing method of choice for various drug-delivery applications. The use of light-sensitive therapies, for example, may require multilayer tubing to prevent exposure of the drug to light, which can result in reduced efficacy. To meet this need, the extrusion branch of Raumedic Inc. (Leesburg, VA) offers the Rausorb line of tubing, designed to absorb light while retaining transparency for clinician reference. Rausorb tubes feature a drug-compatible ID material coupled with an OD material that has been mixed with absorbing substances that are individually adapted to the activation range of the therapy, according to the company. This outer jacket layer of the tube serves to filter wavelength ranges from 200 to 450 nm.

In a diabetes device, on the other hand, a polyethylene ID material may be selected because of its compatibility with the drug, while an implant-grade polyurethane may prove to be most suitable for the OD of the tube, according to Richard DiIorio, technical sales manager, northeast, for Raumedic. Material selection for an IV or drug-delivery device, he adds, is often limited by compatibility issues between the properties of the required therapy and those of certain materials. But a drug-friendly material may also present problems during assembly of the finished device.

"Essentially, you have a tube that is transmitting a drug; however, you often have to also connect that tube to various connectors, luers, and fittings," DiIorio explains. These types of applications, he notes, often require solvent bonding of the medical tubing to some sort of connector. But a material that can be solvent bonded is not necessarily compatible with the designated drug and vice versa. "In this case, you may want to perform a coextrusion of a material on the ID that works well with the drug and, on the OD where the parts of the tubing and the connector are going to mate and touch each other, you may want a different material that bonds well," DiIorio says.

In addition, coextrusion can offer the benefit of reducing the number of operations required to produce a particular medical tubing application. To create braided high-pressure tubing, for example, companies may typically employ a three-step process that entails extruding a tube, braiding over it, and then extruding over the braided structure, DiIorio explains. Because it requires three separate operations, this approach can be expensive and cumbersome. By coextruding two materials, however, companies can achieve strong, high-pressure tubing using only one process. Although the up-front tubing cost for coextruding high-pressure medical tubing would be more than with the multistep method, companies would likely see a dramatic reduction in overall tubing costs, DiIorio comments.

Also among the many benefits of coextrusion is that it enables the inclusion of colored or radiopaque stripes in a medical tube configuration. While colored stripes can help with catheter orientation, radiopaque stripes incorporated within the wall of the tube are often useful for viewing catheters under fluoroscopy. "The stripe itself is usually a compound--often the same as the tube's base material--but it might be loaded with 30% barium sulfate or 40% bismuth subcarbonate," Centell says. "It serves as an aid for physicians to understand where they're at in the human anatomy. A lot of times you'll see that in pain-management devices."

The Tie that Binds
Coextrusion of compatible materials offers a means of creating multilayer tubing that accommodates the different functional requirements of the ID and the OD for a particular application. But sometimes the two desired materials just aren't compatible with each other. As an example, Centell cites the case of a tubing application for which a customer selects high-density polyethylene (PE) for the inner layer of the tube and wishes to pair it with nylon or soft-durometer Pebax. "We can extrude [these incompatible materials] together, but it would be very easy to separate them back apart, which is not something you want to happen in a clinical setting," he says.

To overcome this barrier, companies may have to introduce a third, middle layer to the tube design, aptly named a tie layer. Compatible with both the ID and OD materials, the tie layer serves solely as a bonding mechanism for the incompatible materials.

"In the medical industry, [designers] want the characteristics of the nylon or Pebax for the OD and the high-density PE for its lubricity, but the tie layer becomes a necessary evil," Centell notes. "Unlike other industries that may use three-, four-, or five-layer products, those are serious considerations when it comes to medical applications." Because designers typically want to minimize the impact of the additional layer on the overall size of the tube, the tie layer is frequently applied as thinly as possible--measuring in many cases approximately 0.0004-in. thick, Centell adds. Alternatively, thinner ODs may have to compensate for the incorporation of a tie layer.

Increasing the complexity of a tube by including a tie layer also presents new considerations that must be taken into account for the final product, according to DiIorio of Raumedic. "Whenever you coextrude tubing, within those layers, you need to have concentricity," he states. "So, you need to have some sort of uniform shape between the various layers; the rings of the [different layers of the final tube] must be consistent, and that's a very difficult thing to master."

Miniaturization Meets Multilayer Tubing
Necessitating the use of a process dubbed trilayer extrusion, the incorporation of a tie layer in a medical tube design has become increasingly common in recent years, especially in conjunction with the rise of minimally invasive procedures, Centell notes. He adds that Vesta currently runs trilayer extrusions roughly 10 or 12 times per month compared with two or three times per month just a few years ago.

This rise in activity can be attributed to the fact that miniaturization has become paramount in the medical device industry as physicians attempt to access areas that were previously inaccessible or difficult to treat, including the brain and peripheral arteries. Facilitating such progress, coextrusion, and trilayer extrusion in particular, is enabling the development of these tight-tolerance, small-diameter delivery devices. "Not only does [coextrusion] provide the desired functional characteristics to the ID and the OD, but now that you've got these three layers--though they may be really thin--structurally the tubing is actually a bit stronger," Centell says. "It can handle greater burst strengths, yet it still has the ability to have a low profile and navigate these tortuous areas of the anatomy."

Coextrusion has also offered a solution to problems that have arisen as tubes have shrunk in size. Formerly, hydrophilic coatings were often applied to the ID of a tube to enhance lubricity, for example. But as tube diameters have diminished, this approach has become increasingly difficult, according to Centell. Coextrusion, he states, has provided a relatively simple technique for achieving a lubricious ID that also eliminates the secondary operation and cost associated with applying a hydrophilic coating.

But as tube size continues to shrink while complexity grows, new challenges continue to emerge. "We're seeing the limits being pushed," DiIorio of Raumedic comments. "Customers are demanding very tiny, precision tubing. But now they're demanding this in even smaller sizes in combination with multilumen or multimaterial tube configurations." Among the most significant barriers to achieving these tiny, complex tubes, Centell adds, are the limitations imposed by extrusion tooling. To resolve this issue, Vesta is working with crosshead manufacturers to improve their designs in order to meet customer demands.

"We see some very interesting concepts and questions arise from theoretical designs," DiIorio says. "They're not all possible within physical capability, but they're pushing limits, and it challenges us to be better and make better product."

Drug-Coated Balloons: A Swell Idea

In the great battle pitting bare-metal stents (BMS) against drug-eluting stents (DES), the latter seem to have emerged the victor--though by a smaller margin than originally expected. And yet, with the vulnerability of BMS to restenosis and the risk of thrombosis in DES, stents may not be the panacea the medical device industry was anticipating. In the quest to overcome these drawbacks, however, researchers have set their sights on the next frontier: the drug-coated balloon (DCB). But can DCBs live up to these mounting expectations, or are we inflating their potential?

"No one really thought that this would work in the 30-second span of a balloon angioplasty," Ron Sahatjian, president of Medi-Solve Coatings LLC, said in a presentation at MD&M West in February. "Researchers started to put Paclitaxel in human tissue on balloons and found some very interesting things. It had an antiproliferative effect that could last up to 14 days when put into animal tissue. They also found that a 60-second dilatation of the balloon released most of the drug; an hour later they could still find the drug in the tissue."

By supplanting a DES--thus removing the risk of thrombosis--a DCB can eliminate the need for the lengthy antiplatelet therapy required with a DES. "[Antiplatelet therapy] causes a problem because if you have an ulcer... in the body, they won't want to place a DES," Sahatjian said. "For many economic and patient-safety reasons, this is a reason to go after the DCB."

Drug-coated balloons also offer the ability to treat complex lesions and areas that aren't easily accessible using stents. Of particular interest is the potential use of DCBs to treat peripheral arterial disease. Stents placed in the superficial femoral artery in proximity to or below the knee, for instance, are prone to fracture and often require overlapping stents because of longer lesion lengths. DCBs could offer a safer, more-effective alternative. However, studies using DCBs for peripheral applications to date have produced mixed results, often requiring a bailout by a BMS, Sahatjian noted.

Because of these opportunities, DCBs have a market potential of close to $1 billion if proven successful, Sahatjian said. But there are still plenty of problems to resolve. The brevity of DCB function, for example, necessitates the use of extremely high doses of Paclitaxel. But Paclitaxel concentrations near 500 µg can induce aneurysms, Sahatijian said. Thus, the industry needs to strike a careful balance between safety and efficacy when determining DCB drug concentration. 

Additional barriers to commercialization include limited data for long-term clinical effects and for large sample sizes, as well as uncertainty about what will happen in the vessel without the support of a scaffold. Regulatory requirements, Sahatjian added, would also be challenging as they would be more in line with submissions for DES than standard balloons.

As these hurdles are cleared, DCBs could make an initial splash as part of a combination therapy with a BMS. This approach could dramatically reduce the required course of antiplatelet therapy while also lowering the risk of restenosis, thanks to the DCB's impact on antiproliferation and endothelialization. But over time, DCBs will hopefully also evolve into an effective standalone treatment, reaching their expanding potential.