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Articles from 2011 In August


Inside Look: AngioDynamics

AngioDynamics (Latham, NY) is hoping Smith & Nephew’s loss will be its gain. In mid-August, the maker of minimally invasive medical devices for vascular access, surgery, peripheral vascular disease, and oncology, tapped Joe DeVivo, former global president of Smith & Nephew Orthopedics, as its new CEO. DeVivo left Smith & Nephew after the company announced in July that it would combine its orthopedic and endoscopy divisions. He is also the former president and CEO of RITA Medical Systems, which AngioDynamics acquired in 2006. 


“Joe has been our top choice since we began our search,” Vincent Bucci, AngioDynamics chairman, said in a statement. “Smith & Nephew recently reported that its [o]rthopedic business had the fastest growing rate of all its business segments again during its most recent quarter while continuing to drive share. We are thrilled to have recruited the architect of this growth.”


DeVivo takes the reins this month and  inherits a company that faces challenges and shows promise. For the fiscal year 2011, which ended May 31 for the company, sales were flat and profits were down a third. Starting January 1, AngioDynamics will no longer distribute in the United States its LC Beads embolization product, which accounted for about 13% of net sales through the first three quarters of fiscal year 2011.


But when one door closes, another opens. For AngioDynamics, that door is the NanoKnife System, which interim CEO Scott Solano called the company’s “fastest-growing product line and single largest growth opportunity” during a July conference call. FDA has approved NanoKnife for surgical ablation of soft tissue, though not for treating a specific disease or condition. However, in May AngioDynamics received IDE approval to conduct clinical trials of the NanoKnife’s ability to treat prostate cancer. It has also applied for IDE approval to conduct clinical trials for using the device to treat pancreatic cancer. By mid-July, close to 700 patients had been treated with the system, and seven new commercial sales accounts were added in the fourth quarter of fiscal year 2011. Sales of the NanoKnife were up 170% over the same period in 2010.  

The company’s own predictions of 0–4% sales growth for 2012 are modest, but Wall Street seems optimistic about its future. Analysts responded favorably to both AngioDynamics’ 2011 earnings report (after which investment research firm Canaccord Genuity upgraded its stock to “buy”) and its CEO choice. Investing information site The Motley Fool reported that last year brought rumors of a Johnson & Johnson or Covidien takeover of AngioDynamics. This year, AngioDynamics could be gobbling up companies. In an interview with The Business Review after his hiring, DeVivo said he looks forward to growing the company through “smart acquisitions.”

—Jamie Hartford
 

RoHS Recast Implications to EU Med and IVD Devices

The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. With the exception of the items listed in Article 2.4, the RoHS Directive applies to all electrical and electronic equipment.

Scope:

  • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included. They are both part of the general group called “medical devices” in the directive.
  • Active implantable medical devices remain excluded from the requirements of the directive.

Limits: The maximum concentrations in homogenous materials are limited, by weight:

  • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

  • 22 July 2014 for Medical Devices.
  • 22 July 2016 for In-Vitro Diagnostic Medical Devices

NOTE: A single CE mark and declaration are acceptable. (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

Exemptions:

o Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
o Exemptions available to all devices are listed in Annex III. Specific exemptions for medical devices are listed in Annex IV.
o Exemptions for medical devices will be valid for up to 7 years.
o Requests for exemptions:

  • Will be filed with the Commission and include all information listed in Annex V. Most notably, the request must include an analysis of possible alternative substances, materials or designs.
  • Renewals must be requested at least 18 months before the existing exemption expires.
  • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements. However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

Record Retention:

  • Records must be retained for 10 years after a device is placed on the market. Note that this may be longer than required by the MDD or IVDD.
  • Records to retain include technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
  • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
  • § List of any economic operator to whom you have supplied any electrical or electronic equipment.

—Christine Ruther, Eisner Safety Consultants Associates

Further Reading

RoHS Directive and the Future of Medical Devices

Recasted RoHS Directive will apply to Med Dvcs & IVDs


Critics Call for a Tighter Medtech Approval Process in Europe

Critics Call for a Tighter Medtech Approval Process in Europe

In a telling headline, Ben Hirschler (Reuters) illustrates the ongoing regulatory disintegration that is happening in Europe. The article "Heart Valves and Toasters: Call for New EU Rules," examines the CE mark process and questions whether the system is adequate.

It's a tension that all regulatory systems face. Europe enjoys earlier access to medical technology than many other countries.

In the United States, disgruntled medical technology firms look enviously at the relaxed regulatory regime in Europe and some Republicans have used the European example to scold the Food and Drug Administration over its slower approval process."

medical device clinical trialsIncreasingly, however, critics are asking the real price of such accessibility. Alan Fraser, a cardiologist at Cardiff University, led a review of the European Union regulations and presented his findings to the European Society of Cardiology (ESC).

"It tends to be that clinical trials are done after approval in Europe but before approval in the United States," Fraser told Hirschler. "Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval—and that tends to be Europe."

I have a feeling we will see Fraser's point of view gain traction, which will mean a change in how medical device manufacturers in the U.S. operate. If Europe adopts stricter regulatory processes (which is far more likely than the U.S. softening its process) clinical trials will have to change. It may be that Europe adopting stricter regulations will drive OEMs to go to Asia, the Middle East, and South America.

How would going first to these regions change the design of devices? Would there be more emphasis on portability, battery life, global use?

—Heather Thompson

Out with Traditional Blood Sampling, In with Digital Microfluidics

A new analysis method based on digital microfluidics developed by researchers at the University of Toronto (U of T) Institute of Biomaterials and Biomedical Engineering could eventually eliminate the age-old practice of drawing blood to collect a blood sample. The old method involves drawing several milliliters of blood, separating serum, freezing the serum in preparation for transport or storage, and later thawing and analyzing it. In contrast, the new method relies on dried blood spots (DBSs). After a few microliters of blood are extracted, it is blotted onto filter paper, where it remains stable. While DBSs are currently in use, processing them has remained laborious until now.

Developed by Aaron Wheeler, a professor at the U of T Institute of Biomaterials and Biomedical Engineering, digital microfluidics automates the process of analyzing DBSs using lab-on-a-chip microfluidic devices. Droplets are manipulated onto the sample using electrical signals, and the material needed for analysis is extracted. Thus far, the scientists have quantified amino acids that are markers of three metabolic disorders: phenylketonuria, homocystinuria, and tyrosinemia. Their next step will be to evaluate a range of other diseases.

While conventional blood sampling may be around for a while, Wheeler's digital microfluidics method is the next step in moving to a DBS-based sampling system, says Pranesh Chakraborty, director of Newborn Screening Ontario, which provided the screening and medical perspectives in this research. "This approach could save considerable costs as a result of the lower volumes of reagent required. An automated system based on this approach would also process samples faster, with higher accuracy, less risk of errors, all while freeing up time for technologists to perform other work."

Perspective on Drug-Delivery Coating Companies

Medical device coatings company SurModics recently announced that it would undergo a strategic realignment that unfortunately necessitates the reduction of 9% of its workforce and the exit of its CFO. In response to this news, competitor Biocoat featured an interesting post on its blog in which Josh Simon speculates as to what may have gone wrong.

In essence, he questions the company's focus on drug-delivery technologies. "I think that the idea of creating a business out of making various drug-delivery coatings for medical devices is not sustainable, on a contract basis, licensing basis, or otherwise. Here's why: In order to get ONE good drug releasing coating verified and onto the market on a product, you need a whole company.  Even then, your chances of failing are huge," he writes.

Although Biocoat is a direct competitor of SurModics and thus, its opinions on the struggles of its competitor should be taken with a grain of salt, Simon makes an intriguing argument. And while the issues of supplier companies may not be of major concern to OEMs, SImon's post is nonetheless worth checking out. Click over to Biocoat's blog to give it a read. --Shana Leonard

Shape-Memory Alloy Responds to Magnetic Fields

The unique properties of shape-memory alloys such as nitinol have lent themselves to a variety of applications across numerous industries, including medical devices. These common shape-memory alloys, however, typically require a thermal influence to induce shape change. Straying from the norm, materials supplier Goodfellow Corp. has unveiled a shape-memory alloy that responds to magnetic fields as well as to temperature, which could pave the way for novel medical applications.

Goodfellow Magnetic Shape-Memory Alloy
A shape-memory alloy from Goodfellow changes shape in response to magnetic fields.

Engineered from 50% nickel, 28% manganese, and 22% gallium, the magnetic shape-memory alloy is grown as a single crystal and then cut to shape, according to Martyn Lewis, group business development manager for Goodfellow. Capable of converting magnetic field energy into kinetic energy, the alloy can grow up to 6% in one direction when exposed to a magnetic field. It can then return to its original shape when the magnetic field is rotated by 90º.

Although Goodfellow's magnetic shape-memory alloy is comparable to piezo-based and magnetostrictive materials in terms of functionality, it yields significantly higher strain outputs and energy densities, according to the company. "Piezo-based materials work by applying an electric current, so they won't be generating a great deal of heat," Lewis explains. "They do react more quickly, but the amount of movement you can get from a piezo is between 10 and 100 times smaller than the magnetic shape-memory alloy. You can get far more movement from an equivalent-sized magnetic shape-memory alloy than you could from a piezo-based material." The magnetic shape-memory alloy, Lewis adds, has also demonstrated a faster and more efficient response rate than shape-memory alloys requiring a thermal mechanism to induce shape change.

While the material is not biocompatible, it does show promise for nonimplantable medical applications. Goodfellow has been approached by a company exploring the use of the alloy in bone stretching procedures, for instance. "If someone has a deformed jaw, you can somehow attach the material," Lewis explains. "By applying a magnetic current, you can then slowly, and in a controlled manner, extend the bones. That's where a thermal alloy wouldn't work; the human body is at a constant temperature, so you wouldn't be able to heat it up and cool it down in that application."

Lewis proposes that the magnetic shape-memory alloy could also someday provide sensing capabilities in prosthetics. "We're open to companies coming up with ideas, and we'll see if [the alloy] can fit the application," Lewis says. "The [engineers] are the ones with the ideas; we're the guys that do the materials. Put the two of us together and we can go places."

Goodfellow Corp.
OAKDALE, PA
www.goodfellowusa.com

Wireless Technology Could Help Unplug Heart Pump Patients

Dealing with heart disease and the possible need for a heart transplant are extremely stressful ordeals for patients. While ventricular assist devices (VADs) are certainly less traumatic, they nevertheless encumber the heart patient with the discomfort and inconvenience of having a cable protrude from the body. That's where researchers from the University of Washington (UW; Seattle) come in. Determined to free heart disease sufferers from the nearest electrical outlet, they have developed a technology that could eventually enable heart pumps to power and recharge wirelessly.

A benchtop prototype of a wireless transmitter-receiver system has the capacity to power and recharge centrifugal pump VADs.

"The problem we're trying to solve is that VADs consume quite a bit of power--between 5 and 15 W," comments Joshua Smith, UW associate professor of computer science and electrical engineering. "This means that a transcutaneous cable actually comes out the patient's side to bring power and control signals from outside of the body to the inside of the body." As a result, the patient can't bathe, and the protruding cable also poses a substantial risk of infection.

Designed to solve these issues, the UW wireless technology is based on inductive power. It involves a transmitting coil that emits electromagnetic waves at a certain frequency and a receiving coil that absorbs the energy and uses it to charge a battery. "The transmit side is a tuned circuit that has a certain natural frequency," Smith explains. "And the receive side is another tuned circuit with its own natural frequency. When you put them near each other, they interact, and what you end up with is a new kind of combined circuit that actually has two different resonant frequencies."

The transmitter and receiver each have a natural frequency--13 MHz, for example. When they are put together, however, a phenomenon called 'splitting' occurs. The resonant frequency splits, and the combined system has two new resonant frequencies, both of which differ from the original: One is higher than 13 MHz while the other is lower. "The key thing is that as the transmit-to-receive distance changes, the tension resulting from coupling the two sides changes," Smith adds. "This means that the amount of splitting--the difference between the low frequency and the high frequency--increases the more tightly coupled the transmitter and receiver are."

Thus, for every given distance, there is a certain parafrequency at which the system works efficiently, Smith notes. Consequently, if the transmitter can be set to one of the two special frequencies, very high efficiency can be achieved as the transmit-receive distance changes. "That's different from most people's intuition about how wireless power works," Smith says. "Typically your intuition is that the farther away the receiver is from the transmitter, the less power there is. With this technique, if the control system is working correctly to keep the system tuned, the efficiency actually stays constant as the transmit-receive distance changes."

The scientists envision that their power source will contain a small battery that will fill in the gaps between wireless-power areas. For example, if patients want to roam away from the power source, they will be able to wear a vest incorporating a transmitting coil and a battery, Smith says. Instead of power entering the body through a cable, it will be carried via a magnetic field. The transmitting coil, he adds, could conceivably be placed under a bed, a chair, or other common household item.

Using a benchtop prototype of the power source, the researchers have demonstrated proof of concept by successfully powering an LVAD. Their next goal is to conduct animal tests and eventually progress to human trials--a process that can take several years. LVADs are possibly the hardest medical devices to power wirelessly because they consume a great deal of power, Smith comments. "Therefore, if you can power VADs using this technology, it should also be possible to power or recharge pacemaker batteries or any other sort of implantable electronic device."

Hemocompatibility Testing: The Standard FDA Doesn't Want to Endorse

FDA Won’t Endorse AAMI ISO 10993 Standard; Committee and Agency Meet to Rewrite Guidance

Over the years it has been difficult for medical device manufacturers who make devices coming in contact with the human body’s circulatory system to test for safety due to the FDA's nonendorsement of AAMI ISO 10993-4, the standard for hemocompatibility testing.

As it currently stands, 10993-4 provides a chart—Table 1—of medical device examples. Manufacturers compare their device to one on the chart and then conduct the appropriate hemocompatibility test. FDA doesn’t agree with the chart, but provides no guidance for testing.

The rest of the world widely accepts the standard, but FDA has never endorsedit, instead requesting manufacturers use various tests or trends to show hemocompatibility safety of their devices.

One trend is Hemolysis testing—a test that must be performed on any device coming in contact with blood. The test looks for bursting red blood cells. The test is conducted by placing a device sample in blood to see if there are toxic reactions that impact the red blood cell. If there are none then the sample is perceived to be safe.

A second test—Complement Activation—is part of ISO 10993-4, but in the standard the test only applies to devices with large surface areas that come in contact with blood. FDA is now requiring this for all devices that contact the circulatory system.

The test looks at two pathways to an immune system reaction called classical and alternative represented by two proteins—C3A and SC5b-9. The test looks to see if the medical device activates the two pathways, which is what you don’t want.

The most controversial test, and the only animal test of the three, is In Vivo Thrombosis. It is an expensive test and is not always reproducible. The test requires a sample medical device, along with another similar device known to be safe (predicate device), to be placed in animals to test its reaction.

The in vivo thrombosis test is especially controversial since the results are not always accurate and there is a major push and trend in Europe to discontinue all animal testing.

Realizing the complexities and difficulties coming from a lack of guidance, the AAMI ISO Standard Committee met in Milan, Italy to discuss ways to create new guidance for hemocompatibility testing that would basically work for everyone, including guidance the FDA could readily endorse. The FDA itself participated in the committee meeting indicating a strong desire of the agency to develop acceptable guidance. They will also help in the rewrite of the standard.

The hope is to make the standard more effective in result predictions instead of just for safety purposes. The goal is to get it to the point where tests are not used unnecessarily, but rather use acceptable protocols written directly into the standard. The rewrite will define exactly when to use the protocols.
 

Thor Rollins is a biocompatibility specialist, RM(NRCM) for Nelson Laboratories (Salt Lake City, UT)

More on this Topic

Nelson Labs to Participate on Rewrite of AAMI ISO 10993: New Guidance for Hemocompatibility Testing

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Features:

Where in the United States is the Next Medical Device Hub?

Titled "From FAA to FDA," a recent workshop held in Wichita, Kansas--or as it's affectionately known, the "Air Capital of the World"--served to encourage local aircraft subcontractors to diversify into the medical device industry. Through such outreach campaigns and education, the city hopes to cultivate a medical device cluster as part of its long-term economic goals. And it's not the only one. Cities, counties, and states around the country are launching initiatives, investing funds, and running workshops or seminars such as this one to lay the foundation for a potentially lucrative biomedical device cluster. But with all of these economic development groups focusing on the medical device industry, one has to wonder: Which U.S. region could emerge as the next big medical device hub?

Southern California, Massachusetts, and the Twin Cities area of Minnesota have long ruled the medical device roost. In addition, New Jersey, Florida, and Pennsylvania have nurtured thriving medical device clusters, while areas such as Warsaw, Indiana, and Research Triangle, North Carolina, have made a splash in specialized areas such as orthopedics and medical device R&D, respectively. But despite having an established medical device industry, these regional hubs could soon face serious competition. Some up-and-coming regions are trying their best to set up attractive business environments and incentives to lure medical device business into these fledgling industry clusters. We've highlighted a few contenders below.

Kansas. As noted, Wichita, in particular, sounds like it's legitimately trying to get a medical device cluster off the ground. Although it still seems to be in the early stages of building the cluster, the area has a lot going for it, notably its vast experience in the aircraft industry. Luckily, it could be a relatively smooth transition for local contract manufacturers that decide to the take the plunge and serve the medical device industry. "The buzzwords in medical devices are product safety, sterility in manufacturing and engineering, technological advancement, and alternative materials and coatings," Harvey Sorensen, a local attorney, said at the Witchita conference. "If those words sound familiar to you, they ought to, because you already do those things." This skilled workforce with a transferrable skill set could be the key to a strong base with which the city can attract medical device clients and help the cluster to flourish. Furthermore, the area boasts proximity to the Center of Innovation for Biomaterials in Orthopaedic Research (CIBOR), part of Wichita State University, which certainly couldn't hurt.

Michigan. In response to the crash of the domestic automotive industry a few years ago, Michigan decided to go full throttle and commit itself to building up a medical device cluster. As a result, Michigan is among the fastest-growing life sciences states in the country and employs more than 30,000 people in the life sciences field, according to the Michigan Economic Development Corp. And it also doesn't hurt that medtech giant Stryker calls Kalamazoo, Michigan, home for its global headquarters. In addition, the state also benefits from having a range of established suppliers and service providers that have been serving the medical device industry for years. But don't forget those automotive suppliers looking for opportunities. Their manufacturing expertise and likely competitive prices, if they invest the time and money in quality systems for the medical market, could potentially be a boon for the industry. "The automotive industry is so strong and the manufacturing know-how is so advanced that the medical device industry is a really good place for it to emerge from that basic knowledge of innovation and manufacturing," Christophe Sevrain, CEO of the consulting firm CJPS Enterprises LLC told MPMN in a regional focus on Michigan last year. "Like they say here, if you can make it in the automotive industry, you can make it anywhere. The margins are so tight, the quality systems so stringent, and the cost structure is so strict that the industry has had to be very good at manufacturing."

Ohio. Although it boasts a rich manufacturing history that was perhaps at its apex in the mid-20th Century, Ohio has fallen on hard times as industry has moved elsewhere. Building on this solid manufacturing base, however, Ohio, and the Cleveland area, in particular, has made a concerted effort to rebuild the region's economy and industry, with an eye on the medical device industry. And it seems to be working. At present, roughly 10 of the country's top 20 medical device manufacturers have facilities in the region, including J&J and GE Healthcare, among others. Of course, there is an ample number of suppliers that are more than happy to cater to these powerful companies. But perhaps Ohio's greatest asset is its concentration of research hospitals and academic institutions. Chief among them, of course, is the renowned Cleveland Clinic, as well as Cleveland Clinic Innovations (CCF). "CCF has been a leader spurring medical device design and development in the Cleveland area," Brian Hrouda, director of sales and marketing at medical device supplier Norman Noble Inc. told MPMN earlier this year for a regional focus on Ohio. "The CCF Innovations and Medical Device Solutions teams have been very successful at implementing the steps required to commercialize new medical device technologies."

Texas. A high-tech hub, Texas has enjoyed playing a leading role in the semiconductor industry. But as the semiconductor industry began to lose some steam several years ago, the state and its semiconductor companies started looking for other revenue opportunities and set their sights on the medical device industry. Backed by generous state support and incentives, the medical device industry has begun to take off in the Lone Star State. These state initiatives and incentives, coupled with the growing number of high-tech local semiconductor companies lending their expertise to medical applications, has established Texas as fertile ground for medical device manufacturing. In fact, medical product manufacturing contributed roughly $3.97 billion to the state's economy and currently employs more than 11,800 people. Efforts have also paid off in terms of attracting some of the big guns in the business: Medtronic Inc. announced that San Antonio would be home to its Diabetes Therapy Management and Education Center while Becton, Dickinson and Co. also disclosed that it would be bringing its North American professional services headquarters to the state. Maryland-based Hanger Orthopedic Group relocated its headquarters in September to Austin as well. Also benefiting the local medical device industry has been a large investment and effort to commercialize innovative technologies. "What Boston and California had that Texas didn't early on was a foundation of entrepreneurs and startup companies that could make it to that next level," Greg Crouch, life sciences business director at National Instruments told MPMN last year in a regional focus on Texas. "Where Boston and California were very efficient was bringing technology out of the university and through commercialization groups,the state of Texas is just now lowering the barriers of moving technology intellectual property through the commercialization group out into the industry."

All of these states are really putting the time and money into developing these medical device clusters. And, as a result, I think they'll probably all be successful to varying degrees. But as for which region will be the next big contender, I think it comes down to, as they say in reality competitions, which one wants it the most. To me, that region is Ohio. The state has really committed to developing the cluster and put its money where its mouth is. With the opening of the Cleveland Medical Mart, assistance and encouragement to medtech startups, the presence of the Cleveland Clinic, and pioneering research being conducted at Case Western and other local universities, the state has laid sturdy groundwork for a substantial medical device cluster. Of course, it's a bit soon to tell. Which state do you think will be the next big contender? And did we omit anyone? Let us know in the comments section below or feel free to email. -- Shana Leonard