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Articles from 2011 In June


Exit Strategies: Why Have So Many CEOs Retired or Resigned This Year?

J. Raymond Elliott made the surprise announcement in May that he will retire as CEO of Boston Scientific as soon as a replacement is found. Elliott was supposed to be the savior of the struggling company, so his departure is a blow to the firm, and Wall Street has not been kind to the company since the announcement. William Hawkins’s departure from Medtronic was also unexpected. Medtronic has broken its tradition of hiring from within to nab GE Healthcare’s Omar Ishrak to replace Hawkins.

David Schlotterbeck retired from CareFusion in February, after seeing the company through its transitional spin off from Cardinal Health. His departure is not as much of a surprise, given his long career.

Richard Meelia is one of a few not actually retiring. Meelia left Covidien this month to chair Haemonetics’s board of directors. Along the same vein, Christopher Begley is trading his role as CEO for executive chairman at Hospira.

Additional departing leaders include Immucor president and CEO Gioacchino De Chirico, David Floyd of DePuy Orthopaedics, and Orthofix’s Alan Milinazzo.

I asked MD+DI’s editorial advisory board to hypothesize about these egression patterns. Amid the envious comments from some of our members (“I wish I could retire, too,”) there were some interesting opinions.

Some pointed to the simple passage of time. The oldest members of the Baby Boom generation celebrated their 65th birthdays, and the medical device industry is celebrating its own milestones. Perhaps the age of industry (and its leaders) are just at the right time for transition. “The regulated medical device industry is 45 years old. I think a lot of us got in this industry somewhat by happenstance, but nonetheless, the first wave of professionals who got in would be of an age for retirement,” muses John DeLucia, vice president of regulatory affairs and quality assurance at ICAD. “I would say that many CEOs have been in the industry for 35-plus years. They’ve probably made enough money to retire, regardless of their age.”

Although the argument makes sense, it’s difficult to chalk these high-profile departures up to mere timing. Robert Reich, owner of LexaMed Ltd., says that CEOs are feeling the pressure to meet financial goals in a difficult economic and regulatory environment. Attorney Larry Pilot and Daniel McLain, cofounder and president of Walker Downey & Associates Inc., both pointed to the increased risks CEOs face for personal liability.  Shifts in regulatory processes, not to mention uncertainty about the overall healthcare policy, could be enough to help an industry veteran set his mind to golf or fishing. “Retirement appears to be a viable option under such conditions,” Reich says.

Whatever the reasons for the CEOs’ departures—and there are probably many more not explored here—their replacements will face significant challenges in the next few years. The industry is changing, and new blood will have to demonstrate global perspective and new energy. The latest crop of CEOs have their work cut out for them.
 

Heather Thompson
heather.thompson@ubm.com

First 3-D Breast Tomosynthesis System Combines Technology With Comfort

Designed to detect the presence of calcifications, masses, distortions, and asymmetries in breast tissue that could indicate breast cancer, mammograms can be both physically and mentally uncomfortable for many patients. While feeling stressed in such an environment is understandable, stress can affect results. And receiving clear, accurate results can make a difference in the treatment options and success rates for patients diagnosed with breast cancer. Aiming to optimize patient comfort to yield better results, Hologic (Bedford, MA) spent nine years developing the first commercially available breast cancer screening and diagnostic technology to deliver on the promise of breast tomosynthesis.

After the company's Selenia 2-D digital mammography system gained premarket approval in 2002, Hologic turned its attention to developing a 3-D version. "There's been a lot of work on 3-D breast tomosynthesis for years, but computers were too slow, and digital detectors were too slow," explains Georgia Hitzke, vice president, clinical services and product management for Hologic. "It was the right time because the detectors and computers were able to do this in a screening environment."

In a 2-D mammography image, objects of interest can be hidden in overlapping tissue, while normal breast structures that overlap may appear abnormal. Tomosynthesis is a 3-D imaging mode that reduces or eliminates this tissue superimposition effect, however. In Hologic's Selenia Dimensions tomosynthesis 3-D system, the breast is kept stationary between the detector housing and a compression paddle. The x-ray tube moves in an arc, taking a series of low-dose images from different angles. The slices are then reconstructed by a computer and transmitted to the diagnostic workstation for review by a radiologist. "We can take a 2-D and 3-D image under one compression," Hitzke says. "We can do both images at the same time."

To help incorporate the 3-D functionality with ergonomic components, Hologic sought a design partner and paired with Farm Design Inc. (Hollis, NH), a product development company that focuses on medical device design. Over the course of a year, Farm Design aided in the development of the Selenia Dimensions by creating an entirely new work station and full redesign of the digital detector system where the patient is postioned. Included in this work was human factors engineering, studying how patients interact with the device to maximize comfort and creating a unique graphical touch screen interface and proprietary x-ray exposure controls for operators to eliminate repetitive joint motion and user fatigue.

The design approach, according to Darrin Manke, director and program manager at Farm Design, was to make everything flush. This meant creating a constant level surface so that objects do not stick out when operators or patients interact with the device. On the workstation portion of the Selenia Dimensions 3-D system, improvements were made to the user interface. The x-ray image display, for example, can rotate out in the field so that operators can interact with the patient while they are also looking at the screen.

Farm Design also created a new control method to activate the x-ray system. "Typically, there are two switches on the top of a workstation, and you have to press them simultaneously to operate [the system]. They are tough to push, so they can't be triggered accidentally. Operators' fingers and thumbs were getting very sore," Manke says. "We developed recessed handle areas, with handles you reach in to pull levers, much like a bicycle break. Using all four fingers allows the operators to be relaxed."

To better understand the patient's perspective, on the other hand, Manke and another member of his design team experienced mammograms firsthand. "We wanted to understand the entire process, including the compression, and how the patient is positioned," Manke explains. "It is very uncomfortable. Your head is one way, [your] arm another, and you're hugging the device."

Such discomfort during the screening process can impact results, Manke adds. "You want the patient relaxed so that you can pull more breast tissue into the x-ray field," he says. "Trying to maximize the comfort reduced the stress to get better imagery."

One of the most challenging design aspects of the 3-D system, however, involved positioning the patient's head out of the x-ray field. Because it is performing 3-D imaging, the tube head rotates during the imaging process. Thus, the patient's head must be kept out of the rotational field using a face shield. The Farm team had to determine if patients were pressing against the shield for comfort and were able to reduce the size of the shield without decreasing functionality. "There's always a balance in addressing human factors and ergonomics and developing that around advanced technology," Manke comments. "There are certain things we could have done that could have made patients more comfortable, but it would have sacrificed imaging quality."

In addition to Farm Design's contributions, the Hologic team had to design the x-ray tubes from the ground up, maximizing what they could to get the exam done quickly. Hitzke of Hologic notes that short compression time was required to avoid patient motion, which results in blurry images. Hologic also had to design the electronics and software to reconstruct the 3-D images.

Because the 3-D system generates many more images for a radiologist to review than 2-D systems, a CAD system is currently being tested in international clinical trials to help improve the usefulness of the tomosynthesis technique. Once this software is approved in the United States, it will help radiologists with diagnosis, increasing their confidence to rule out breast cancer without having to recall the patient for further examination.

"The potential is really great," Hitzke says. "It's amazing, even better than we all thought. We tried to make the image quality the best that it could be. We continue to find new ways to find cancer."

July 2011 Contributors

John Bashkin is the principal at Bashkin Consulting (Fremont, CA), where he advises early-stage companies on corporate strategy and agreements, financing, intellectual property, SBIR grants, and business plans. He is listed as a coinventor on six issued U.S. patents and has coauthored more than 20 articles. Reach him at jbashkin@comcast.net.

Anna Berkovich is president of Russamer Lab (Pittsburgh). She specializes in finishing medical implants, instruments, and invasive devices. Berkovich has worked on cobalt-chrome knee implants, disposable invasive titanium devices, and nitinol wire and stents. She can be contacted at admin@russamer.com.

Harry F. Bushar is a statistical consultant for CDRH Office of Surveillance and Biometrics, Division of Biostatistics. At CDRH, he has provided critical evaluations of premarket submissions, collaborated on research projects and epidemiological studies, and done risk assessments to support compliance actions. E-mail him at harrybushar@verizon.net.

Debbie Donovan is a marketing and sales consultant at eGold Solutions (Mountain View, CA), where she focuses on developing digital marketing programs for medical technology companies. Donovan holds a bachelor’s degree in public relations journalism from the University of Southern California. Reach out to her at deb@egoldsolutions.com.

John B. Kowalski is a principal consultant with SteriPro Consulting (Corona, CA), a division of Sterigenics International Inc. (Oak Brook, IL). He has worked in absorbable medical devices, sterilization microbiology, and sterilization process development and validation with moist and dry heat. Kowalski can be contacted at jkowalski@sterigenics.com.

Gregg Mosley is president and founder of Biotest Laboratories Inc. (Minneapolis). He has 40 years of experience as a microbiologist, chemist, and biochemist in academic and industry positions and cochairs the AAMI Biological Indicators and Industrial Moist Heat Sterilization committees. Get in touch with him at gmosley@biotestlabs.com.

Kevin O’Keeffe is an associate principal in the life sciences practice at Charles River Associates (Boston). He advises medtech companies on new product development and licensing and manages due diligence engagements on behalf of medtech investors. Reach O’Keeffe at kokeeffe@crai.com.

Kent Royer is director of global medical business development at Milacron Inc. (Batavia, OH), where he has worked with the Roboshot product line for 26 years. His background is in development of electric machines, and he has done development work in LSR and other cleanroom applications. Royer can be e-mailed at kent_royer@milacron.com.

Suture Anchor System Flings Soft- Tissue Injuries Under the JuggerKnot

From the ligament-replacement procedure known as Tommy John surgery to reconstructive knee surgery, sports medicine is a way of life for many professional athletes. But it's not just athletes that suffer from sports-related injuries. As a result of such everyday forms of exercise as jogging and recreational activities ranging from snowboarding to basketball, growing numbers of people are turning up at hospitals with sports-related sprains, breaks, or torn tendons.

Addressing the escalating need to repair sports-induced soft-tissue injuries and reattach soft tissue to bone, Biomet Sports Medicine (Warsaw, IN) has introduced the JuggerKnot. This anchor technology, according to the company, may eliminate many soft-tissue repair concerns associated with bone loss and hardware issues. "It's an all-suture anchor," comments Kevin Stone, Biomet Sports Medicine's vice president of research and development. "It does not have the typical plastic or metal anchoring element seen in other anchors, and its small size allows for flexibility in the placement of the anchors to achieve the desired surgical repair." Additionally, the anchors' small size preserves more of the patient's bone.

Made of high-strength polyethylene MaxBraid suture material with a polyester-sleeve anchoring element, the 1.4-mm anchor is placed in a prepared hole. Then, when tension is applied to the sutures, the anchor sets by bunching up to a size larger than the prepared hole. "This anchor technology is the first of its kind made entirely of suture material," according to Stone. "And it has the added benefits of being very small while maintaining high fixation strength."

To introduce the JuggerKnot system, special insertion tools and guides are required so that the surgeon can properly locate the insertion point for the implant. Addressing the need to manufacture these components, Biomet turned to supplier PMC Smart Solutions (Cincinnati). PMC was well positioned to collaborate with Biomet because it had prior experience with a challenging application that relied on similar techniques and production methods as those used in the JuggerKnot project. "This earlier orthopedic application was also related to sports medicine, and it provided us with the knowledge, skill, and experience to contribute to the JuggerKnot," says Phil Cashen, PMC's director of new business development.

Providing injection- and insert-molded components made from biocompatible materials, PMC uses special manufacturing equipment to optimize the insert molding of complex parts, such as those used in the JuggerKnot. "We manufactured the insertion tools and the guides for the system using biocompatible ABS materials," Cashen remarks. "The insertion tools are insert molded using proprietary mold designs."

Insert molding flexible nitinol inserts into the insertion tools proved to be a technical challenge, according to Cashen. "To do this, the mold tooling was designed in such a way as to prevent the insert from moving during the molding process." Because the nitinol inserts are flexible, they tend to push to one side of the tool if they aren't secured properly in the mold, Cashen adds. "Thus, we developed a mold design that would allow us to achieve the specifications for the insert-molded flexible insert."

The scope of the project was developed with the understanding that PMC would have to transition through the prototyping phase quickly to get to the production tooling, Cashen states. "We were able to accomplish this because we designed our production tooling to be able to utilize it in the development phase of the project. Our designs used tooling configurations that allowed us to bypass the prototype tooling phase and go directly into production tooling." And with an eye toward the future expansion of the product line, PMC also developed tooling configurations that will allow Biomet to add new sizes of the product at minimal cost.

Noting that there are a lot of molders out there, Stone states that one of the things that attracted Biomet to PMC was the supplier's process control systems and its experience with a range of materials. "Although PMC was historically heavily involved in the automotive space, it had excellent systems in place that are absolutely necessary in the medical device arena, and it invested heavily in its medical business unit." Those qualities, combined with Biomet's design and development efforts, resulted in a compact, high-strength orthopedic device that represents a giant step forward in suture anchor technology, Stone concludes.

Active Chest Tube Drainage System Clears the Way for Better Patient Care

Cardiothoracic surgeon Edward Boyle was a man on a mission when he partnered with Cleveland Clinic heart surgeon Marc Gillinov to establish Clear Catheter Systems Inc. (Bend, OR). After years of observing clogs and blood clots form in chest tubes and their resulting adverse effects on patients, Boyle was determined to develop a solution that overcame this dangerous design flaw. Responding to this unmet clinical need, Clear Catheter has introduced the PleuraFlow Active Tube Clearance system to prevent chest tube occlusion and improve patient safety.

Following heart, lung, or trauma surgery, chest tubes are inserted into patients and coupled to a drainage system in order to remove excess fluid or air from the body. "A lot of what is drained is blood," Boyle, CEO of Clear Catheter, explains. "If blood clots or coagulates in those tubes, which it tends to do, then they don't drain very well. If that happens, it can contribute to complications and impair outcomes." Complications resulting from clogged chest tubes can include a pneumothorax, pericardial tamponade, and excessive blood loss--the latter of which can occur if blood pools unnoticed in the chest cavity as a result of a clot formation in the portion of the tube positioned inside the body. Difficulty even arises when a clot is quickly identified in the chest tube, Boyle adds, because current methods of removal are undesirable for clinicians and may cause additional discomfort or risk for patients.  

In an effort to avoid these unnecessary complications, Clear Catheter developed the PleuraFlow system. The product consists of a standard chest tube that is inserted into the patient and then connected to a guide tube, over which is a shuttle guide set. The guide tube is then connected to a standard chest drainage system. Located within the guide tube, a guidewire featuring a distal loop moves backward and forward in the chest tube via a proprietary drive system to prevent clot formation. "We call this active tube clearance," Boyle comments. "No other products have anything on the inside; they're just a tube. With the PleuraFlow system, we're moving from passive drainage to active drainage."

To develop the PleuraFlow system, Clear Catheter Systems, armed with the initial concept for the clog-preventing device, sought the expertise of product development consultancy firm Carbon Design Group (Seattle) to help take the idea to the next level. Together, engineers and designers from both companies participated in brainstorm sessions to determine the optimal design of the system. "One of the most important design elements was that we had to figure out how to move the guidewire inside the tube from outside the tube," Boyle recalls. "You can't have an opening or a hole in the tube because that breaks the sterile barrier on the inside."

A design epiphany came in the form of magnets, notes Robert Hubler, an industrial designer at Carbon. "There's a magnet on the inside of the plastic tube that's attached to the guidewire; on the outside, you have another magnet," he explains. "The magnets will attract each other through the tube because the tube is naturally very slick on the inside and the magnet is a polished metal piece. So, it's easy for the magnet to move on the inside of the tube with that attraction to the other magnet that's moving back and forth without breaking the sterile barrier." This back-and-forth movement of the guidewire in the tube serves to break up blockages, thus encouraging fluid flow and preventing coagulation.

Once the use of magnets was agreed upon, Carbon launched into the industrial design, mechanical engineering, and testing of the PleuraFlow system based on feedback from Boyle and his surgeon colleagues. "Once Clear Catheter decided it wanted to go with the magnetic solution, we figured out a scheme for the use of the device pretty quickly," Hubler says. "The basic architecture is that the shuttle gets released, moves back and forth, and then docks back in the home position."

As part of the design and development process, Carbon took a close look at the forces required for the system. One challenge it faced was striking a balance so that the magnets provided enough force to drive the guidewire without interfering with nearby telemetry and other electronic systems. Achieving a balance in decoupling force also proved to be challenging. It needed to be strong enough to withstand the force of clot removal but forgiving enough to allow for separation of the wire in the shaft, if necessary, for safety reasons.

Upon finalizing the design and engineering with Carbon, Clear Catheter approached Xeridiem Medical Devices (Tucson, AZ), a company specializing in the design, development, and manufacture of complex, single-use medical devices. "We optimized the design for manufacturability," says Mike Cusack, director of business development at Xeridiem. "We developed a manufacturing process and ensured that the device would work within the requirements of the ICU."

Xeridiem also molded the silicone housings, and assembled, tested, packaged, and sterilized the device. The company helped with regulatory filings for the PleuraFlow system as well. In essence, Cusack remarks, Xeridiem has served as the bricks and mortar of Clear Catheter Systems in that it manufactures the PleuraFlow in addition to taking orders, providing technical support, answering phones, maintaining inventory, shipping for distribution, and invoicing.

Obtaining FDA approval in December, the PleuraFlow system offers a simple solution to the common--and life-threatening--problem of chest tube clogging. And if that weren't enough, it offers the additional benefit of enabling the use of smaller chest tubes. "Rather than using large chest tubes that look like a garden hose, our goal is to eventually be able to use a tube that is smaller and maybe only the size of a drinking straw," Boyle says. "We think that it will not only help reduce complications, but it will also improve patient comfort."

Milk From ‘Spider Goats' Could Produce Tendon Replacement Material

What's stronger than Kevlar, stretchier than nylon, and a natural material that has long intrigued scientists and engineers because of its potential medical applications? The strongest of the six types of spider silk, referred to as "dragline" silk, is used for outer circles of a web, or for repelling from ceiling to floor.

In the early '90s molecular biologist Randolph Lewis and his colleagues at University of Wyoming in Laramie identified the two proteins that make up the strong silk, but the large size of the proteins made the attempts to mass-produce the silk from spiders unsuccessful. Cannibalistic spiders also aren't the ideal animal to farm commercially for the quantities needed, so the researchers have experimented with inserting the silk-producing genes into the genome of animals including cows, hamsters, and most recently, goats.

Lewis recently left Wyoming for an endowed position at Utah State University (Logan, UT) where he continued his research using goats, because of their manageable size, friendliness, and faster speed from birth to lactating age. The silk gene is implanted into a goat embryo, and the goats' milk is the source of the spider silk protein. The proteins are purified from the milk, which is dried down and redissolved to get material that can be spun into fibers.

The elasticity and strength of spider silk make it a material that could be used for artificial ligaments and tendons, or for sutures in ophthalmic and micro surgery. Lewis estimates that a week's worth of milk from one goat would provide enough silk protein for one single tendon or ligament replacement surgery. Extensive animal testing would come before any surgery on a human subject, which is years away from reality.

Lewis currently has 34 goats altered with the spider silk gene, including 20 milking females, two of which are currently lactating. The hope is that the spider silk research will lead to commercial products in the future, which will benefit Utah's economy and potentially create jobs.

This Week in Devices: Implantable Market to Exceed $50 Bil; Lawmakers Critique IDEs

This week in medical device news, Minnesota’s congressional delegation sent a letter on June 30 to FDA commissioner Margaret Hamburg expressing their concern about the Investigational Device Exemption (IDE) review process. Also, new devices being developed to treat and manage cardiovascular problems and other disorders will lead the U.S. implantable device market to an 8% annual growth rate through 2015, according to a new report.

510(k) Process is Harder on Small Companies

510(k) Process is Harder on Small Companies

Two-thirds of small medical device companies obtain initial clearance for new devices in Europe. That was the finding of an industry-wide survey on FDA’s 510(k)  approval process conducted by a research team at Northwestern University.

It’s also a problem, says a spokesman for the Medical Device Manufacturers Association (MDMA).

“Tomorrow’s innovations are being developed today overwhelmingly by small and mid-sized medical technology companies,” says Brendan Benner, MDMA vice president of public affairs. Companies, he says, are turning to overseas markets for launch because FDA’s review process is too unpredictable. “This means that patient care and job creation are also moving in that direction,” Benner adds. “The fear is that if this continues, many of these jobs will never return, and patients are waiting months if not years longer until they have access to these innovations.”

The survey, funded by the nonprofit Institute for Health Technology Studies—whose board includes device company executives—also showed that the road to device approval is longer for small companies than for bigger players. Companies with fewer than 100 employees are more likely to seek presubmission meetings and spend more time in the pre-IDE process than their larger counterparts. Overall, small companies wait nearly twice as much time for 510(k) reviews to be completed.

It’s no surprise, then, that more small firms, which are more than twice as likely as large firms to seek approval for new products rather than existing line extentions, feel FDA requests affect time and financial resources.

“In speaking with companies of all sizes, they all face similar challenges attempting to navigate the moving goal posts at FDA,” Benner says. “However, given that larger companies already have products on the market generating revenues, they have a better ability to subsidize delays than a start-up who is working on the initial product.”

—Jamie Hartford

Linear Stepper Motors Can Provide Constant Positioning Force

A series of linear stepper motors can provide constant positioning force to 400 N over full travel lengths of 300 mm. The Saia ULE Series is available in unipolar or bipolar configurations and can operate in ambient temperatures of –15°–60°C. The 55 × 55-mm design envelope and NEMA 23 mounting flange enable the motors to be mounted in space-restricted applications, including valve control, positioning and adjustment systems, and control systems.

Johnson Electric

Vandalia, OH, 937/454-2345

Frameless, Brushless Motors Available for Low- or High-Voltage Operation

A series of frameless, brushless motors is available in 14 different sizes for low- or high-voltage operation. KBM Series motors come in standard frame sizes ranging from 60 to 825 mm in diameter, for 240 or 480 V ac operation. Additional motor windings are offered that can optimize performance at voltages as low as 12 or 24 V dc. Each frame size is available with up to three or four stack lengths. The motors feature encapsulated stator windings. Internal windings are rated for continuous-duty operation at temperatures as high as 311°F.

Kollmorgen
Radford, VA, 540/633-3545