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Manufacturer Commits to FDA's Home Use Initiative

In April 2010, FDA announced its "Medical Device Home Use Initiative." The aim of the plan is to provide greater protection for patients who receive home healthcare. According to FDA, many home use devices provide no instructions or instructions that are not suitable for lay caregivers to follow. With the hopes of improving the instructions, FDA has created a pilot program that enables manufacturers of home devices to submit their labeling electronically to the agency. The instructions will be posted in a central location on FDA's Web site, which makes it easier for caregivers to find what they need.

KCI's president and CEO says about the initiative, "We not only commit to take this important and needed step, but believe in the FDA's broad goal of putting patients and safety first."

Spartanics Opens Die-Cutting Applications Lab

Spartanics's new materials research lab determines the suitability of different materials for laser die cutting operations.

Spartanics (Rolling Meadows, IL) has opened a materials research laboratory that will help medical device designers and manufacturers to determine whether the materials they use can be processed using modern laser die-cutting technology. By sending samples for engineering studies and analyses to the Laser Cutting Applications Laboratory for Materials Research, customers can learn whether the materials are suitable for a range of laser die-cutting applications, including faceplates, membrane switches, RFID tags, flexible circuits, panels, and other medical device components.
 
Spartanics's engineers have tested laser die cutters on a variety of materials, including plastic films, polyesters, polycarbonates, foams, textiles, paper, adhesive tapes, nonwovens, wood, laminates, pressure-sensitive substrates, magnetic materials, polypropylene, polymides, abrasives, and rubber. The establishment of the laboratory signals the company's intent to make this growing knowledge base accessible to the industry.

Based on different laser power levels and other variables, the laboratory provides free detailed engineering analyses of how thick differet materials can be to undergo laser die cutting. Paul Dirienzo, Spartanics's director of engineering, comments, "The explosion in new materials with different properties--tensile strengths, toughness, resilience, etc.--has been especially pronounced in the last decade. During this same time period, laser die-cutting technology, largely due to more-sophisticated software engineering, continues to evolve at such a rapid pace that the conclusions one might make today about whether a certain plastic, nonwoven, or even nanomaterial can be adequately handled by digital die cutting is likely not going to be the same in just a few years."

The company has opened the laboratory to facilitate the systematic match-up between laser die cutting and materials, including brand names and new material innovations, Dirienzo adds. "We will also be publishing these studies in the future in some manner, to be announced, and partnering with the major materials suppliers around the world to create a knowledge base that will become a standard reference across industries."

This Week In Brief: June 1, 2010

Ametek Inc. (Paoli, PA), which specializes in electronic instruments and electromechanical devices, has announced the acquisition of Technical Services for Electronics (TSE; Arlington, MN). As part of Ametek's Electromechanical Group, TSE will continue to provide interconnect products for such medical device applications as ultrasound and neurostimulators.

Robotic systems integrator Ellison Technologies Automation (ETA; Council Bluffs, IA) will host the 'Celebrate Manufacturing' technology forum at its facility on June 16 and 17. The event will combine robot system demonstrations, informative seminars, and operating systems for machine load/unload, arc welding, picking, packing, and palletizing applications. Other sessions will cover 2- and 3-D robotic vision, force sensing, offline programming, simulation, customer support services, and robot programs for education. 

Motoman Inc. (Dayton, OH) and Yaskawa Electric America Inc. (Waukegan, IL) announced today that they will combine to form Yaskawa America Inc. From an operational standpoint, both the Yaskawa Electric America's drives and motion division and the Motoman robotics division will continue to operate as independent business units, retaining the same management structures and operating in the same geographical regions that are currently in place.

Sandvik Coromant (Fair Lawn, NJ) has released its new Metal Cutting Technology Technical Guide to help customers optimize their use of the company's products. Replacing the previous guide from 2005, the new version contains more than 800 pages of information and is available in PDF and DVD formats. The handbook also provides data on how to best use and maintain products, as well as steps to maximize productivity and avoid problems.

 

MIS: Reimbursement in the Way of Innovation

And despite the need to develop new treatment methods to combat infection and speed up recovery time in patients, the current system facilitates the status quo.

“The existing reimbursement coding system is stifling true leapfrog innovation,” said Andrew Diston, Head of Global Medical Technology Practice, Cambridge Consultants. “Even in today’s challenging economy, it is the long-term, sometimes higher-capital investments that will in the end bring about the improvements that can radically reduce MIS costs and improve patient outcomes in the process. Device makers want codes that reward innovation and patient care rather than short, dispensable income. This reimbursement issue has been hidden under the layers as an afterthought for too long.”

Request a full copy of the report, called "Navigating Surgical Options: The Future of Minimally Invasive Surgery," here.


50 Companies to Watch

Choosing just 50 companies to watch in the medical device industry is no easy task. After all, the industry is known for its diversity, not to mention its daily innovations. The challenge for MD+DI editors was to identify not only those companies that have achieved success, but also to find those manufacturers with the potential to revolutionize care practices. To that end we found some companies you may not have heard of, and we found some that may not even have products on the market.

We solicited nominations from readers, our Editorial Advisory Board and Reader Board, and industry observers. We meticulously analyzed any information we could get our hands on about each nominee, and then we debated among ourselves until we produced the list you see on the following pages.

There are some firms whose products walk the line of what constitutes a medical device. Biologicals and other convergent trends are blurring traditional categorizing, and MD+DI editors felt that the evolving medical device space allowed for some firms to erase that line altogether.

Another trend that emerged was the number of orthopedic companies that were selected. These firms often boast both groundbreaking technology and something altogether more rare these days—profit. Several of these companies have seen growth over the last year, a trend not everyone could report during a recession.

This isn’t a ranking, nor is it a declaration of the top, best, or most-likely-to-succeed companies in the device industry. The firms are listed alphabetically, for the most part, so what’s important is the content, not the order. And what you’ll find are tales of companies that are making an outstanding contribution to healthcare and that are expected to continue doing so.

There are certainly many companies we’ve forgotten, overlooked, or otherwise cast aside. With humility, here are the editors’ 2010 selections for ­­50 Companies to Watch.

Ben Pless, president and CEO

Autonomic Technologies (ATI)
Redwood City, CA
Annual revenue: N/A (privately held)
Key products: Migraine headaches treatment
Reason to watch: Its novel treatment for migraine headaches may revolutionize treatment methods. The design team is led by management with success in medical implants as well as investment teams that are convinced that even in the down economy, ATI’s product will be the next big thing in the neurotechnology industry. This is a company with a vision. The Cleveland Clinic-backed company raised $20 million in Series B funding in May 2010.
www.autonomictechnologies.com

Greg Baldwin, CEO and chairman of the board

Baxa Corp.
Englewood, CO
Annual revenue: $146 million (FY ended 12/09)
Key products: DoseEdge system
Reason to watch: The company promotes pharmacy safety. Its STAR Center (skills training, academics, and resources) was created for professional development in pharmacy, healthcare, and environmental control. Baxa believes that the best way for pharmacists to understand and implement state-of-the-art standards of practice is for them to have a practical, hands-on experience with expert faculty. It is committed to promoting safety in pharmacies.
www.baxa.com

 

Edward L. Erickson, president and CEO

BioNanomatrix Inc.
Philadelphia
Annual revenue: N/A (privately held)
Key products: NanoAnalyzer and Nanochannel Array
Reason to watch: The developer of whole genome imaging and analysis platforms for biomedical research, molecular diagnostics, and personalized medicine has a low-cost nanofluidic genome analysis technology. It is applying expertise in nanosystems to provide analysis of genomic and epigenomic data with sensitivity at the single-molecule level. It has a federally funded project to sequence the human genome in eight hours at a cost of $100.
www.bionanomatrix.com

 

Paul J. Southworth, president and CEO

CircuLite Inc.
Saddle Brook, NJ
Annual revenue: N/A (privately held)
Key products: Synergy partial circulatory-assist device
Reason to watch: Due to the lack of heart-transplant donors, circulatory support is becoming necessary for many patients suffering from congestive heart failure. CircuLite has developed a miniature circulatory-assist device (about the size of an AA battery) that is implanted using minimally invasive techniques that potentially could help ~2 million patients worldwide who have failed pharmacological and rhythm management therapies.
www.circulite.net

 

Charles R. Klasson, president

CIVCO Medical Solutions
Kalona, IA
Annual revenue: N/A (part of Roper Industries)
Key products: Protura 6 Degree of Freedom
Reason to watch: The company has developed a technical breakthrough in precision and is introducing  the Protura 6 Degree of Freedom robotic couch for radiation therapy. The Protura will work with most linear accelerators. When combined with the company’s Universal Couchtop and SBRT Body Pro-Lok, it becomes an all-in-one motion management system.
www.civco.com
 

 

Philipp Lang, MD, CEO, president, chair

ConforMIS Corp.
Burlington, MA
Annual revenue: N/A (privately held)
Key products: Patient-specific knee implants
Reason to watch: The company has shown rapid growth and phenomenal market acceptance and recognition for its patient-specific knee implants. These patient-specific implants have been shown to be a superior alternative to off-the-shelf knee implants. In April 2010, the firm received a CE mark for its iUniG2 knee resurfacing implant.
www.conformis.com

Mel Schatz, president and CEO

Crux Biomedical Inc.
Menlo Park, CA
Annual revenue: N/A (privately held)
Key products: IVC filter system
Reason to watch: The Crux Biomedical IVC filter is the world’s first bidirectionally retrievable filter system. Its helical geometry makes it capable of dynamically adapting to vena cava diameters and shapes. The coaxial over-the-wire delivery system is the first of its kind for IVC filter delivery. It provides ease of use, precision deployment, and user-controlled release of the implant. The firm just received FDA approval in the United States.
www.cruxbiomedical.com

Patrick R. Spearman, CEO 

Envoy Medical Corp.
St. Paul, MN
Annual revenue: N/A (privately held)
Key products: Esteem surgical implanted prosthetic hearing restoration device
Reason to watch: FDA recently approved Envoy to market a “first of its kind” prosthetic hearing restoration device. The approval follows a unanimous vote by a 15-member independent advisory panel in favor of approving the Esteem for moderate to severe sensorineural hearing loss. FDA expedited the review process, noting that it believes the Esteem “represents a breakthrough technology.”
www.envoymedical.com

Robert J. Palmisano, president and CEO

ev3 Inc.
Plymouth, MN
Annual revenue: $449.1 million (FY ended 12/09)
Key products: Plaque excision systems, embolic protection devices, liquid embolics, retrieval devices
Reason to watch: ev3 is expanding its portfolio of neuro and peripheral products. In 2009, it acquired Chestnut Medical Technologies, a maker of minimally invasive therapies for interventional neuroradiology. In Q1 2010, ev3’s neurovascular segment grew 44% compared with Q1 2009. The company has initiated a trial to evaluate a 200-mm-length stent for treating peripheral arterial disease in the legs.
www.ev3.net

Frederick Moll, president and CEO

Hansen Medical Inc.
Mountain View, CA
Annual revenue: $22.2 million (FY ended 12/09)
Key products: Sensei robotic catheter and Artisan control catheter
Reason to watch: Hansen makes robotic catheter systems that allow surgeons to remotely guide a heart catheter with hand movements while seeing a 3-D view of the operation. Studies show that the systems lead to faster operations than manual catheter techniques. In May 2010, the company received conditional approval for a clinical trial of the Sensei and Artisan to treat atrial fibrillation.
www.hansenmedical.com


Ken Ferry,
president and CEO
iCAD Inc.
Nashua, NH
Annual revenue: $28.1 million (FY ended 12/09)
Key products: Image analysis technology for mammography, CT, and MRI
Reason to watch: iCAD is the only company with an FDA-approved CAD product for computed radiography mammography. Its SecondLook systems can detect up to 72% of missed breast cancers an average of 15 months earlier than screening mammography alone. The company was granted a patent for future iterations of SecondLook for use with the manufacturer’s other image analysis products.
www.icadmed.com
 

Marcelo Lima, president and CEO

ImThera Medical
San Diego
Annual revenue: N/A (privately held)
Key products: Targeted hypoglossal neurostimulation (THN) system
Reason to watch: ImThera is banking on neurostimulation as an alternative to sleep masks used to treat obstructive sleep apnea, which are plagued by patient noncompliance. THN stimulates the nerve that provides motor innervations to tongue muscles. This prevents the tongue from falling into the throat and keeps patients’ airways open. ImThera is currently conducting a pilot study in Belgium.
www.imtheramedical.com

James E. Muller, founder and CEO

InfraReDx
Burlington, MA
Annual revenue: N/A (privately held)
Key products: Coronary imaging system
Reason to watch: InfraReDx’s LipiScan is the only FDA-cleared product that detects and analyzes the intracoronary composition of lipid core plaque. This plaque, believed to cause heart attacks and complicate stenting, typically escapes detection from common diagnostic tests such as treadmill exams and coronary angiograms. The system measures light delivered through the blood and reflected from the artery wall, and eventually creates a map of the artery’s chemical composition.
www.infraredx.com
 

 

J. Joseph Kim, president and CEO

Inovio Biomedical
Blue Bell, PA
Annual revenue: $9.1 million (FY ended 12/09)
Key products: In vivo electroporation device
Reason to watch: By merging with VGX Pharmaceuticals in 2009, Inovio increased its capabilities to develop DNA vaccines. The companies are creating a vaccine that targets H5N1 and have earned approval to test the vaccine in Korea. Inovio was named Best Early-Stage Biotech Company at the World Vaccine Congress in 2010. The award recognized the firm’s electroporation device and development of DNA vaccines for influenza, HIV, and cancer.
www.inovio.com
 

Mike Nash, cofounder, president, and CEO

iScience Interventional
Menlo Park, CA
Annual revenue: N/A (privately held) 
Key product: Microcatheters and microcannulae
Reason to watch: iScience was the first company to develop microcatheter and imaging systems that enable opthalmologists to conduct site-specific surgery.  Its products are used in canaloplasty—a minimally invasive procedure to lower the intraocular pressure in glaucoma patients. Each year about 3000 canaloplasty procedures are performed in the United States and about 2500 are performed outside the United States.
www.iscienceinterventional.com

Emma A. Durand, CEO and CTO

Isis Biopolymer Inc.
Providence, RI
Annual revenue: N/A (privately held)
Key product: IsisIQ active drug-delivery patch
Reason to watch: The company’s early-stage drug patch could give doctors better control of drug delivery. The wireless, active iontophoretic patch is fully programmable, enabling the patch to be customized to the needs of the patient. The improved control also reduces the chance of under- and overdosing. Additionally, the patch is a biosenser that can detect skin emanation, which can be a sign of heart attack, shock, or diabetic reactions.
www.isisbiopolymer.com
 

Eric Major, president and CEO

K2M Inc.
Leesburg, VA
Annual revenue: N/A (privately held)
Key products: Spinal stabilization and minimally invasive systems
Reason to watch: On top of earning multiple 510(k) clearances and industry awards since 2009, the spinal device company is busy expanding into international markets. K2M recently entered a distribution agreement to market products in Germany, opened a sales and distribution office in the UK, and got clearance to market its Mesa spinal system in Japan. Its Serengeti minimally invasive retractor system garnered a Medical Design Excellence Award in 2010.
www.k2m.com

Clyde Pratt, CEO

Kinamed Inc.
Camarillo, CA
Annual revenue: N/A (privately held)
Key products: Implantables and instruments for orthopedics and neurosurgery
Reason to watch: Despite a tough economy, the company has experienced double-digit growth for three consecutive years. Kinamed’s financial success is due to its aggressive international marketing—about 50% of its sales are made abroad—and its ability to meet regulations in countries like Japan and China. Several products are FDA approved and the Gem total knee system is approved for investigational use.
www.kinamed.com

 

Manny Villafaña, founder, CEO, and chairman

Kips Bay Medical Inc.
Minneapolis
Annual revenue: N/A (privately held)
Key products: eSVS mesh
Reason to watch: In 2010, the company filed to raise $57.5 million through an initial public offering. Its CEO, Manny Villafaña, is an experienced entrepreneur who has founded and taken such medical device companies public as St. Jude Medical. Kips Bay’s eSVS mesh is an extravascular prosthesis that is placed over a patient’s saphenous vein graft during coronary artery bypass grafting. The technology is being tested in a multinational clinical trial.
www.kipsbaymedical.com

Maurice R. Ferré, president, CEO, and chairman

Mako Surgical Corp.
Fort Lauderdale, FL
Annual revenue: $34.2 million (FY ended 12/09)
Key products: Rio Robotic Arm Interactive Orthopedic System
Reason to watch: In just five years, the company developed Makoplasty, a procedure to perform joint resurfacing on the knee that preserves tissue, and received FDA clearance for a robotic arm system used in the surgery. In Q4 2010, 561 procedures were performed—a 181% increase from Q4 2008. The firm is currently investigating whether Makoplasty has applications to the hip, shoulder, and spine.
www.makosurgical.com
 

Gopal Muppirala, CEO

Mardil Inc.
Morrisville, NC
Annual revenue: N/A (privately held)
Key products: Mitral valve repair device
Reason to watch: Mardil’s external BACE (Basal Annuloplasty of the Cardia Externally) device addresses functional mitral valve regurgitation with technology that supports the heart muscle rather than the valve itself. Postoperative remote adjustments can be made by a cardiologist through subcutaneous ports. Both the initial prototype and pilot study showed significant improvement in the degree of mitral regurgitation, ejection fraction, functional status, and quality of life.
www.mardil.com

Joe Kiani, CEO


Masimo Corp.

Irvine, CA
Annual revenue: $349.1 million (FY ended 1/10)
Key products: Noninvasive patient monitors
Reason to watch: Masimo’s Rainbow SET Pulse CO-Oximetry platform is the first and only FDA-cleared technology that noninvasively and continuously measures total hemoglobin. The company expects it to open new markets and expand growth. The OEM established the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare. It supports programs for patient safety and expanding access to healthcare.
www.masimo.com

Frank Codella, CEO

Medical Acoustics LLC
Buffalo, NY
Annual revenue: N/A (privately held)
Key Products: Lung Flute
Reason to watch: The Lung Flute is a disposable device that uses a low-frequency acoustic wave to collect mucus samples for diagnostic purposes. It’s a noninvasive alternative to hypertonic saline, which can cause bronchial inflammation. It has the potential to help diagnose or treat lung cancer, tuberculosis, chronic bronchitis, asthma, and community-acquired pneumonia. Popular Science magazine named the device a best innovation for 2009.
www.medicalacoustics.com

Ajit S. Gill, president and CEO

MicroCHIPS
Bedford, MA
Annual revenue: N/A (privately held)
Key products: Glucose monitor, drug-delivery devices
Reason to watch: MicroCHIPS builds devices based on reservoir arrays that store and protect chemical sensors or drugs in the body for long periods of time. The arrays are compatible with microprocessors, wireless telemetry, and sensor feedback loops. In 2010, the World Economic Forum named the company a technology pioneer. It also received a 2010 Edison Best New Product Award for its Illume product. Its IP portfolio includes 25 patents and 40 pending applications.
www.mchips.com

Wayne Poll, MD, CEO

Minimally Invasive Devices (MID)
Columbus, OH
Annual revenue: $750,000 (FY ended 12/09)
Key products: FloShield
Reason to watch: MID’s core technology improves surgeon visualization. During laparoscopic procedures, condensation can form on the end of the laparoscope, which can obscure vision. Instead of removing the scope during surgery to clean, the FloShield flows carbon dioxide over the lens to keep away debris. The OEM is looking at device concepts from universities as potential technologies for development and commercialization.
www.midsurgical.com

Michael Afremov, president and CEO

Minnesota Medical Development Inc. (MMDI)
Plymouth, MN
Annual revenue: N/A (privately held)
Key products: Rebound HRD
Reason to watch: MMDI developed the only hernia repair device that uses a nitinol frame and mesh. Rebound HRD withstands laparoscopic deployment and reduces procedure time by 50%. The device received the Innovation of the Year Award from the Society of Laparoendoscopic Surgeons in 2006, before it had received 510(k) clearance. MMDI says the device is gaining market share.
www.2mdinc.com

Chris Rowland, CEO

Neotract Inc.
Pleasanton, CA
Annual revenue: N/A (privately held)
Key products: UroLift System
Reason to watch: Start-up Neotract is preparing to launch UroLift for treating benign prostatic hyperplasia. The UroLift System directly opens the urethra without removing or ablating prostate tissue. It is an alternative to invasive transurethral resection of the prostate. Sutures are placed transurethrally to retract the obstructing prostatic lobes while leaving the prostate intact. Clinical results have shown symptom relief within two weeks and preserve long-term normal sexual function.
www.neotract.com

Alexel Marko, CEO and director

Neovasc Inc.
Richmond, BC, Canada
Annual revenue: $3 million Canadian (FY ended 12/09)
Key products: Neovasc Reducer
Reason to watch: The company’s product treats refractory angina. It has raised funding for a multicenter clinical trial intended to demonstrate the safety and efficacy of the Reducer product for this indication in patients lacking other treatment options. The company says results will provide key data for a CE mark application and will help drive adoption. The company expects its biological tissue business to be profitable in 2010.
www.neovasc.com

 

Frank Fischer, CEO

Neuropace Inc.
Mountainview, CA
Annual revenue: N/A (privately held)
Key products: Neurostimulator for epilepsy
Reason to watch:  Neuropace’s neurostimulator provides hope for patients who have unsuccessfully tried drug treatment to reduce seizures. The cranial implant is attached to surface or deep brain electrodes that can detect the early electroencephalograph signal that precedes a seizure. The device stimulates the brain to stop or prevent the spread of the seizure. The company filed its PMA for the device following a successful pivotal clinical trial.
www.neuropace.com

 

Laura King, president and CEO

NeuWave Medical Inc.
Madison, WI
Annual revenue: N/A (privately held)
Key products: Microwave ablation
Reason to watch: NeuWave Medical’s Certus 140 is a soft tissue ablation system with pending FDA clearance. It was designed to minimize invasiveness and provide an ergonomic user interface. NeuWave is the result of an academic collaboration between engineers and physicians who wished to improve clinical outcomes. Raising venture capital enabled NeuWave to attract a strong leadership team, driving product conception to submission within 24 months.
www.neuwavemedical.com

Jeffrey Morrill, CEO

NuOrtho Surgical Inc.
Falls River, MA
Annual revenue: N/A (privately held)
Key products: Tissue preservation RF probe
Reason to watch: NuOrtho Surgical focuses on treating damaged tissue and preserving healthy tissue. Its radio-frequency device can use a standard monopolar generator located in any operating room. NuOrtho has three main product platforms—soft tissue treatment, agent delivery, and bone fusion. Its first product launch will be Ceruleau, a technology for knee cartilage. The company’s nine patents could pave the way for opportunities in tissue preservation.
www.nuorthosurgical.com

Alexis V. Lukianov, president and CEO

NuVasive
San Diego
Annual revenue: $370.3 million (FY ended 12/09)
Key products: Spine surgery procedures, implants, and instruments
Reason to watch: Among private companies that go public, NuVasive is a poster child of how it’s done. NuVasive’s total revenue is up 48% from 2008, and it expects annual sales of $500 million this year. Its spinal device is based on spreading the psoas muscle rather than cutting it. A software algorithm allows the surgeon to see where the nerves are in real time. Despite hiccups in getting reimbursement, the firm has built a strong base of loyal patients.
www.nuvasive.com

Jeffrey Burbank, president and CEO

NxStage Medical Inc.
Lawrence, MA
Annual revenue: $148.7 million (FY ended 12/09)
Key products: NxStage System One, NxStage PureFlow SL
Reason to watch: NxStage has expanded with international partnerships. In 2007, it acquired Medisystems, a dialysis firm that provides technology for the System One, the first FDA-cleared hemodialysis tool used in the home. MassMEDIC gave the company a Medical Device Innovation Award in the start-up category in 2005. In 2009, its revenues grew 31% for its home dialysis business unit. The firm finished an IPO in 2005.
www.nxstage.com

John Spitznagel, chairman and CEO

Oceana Therapeutics Inc.
Edison NJ
Annual revenue: N/A (privately held)
Key products: Deflux, Solesta, Uriprine
Reason to watch: Within a year of start-up in 2008, Oceana acquired rights to two medical products. Deflux, a gel used in endoscopic injections to treat pediatric urinary conditions, recently received approval in Japan. In 2009, Oceana obtained exclusive marketing rights to Solesta and in April 2010, it filed for PMA. Oceana is developing Uriprene, a biodegradable ureteral stent, which eliminates a second procedure for device removal.
www.oceanathera.com

 

John Stalcup, CEO

Osseon Therapeutics
Santa Rosa, CA
Annual revenue: N/A (privately held)
Key products: Osseoflex, Osseoperm
Reason to watch: Since launching in early 2009, Osseon’s technology has been used on more than 700 patients. It focuses on bone cement delivery devices and bone cement composite for treating symptomatic compression fractures of the vertebral spine. Osseon is a spinoff of the University of Northern California. The university, founders, and private investors have raised $14 million for the start-up, including $6 million in a recent round.
www.osseon.com

 

Jeffery W. Millin, president and CEO

Pioneer Surgical Technology
Marquette, MI
Annual revenue: N/A (privately held)
Key products: Quantum Spinal Rodding System; nanOss Bioactive
Reason to watch: Pioneer has made a push into orthobiologics and expanded its spinal implants offerings. In 2006, the firm formed a distribution agreement with Regeneration Technologies, which makes BioSet demineralized bone matrix. Also in 2006, Pioneer acquired Encelle Inc. (renamed Pioneer Surgical Orthobiologics), which makes E-Matrix, a sterile, injectable biopolymer for the repair of diseased or damaged tissue.
www.pioneersurgical.com

Keiran T. Gallahue, president and CEO

ResMed
San Diego
Annual revenue: $921 million (FY ended 12/09)
Key products: Activa LT and swift LT for Her sleep-disordered breathing devices
Reason to watch: ResMed has seen revenue growth and sustained sales and has gained market share with sleep-disordered breathing devices. Sleep apnea, snoring, and other respiratory disorders are linked to complications and increased risk in diabetes and heart failure. ResMed has made research and education its priority. Strategic acquisitions, partnerships, and international markets enhance the firm’s growth potential.
www.resmed.com

S. Wayne Kay, CEO

Response Biomedical Corp.
Vancouver, BC, Canada
Annual revenue: $9.95 million Canadian (FY ended 12/09)
Key products: RAMP, a platform lateral-flow immunoassay
Reason to watch: The company’s RAMP system is used in various diagnostic practices. It assists in diagnosis of a heart attack. It is also used in Flu A+B Test, launched in October 2008. The company has made inroads with its Chinese distributor O&D Biotech Co. Ltd. in selling the cardiac products. In February 2010, the company added a second such distribution partner in China, Wondfo Biotech Co. Ltd.
www.responsebio.com

David L. Lucchino CEO and cofounder

Semprus BioSciences
Cambridge, MA
Annual revenue: N/A (privately held)
Key products: Semprus Surfaces platform to address adverse reactions to implanted materials
Reason to watch: Founded out of the MIT’s Langer Lab, the company has developed a biofunctional surface platform. Permanent nonleaching biomaterial modification introduced to a device surface is designed to prevent medical complications. In December 2008, Semprus BioSciences completed an $8 million Series A financing. This funding came on the heels of $2.5 million seed capital raised in 2007.
www.semprusbio.com

Jean-Marc Wismer, CEO

Sensimed AG
Lausanne, Switzerland
Annual revenue: N/A (privately held)
Key products: Triggerfish intraocular monitoring system
Reason to watch: Sensimed’s Triggerfish system is a breakthrough in the optics field. It is a soft contact lens embedded with MEMS technology to monitor intraocular pressure for 24 hours a day in patients suffering from glaucoma. Already armed with a CE mark and seeking FDA approval, the product is the first of its kind on the market. It is designed to allow patients to sleep at home instead of in a sleep laboratory.
www.sensimed.ch

 

Charles Scarantino, founder and chair

Sicel Technologies
Morrisville, NC
Annual revenue: N/A (privately held)
Key products: Surface dosimetry radiation measurement devices
Reason to watch: Radiation treatment for cancer is clearly no walk in the park, and accuracy is critical to prevent cancer reoccurrence or damage to healthy tissue. Sicel has developed a tiny sensor (2 mm in diameter) that measures the amount of radiation delivered to a tumor site. Readings are transmitted wirelessly to a reader outside the body. These readings enable doctors to adjust radiation levels to ensure the proper dose.
www.siceltech.com
 


Daniel Sullivan, CEO

SuperDimension
Minneapolis
Annual revenue: N/A (privately held)
Key products: i·Logic system
Reason to watch: SuperDimension has brought the first virtual visualization technique to interventional procedures (bronchoscopy), creating new possibilities in accessing problem areas inside the body. Its offers minimally invasive access to lesions deep inside the lungs as well as mediastinal lymph nodes. The company spearheads a new field called electromagnetic navigation bronchoscopy. Software lets physicians see reconstructions of the bronchial airways of the lungs.
www.superdimension.com
 

Kimble Jenkins, CEO

SurgiVision Inc.
Memphis
Annual revenue: N/A (Privately held)
Key products: MRI-guided intervention technology
Reason to watch: SurgiVision’s ClearPoint neurointervention system is changing the landscape of brain surgery. By integrating medical devices that are compatible with magnetic resonance imaging (MRI), the company is enabling surgeons to perform precise surgery using MRI for guidance. The company is also developing the ClearTrace system for MRI-guided cardiac ablation to treat atrial fibrillation.
www.surgivision.com
 

Rodger G. Ford, CEO 

SynCardia Systems Inc.
Tucson, AZ
Annual revenue: N/A (privately held)
Key products: Total Artificial Heart
Reason to watch: The SynCardia Total Artificial Heart is the only device of its kind with regulatory approval in the United States, Canada, and Europe. The device, meant for people dying from end-stage biventricular failure, works similar to a heart transplant in that it replaces both the right and left heart ventricles. Plus, there’s no waiting list like there is for donor hearts (the company has certified centers set up throughout the world).
www.syncardia.com
 

Ken Moore, CEO 

Tenet Medical Engineering
Calgary, AB, Canada
Annual revenue: N/A (privately held)
Key products: Surgical positioning devices
Reason to watch: Tenet continues improve on advanced patient positioning for surgical procedures. The company has been one of the fastest-growing firms in Canada in recent years, thanks in part to its Spider Limb Positioner. Tenet also has unique ties to the University of Calgary, and not just for recruitment. To continue the innovation cycle, a portion of Tenet’s profits go back to the school to fund more bone and joint research.
www.tenetmedical.com
 

 

Todd M. Pope, CEO

TransEnterix
Durham, NC
Annual revenue: N/A (privately held)
Key products: Laparoscopic instruments
Reason to watch: TransEnterix is a pioneer in flexible laparoscopy. The firm’s SPIDER Surgical System allows  surgeons to perform various procedures through a single incision in the navel. The system opens up like an umbrella, providing the surgeon with two flexible channels for right- and left-hand instruments with 360° range of motion, and two rigid channels for small cameras and other instruments. SPIDER presents a significant shift and may change minimally invasive surgery.
www.transenterix.com

 

Alan Shortall, CEO

Unilife Corp.
Lewisberry, PA
Annual revenue: $4.6 million Australian (FY ended 6/09)
Key products: Safety syringes
Reason to watch: Unilife can significantly improve injection safety with its core safety syringe technology. The needle automatically retracts, and an automatic disable feature prevents reuse. The integration of automatic and controlled needle retraction features could give Unilife a major competitive advantage. The company is capitalizing on increased syringe use, which is partially driven by an aging population, increased incidence of diabetes, and the development of new vaccines.
www.unilife.com

Robert Goldman, founder

Vascular Designs
San Jose
Annual revenue: N/A (privately held)
Key products: Platform lateral-flow immunoassay technology
Reason to watch: Vascular Designs recently launched a potential breakthrough device called the IsoFlow infusion catheter. The catheter, which received 510(k) clearance in September 2009, makes it possible to direct the delivery of chemotherapy to cancerous tumors. It enables sideways perfusion, which allows physicians to precisely target and isolate areas within the body where the infused drugs are delivered.
www.vasculardesigns.com

 

Michael Yang, general manager
 

Veridex
Raritan, NJ
Annual revenue: N/A (part of J&J)
Key products: Diagnostic systems
Reason to watch: Already lauded with a Prix Galien USA Award, Veridex is making waves in diagnostics with its CellSearch System. The tool is the first diagnostic test used to automate the detection and capture of circulating tumor cells that have entered a patient’s blood. It represents a shift in managing certain types of cancers and provides oncologists with a clearer picture of the prognosis and overall survival of patients with metastatic breast, colorectal, or prostate cancer during treatment.
www.veridex.com

Howard Edelman, CEO

VitalWear
San Francisco
Annual revenue: N/A (privately held)
Key products: Therapeutic devices
Reason to watch: VitalWear is on a quest to expand its suite of low-cost, reimbursable, durable medical equipment, which is used in the orthopedic, sports medicine, and home healthcare markets. Its thermal therapy devices, such as the VitalWrap, its first product, are used to accelerate recovery and treat pain from a broad range of injuries and chronic conditions. With millions of people in the United States alone suffering from persistent pain, VitalWear is well positioned.
www.vitalwear.com

Developing Medical Device Software to IEC 62304

Ken Hall
 
Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical product by the Medical Devices Directive. This has now changed. A new regime is in force governing all medical device software development for all classes of device.
 
Previous software safety standards were best suited to medical devices with low levels of risk, as opposed to products where software failure could be extremely serious and result in death. As more electronic products have become dependent on embedded software, the focus has shifted to the reliability of software systems within the devices and the associated risks at all levels of usage. As a result, the new EN/IEC 62304 standard has emerged as a global benchmark for management of the software development lifecycle.
 
Risk analysis for hardware and software design
Medical product designers have used risk management techniques to help reduce the risks associated with device hardware. BS/EN/ISO 14971 has traditionally been adopted as the base standard for risk management for medical devices. The 2007 version of this standard is considerably extended from its previous version, and the techniques described are now intended to be applied to both software and hardware systems.
 
The approach that should be taken is to consider the risks posed by the medical device as a whole, before the software/hardware split has been decided. Hardware risk analysis can then run alongside software risk analysis to define the required safety systems for the device.
 
A harmonised standard
IEC 62304 is a harmonised standard for software design in medical products adopted by the European Union and the United States. Because the standard is “harmonised,” medical device manufacturers adopting it will satisfy the essential requirements contained in Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC) as related to software development. This is the least onerous route to ensuring compliance with the MDD. US FDA will also accept ANSI/AAMI/IEC 62304:2006 as evidence that medical device software has been designed to an acceptable standard. This standard is identical to the EN/ISO variant in all essential details.
 
Designing to IEC 62304 ensures that quality software is produced by means of a defined and controlled process of software development. This process must contain a set of requirements based on the safety class of the software that is being developed.
 
Software safety classification
Initially the IEC 62304 standard expects the manufacturer to assign a safety class to the software system as a whole. This class-ification is based on the potential to create a hazard that could result in an injury to the user, the patient or other people.
 
The software is classified into three simple classes, as follows:
  • Class A: No injury or damage to health is possible
  • Class B: Nonserious injury is possible
  • Class C: Death or serious injury is possible
Defining “serious injury,” “nonserious injury,” “injury” and “damage to health” is important to apply this classification effectively. It may at first appear to be obvious what constitutes an injury; however, this can be a far more complex question when the context of the device is taken into account. Unfortunately the standard only defines “serious injury,” and this is as follows:
 
Serious Injury
Injury or illness that directly or indirectly
a) is life threatening,
b) results in permanent impairment of a body function or permanent damage to a body structure, or
c) necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
 
Note: Permanent impairment means an irreversible impairment or damage to a body structure or function excluding trivial impairment or damage.
 
It is relatively simple to apply a negative to the above to derive a nonserious injury definition. However, the definition of injury for use with the Class A software safety classification may be debatable. This is complex because of the lack of definition of injury or damage to health. For example, there may be a grey area involving the normal side effects of treatment of a condition as opposed to the device itself causing injury.
 
Procedures for carrying out this initial analysis and defining the class to be applied have been developed. In some cases, the notified body being used can affect this decision. Some will recommend that Class B is the minimum standard to be applied for any medical product, as the Class A safety classification does not insist on a sufficiently rigorous software development process.
 
There are major differences in the development process in terms of cost and time between a Class A and Class B code. It is therefore essential that medical device developers get this right at the outset. The safety classification also has a great impact on the documentation and process that is required.
 
Software items and units
Once the initial safety classification has been carried out for the system, it is possible to break the system down into software items and software units. These are defined as follows:
  • Software Item: “Any identifiable part of a computer program” [ISO/IEC 90003:2004, definition 3.14, modified]
  • Software Unit: “Software item that is not subdivided into other items” [ISO/IEC 90003:2004, definition 3.28, modified]
In practice, the software items can be any subsection of a system or its constituent parts. An architectural diagram is required to show the software items and software units. It is possible to then downgrade the safety classification of parts of the software system provided that these can be segregated. The note on section 5.3.5 of the standard gives an example of this segregation:
 
“An example of segregation is to have software items execute on different processors. The effectiveness of the segregation can be ensured by having no shared resources between the processors.”
 
In practice, this means that a safety-critical software system can be split into items, each one running on different processors and each with a different safety classification. Again, it is important to get this split correct at the outset to ensure that the system is safe and high quality, but also produced within the appropriate cost and time guidelines. Systems are available to analyse medical product software architecture and to define these items. Such processes can greatly reduce timescales and costs for the development of medical devices.
 
Table I: Summary of safety classification effects on the code development documentation and process.
Software DocumentationClass AClass BClass C
Software development planMust contain contents to sections 5.1 IEC 62304:2006. The plan's content list increases as the class increases, but a plan is required for all classes.
Software requirements specificationSoftware requirements specification conforming to 5.2 IEC 62304:2006. The content list for the software requirements specification increases as the class increases, but a document is required for all classes.
Software architectureNot required.Software architecture to 5.3 IEC 62304:2006. Refined to software unit level for Class C.
Software detailed designNot required. Document detailed design for software
units. (5.4).
Software unit implementationAll units are implemented, documented and source controlled (5.5.1). 
Software unit verificationNot required.Define process, tests and acceptance
criteria (5.5.2, 5.5.3).
Carry out verification (5.5.5)
Define additional tests and acceptance
criteria (5.5.2, 5.5.3, 5.5.4).
Carry out verification (5.5.5).
Software integration and integration
testing
Not required.Integration testing to 5.6 IEC 62304:2006.
Software system testingNot required.System testing to 5.7 IEC 62304:2006.
Software releaseDocument the version of the software
product that is being released (5.8.4).
List of remaining software anomalies, annotated with an explanation of the
impact on safety or effectiveness, including operator usage and human factors.
 
Impact of safety classification
The safety classification has a tremendous impact on the code development process. It is therefore in the interests of medical device manufacturers to get this right the first time to avoid expensive, time-consuming rework late in a project.
A brief summary of the effects of safety classification on the documentation and process is shown in table I. In practice any company developing medical device software will carry out verification, integration and system testing on all software classes. However, the difference is that formal detailed documentation does not need to be generated for Class A code. Cross-referencing and verification of requirements also does not need to be formally proven. This can save a great deal of time and money in software development.
 
SOUP
Software of unknown provenance, or SOUP, is any code (tools or source code) that does not have formal documentation or was developed by a third party and has no evidence as to the controls on the development process. This code by definition is deemed to be capable of producing faults. It is important to carry out a software risk analysis on any SOUP code being proposed for the software under development and produce a rationale as to why this code should be used.
 
The use of SOUP is affected by the code safety classification. If the code is deemed to be Class A, then SOUP code can be used without further justification. As the class increases, the risks increase and the rationale becomes harder to justify. In practice this means that only simple function, well known and diversely applied SOUP code can be used for Class C applications.
 
A technology solutions provider specialising in electronics design and production services has developed processes to identify and justify the use of SOUP in medical device software. Its own experience with this has proved that such processes can drastically reduce development time-scales and costs. This is a route that medical device developers should incorporate into their design procedures.
 
Conclusion
IEC 62304 is a well considered, logical standard for developing safety critical and high reliability software for medical devices. Now that this standard has been adopted it would be very difficult for a medical device software developer to justify any equivalent approach that meets the requirements of the MDD, without effectively complying with this standard. This is good news for the safety of patients, but also for the manufacturers themselves, as the standard establishes a more level playing field. There is no longer any opportunity for uncontrolled rudimentary software development processes, and this raises quality across the board.
 
In addition, as IEC 62304 is a harmonised standard that has been adopted internationally, it tends to equalise quality expectations between Europe and the United States.
 
For medical device manufacturers, it is important that they select software designers who have well-established risk management systems, as they will already have the foundations in place to meet IEC 62304. Additionally, my professional experience has proved how valuable processes can be to analyse medical product software architecture and usage. Such processes can greatly reduce timescales and costs for the development of medical devices. 
 
Ken Hall is Technical Director at Triteq Ltd.

Is It Catching? Researcher Spreads Virus from Implanted Device

The subject of potential implant hacking has generated a great deal of discussion and exploration in recent years. However, a British researcher has taken investigation of electronic implant vulnerability to the next level by becoming the first man to be 'infected' by a computer virus.

Modeling an RFID-based microchip after those used to tag pets, researcher Mark Gasson of the University of Reading's School of Systems Engineering (Reading, UK) programmed the chip to communicate with other devices in order to perform such tasks as allowing secure access to his lab. Along with programming such functionality into the chip, he also infected the implant with a virus and then planted it under his skin. The ultimate goal, according to Gasson, was to demonstrate that the virus could spread from the chip to other devices with which it interacted, similar to how computer viruses spread.

"Our research shows that implantable technology has developed to the point where implants are capable of communicating, storing, and manipulating data," Gasson told the UK's Telegraph. "This means that, like mainstream computers, they can be infected by viruses and the technology will need to keep pace with this so that implants, including medical devices, can be safely used in the future."

Gasson notes that electronic implants, such as pacemakers, that wirelessly exchange information with other electronic devices could fall prey to viruses. Likewise, an implant could spread a virus to other other devices, as Gasson proved was possible.

To learn more about Gasson and his work with spreading viruses from an implant, view the below video from BBC News.

Covidien Buys eV3

The acquisition adds ev3’s stents, angioplasty balloons, plaque removal systems, and catheters to Covidien’s product range of staples, suture needles, wound care, scalpels and products used in surgery. The deal positions Covidien in the vascular surgery market.

The transaction is expected to be completed by July 31. Ev3’s directors and officers plan to tender their shares, according to the statement. The purchase will reduce Covidien’s earnings per share this year and next, according to the statement. Covidien says it has no plans to move any of ev3’s operations out of Minnesota. Ev3 had 1,350 employees at the end of 2009.

Feel the Heat: Thermal Design Trends in Medical Devices

 

In a heat pipe heat exchanger, heat spreads through a heat pipe and is dissipated through a finned heat sink, where it is rejected to the ambient atmosphere.

The impressive capabilities of twenty-first century medical technology, from imaging equipment to surgical instruments and automated immunoassays, are in many ways a tribute to the advances in microprocessor computing power. However, for thermal engineers, these advances come with a price. More power means more heat, generally in a smaller space. And as greater demands for precision and reliability are placed on medical equipment, thermal control becomes more critical.

Another challenge arises from the fact that medical devices have unique requirements because of the high stakes involved. For example, some common materials used in thermal solutions, such as copper, cannot be used in many medical applications because of concerns about the proximity of these materials to the human body (in addition to causing tissue irritation, copper has been implicated in serious, irreversible neurodegenerative conditions). The precise nature of some medical applications can reduce the available space for cooling solutions almost to the vanishing point—some surgical instruments that need thermal management to avoid causing tissue damage, offer designers as little as 0.5 mm in which to place heat transfer technology. 

Another field requiring ultraminiaturized thermal management is the design of implantable devices, which combine tiny size with the need for precise temperature change coefficients (?T°) to protect human organs. Finally, rapid temperature cycling, with variations of up to 50°C within milliseconds, is a common feature of many laboratory devices such as DNA splicers.

All of these elements add up to accuracy requirements, reliability needs, size constraints, and restrictions on material selection that can make medical thermal engineering a juggling act for designers. Thermal engineers must balance efficiency and size versus cost, and increasingly, thermal performance versus low noise (which means fans cannot be used in some applications, even when their high volumetric airflow would make them the best performing option).

Heat Transfer

Increasingly, thermal engineers have turned to passive heat transfer devices, such as heat pipes, to meet these challenges. Heat pipes are considered two-phase cooling devices because the working fluid exists as both a liquid and a vapor inside the heat pipe. The transition from the liquid to the vapor phase provides heat transfer. Heat pipes enable a continuous cycle of vaporization, transport, condensation, and return of the condensate to the area of evaporation. They can do so with no moving parts to fail—a key consideration in applications in which reliability is essential for precise results or patient health. Their straightforward design, generally involving a vacuum-sealed tube injected with a working fluid, is relatively easy to miniaturize. Continual advances in wicking structure technology have helped ensure that cooled, condensed fluid can efficiently and reliably return to the heat input portion of the heat pipe even against gravity. This allows the heat pipe to operate in any orientation. Designers can even turn to flexible heat pipes in some situations for additional design freedom. 

Another favored thermal approach is the heat sink, which can operate via forced or natural convection. But again, either approach means trade-offs. More airflow, for greater cooling, means that a heat sink can have fewer or smaller fins. However, fans that produce more airflow also produce more noise. Using quieter and smaller fans, which produce less airflow, means that the heat sink must have more or larger fins. It’s difficult therefore to make thermal assemblies both smaller and quieter within the same device.

But it can be done. The way to reduce both size and noise is to make the heat sink more isothermal. A heat sink previously cooled by a single thermoelectric cooler (TEC) can be redesigned to use multiple TECs to spread the heat evenly across the face of the heat sink, rather than rely on pure conduction to spread the heat. However, this adds electronic complexity and costs in addition to maintenance requirements.

 

A rack-mounted heat pipe assembly can provide complete thermal reliability with low

maintenance.

A simpler approach is to use passive thermal techniques by pairing a heat sink with an embedded vapor chamber (essentially, a heat pipe flattened to form a planar heat pipe) or a heat sink with heat pipes incorporated into the surface of the heat sink. Either approach can be used to spread heat evenly and quickly via the vapor formed by the working liquid in the embedded heat pipe or the vapor chamber. Vapor transports heat uniformly across the entire base plate surface of the heat sink and past fins, preventing hot spots. Because the heat sink is isothermal, the air moving across the fins removes a maximum amount of heat. 

The trend toward passive heat transfer devices such as heat pipes, heat sinks, and vapor chambers in medical devices reflects the ongoing evolution of smaller, more powerful and more miniaturized electronics in general. While more traditional cooling approaches (refrigeration, TECs, liquid cold plates, etc.) are still the most appropriate choices for some medical equipment, designers are finding passive cooling technology to be more and more attractive as this technology develops. 

A number of advances in material fabrication have made passive thermal options more attractive for designers of medical equipment. For example, the development of annealed pyrolytic graphite (APG) enables the development of thermal components that are smaller, lighter, and more efficient than traditional heat sinks using aluminum or copper. Higher-conductivity materials help designers as products trend toward greater miniaturization and smaller electronic enclosures. APG offers effective thermal conductivity of 1000 W/mK, 5 times greater than that of solid aluminum and 2.5 times greater than that of solid copper. APG can also be encapsulated for applications such as surgical instruments, for which it is critical to avoid contact between APG and human tissue due to concerns about tissue damage, scarring, or contamination. 

Developments like APG help explain why medical device designers are choosing passive thermal control systems more often. These systems offer not only a wider range of choices, but in many cases better choices, for thermal management. Compared with traditional liquid cooling approaches, passive thermal systems offer higher reliability (fewer moving parts means less failure risk), reduced maintenance, greater design flexibility, quieter operation, and in many cases, more manageable cost. Here are some examples of passive thermal management concepts incorporated in some key medical equipment applications.

Diagnostic Imaging

Because the capabilities of electronics decline quickly after a critical temperature is reached, enclosure cooling is critical for electronics-rich technologies such as magnetic resonance imaging (MRI), computed tomography (CT), ultrasound, and radiography (x-ray). Slight fluctuations in temperature can influence calibration and results, leading to costly downtime and maintenance. FDA, of course, plays a critical role in the drive toward near-perfect (≥95%) repeatability and reproducibility of results from medical devices such as scanners, biotechnology equipment, and laboratory microassays. The regulations for one diagnostic imaging machine alone (21 CFR 900.12) mandate 31 separate tests, many of which are affected by thermal performance, to ensure accuracy. A competitive diagnostic market makes exacting thermal control an even more important aspect of electronic design.

Designers typically have a narrow window of temperature change (?T) to work with, generally 10°C between the cabinet interior and exterior ambient temperature. Multiple heat sources, such as the device power supply as well as other discrete electronic components, can produce a total power output of 1200 W or more, with a potential heat load of 400 W of waste heat to dissipate. The desire for quiet operation complicates matters further by limiting fan size and speed.

These challenges are often best met through a heat pipe heat exchanger, in which heat is transferred from inside the equipment to outside the equipment via a heat pipe and is dissipated through a finned heat sink, where it is ejected to the ambient atmosphere. The large fin area of the heat exchanger and the efficiency of the heat pipes allow the use of smaller, quieter fans than would otherwise be required while meeting the stringent thermal demands of the regulatory and clinical environments. In some cases, heat pipe technology can be used on its own, allowing the laws of thermodynamics, rather than electronic devices or fans, to provide heat transfer.

A similar use of heat pipe technology is used to cool monitors found in critical-care monitoring devices. Here, a rack-mounted heat pipe assembly can provide complete thermal reliability with low maintenance. The lack of moving parts puts the heat pipe’s time-to-failure performance in the millions of hours, leaving virtually no chance of failure during a critical-care operation.

Assays and Sample Screening

Some of the most challenging demands for accuracy and reproducibility are associated with automated serum and urine screening assays. These devices use lasers and advanced optical systems to ensure complete calibration and measurement consistency across thousands of samples. These systems must be protected against heat produced by mechanical systems such as conveyors (to move samples and reagents) as well as other electronics and power sources.

Previous thermal management approaches for automated assays used TECs, which often dissipate heat inconsistently from the sides of a sample calibration area. However, a passive heat transfer approach relies on a copper thermal reservoir, moving heat through heat pipes into a finned heat sink. Extremely precise machining of the heat pipe groove or vapor chamber pocket is necessary, because surface roughness can reduce the efficiency of heat transfer. Precision machining minimizes the peaks and valleys profile (at the micron level) of surfaces, thus ensuring that heat transfer surfaces have maximum actual contact with each other. That reduces interface resistance and helps achieve the same levels of thermal control as thermoelectric devices. At the same time, passive systems also meet the challenge of consistent, isothermal performance.

 

A passive heat transfer approach relies on a copper thermal reservoir, moving heat through heat pipes into a finned heat sink.

Some automated assay devices provide the ideal settings for heat pipe assemblies, which are most commonly used in one of two different ways. In the first approach,  heat is moved by the heat pipe to a metal casing or other thermal sink. The heat then dissipates into the ambient air outside the casing. This is the simplest approach and has the benefit of flexibility because heat pipes can be manufactured in many different shapes and sizes to meet individual equipment needs. 

In other applications, a second approach, a heat sink with an embedded vapor chamber, using convective cooling, provides optimal isothermalization for more efficient cooling. This approach can deliver higher thermal performance than a traditional heat sink by alleviating spreading resistance found in solid heat sink construction, via three-dimensional spreading which produces lower device temperature and greater component reliability. It should be noted that this option might require changing the geometry of the heat sink and the electronic component’s base.

Heat pipe assemblies are not always feasible. Some large and powerful automated assay devices could require a centralized liquid cooling system in which hot air from inside an electronics cabinet is transported over cooling liquid. This method provides reliable thermal control but can be costly and space-consuming. There is also the potential for leakage and the need for maintenance to ensure optimum system performance.

Whichever configuration is chosen, assay devices generally require specialty engineered thermal components designed for extremely narrow ?T windows. Both assay designers and regulatory requirements often calculate the acceptable ?T and then narrow it further to provide an extra margin of safety. Heat pipes and other passive devices can also be used to cool design elements such as conveyors, with the heat being rejected to outside air using a thermal solution that features few or no moving parts.

Biotechnology and Research

Cycling devices to facilitate polymerase chain reaction (PCR) technology have emerged as real workhorses in biotechnology and research, but they can also produce impressive thermal management challenges. The device temperature must not only be kept at exactly the right range for efficiency, it must do so while cycling between hotter and cooler conditions thousands of times per minute to provide optimal conditions for PCR reactions to unfold. 

 

Passive thermal control systems offer 

simplicity, design flexibility, manageable cost,

and quiet operation.

PCR cycler thermal control has traditionally relied on up to six TECs. However, complex and expensive electronics and software are required to produce consistent thermal control across all TECs. Differing levels of degradation over time among the TECs can reintroduce thermal inconsistencies and prevent isothermalization.

A recent process developed for a PCR device manufacturer connects TECs to a vapor chamber via a graphite interface (using a proprietary method with 32 precision-drilled holes to mount the vapor chamber assembly base to thermoelectronic controllers) so that heat is dissipated consistently across three dimensional axes. This process provides instantaneous isothermalization that matches the constant fluctuation between hotter and cooler cycles, using the laws of thermodynamics in place of complex electronic algorithms. 

Surgical Tools

Vapor heat dissipation via small-diameter heat pipes contributes significantly to a forceps design used in procedures such as brain surgery. This design includes precise temperature control to improve surgical efficiency. Several experiments conducted by surgical products manufacturers have shown that when the temperature of cauterizing forceps exceed about 80°C, the tissue being cauterized tends to stick to the forceps during procedures. The forceps’ proprietary thermal design in this case employs active heat transfer to draw heat from the very small (1 mm diameter and smaller) forceps tip (and tissue). The working fluid is evaporated by the heat generated during cauterization. The vapor then travels to the coolest part of the heat pipe where it condenses releasing the heat to be dissipated more efficiently. The condensed fluid then returns to the forceps tip by capillary action, even if it must travel against gravity. 

Precision engineering on a micron scale makes this application of passive thermal technology possible. This surgical cooling system utilizes the smallest known mass-production heat pipe assembly (2.34 mm in diameter) to allow precise thermal control of forceps tips that range in size from 0.5 to 4 mm wide.

Conclusion

In the development of medical devices, passive thermal management is clearly a major factor in helping ensure the accuracy and advanced capabilities of today’s medical devices, and extending these capabilities still further. Passive thermal approaches also offer valuable advantages in terms of saving space, minimizing weight, and reducing maintenance costs, and they produce less environmental impact than cooling systems that rely on technologies such as pumped liquids. Because increases in electronic capabilities and computing power invariably produce increased heat to be dissipated, and because miniaturization is steadily reducing the amount of space available for thermal management, innovative thermal technologies will play a major role in the evolution of tomorrow’s medical devices. 

W. John Bilski is senior engineer for Thermacore Inc. (Lancaster, PA). John Broadbent, is sales and marketing manager for the company.