Pressure Mounts for Medical Device OEMs to Help Address Alarming Trend in Hospitals

Medical device manufacturers need to pay attention to the warning signs emerging from the clinical setting regarding the growing problem of alarm hazards. After all, FDA's indication that it would enforce 'increased awareness' of alarm fatigue and associated hazards, in addition to the topic's status as the top health technology hazard and subject of a recent medical device summit, seem to signal impending change. But will the industry be prepared?

Physiologic monitors, ventilators, infusion pumps, and dialysis units, among other medical devices, typically feature alarms designed to ensure patient safety. Despite their intent, however, medical device alarms are being blamed for an increasing number of adverse events that actually threaten patient safety. In fact, the nonprofit ECRI Institute even went so far as to name alarm hazards as the top technology health hazard of 2012. ECRI also notes that medical device manufacturers filed 216 reports with FDA between January 2005 and June 2010 that dealt with monitor alarm-related fatalities. Other sources report even higher instances, and some people believe the issue to be underreported.

Many of these alarm-related adverse events are attributed to a phenomenon called 'alarm fatigue.' At the Medical Device Alarms Summit convened by AAMI, FDA, The Joint Commission, ECRI, and the American College of Clinical Engineering last October, the diverse group settled on a definition of the issue:

  • Alarm fatigue is when a nurse or other caregiver is overwhelmed with 350 alarm conditions per patient per day.
  • Alarm fatigue is when a patient can't rest with the multitude of alarm signals going off in the room.
  • Alarm fatigue is when a true life-threatening event is lost in a cacophony of noise because of the multitude of devices with competing alarm signals, all trying to capture someone's attention, without clarity around what that someone is supposed to do.
  • Alarm fatigue is compounded by inconsistent alarm system functions (alerting, providing information, suggesting action, directing action, or taking action) or inconsistent alarm system characteristics (information provided, integration, degree of processing, prioritization).
  • Alarm fatigue is a systems failure that results from technology driving processes rather than processes driving technology.

In essence, according to a report detailing the event, "True clinically actionable messages are drowned out by a din of clinically nonactionable or self-correcting alarm conditions."

So, what's the solution? Of course, much of the work to be done to avoid alarm fatigue and associated alarm hazards has to be done at hospitals and in clinical environments. But there are several steps medical device manufacturers should take--and may eventually have to take--to minimize alarm fatigue and alarm hazards. Among them, according to the summit's participants, is the inclusion of a 'black box' in alarm systems in order to compile complete, standardized sets of data; improvement of alarm system integration; and increased emphasis on human factors. The latter, in particular, is critical to successfully minimizing or eradicating instances of alarm fatigue.

And if ensuring patient safety isn't motivation enough for medical device manufacturers to more carefully consider alarm fatigue when designing their alarm systems, perhaps the FDA's recent dedication to the issue will be. William Maisel, deputy director and chief scientist at CDRH, recently told the Boston Globe that FDA was addressing the issue of alarm fatigue by intensifying its premarket review process of medical devices equipped with alarms and providing additional training on associated standards and safety protocols to its reviewers. He also alluded to the potential for future guidance documents that would indicate a "significant changing expectation" related to alarm use in medical devices.

"[He] said the FDA is particularly focused on 'new alarms trying to measure new things,' such as alarms that monitor various physiological functions at once. Manufacturers of these devices claim that considering several parameters together allow them to better predict when a patient is in trouble. Many monitors measure just one function, such as heart rate and rhythm," according to the paper.

With the rapidly increasing awareness and concern for alarm fatigue, coupled with FDA's and other organizations' pledged commitment to the cause, medical device manufacturers should be heeding the signals and reevaluating medical device alarm systems. Otherwise, they might find themselves in an alarming situation of their own.--Shana Leonard

Tiny, Flexible Sensors Gauge Pressure

Flexible, transparent pressure sensor developed at UC Davis
Flexible, transparent pressure sensors invented by UC Davis biomedical engineers. Image: Tingrui Pan/UC Davis

A new kind of flexible, transparent pressure sensor developed at UC Davis for use in medical applications relies on a drop of liquid, reports the university's media office.

The droplet is placed in a flexible "sandwich" of polydimethylsiloxane (PDMS). The sensor acts as a variable electrical capacitor. When the sensor is pressed down, the sensing droplet is squeezed over conductive electrodes, increasing its capacitance.

"There's a huge need for flexible sensors in biosensing," said Professor Tingrui Pan, who led the research project.

He and his colleagues used the sensor successfully in measuring pulse in the human neck. The sensor also has potential for use in "smart gloves," giving physicians an enhanced ability to measure the firmness of tissues and detect tumors, and in "smart contact lenses" to monitor intraocular pressure without affecting vision.

Pan's research paper -- for which graduate students Baoqing Nie and Siyuan Xing and ophthalmology professor James Brandt served as co-authors -- appeared in the December 2011 issue of the journal Lab on a Chip.

The National Science Foundation gave partial support to the project.

You Need Human Factors Folks and Designers: Adventures in Medical Device Usability

You Need Human Factors Folks and Designers: Adventures in Medical Device Usability

Usability has been forcefully thrust into the medical device world by, among other things, recent developments at FDA, which, in turn, has meant that more usability experts are working in medical-device development. One thing you may have noticed about my fellow usability folks (i.e., human factors professionals) is that they are prone to whining that they “aren’t involved early and often enough” in the development of medical devices. They have a legitimate point—it’s not ideal to start worrying about usability when you’re doing summative usability testing (i.e., validation research) to prove to the FDA (and TUV and its kin) that your device is adequately safe.

However, not being a whiner, I want to turn this complaint on its head and address the opposite problem—not device design that doesn’t involve enough human factors research, but, rather, human factors research that doesn’t involve enough design.
The problem with human factors professionals is that, if left to their own devices, they are prone to:
  1. Going off on tangents.
  2. Reporting information in a way that’s ugly and inaccessible.

More Adventures
in Medical Device Usability

Why Old-Timey Radio Programs Could Create Better Alarms

The Myth of Brainstorming

The reason that we suffer from these character flaws, is that we human factors professionals typically have scientific backgrounds. And scientists tend to suffer from certain eccentricities:
  • They don’t like to work on your problems rather than their own.
  • They’re aesthetically challenged (just look at how they dress).
  • They actively avoid making anything accessible, starting with the language they use.
Yeah, I know, this is a cheap stereotype. The problem, though, is that, like many cheap stereotypes, there’s a lot of truth to it.
Which brings me to the antidote that I want to propose for this syndrome—partner human factors professionals with industrial designers. In addition to their more obvious function of designing devices, industrial designers are fully capable of keeping human factors professionals on track and of working with them to present information in a form that actual humans can use. I know it’s ironic that usability experts need help in making their own deliverables usable, but, all you have to do is sit through some of the paper sessions at the annual Human Factors and Ergonomics Society ( meetings to see what I’m talking about.
Just to make sure we’re on the same page, I’ve provided images of a typical human factors professional and a typical industrial designer (photos by iStock). Can you tell which is which?
The first role, then, of the designer, as a member of the human factors research team, is to help the human factors professionals focus on only those issues that have implications for device-design decisions. Without the designer’s help, the human factors effort is at risk of losing this laser-like focus and, thus, wasting time and money. The second role of the designer is to design the way information is presented—to use design tools to make complicated ideas easier to understand (particularly relevant when conducting contextual inquiry (real-world observational research), as mentioned in the FDA Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 6/22/2011) and to generally make deliverables look better, so that the rest of the team is more inclined to use them.
One interesting thing about designers is that they may be the last renaissance people. While the rest of the world has gotten more and more specialized—something those of us who work in the healthcare world are intimately familiar with—design, as a discipline, has remained resolutely catholic (with a small c). The designer has to know something about engineering, something about marketing, something about users, something about risk analysis, and so on, but not necessarily everything about anything. This makes the designer the “odd man out (sorry, but “odd person out” doesn’t quite work; I’m not implying that designers aren’t also women), the nonspecialist in a specialized world, the seeming amateur among the pros.
Except that now we’re all working in multi-disciplinary teams, and we need someone who can communicate across disciplines, giving the designer a particularly important additional role in device development. It also doesn’t hurt that the designer is the one who can stand up in the brainstorming session (see my previous posting about brainstorming) at the whiteboard and illustrate everyone’s ideas.
In sum, yes, it’s important for human factors researchers to be an integral part of the device design effort, particularly if you want to adequately address FDA requirements. However, it’s also important for designers to be an integral part of the human factors research effort. Based on what I saw this year as a judge in the MDEA awards, I would say that the device world has gotten the message that industrial design has a role to play in device development.

My point here is that designing devices, per se, is not the only thing that the industrial designer can contribute to a device development project (by the way, for a particularly interesting summary of the various roles the designer can play, see Chris Conley’s article in the DMI Review, "Educating Designers for Broad Roles in Organizations".  


Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.

Outsourcing Outlook: Electronics Manufacturing

Medical device OEMs can benefit from working with EMS partners with the technology expertise to start up new manufacturing lines quickly, perform final testing, and ensure that products meet appropriate standards, says Kathryn Olson, business development director, BIT MedTech LLC (San Diego).

Kathryn Olson BIT MedicalMPMN: What benefits do medical device OEMs derive from partnering with EMS providers?

Olson: EMS providers have extensive technology expertise, which significantly reduces OEMs' project risk and time to market. Partnering with an EMS provider to develop and manufacture medical devices enables OEMs to focus on what they do best: intellectual property, clinical trials, regulatory submissions, and sales and marketing efforts. And while it can be challenging for large medical device OEMs to implement a new manufacturing line cost-effectively or ramp up manufacturing when a technology takes off, EMS providers have experience at taking on new projects. They can respond quickly to changes in manufacturing volumes and can often manufacture devices more cost-effectively than can OEMs.

MPMN: What systems, expertise, equipment, and skill sets should the medical device OEM expect of an EMS partner?

Olson: An OEM should partner with an EMS provider that has the appropriate certifications, quality systems, supply chain, and technology expertise for the product in question. When introducing a new product, the OEM should also consider a contract manufacturing company that maintains an engineering support staff. An experienced supplier's engineering team can implement small changes to the design of a product or the manufacturing process, helping to reduce costs without erecting regulatory hurdles. It is also important for EMS providers to have experience performing final device testing, since testing can be technically challenging and the consequences significant if it is not performed correctly. Testing experience could include burn-in testing for electrosurgery devices or wet QC tests for IVD instruments.

MPMN: Are there changes to EMS requirements and regulations that medical device OEMs should be aware of?

Olson: Full-service EMS suppliers, which provide engineering as well as manufacturing of finished products, should be aware of the new IEC 60601-1 third-edition testing standard. After June 2012, EMS providers will be required to implement this standard in order to receive a CE mark and sell medical products in Europe. Although similar to the second edition, the new testing standard is risk-based, and the documentation required is significantly different from that stipulated in the earlier iteration. Upon bringing this change to the medical device OEM's attention, the contract manufacturer should be able to help the OEM to understand the third-edition documentation and testing required to receive a CE mark. For laboratory instruments, IEC 61010-1 third edition will be required in 2013.

Cirtronics PCB ManufacturingFull-service PCB manufacturing
Specializing in PCB surface-mount, through-hole, hybrid, box-build, test, and fulfillment services, Cirtronics Corp. provides a range of offerings, from individual PCBs to completely assembled and tested systems. Offering turnkey medical product manufacturing services, the ISO 9001:2008-certified PCB contract manufacturer operates a 175,000-sq-ft facility that provides complex product builds, low- to medium-volume production runs, high-mix assembly types, and quality assurance services. The full-service manufacturer also specializes in the fabrication of components for Class III medical products.
Cirtronics Corp.
Milford, NH

Stellartech electronicsElectronic medical technology
A manufacturer of electronic medical technology uses radio-frequency energy, low-frequency ultrasound, high-frequency focused ultrasound, high-voltage x-ray, microwave, and cryogen to manufacture electronic medical systems that deliver these energy modalities. Employing electronic, electromechanical, user-interface, and software systems, Stellartech Research Corp. specializes in Class II and Class III medical instruments and 'smart' disposables. It makes finished, clinic-ready devices for atrial fibrillation ablation, esophageal ablation, vein ablation, and pain management. Its facility also houses a controlled environment for the manufacture of energy-delivery catheters, surgical tools, and other sterile devices. The company also provides fabrication, product assembly, final test, packaging, and postproduction support as part of its contract manufacturing services.
Stellartech Research Corp.
Sunnyvale, CA

Electronic Technologies InternationalPCBs, wire harnesses, and box-build assemblies
Specializing in low- and medium-volume assembly projects with a moderate to high degree of complexity, an electronics service provider manufactures printed circuit boards, wire and cable harnesses, and box-build assemblies. Electronic Technologies International Inc. concentrates on design, layout, prototype, programming, testing, reengineering, and burn-in services. It also offers revisions, material selection, ball-grid arrays, x-rays, and RoHS-compliant components, relying on design for manufacturing and design for test practices.
Electronic Technologies International Inc.
Fort Atkinson, WI

Inovar EMSElectronics design and manufacturing
Employing cell-based lean production techniques to optimize efficiency, a contract electronics manufacturer can assemble complex medical electronic devices in its ISO 13485:2003- and ISO 9001:2000-certified facility. Inovar Inc. supports medical device OEMs by providing design and layout, design validation, design for manufacturing, PCB assembly, and testing and test development services. It can also perform rapid prototyping of any PCB assembly. About 30% of the business is devoted to box-build services and system integration.
Inovar Inc.

BIT MedTech electromechanical instrumentationElectromechanical instrumentation
BIT MedTech LLC, a full-service outsourcing partner, provides turnkey design, development, and manufacturing of electromechanical instrumentation to the medical device industry. Focusing on finished goods manufacturing--including box builds--the FDA-registered and ISO 13485-certified company designs and manufactures Class I, II, and III medical devices. Its engineering capabilities cover all major medical device disciplines, including fluidics, thermodynamics, motion control, optics, photonics, and radio-frequency engineering.
San Diego

Rep. Markey Calls for Closure of Dangerous Medical Device Loophole

Congressman Edward J. Markey (D-MA) released a comprehensive new report titled, “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices.” Markey’s report highlights the federal loophole that requires FDA to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect. This loophole in the 510(k) device approval process has enabled a number of defective products to enter the market and cause serious harm, and in some cases even death. Markey was joined in the release of the report by a victim of a serious injury caused by such a device and a consumer advocate who both understand the devastation caused when defective medical devices are implanted in unsuspecting patients. Markey introduced H.R. 3847, the Safety Of Untested and New Devices Act (SOUND) of 2012, to close this regulatory loophole and ensure that new medical devices are not cleared by FDA if they are based on an product that was recalled because it caused serious harm to patients.
“The 510(k) process should really be called ‘510 pray’ since patients should hope and pray that the medical device implanted in them won’t cause serious harm,” said Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over FDA. “The SOUND Devices Act closes a major loophole in the current 510(k) device approval process. I will fight to include this bill in FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects.”
A copy of Rep. Markey’s report, “Defective Devices, Destroyed Lives,” can be found at his website.

Manufacturing Systems Today: Test, Measurement, and Inspection

OGP benchtop metrologyBenchtop metrology system
Optical Gaging Products (OGP) offers medical device manufacturers high-speed measurement and QC capabilities with the SmartScope Specialist 300 benchtop measurement system and companion Kotem SmartProfile 3D GD&T analysis software. The noncontact video and multisensor metrology system verifies the critical dimensions of such medical parts and products as prosthetic joints, implants, syringe components, and flow components with micron-level accuracy. It features x-y-z travel of 12 × 12 × 10 in., machined-in axial straightness and perpendicularity, and a patented twin-Z elevating bridge for structural integrity. Telecentric motorized zoom optics, a high-resolution gray-scale camera, narrow-band green LED surface and profile illumination, and sophisticated image processing together produce sharp images scarcely affected by variations in part finish. In addition, a system configured with a special miniature probe can access tiny features on delicate microparts while one equipped with an optional through-the-lens laser can map complex surface contours.
Optical Gaging Products (OGP)

Microminiature borescope
Available in flexible and semirigid models, the Micro borescope from Lenox Instrument Company, Inc. delivers a cleLenox Instrument boroscopear, bright image in close-range inspection of medical devices such as coronary stents; tubing; electronic and mechanical assemblies; and micromolded, machined, and cast parts. It is optimized for use in applications in which access is limited and the insertion point is only a few millimeters in diameter. Provided in diameters down to 0.02 in. and in standard lengths of 4 in. to 50 ft, the borescope can be supplied in other lengths and custom configurations as well. Featuring a focusing eyepiece and a fiber-optic bundle that provides good resolution, the product can tolerate tip deflections and moderate bending owing to its rugged design and durable construction. All models are video- and digital-adaptable, allowing users to view and record real-time or still images and store them for reference. The borescopes are compatible with the manufacturer's color video systems and light sources.
Lenox Instrument Company, Inc.

Cincinnati Sub-Zero test chambersEnvironmental testing chambers
Environmental chambers suited for performing accelerated-aging, stability, reliability, and other temperature- and humidity-exposure tests on a range of medical devices and packaging are available from Cincinnati Sub-Zero. Available in versions covering temperatures from -73° to 190°C with humidity selectability from 10% to 95% RH, the test chambers are offered in sizes ranging from small benchtop units to walk-in rooms. Standard chamber features include the manufacturer's touch screen controller, remote control and monitoring, data logging, alarm notification via e-mail or text message, a data file backup system, full system security with audit trail files, and digital signatures. Among the various test standards the chambers satisfy are such specifications as ASTM F1980 for accelerated-aging and ICH Q1A guidelines for pharmaceutical stability testing.
Cincinnati Sub-Zero

Digital measuring machine
The QVI Snap full-function, benchtop noncontact digital measuring machine from RAM Optical Instrumentation Inc. is desigEAM Optical measuring machinened for ease of use, speed, and accuracy in measuring a variety of medical parts. With telecentric optics that offer a 78-mm field of view and a large focal range, along with a worktable that can be adjusted vertically within a 75-mm range of travel, the machine can accommodate a variety of products, including hypodermic needles, medical tubing, implant components, and flow-control products. A digital megapixel camera provides high-definition video images with potential subpixel resolution of 50:1. In addition, advanced image processing allows the user to zoom in on any part of the field of view to isolate and measure small component details with resolution as high as 50 nm. Three all-LED lighting systems are included with the system: a substage profile light, coaxial surface light, and programmable eight-sector multicolor ring light. Intuitive 2-D metrology software with part-recognition capability provides a comprehensive choice of feature measurements and allows routines with an effectively unlimited number of measuring points or measurement steps.
RAM Optical Instrumentation Inc.

Imada test standMotorized test stand
The EMX-275 vertical motorized test stand from Imada Inc. has a precision stepper motor and a ball screw drive that provide precise movement and smooth operation. The stand's rigid construction ensures minimum deflection and thus consistent application of force and distance for reliable compression and tension test results. Its program dial and menu screens for controlling distance, mode, speed, time, and cycles are designed to facilitate the setup of destructive, fatigue, and nondestructive tests. Other standard system features include a speed range of 0.01 to 23.5 in./min, maximum force of 275 lbf, a timer programmable in 0.1-second increments, a jog-movement control that moves the crosshead precisely in 0.01-mm increments, and a cycle counter. Force gauges are available for performing force-controlled nondestructive tests. The product is suited for pull and shear testing of components on circuit boards; spring testing for tension and compression; puncture and burst testing for IV bags; safety seal peel testing; and adhesion-strength testing of adhesives.
Imada Inc.

Bioabsorbable Magnesium Provides Temporary Strength and Stiffness to Next-Gen Orthopedic Implants

The rapidly expanding use of orthopedic implants engineered from bioabsorbable polymers has, in many cases, dramatically improved patient care by eliminating the presence of 'temporary' medical devices long after their function has been fulfilled. But a number of orthopedic devices require or would benefit from high strength or stiffness properties that current bioabsorbable polymers simply can't provide. Catering to this niche need, nanoMAG LLC (Livonia, MI) has developed a lightweight, high-strength magnesium alloy technology capable of reabsorbing safely into the body as the healing process is completed.

Nanomag Bioabsorbable Magnesium
A bioabsorbable magnesium techology developed by nanoMAG provides temporary support during the healing process and is safely absorbed by the body.

Building on 20 years of experience working with magnesium, nanoMAG has developed a specially milled, bioabsorbable magnesium technology that can be provided in specialty chemical compositions, tailored to meet customer requirements, and produced in short runs. More importantly, however, the material addresses several unmet market needs for orthopedic implant applications.

Current polymer-based orthopedic implants, for example, often lack the hardness and durability required for strong structural support as well as properties that promote bone on-growth for rugged fixation of the device, according to Stephen LeBeau, nanoMAG president. Traditional metallic implants, in contrast, may offer the necessary support, but remain permanently in the body. Combining the best characteristics of both materials, bioabsorbable magnesium is engineered to provide the temporary structural reinforcement required for optimal healing without the burden and limitations of a permanent implant.

In addition to being biocompatible, magnesium can promote bone growth and healing, LeBeau states. "[Magnesium] has reasonable strength to density compared to other [metallic] materials, such as titanium and stainless steel," he adds. "If you look at matching the density and stiffness of materials to bone, however, this [technology] is a closer match to bone than any other material out there in terms of structural reinforcement."

And while some experts might argue that the ideal implant material would be stronger than bone, LeBeau disagrees. "We actually think that our technology will promote bone regrowth and healing better because it will be degrading and absorbing in the body as it's supporting the bone structure." LeBeau speculates that, by dissolving over time in a controlled manner, the material may help to prevent bone from relying on a permanent implant, thereby prompting the bone to support the load as it gradually heals.

Such characteristics could enable the development of novel bioabsorbable devices for a range of orthopedic areas, including trauma, pediatrics, sports medicine, and craniofacial applications. Bioabsorbable magnesium could also potentially replace polymers in applications that require navigation through narrow or tortuous areas of the anatomy, providing comparable mechanical reinforcement properties with a smaller-diameter cross section to avoid causing trauma.

Before it can contribute to the development of such innovative products, however, nanoMAG must face the long, hard path to FDA compliance. "We've received some interest from the medical device industry, and we'll see if there's some way to leverage existing products that are similar--staples, for example," LeBeau states. "We want to tackle something fairly simple at first, get it to first man in testing, and then talk about more-advanced devices and applications."

Exclusive: Noted Inventor Thomas Fogarty, MD Shares Insights on the Crux Inferior Cava Filter

Exclusive: Noted Inventor Thomas Fogarty, MD Shares Insights on the Crux Inferior Cava Filter

Famed inventor Thomas Fogarty, MD, who is the founder of Crux Biomedical, was recently awarded the MDEA Lifetime Achievement Award.
The Crux retrievable inferior vena cava filter (VCF) represents the first significant innovation in vena cava filters in 40 years. Crux Biomedical designed the device to overcome problems associated with retrievable VCFs, including tilting of the filter, device migration, fracturing, and retrieval difficulties.

To address these problems, the Crux VCF features a self-centering design in the inferior vena cava to prevent filter tilt, which avoids complications that make retrieval of the device difficult. In addition, the device supports bidirectional retrieval to enable it to be removed from either a jugular or femoral approach. The device also offers tissue anchoring that provides fixation in the presence of large clot burden without perforating the wall of the inferior vena cava.

The safety of the device is supported by a recent study presented at the Society of Interventional Radiology meeting, in which the VCF achieved 98% success in filter deployment and 98% success in attempted retrieval. In the study, the average retrieval time was 7 minutes. The average filter retrieval was attempted at 83 days with a range of 6 to 190 days.

To gain some perspective on the device, MD+DI editor-at-large Brian Buntz spoke, in a one-on-one interview, with Crux founder and noted device inventor Thomas Fogarty, MD. Fogarty is a cardiovascular surgeon and a former Stanford University professor who has also been inducted into the Inventors Hall of Fame.

MD+DI: I was wondering was whether you can give me some perspective on the development of the device and how its unique design came about?

Fogarty: We had observed that available vena cava filters weren’t working as well as they should be. And that was further reinforced by an FDA alert issued in August 2010, which cautioned industry that there were some serious problems with defects with the current filters on the marketplace. That reinforced the need to do something better with regard to vena cava filters.

We started about seven years ago addressing the problems. A group of engineers, Frank Arko, MD and myself got together and essentially came up with a design that specifically addressed the existing problems point by point.

Those problems were that you often had penetration of the cava wall, which obviously led to significant complications—sometimes fatal hemorrhages because the device went into the aorta. The other complications were penetration to adjacent organs such as the small bowel and the fact that the filters tilted—in other words, they didn’t go in a straight line as they were designed to do.

Vena Cava filterThe existing technology, virtually all of it, is based on a concept that was introduced about 40 years ago. Those devices are built like a tent: you have an apex and a base. And sometimes on implantation, that base would tilt and push the apex of the device into the cava wall. It would essentially grow into the cava wall. Because it tilted, the base was on an angle so emboli would get by. And when the tip grew into the cava wall, it made it virtually impossible to remove it.

Those were the problems that we identified and addressed. We did all of the bench testing, durability testing, animal testing, cadaver testing, a clinical trial, and submitted to the FDA.

MD+DI: Do you think this filter has the potential to be a revolutionary product? If so, why?

Fogarty: It is certainly going to cause a major paradigm shift. From an acceptance standpoint, when you have a new product on the market that addresses all of the problems that the prior products have, physicians recognizing that will use the newer product for many different reasons. One of them is they want to do a better job for the patients. Another compelling reason: if you use a product on the marketplace, and the FDA has made public observations about it, there is a pretty strong legal incentive to use the newer product.

MD+DI: The device has been submitted to the FDA via the 510(k) pathway. Can you help me understand why the 510(k) pathway was used for this device rather than the PMA route? What kind of product is it substantially equivalent to?

Fogarty: Well, it is substantially equivalent in terms of intended use to products currently on the market. So, FDA clearance depends on that. But the fact is that all of the other devices required clinical trials. We did a clinical trial that is larger than any other that had been done for this type of device.

MD+DI: Can you explain the importance of the bidirectional retrieval?

Fogarty: You need bidirectional retrieval and bidirectional delivery.

Let’s talk about delivery first. You can deliver this from the jugular vein in the neck or you can deliver it from the femoral vein in the leg. Sometimes, because there is a lower injury to the pelvic area, it is dangerous to access from the femoral approach or you just can’t do it because it may not be accessible. So you need access to the jugular, which is the conventional way these filters have been delivered for a long, long time.

Sometimes, you do not have access to the jugular for a variety of reasons. For instance, the patient may have a pacemaker, which often is placed through the jugular. So delivering a device through the jugular, when you have pacing leads there, can be dangerous. In that case, you want to be able to deliver that from the femoral vein.

The same is true of bidirectional retrieval: it gives you many more options than we used to have. And that provides more safety.

MD+DI: Does Crux Biomedical have plans to target conditions other than pulmonary embolism?

Fogarty: We actually are in a process of developing another application of the same technology, which is related to the distal protection during endovascular placement of aortic valves.

Now, when aortic valves are put in through a catheter system, the largest complication is stroke due to breaking off of material from the valve that you are replacing. Obviously, that is not good for the patient.

The same technology that is used in this vena cava filter has the capability of preventing this material from breaking off and going to the brain and causing strokes. So far, all we have done is the animal testing to show this, the bench testing, and cadaver testing. We are going to have to do a clinical trial and we have begun to initiate that effort.

So, there are going to be two very significant applications of this technology.

The footage below shows the deployment of the Crux inferior vena cava filter:


The footage below shows the retrieval of the filter:

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

New Prefilled Insulin Injection Pen

This new prefilled insulin injection pen has a unique spring-loaded mechanism. The pen has a no push-
button extension at any dose and a low injection force, designed to make self-injecting easier for people with diabetes. Manufactured by Novo Nordisk A/S (Hillerød, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, UK).


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Vibrance Kegel Device

The Vibrance Kegel Device provides active biofeedback and audio-guided interval training to assist women in performing pelvic floor exercises correctly. Manufactured and submitted by Bioinfinity (M) Sdn Bhd (Kuala Lumpur, Malaysia).

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