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Articles from 2007 In May


Seized Shelhigh Devices Won't Be Released Yet

Shelhigh executives say the company's future is in jeopardy if it cannot export the seized devices. The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA's request to recall devices it already shipped to hospitals. That's not an indicator of being willing to settle, either.  

Contact Lens Firm Deflects Blame for Recall

But he didn't have a definitive answer, nor a sense of the recall's financial impact on the firm. Meanwhile, the New York Times speculates that this recall, combined with Bausch & Lomb's recall last year, could drive consumers toward disposable lenses, which don't need solution. While disposables make up 70% of the contact lens market in Asia and 40% in Europe, they are just 8% of the U.S. market. Let's draw this out one step further -- will we see a spike in laser eye surgery? It's not without risks, but, we are learning, nor is contact lens use. I'll be sticking with my glasses, thanks.

Another Contact Lens Solution Recalled

It found that users of the solution were seven times more likely to develop the infection than those who do not use it. A similar scenario last year caused Bausch & Lomb to recall one of its contact lens solutions. Ironically, one day before the recall announcement, Advanced Medical Optics expressed interest in buying Bausch & Lomb. It said it might try to trump a private equity firm's offer that B&L accepted earlier this month. B&L put itself up for sale after its bottom line and stock price took a beating over its recall.   FDA also states: "Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection, as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing, but Acanthamoeba is more difficult to treat."

Burr Hole Base Cap Supplies Security, Comfort for Neurological Procedure

ENGINEERING EXCELLENCE

Burr Hole Base Cap Supplies Security, Comfort for Neurological Procedure

Shana Leonard

Used in the treatment of movement disorders such as Parkinson’s disease, dystonia, and essential tremor, deep brain stimulation entails drilling a hole into a patient’s skull and inserting an electrical lead into it to a targeted area of the brain, which is then stimulated with electrical signals to alleviate symptoms. Lastly, the burr hole must be covered.

To perform the surgery, the patient’s head is numbed and immobilized through the use of a stereotactic head frame. Deeming the commonly used version of the head frame invasive, Image Guided Neurologics (IGN; Melbourne, FL; www.igneurologics.com) set out to create the Nexframe, a frameless version, to replace it. In the process of talking with neurosurgeons about the Nexframe, IGN discovered that the doctors were also unhappy with the cap currently used in the surgery to cover the burr hole after the lead was implanted—as were patients. After stumbling across this problem by accident, IGN was compelled to remedy it by developing StimLoc, an MDEA-winning sterile burr-hole cover.

“We identified very quickly that there was a product need both from the patient’s side and the physician’s side that needed to be addressed,” says Matthew Solar, vice president, engineering, for IGN.

Neurosurgeons complained that the existing cap was vulnerable to inadvertent lead dislodgment. This event could negate hours spent testing to find the “sweet spot” in the brain targeted for stimulation. And neurosurgeons weren’t the only ones disgruntled with the original design: Patients had to deal with the cosmetically undesirable protrusion from their skulls resulting from the large profile of the device.

Products implanted under the skin also can cause Twiddler’s syndrome in some patients, which is the repeated scratching of the device that potentially causes skin erosion or infection. This can be improved with a lower, more contoured profile, according to Solar.

Building on the current technique of plugging a stopper into a plastic piece, IGN modified the design to center on a base cap to cover the burr hole. The StimLoc features a base that mounts to the surface of the skull using two bone screws. After the lead is implanted and in the desired position, a secondary support clip snaps into the base and anchors the lead to prevent shifting. The lead is then folded over and a cap is snapped shut to further secure and protect the lead.

Physicians have confidence knowing that the lead will not dislodge, while patients profit from a contoured shape and low-profile design for a more comfortable and aesthetically pleasing device, Solar says. He maintains that the profile has been reduced by half from the original cap and is lower in profile than any other FDA-approved lead fixation device. Moreover, StimLoc enables repositioning, revision, or removal of the lead without causing damage.

“Medtronic (Minneapolis; www.medtronic.com) was the first company to have a product available for this market and they’re really the ones that invented the technology,” explains Solar. In an industry shrouded in nondisclosure and proprietary agreements, it is rare for a company to actually collaborate with an outside firm to improve upon a product—but that’s exactly what Medtronic did.

“They [Medtronic] were very open to helping us develop this product,” Solar says. “They helped us with identifying the proper materials to use that were compatible with the leads and supported us from a development standpoint all the way through the process. With that help, we were able to do it a lot more quickly than having to reinvent some of that stuff ourselves.”

IGN partnered with Vertex Technology LLC (St. Paul, MN) to design the components. Working together, IGN and Vertex developed the snap fits and the design for moldability of the extremely small and thin parts. Next, Reflex Medical Molding (White Bear Lake, MN; www.reflexmedical.com) was contracted to carry out the injection molding of the parts. Vertex collaborated with Reflex Medical to establish an approach that would allow the consistent running of parts and hold the tight tolerances necessary for the small snap features of the device, Solar says.

“We basically did all of the manufacturing part of it. They designed the part in-house, but we had some input on the tooling design,” says Tim Etters, chief operating officer of Reflex Medical. He adds that the precise tolerances and the need for maintaining consistent tolerances were challenges, but ones that were overcome.

After developing the StimLoc with input from Medtronic Neurological, IGN was acquired by Medtronic to complement its neurological device offerings, especially those for deep brain stimulation. Studies currently are being conducted that focus on using deep brain stimulation for treatment of additional neurological disorders such as depression, incontinence, and obsessive-compulsive disorder. If the studies yield positive results, there could be a significant expansion of applications in which the StimLoc is employed.

Copyright ©2007 Medical Product Manufacturing News

Company’s Combined Capabilities Tapped for Development of New Epidural Syringe

ENGINEERING EXCELLENCE

Company's Combined Capabilities Tapped for Development of New Epidural Syringe
Daniel Grace
When a clinician successfully locates the epidural space, the Episure AutoDetect syringe provides objective, visual confirmation.

When a medical device design requires both rubber and plastic molding, the manufacturer will usually have to go to separate manufacturing sources. Not so for Indigo Orb Inc. (Irvine, CA; www.indigo-orb.com), the designer of the Episure AutoDetect syringe. Its partnership with the Hi-Tech Group Inc. (Anaheim, CA; www.hi-tech-group.com) meant simplifying the process.

Formed three years ago, as a combined enterprise between Hi-Tech Rubber, Inland Technologies, and A.C. Hoffman Engineering, the Hi-Tech Group is unusual in the medical product manufacturing industry as a company that provides both rubber (or silicone) molding services and plastic molding services. The company engineered the plastic used for the barrel of the Episure AutoDetect syringe, and the rubber used as part of the plunger mechanism. The transition from low- to high-volume production was also managed, in part, by the Hi-Tech Group.

“With both injection- molded plastic and rubber capabilities, the Hi-Tech Group was able to support this project within the same company structure, easing burden on supplier management,” says Kevin Kirchner, a research and development product manager at Indigo Orb. The Hi-Tech Group eased the burden further with its project management concept, says Shubroto Chattopadhyay, a marketing manager for the Hi-Tech Group.

“The project management concept is very important to the company,” Chattopadhyay says. “The customer doesn’t have to call five different people to get the information he wants, rather, the company calls one specified person who then provides up-to-date information.”

The result of the collaboration is a device designed to address what Indigo Orb believes is a specific need in the natal labor and delivery area. With standard loss of resistance (LOR) syringes used for epidurals, there is subjective “feel” required of the anesthesiologist in determining whether or not the epidural space has been located. With the Episure AutoDetect syringe, the plunger automatically depresses when the needle enters the epidural space, providing an objective, visual confirmation. The syringe also allows the user to keep both hands on the epidural needle during advancement to provide greater user control and sensitivity than with standard LOR syringes, according to Indigo Orb.

An internal compression spring applies a precise and constant force on the plunger, regardless of the amount of saline drawn. The company believes the syringe improves safety by reducing the chance for dural punctures.

Kirchner credits other suppliers as well. “Apex Engineering (Torrance, CA; www.apexeng.net) was an essential partner for supporting the design and development of our injected-molded parts and developing bridge tooling,” he says. “Venture Manufacturing (Santa Clara, CA; www.vmgroupinc.com) played an important role in incubating the company, managing early prototype developments and regulatory approvals.”

Copyright ©2007 Medical Product Manufacturing News

Infusion System Promotes Safe Dispensing of Medication

ENGINEERING EXCELLENCE

Infusion System Promotes Safe Dispensing of Medication
Daniel Grace
The Symbiq infusion system dispenses medication precisely at a low level, a must for safe infant care.

There is always the chance of a mistake being made when medicines are dispensed through hospital infusion systems. Human error can result in the wrong medication or dosage being dispensed, or the pump mechanism can malfunction, causing a patient to receive too small or too large a dosage. To address the need for greater patient safety, Hospira Inc. (Lake Forest, IL; www.hospira.com) began planning and developing a device in 2003. Now completed, the Symbiq infusion system—the result of collaboration between Hospira, Minnetronix Inc. (St. Paul, MN; www.minnetronix.com), Design Concepts Inc. (Madison, WI; www.design-concepts.com), and others—has won a 2007 Medical Design Excellence Award (MDEA). The device is an electronics-based medication management infusion system that delivers and monitors infused (intravenous) patient medications.

Minnetronix was brought in on the project because of its expertise in systems design engineering and integration, says Rich Nazarian, company president. Founded in 1996, Minnetronix specializes in complete product development—design, engineering, and manufacturing—and exclusively works on medical products. Previously, the company has developed a cardiac recovery system, the cPax aneurysm treatment system, a neuromuscular electrical stimulator, and a total artificial heart. But it was Minnetronix’s experience with electronics related to infusion pumps that attracted Hospira. Hospira developed a new pump for the Symbiq infusion system specifically for use with electronic components, as none of its existing pumps had enough horsepower for electronic integration.

“We knew a lot going in about infusion pumps as far as the product needs and the possible problems that could occur,” Nazarian says. “Safety is critical, and [the Symbiq infusion system] is a complicated device.” Minnetronix ended up serving as an electrical design consultant on the project, and wrote some of the embedded code. Fluid control is vital, and the Symbiq infusion system avoids free flow, boasting a ±5% rate of accuracy across the entire delivery range, enabling hospitals to meet the needs of all care areas. The ability to dispense precisely at a low level is particularly important in providing safe care to infants.

Electronic control of the pumping system enables most of the Symbiq infusion system’s key safety features. The device software is not a stand-alone platform, but allows for the complete integration of medical management software when the device is connected to a network. The nurse or caregiver can look up patient information, medication information, and dosage guidelines on the device’s touch screen monitor, helping to reduce the chance of human error. The integrated drug library design allows hospitals to ensure compliance with their best practices in all medication programming sequences, and an event log feature allows practitioners to track medication risk events. Despite the abundance of features, simple programming was emphasized in the development phase to make the device easier for clinicians to learn to use.

Design Concepts—a product development and design company that serves several industries—was brought on the project to simplify the user experience further. The company designed the large, backlit LCD touch screen, which features large buttons, as well as graphics and text that can be viewed easily by a clinician with 20/40 vision.

Dave Franchino, president of Design Concepts, says that although the Symbiq infusion system is a “very clever device,” he emphasizes that it was not created in a vacuum. “Hospira located an area of care where they thought they could make an impact and difference,” Franchino says. “And they were collaborative and team oriented from the beginning with the companies and suppliers that contributed to the project.”

Copyright ©2007 Medical Product Manufacturing News

Diagnostic Tool to Detect Breast Implant Rupture

According to the article, the dime-sized RFID tag, called Novalert, fits on the back of an implant. If it senses a silicone leak, the device emits a signal. Upon a google search of "Novalert," there is a San Francisco-based start up company named Novalert Inc. Its limited Web site states that the company is developing technology to monitor and control implantable devices, with a near-term focus on aesthetics. It sounds like it could be related to the device discussed in the Times piece, but the connection hasn't been confirmed.

Industrial Designer Delivers Multifaceted Care Management Device

ENGINEERING EXCELLENCE

Industrial Designer Delivers Multifaceted Care Management Device
Daniel Grace
The Mobile Clinical Assistant enables online care management at the bedside.

When Intel (Beaverton, OR; www.intel.com) decided to commission a prototype for the Mobile Clinical Assistant (MCA), the company knew what elements it wanted to include and what it wanted the device to achieve. Conceived of as a point-of-care computer reference platform for use at the bedside, the MCA would manage the administration of medications. It would track patient progress. It would operate on a Windows-based system to allow efficient training and easy incorporation by hospital technology departments. It would allow nurses to spend more time with patients by increasing the efficiency of recordkeeping and information verification. It would increase safety by reducing human error. It would allow nurses to do their jobs on the move while staying connected. It would include built-in supplemental devices, such as a digital camera and a wireless stethoscope with recording capability. With that in mind, Intel went to Whipsaw Inc. (San Jose; www.whipsawinc.com).

“Basically, Intel handed us a pile of technology and said, ‘Put this together into a holistic package that we can sell,’” says Dan Harden, principal designer and founder of Whipsaw, an industrial design and product development company.

Though Whipsaw is relatively small in scale with 20 employees, and fairly new, having been founded in 1999, the company has already shown off its medical design capability.

Whipsaw previously won a Medical Design Excellence Award (MDEA) for the Optovue retina scanner, an imaging device used by doctors to diagnose conditions and diseases such as glaucoma, macular hole degeneration, and diabetic retinopathy.

But the development of the MCA, envisioned as a multifaceted care administration and delivery device to increase safety and efficiency, would present a daunting challenge to any company. Though an assortment of mobile hardware and software products are available to clinicians today, ranging from large computers-on-wheels with automotive-size batteries and bulky carts to more-compact laptops and personal digital assistants, none of these products are intended to be as all-encompassing for nurse work flow as the MCA.

Whipsaw’s prototype for the physical unit is smaller than most laptop computers. It has enough battery life to last through a nurse’s entire shift, a feature lacking in many of the other frontline medical technologies, and the battery can be replaced without turning off the unit. The MCA can be gripped or held from several different angles, allowing a caregiver to perform various physical actions while holding it. The prototype can be easily and repeatedly cleaned by wiping it down with alcohol, and it is drop resistant.

The MCA includes a bar code scanner and a radio-frequency identification (RFID) scanner. Bar coding is a common way for the healthcare industry to identify medications and patients (via wristbands), and MCA’s scanner serves as a safety tool for matching a patient with the proper treatment. Similarly, RFID technology is becoming widely used for clinical identification. Nurses can use RFID scanning to identify patients unobtrusively, as well as to verify themselves as the authorized caregivers. Harden is particularly proud of the digital camera that Intel asked to be incorporated. He describes Whipsaw as dedicated to developing products that are both mechanically functional and that appeal to users on the emotional level. The camera has the practical purpose of enabling clinicians to visually track the healing process, but it also provides patients with emotional relief, says Harden, to be able to see, through comparison, the progress of a wound or bruise injury.

Whipsaw’s work on the MCA extended to product testing. Whipsaw employees joined Intel employees in assessing the performance of the prototype in test studies. Whipsaw employees even posed as hospital patients during the testing period to get a better idea of how easily the unit could be integrated by practitioners in real-world healthcare settings.

Medical device development will continue to be a significant part of Whipsaw’s business, says Harden. The first product based on Intel’s MCA platform, the C5, manufactured by Motion Computing (Austin, TX; www.motioncomputing.com), is now ready for use.

Copyright ©2007 Medical Product Manufacturing News

Subpoenas Over Promotional Activities Continue

Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional "and other" activities. While not much details were given, it noted that the subpoena sought documents from Amgen's sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a device conference a couple of months ago told attendees that the government has been looking at these very same documents at device companies in efforts to find evidence of a violation. Their strongest advice--conduct audits and make sure you respond to them appropriately.

Blood Measurement Device Draws Praise for Ultrasound Use

ENGINEERING EXCELLENCE

Blood Measurement Device Draws Praise for Ultrasound Use
Shana Leonard
Using ultrasound technology, the UltraCrit hematocrit measurement device quickly and accurately evaluates the quality of a donor's blood.

Responding to the desire to help people, the temporary escape from work or school, or maybe just the free snacks afterward, blood donors are helping to save lives regardless of the incentive. But unfortunately, not enough people are finding that reason to sit down and roll up their sleeve. In fact, only 5% of eligible donors in the nation actually donate blood, according to the Mayo Clinic. Meanwhile, the number of transfusions increases 9% annually.

With donors so scarce, ensuring the quality of their blood is critical—that’s where the UltraCrit hematocrit measurement device comes into play. Manufactured by Separation Technology Inc. (Altamonte Springs, FL; www.separationtechnology.com) and developed by Key Technologies Inc. (Baltimore; www.keytechinc.com), the device is the only one of its kind that employs ultrasound technology to calculate red blood cell counts in blood donors. This novel screening method for the blood banking industry boasts a tolerance that is less than or equal to 0.4% hematocrit and has earned the device a Medical Design Excellence Award.

Equipped with a strong background in ultrasound technology, Key Technologies, a high-tech development firm, acquired some seed funding from the National Institutes of Health to pursue development of its brainchild. Though it typically drew most of its business from consulting services, the company took the reins in the design, engineering, development, and some testing phases of the project. Midway through the project, Separation Technology licensed the product and became involved with the remaining development tasks. As a player in the blood banking industry, Separation Technology was able to offer insight as to how the product should look, feel, and operate, according to Ben Lane, lead engineer and designer for Key Technologies.

Use of the device is simple: a technician obtains blood from a donor via a fingerstick or venous method. The sample is placed in a disposable cuvette, which is then inserted into the device. Within 20–30 seconds, the device interrogates the blood using ultrasound technology and yields a hematocrit measurement that is then displayed on the screen. The cuvette is ejected and thrown away.

“I believe the ultrasound approach is more accurate than the competition,” says Lane. “When we developed the device, the big competitors were centrifuge devices, which are inherently not as accurate, and optical devices, which are also not as accurate—or were not at the time.”

The ultrasound penetrates through the entire blood sample several hundred thousand times per second. This differs from optical and centrifuge devices, resulting in an accurate reading, according to Lane. He does point out that laboratory-grade equipment such as a complete blood count test (CBC), on the other hand, counts cells and is considered to be the gold standard of hemoglobin testing. However, Separation Technology claims that the UltraCrit has shown a bias versus a CBC better than 0.4% at three separate user sites.

In addition to the myriad technical challenges the team encountered in relation to ensuring the accuracy of the product, the material surface treatment of the disposable cuvette proved to be especially tough.

“It had to have very specific properties in order to work properly,” Lane explains. “We’re talking about very small amounts of blood, and when you get into very small amounts of fluid, the microfluidics that define how the fluid moves become very complicated.”

Key Technologies called on Conductive Technologies Inc. (York, PA; www.conductivetech.com) to assist with the material surface treatment of the cuvette. Having worked with them in the past, Key Technologies also consulted the company regarding some aspects of the microfluidics of blood flow. Input by CD Product Design (Columbia, MD) in the form of industrial design and user research and interviews rounded out development of the UltraCrit.

Copyright ©2007 Medical Product Manufacturing News