2006 MEDICAL DESIGN EXCELLENCE AWARDS
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On the line was a Georgia neurosurgeon whose 14-year-old son was in a drug-induced coma at Children’s Hospital of Atlanta, his lungs damaged, his blood being oxygenated by a machine. Doctors were uncertain whether the boy’s brain was damaged, and needed confirmation of brain function in order to qualify him for a lung transplant. But his condition made moving him to another room for a CT scan too dangerous.
The father hoped Bailey’s CereTom mobile computed tomography scanner—which NeuroLogica loaded on an Atlanta-bound truck that day—could offer hope. Bailey himself was there to see the device in action. “I can say it was quite an emotional thing,” he says, adding that the scan showed the boy’s brain was functioning well. “At least now he qualifies for a lung transplant,” says Bailey. “There’s a chance this kid could live.”
The Medical Design Excellence Awards (MDEA) programme, organized by EMDM publisher Canon Communications llc, seeks to spotlight products like the CereTom. The programme, in its 10th year, considered the user, patient, and business benefits; design and functionality; and contribution to the advancement of healthcare of a host of products. Those deemed worthy of silver and gold awards by the programme’s judges, experts from across the medical spectrum, had to overcome a host of challenges to achieve their final form.
Simple Access to a Complex Device
For its scanner, NeuroLogica wanted more than portability. “NeuroLogica had some very clear ideas about what it wanted the user experience to be,” says Janice Archer, integration manager at Barco (Kortrikj, Belgium). “The scanner needed to be very uncluttered and simple to use, so that a wide range of people could operate it.” The advanced visualization software provided by Barco for the scanner and its Clarus workstation made that possible.
Barco’s 3-D application, called Voxar 3D ActiveX control, allows customers to design their own user interface, and the company offers a custom-solution service to assist in this process. NeuroLogica asked for a new functionality to be built into the software. It wanted to be able to perform CT perfusion scans, and the Barco team had to identify and implement the correct algorithms. “That was exciting for us . . . to go into a new area,” says John Field, senior director of engineering and custom solutions.
Complex Development Process Leads to Patient-Friendly Pump
For Debiotech (Lausanne, Switzerland), designers of the IVantage volumetric ambulatory infusion system, keeping the device simple for patients to use was a major goal. “We wanted to make it the smallest, most convenient, and easy to use ambulatory pump, compatible with every potential use in the hospital setting (meaning up to very large flow rates of 999 ml/hr),” says president and CEO Frederic Neftel, MD.
First, this meant designing a disposable cassette that was simple and safe for the end-user, yet still cost-effective to manufacture. In addition, the programmable pump’s menus had to be simple for caregivers and patients to understand. The pump is also remotely programmable, with nurses able to access the parameters and history of the infusion through a PDA device and having voice contact with the patient by phone.
“The development of the product took a long time,” says Neftel. “It became more and more obvious that to make it extremely simple for the patient meant a lot of complexity on the development side.” A transparent cassette incorporating the pumping elements, and a very quiet pump, provided extra patient benefits. “The most rewarding [result] was to see the patients able to use the device almost instinctively and tell us, ‘For the first time, I felt confident because I could see the pump working, while not being disturbed by any noise,’” he adds.
A Sticky Situation
For the Cleo 90 infusion set by Smiths Medical MD Inc. (St. Paul, MN, USA), which delivers insulin to patients with diabetes, one patient factor was getting the device to stay in place comfortably—a challenge presented to engineers at Precision Gasket Co. (Edina, MN, USA). Senior sales engineer Duke Schneider, director of manufacturing Daniel Harvey, and senior manufacturing technician Walt Mengs worked two years to develop the manufacturing processes for the adhesive-coated artificial skin that secures the device comfortably on the body.
“No one will easily duplicate this product,” says Schneider. The size and proximity of the cuts to be made, along with the fact that different depths are required for each, meant the product required a very difficult tooling design. Multiple layers of adhesives had to be cut to varying depths within one-thousandth of an inch—simultaneously from top and bottom—on an unsupported skin with no structural integrity. “Then, on top of that, the part is
very small and the wall thickness is very thin,” Schneider adds. “It was a lot of trial-and-error and tooling revisions and tooling designs. It’s a tricky little part.”
Overcoming the Fear Factor
Just knowing that an injection system is needle-free isn’t enough to quell patients’ fears. Which is why CrossJect S.A. (Paris) sought help from InterDesign S.A.R.L. (Paris) to make its single-use needle-free injection system more user-friendly. According to InterDesign managing director Marc Piel, other needle-free systems are already available, “but they all look like needles.”
Overcoming users’ initial apprehension in the face of something they have never seen before is a specialty of InterDesign. InterDesign worked very closely with CrossJect engineers, staying involved at every level. “The simplest products come from very extensive and detailed step-by-step analysis,” says Piel. “Good design is a lot of sense, and it’s not always easy to have good sense because you have to be as objective as possible.”
Designers from InterDesign helped guide CrossJect engineers to create a device that in no way resembles a traditional syringe, and is simple and safe enough for patients to use themselves. “Needles can cause injuries when used by nonprofessionals, and this product can’t,” explains Piel.
Because the system relies on a proven technology and is modular in design so that it can be used for various types of injections, it does not need to be redesigned, retested, or revalidated for each new application.
Picking the Right Plastics
To keep their regulatory pathway streamlined and get the eFlow electronic nebulizer to market more quickly, engineers at Pari GmbH (Munich) found themselves getting choosy about the plastics they would use. “The materials used in the device had to be common materials known by the regulatory bodies for similar devices,” says Geoff A. Hunziker, president of eFlow LLC, a Pari company. “We wanted to choose plastics that had a proven track record with aerosol delivery devices, especially our previously approved devices.”
This left a fairly narrow range of plastics, narrowed even further by the chosen FDA submission pathway. “As part of this journey of choosing plastics, we also had to use plastics that would allow us to submit to the device-only category under the premarket notification 510(k) approval process,” Hunziker explains, adding that using this process resulted in gaining approval in approximately seven months—an amount of time that is significantly shorter than what is typically necessary for combination products.
Another challenge the project presented was achieving harmony between industrial design and functionality. “Specific to aerosol devices, you can get into a conflict between what an industrial designer would think is visually pleasing, and the scientific performance of the device,” comments Hunziker.
Stefan Eckstein, of Eckstein Product Design (Munich), was hired as the industrial designer, with the proximity of the two companies facilitating strong communication. “There was just a great interface between the engineering team at the Pari Aerosol Research Institute and Eckstein Product Design,” says Hunziker.
Moulding in Micro
In the world of medical devices, “small” is “big” these days. And the OmniPod insulin management system from Insulet Corp. (Bedford, MA, USA) is filled with plastic parts so small they are best described as “micro.” To keep the device, which delivers insulin at preprogrammed rates to people with diabetes, small and light enough for patients to wear, plastic component manufacturer Phillips Plastics (Hudson, WI, USA) found itself faced with the challenge of “trying to get all of these small parts into a confined area,” according to business development manager Chriss Oseland.
Phillips uses a proprietary process called Micromolding, which it has been working with for about three years, allowing it to produce plastic parts as small as 0.002 to 0.06 g and metal parts as small as 0.013 to 0.375 g. One especially challenging component involved the two-shot moulding of a plateable-grade material and a nonplateable material. The plateable material was plated with a conductive metal designed to work with the circuit board of the device, and the plating was done in multiple areas in the part. “A very complex tool produces that part,” Oseland says.
Air In, Water Out
The Nucleus Freedom system from Cochlear (Lane Cove, Australia) needed a processor sufficiently small and light to be worn behind the ear, to interface with implanted electrodes to restore hearing to people with profound hearing loss. It also had to operate with a battery.
This isn’t unusual for hearing aids, but Cochlear also decided to make the device waterproof, presenting a challenge to designers at Helbling Technik AG (Liebefeld-Bern, Switzerland), which was in charge of the mechanical design of the external part of the product. Water had to be kept out of the device to keep from damaging its air batteries, while air had to be allowed in so that they could function. Helbling solved the issue by covering openings with a waterproof membrane that still allowed for airflow, according to partner Christian Peclat. The main external part of the device had to be connected to the user interface, and be robust as well as waterproof. “This is a very condensed system with a lot of functions,” says Peclat. “We learned to design in a very compact way.”
Another challenging part of the process was the fact that Cochlear is located in Australia, while Helbling Technik is based in Switzerland. “We had two, three, or four conference and video conference meetings per week,” Peclat says. “Obviously we had to wake very early, and our Australian friends had to stay up very late.”
A New Cold-Drawing Process
The manufacture of the Gynecare Prolift pelvic floor repair system from Ethicon Inc. (Somerville, NJ) led one of the company’s suppliers to develop a new cold-drawing process. Medi-Line S.A. (Angleur, Belgium) was faced with the challenge of developing the retrieval device used to facilitate the removal of the strap on a mesh implant used to correct pelvic organ prolapse. The company designed the manufacturing process and tooling.
The challenges were at two levels, according to Henri Decloux of Medi-Line. First, the blue Prolene monofilament that forms the loop had to withstand a specific load that could only be achieved by the orientation of the crystalline structure of the polypropylene material. The cold drawing process that is generally used forms monofilaments with small diameters. “In our case, to comply with its retrieval function, the monofilament needed a quite large diameter,” says Decloux. “Thus, we had to develop a special cold drawing process that allowed us to achieve a very high tensile strength while having a 0.9-mm-diam oriented filament.”
Second, it was necessary to join the two monofilaments under a heat-shrink tube. Here the challenge was to develop a process and equipment able to perform in a cost-effective manner, while ensuring the integrity of the crystalline orientation of the blue monofilament. This meant that maximum heat had to directed at the heat-shrink tube, without heating the monofilament. “Though we had theoretical knowledge of the plastic cold drawing process, we had never had the opportunity to experiment with it. It is probably why we faced the monofilament development with completely new eyes,” says Decloux.
Keeping Chemicals Uncompromised
The Afinion AS100 analyzer from Axis-Shield PoC AS (Oslo, Norway) is a benchtop multiassay analyzer for in vitro diagnostic point-of-care testing. The sensitive nature of the chemicals involved presented materials challenges for Carclo Technical Plastics (Mitcham, Surrey, UK), the firm in charge of adapting the design for manufacturing. “It was surprising how sensitive the chemistry was to different materials,” says Carclo sales director Martin Day. Thus the plastic for the cuvette, which holds the reagent within the test cartridges, had to be chosen carefully.
The firm settled on crystal polystyrene, a material that became available about five years ago, and so is still considered “brand new,” according to Day. “New plastics don’t come around very often,” he says. “Many of the materials we work with have been around 20, 30, 40 years.” The material presented tremendous advantages for this particular application. “It has very good optical properties, and very good moisture vapour performance,” says Day. “This meant that the manufacturer’s shelf-life target could be met.”
Separating Oxygen
To address the adsorption-related challenges in its Inogen One oxygen concentrator system—a portable device that concentrates oxygen from room air—Inogen Inc. (Goleta, CA, USA) turned to Adsorption Research Inc. (Dublin, OH, USA). “The challenge was how to make a small, lightweight, and therefore portable pressure swing adsorption (PSA) system that could deliver enough oxygen at sufficient purity for a patient having COPD,” says Adsorption Research president Kent Knaebel. “This meant keeping the adsorption part of the device small, and making it perform very well in order to meet the oxygen purity and quantity requirements.”
Though PSA has been used for more than 20 years to create home medical oxygen generators, “until recently, those devices were large and heavy, too much so for someone who suffers from chronic obstructive pulmonary disease (COPD) to move them,” explains Knaebel.
No matter how rewarding it is for them to overcome technical challenges, though, most people involved in the creation of medical devices also think about the human impact of their products. Like Knaebel, whose mother suffered from COPD before her death in December. “Thanks to Inogen, she was able to have a portable oxygen concentrator,” he says. “It gave her freedom. Knowing that many other people can get that sort of freedom is very satisfying.”
It’s Not too Soon to Start Thinking about 2007
Celebrating its 10-year anniversary in 2007, the Medical Design Excellence Awards (MDEA) programme recognizes the achievements of medical product manufacturers and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare.
The MDEA competition is open worldwide to companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging.
Located at www.MDEAwards.com, the MDEA Web site will be updated with information about the 2007 competition beginning this July. The standard deadline to submit materials is 18 December.
