Keeping it simple is a complicated process, but it can also be rewarding. The AtomoRapid in vitro diagnostic (IVD) test platform from Atomo Diagnostics (Sydney) is a case in point: Not only did it receive a gold award in the IVD category of the Medical Design Excellence Awards, which were announced in New York City on June 11, 2014, it was also named best in show. Why? At least partly because the company engineered out inconvenience and potential user error from the device.
Medical device companies have made inroads in usability that IVD manufacturers would be well advised to emulate, says Atomo Diagnostics CEO John Kelly. "Many of the usability features we built into the AtomoRapid were transferred from the medical device industry," he told PlasticsToday during an interview prior to the awards ceremony. "It's a fully integrated device that replaces the all-too-common 'bits-in-a-box' test kits that are not intuitive and do not perform as well as lab tests. The lancet and blood-collection system are built into our test kit, and it is sequence-based, meaning that it only allows the user to go through the steps in the correct sequence," says Kelly. Building in those features and hiding the engineering complexity from the user was an arduous process, but it was needed for a device that was designed with self testing in mind. "Diagnostics companies need to be more user focused," adds Kelly. "They are missing the transition to home-based testing."
Ensuring access to the device in the developing world was an important goal for Atomo Diagnostics and its design partner IDE (Sydney). Consquently, cost was a significant factor. "Molding and materials are a large cost component for us," says Kelly. In addition to being affordable, the materials had to be easily accessible throughout the world, he adds. Finding appropriate materials for the application turned out to be more taxing than Kelly had anticipated.
Materials sourcing took several months, and it's an experience that Kelly does not remember fondly. "It's important to us that the product be manufactured locally," says Kelly, citing benefits in terms of local employment, logistics, and the company's overall carbon footprint. Needless to say, the device also had to meet rigorous medical requirements.
"The blood collection element had to have high capillary performance," explains Kelly, adding that the device's shelf life also was a key consideration in choosing materials. "We investigated postmolded coatings, but that added in too much cost, and we tried high glass fiber, but that turned out to be too brittle," he explains. The company settled on ABS for the housing; Kelly would not say which material they chose for the blood collection assembly. But he does have a few choice words for materials suppliers.
"I would suggest to materials companies that they have samples available. In some cases, they needed a 14-week lead time to send us a very small sample! My feeling overall is that they are not customer friendly," says Kelly.
The company launched its first AtomoRapid test for HIV in South Africa earlier this year. A test for malaria on the same platform will be available in a couple of months. Clinical trials are scheduled in Europe later this year, and, while in the United States for the MDEA ceremony, Kelly is meeting with potential partners.
The AtomoRapid platform also is available to diagnostic companies on a contract basis, and the company is currently working on apps for the tests.
To see the device in action, check out the video below. And for a glimpse of the other MDEA gold winners, see our slide show: Medical Design Excellence Awards 2014: And the gold goes to . . .