Medical Device Link.

REGIONAL FOCUS

It takes two, as the song goes. That can also be true in business. AK Industries Ltd (AKI; Hereford, UK) was part of Nalge Nunc International, headquartered in Rochester, NY, USA, until a buyout in 1996. Since then, it has been providing injection-moulded components and subassemblies to more than 50 industries. Over the years, competition from China, India and Eastern Europe has taken its toll. Demand for commodity plastic parts made in the Midlands was leaving, and it wasn’t coming back. To remain competitive, “AK Industries had to be creative and bring something special to the table,” says Allen Green, managing director. “Our relationship with Pera has been important in that regard.” The companies have collaborated on roughly a dozen projects, a number of which are medical related.

Applying Innovation

Pera was founded immediately following World War II to “improve the efficiency of UK manufacturing,” as stated in its remit. The Production Engineering Research Association, as it was called then, applied innovative technologies to production environments from its base at Loughborough University. It soon became apparent that the association would need more elbow room, and it moved operations to larger premises in Melton Mowbray. It remains there to this day.

Pera now offers UK industry a range of business and technology services and it has positioned itself as a programme manager for many UK and EU public-private initiatives. Two medical-related projects undertaken with AKI are indicative of how a combination of EU funding and a collaborative research and manufacturing partnership can inspire innovation.

Using Polymers to Make a Point

Needle-stick injuries are a surprisingly common problem in the developed world—some studies suggest that as many as one-third of hospital personnel may be affected—but they are arguably much worse in terms of consequences in emerging economies. The availability of sharps-safe containers is woefully inadequate in developing countries, where needle-stick injuries are a major source of infections of HIV and hepatitis B. One way to prevent the spread of needle-based infections is to develop a polymer needle, which can be easily destroyed after use either by physically blunting the needlepoint or exposing it to an open flame and melting it.

“This project initially was articulated around laser drilling,” says Green. “But as a project moves forward, you often discover that you need to adapt technologies,” he adds, and that is precisely what happened here. A manufacturing technique was developed that would allow a needle to be moulded with a 50-µm ID and 300-µm OD and a wall thickness of approximately 100 µm. Finding a suitable material, however, has proved to be problematic.

A liquid-crystal polymer was trialled, but the needle did not maintain sufficient lateral and longitudinal strength at the aforementioned wall thickness. Other materials were tested, including glass-filled nylon and PEEK, but none of them had the combined requisite properties. Serendipitously, a nonrelated nanoclay-filled polymer project, in which Loughborough University is partnered with AKI and Pera, may provide a solution.

The proper dispersion of clay platelets in injection moulding polymers can improve performance in specific applications. The Pera project aims to improve the preparation of nanoclays before they are blended with the polymer. One of the programme’s objectives is to develop engineering polymers that can replace metals in medical instruments, hence the possible use of nanoclay-filled polymers to fabricate needles. The theory soon will be put to the test.

The Talking Pill

Did you remember to take your meds today? That is an increasingly common refrain in an ageing and memory-challenged population. The Medi-Voice talking pill-wallet may have the final word on the matter. This EU-funded project, coordinated by Audio International Ltd (Moneymore, Co. Londonderry; www.audiointernational.co.uk), is designed to ensure that people are prompted to take their prescribed dosage of medication without having to rely excessively on doctors or pharmacy personnel. It will benefit especially the elderly, illiterate and sight impaired.

A rotating cam roller in the wallet allows easy insertion of blister packs containing the medication. The Medi-Voice not only reminds users when to take the drugs, it also keeps track of how many pills have been consumed and when. The device even reads back the prescription to the user as often as necessary and has a built-in USB connector to facilitate communication between the wallet and a computer.

A graphical user interface can be used to program prescriptions into the device as well as monitor patient compliance. The device specs were precise and challenging, notes Dr. Jo Love, Development Engineer, Polymers, at the UK Materials Technology Research Institute, which is part of the Pera network.

“The wallet had to be rated to IP-65 and could not weigh more than 130 g,” says Love. “It had to function in temperatures between 0º and 60ºC, withstand a 120-cm drop, and comply with the Waste Electrical and Electronic Equipment (WEEE) Directive. In fact, we had to adjust our design midway through the project to achieve compliance,” she adds. (The electronics originally were going to be encapsulated, but they were later modified to facilitate disassembly.)

Testing and validation was endless on this project, says Love. It involved everything from careful calibration of how the blister pack is inserted into the wallet to optimising keypad ergonomics for partially sighted and blind users. “A lot of failure mode effects analysis has gone into this project,” says Love, but she and other team members are now seeing a light at the end of this long development tunnel.

The product is currently in the preproduction prototype stage and, barring any unexpected delays, will be in mass production in two to five years.

Medi-Voice has the potential not only to improve the quality of life for millions of people, but also contribute to cost savings in healthcare. Taking into account the amount of time medical personnel spend explaining prescriptions to patients and the societal costs of noncompliance, “it has been estimated that we can achieve savings of €78 billion,” says Love.

Let’s Work Together

Once arguably the workshop of the world, the Midlands’ industrial tapestry has frayed. A few more threads will undoubtedly unravel under the effect of the current economic crisis. There are always opportunities for smart, nimble and skilled entrepreneurs such as AKI, however. In the following pages, we profile a small sampling of regional suppliers with skill sets that may be of value to medical device manufacturers.