Medical Device Link.

REGIONAL FOCUS

Clamason Industries Ltd

Riding the automotive and IT roller coasters in the 1990s left Clamason Industries Ltd (Kingswinford; www.clamason.co.uk) feeling a little woozy. “After having lived through these boom-and-bust cycles, we decided 15 years ago that we would no longer rely on any single industry,” says Timothy Jones, Business Development Manager. “Today, our largest customer represents 13% of our turnover,” he notes with satisfaction, before adding that the med-tech industry represents a cornerstone of the company’s diversification strategy. “By 2010, medical manufacturing will be our biggest financial contributor. Right now, that sector is neck and neck with automotive,” says Jones. It makes for a good fit, he adds. “To be successful in making parts for cars, you have to prove that you can make it right. When you are supplying components to medical device manufacturers, you have to prove that you can prove it.”

Operating presses ranging in tonnage from 5 to 250 tn, Clamason can produce metal parts to tolerances as small as 50 µm in as little time as one-tenth of a second. Approximately 90% of the pressings that come out of the facility are less than 2 mm thick; technically complex parts typically are produced in medium to high volumes.

One medical project where the company contributed its expertise culminated in the SoloStar insulin pen from Sanofi-Aventis. Clamason developed an indexing washer that is used in the device and that it currently manufactures in a production cell that meets US FDA and BS/EN 13485 quality system requirements. The washer is the only metal part in the device with the exception of the injection needle.

Originally, the washer was going to be made of plastic but the decision was made to shift to metal early in the product development cycle. That illustrates a point that Clamason takes great pains to make, as it constantly reminds customers not to summarily dismiss metal during the material selection process. “You end up with lots of plastic parts these days because that is what young engineers understand best,” says Jones. “We are asking the design community to think it through and not have this knee-jerk attitude to immediately choose a plastic material for an application.”

The indexing washer is designed to sit tightly within the grooves of the mating plastic, enabling the SoloStar user to accurately dial and dispense the correct dosage of insulin. The washer flattens during the dispense cycle before returning to its original shape in preparation for the next cycle. This operation is repeated several times, hence the need for a hard and thin stainless steel.

This project is emblematic of how Clamason likes to approach an application, notes Jones. “The insulin pen started life as an engineering product. In essence, it’s a clutch,” he says. “That’s where we see our potential for growth: engineering solutions for medical problems.”

Maxell Moulding Services

The first Japanese company to set up shop in the Telford area, Hitachi-owned Maxell (Apley; www.maxellmms.eu.com) inaugurated an 18,400-sq-m plant in 1984 to produce VHS cassettes. More than 400 employees worked at the facility during its prime; as the analogue recording media market contracted, so did the workforce. “We had a dilemma: what to do with all of this spare manufacturing capacity,” says Geoff Gamage, New Business Development Executive. Armed with a range of injection moulding machines that had been used to make components, shells and cases for multimedia products, Maxell Moulding Services (MMS) was launched in 2002. The medical market was an immediate target. “The number of moulding machines at our disposal and our familiarity with clean manufacturing principles [because of its experience in handling magnetic recording tape] made contract services for the medical industry an obvious outlet,” says Gamage.

The company has more than 900 sq m of cleanroom space, which is equipped with ultrasonic cleaning baths and blister and pouch sealing machines. ISO Class 8 and Class 7 facilities are available. “The Class 7 cleanroom was set up for the production of the short-lived MiniDiscs in 1998,” explains Gammage. “For most companies, the Class 8 cleanroom is adequate.”

MMS ceased working for Maxell last year and is now devoted exclusively to providing contract services for OEM customers. On the medical side, the company has been involved in the development and moulding of the J Hook, a novel device that is designed to safely hold IV bags on the curtain rails of hospital beds, and the production of moulded assemblies for foetal-scalp electrodes. MMS is currently involved in the moulding (and potential assembly) of parts for a safety syringe that, says Gamage, could result in huge production quantities.

DCA Design International

Design bureaus tend to be quite stylish—they are, after all, an advertisement of sorts for the firm’s core activity—and DCA Design International (www.dca-design.com) is no exception. This warren of corridors, offices and meeting rooms occupies a significant tract of real estate in the heart of Warwick. It has grown through accretion over more than 50 years, and not necessarily in a straight line. As you navigate the various passageways, tactful reminders of the company’s illustrious heritage come into view. There is the Stanley knife, of course, along with the BT phone booths. Equally, if not more, important than those iconic products, however, are the devices the company has designed for medical applications. In fact, healthcare products and scientific instruments represent more than 50% of the company’s business.

Its medical device design services cover every step of the process including formulation of the product direction and concept creation as well as full design and development. “We have a remarkable breadth of expertise among our staff, from ergonomics and aesthetics to mechanical engineering and electronics,” notes Managing Director Robert Woolston. This allows the firm to knit together teams with skill sets that are perfectly aligned with a given project. Special emphasis is placed on the creation of a robust design in which risk is mitigated.

A strong evidence-based design philosophy is a fundamental DCA hallmark. Woolston cites the SoloStar disposable pen injector as an example of how such an approach leads to highly successful device design.

“The SoloStar was a three- to four-year development project,” says Woolston. “We were involved from the outset and supported Sanofi-Aventis all the way to production. The product specifications were rooted in evidence-based research, he adds. “For example, a great deal of time was spent analysing the optimal pressure to apply to the dose button and creating a mechanism to reflect this.”

In recognition of its safe and robust design as well as its visual appeal, the injector is part of the permanent Design Collection of the Chicago Athenaeum: Museum of Architecture and Design in Chicago, IL, USA.

DCA has been a key partner in the design of many medical products from drug delivery and diagnostic systems to surgical devices and prosthetic limb controllers. Certified to ISO 13485:2003 and ISO 9001:2000, the company is equipped with prototyping and testing facilities and has a global supplier network of toolmakers, manufacturers and equipment producers. “We typically deliver highly demanding, strategically important and technically complex projects with significant risk control and transparency,” notes Woolston.

Ceram

“Everything that can be measured on a stent has been done here,” says Richard White, Senior Manager, Ceram (Stoke-on-Trent; www.ceram.com). Ceram researchers notably have developed expertise in characterising a stents surface topography, determining the distribution of actives and excipients and providing a depth profile of the active ingredient within the coating. Not surprisingly, the location has earned the nickname Stoke-on-Stent. But evaluating the tiny scaffolds, be they bare metal or drug eluting, is only the tip of the expertise available here. Ceram provides a range of medical device materials analysis, testing and consultancy services.

In addition to evaluating the biocompatibility of implant coatings, determining the surface roughness of materials, and verifying packaging integrity, the company has developed a cleanliness validation programme for medical products called Validata. “One of its unique features is an algorithm that encapsulates within a single number the cleanliness of a product,” says White. The numerical value, or Validata index, provides a comparison between samples and permits the simple monitoring of trends. “Our process will tell you, for example, not only that your product is 95% clean but what that other 5% is,” says White.

Ceram has recently published a white paper titled How a Detailed Understanding of Materials Is Playing a Vital Role in the Evolution of Medical Device Technology. Authored by White, the paper stresses that manufacturers need to understand how materials and their properties affect products from concept and design to manufacturing to the end of their life cycle. The white paper is available as a free download at www.ceram.com/medical.

3C Test

An independent specialist EMC test facility, 3C Test (Northants; www.3ctest.co.uk) works out of state-of-the-art facilities in the Silverstone Technology Park at the world-famous motor racing circuit. The firm’s comprehensive services run from precompliance testing to iron out potential problems to full EMC evaluations. The ever-increasing number of electrical and electronic products used in the medical industry has increased the need for awareness of the correct operation of the product within its intended electromagnetic environment.

Primasil Silicones

A low-key supplier of silicone-based products to the med-tech industry for many years, Primasil Silicones (Weobley; www.primasil.com) has begun to flex its medical muscle in earnest with the recent completion of an ISO Class 7 cleanroom.

“All of the products coming out of our cleanrooms are branded Medisil,” says Managing Director Steve Wheeler. And this does not apply only to tubing, he stresses, but also to custom designed products. “We have not really emphasised our product development expertise, but that is, in fact, one of our strengths,” says Wheeler. He adds that the company’s in-house capabilities and its access to medical personnel can facilitate projects.

One such recent project involved designing a tourniquet that could be easily tied using one hand. Because Primasil mixes its own materials, it has greater latitude to experiment. In this instance, “the doctors were looking for a tourniquet that would stretch extensively without breaking,” explains Wheeler. “It took us a couple of days, after which we took it straight to the doctor, who was nearby, for an opinion. There is no bureaucracy here.”

Primasil manufactures liquid silicone injection-moulded parts and extruded platinum-cured silicone. Assembly and packaging work can be carried out in three separate cleanroom areas, and quality systems are certified to EN ISO13485:2003. The company offers SureTrace laser etching, which permanently marks the tube with the part number, batch number and expiry date. SureTrace does not use ink and has no effect on the performance of the tube.

Proto Labs

Proprietary software allows Proto Labs (Telford; www.protomold.co.uk) to dramatically reduce lead times that are typically associated with the low-volume production of injection moulded and CNC machined parts. In addition to a rapid injection moulding service called Protomold, the company offers First Cut, which manufactures CNC machined prototype parts in as little as one business day.

The First Cut service machines plastic prototype parts directly from solid resin. The process is as quick and easy as traditional rapid prototyping, but the resulting parts are stronger and feature a better surface finish and more-accurate dimensions.

Just like Protomold users, First Cut customers are encouraged to upload CAD models to receive a detailed cost and manufacturing analysis. Once the model is finalised, the First Cut software, running on large-scale parallel processing computers, produces tool paths and programs the CNC machines.

The firm recently introduced a web-based quoting system that enables product designers to receive detailed manufacturability analysis and a production price based on their CAD models in as little as one hour. Finished parts in production-intent material can be ready to ship in one business day.

Advena Ltd

An international medical device consultancy established in 1998, Advena Ltd (Hereford; www.advenamedical.com) has UK and US offices. It offers authorised representation in the European Union as well as US agent services in compliance with US FDA requirements. The company helps manufacturers, distributors and importers from all over the world navigate complex medical device regulations in Europe and the United States.

Managing Director John Adcock is well versed in the legal obligations of the EU’s medical device directives, and is able to offer assistance with quality systems, technical files, vigilance reporting, product registration, product testing and so forth. US Operations Director Judy Burton has established amicable relationships with US FDA medical device personnel, according to the firm, and can assist clients with 510(k) submissions, establishment registration, device listings, audits and recall follow-ups.

RNA Automation

Active in the area of specialised automation engineering, RNA Automation (Castle Bromwich; www.rna-uk.com) provides automatic parts-handling equipment for high-volume production. It serves the pharmaceutical and other industries where there is a need to automate the handling and orientation of component parts.

The company operates seven manufacturing facilities across Europe and North America and maintains a global sales and service network. An extensive range of drive units, controllers and accessories for standard or special requirements is available.

Schaeffler (UK) Ltd

Linear guidance systems developed by a maker of bearing systems have a long failure-free history of use in radiotherapy machines and patient couches manufactured by Varian Medical Systems (VMS). The KUSE range of six-row ball monorail guidance systems from Schaeffler (UK) Ltd (Sutton Coldfield; www.schaeffler.co.uk) offer accuracy, rigidity and high load carrying capacity.

“As the manufacturer of the couch, we see benefits in terms of product performance, reliability and safety,” says Derek Flanagan, Manufacturing Manager at the VMS UK facility in Crawley. “We haven’t had a single failure of a Schaeffler linear guide in 10 years.”

The KUSE guidance system is available with guideway widths from 20 to 55 mm and can be coated with an anticorrosion agent. Schaeffler offers a range of other linear guidance systems for medical devices, CT scanners and radiotherapy machines, and produces bearings used in everything from miniaturized dental products to CT scanners.

Precision Micro Ltd

Featuring innovative design capabilities and rapid prototyping resources, Precision Micro Ltd (Erdington; www.precisionmicro.com) endeavours to help medical device manufacturers achieve desired results while meeting stringent time-to-market requirements.

The companys core capabilities, which include etching, wire EDM, electroforming, forming, finishing and micromachining, can be used individually or in combination. This array of manufacturing technologies enables the firm to work with ferrous and nonferrous metals and alloys and other difficult-to-machine materials. Nitinol, titanium, and other implantable materials can also be processed.

Low-cost digital and modular tooling is used in the early stages of a project to reduce the customers cost exposure while ensuring fast time to market. Design optimisation and modifications can be carried out quickly at minimal cost. The availability of ultra-high-volume etching ensures that all volume production requirements can be met in a timely and economical manner, according to the company.

Jones & Shipman Precision Ltd

A cylindrical grinding machine with a modular wheel-head design provides power and flexibility for machining metal implants, surgical instruments and medical device components. Developed by Jones & Shipman Precision Ltd (Leicester; www.jonesshipman.com), the wheel head’s multiple spindles are configured to suit the complex compound shapes and exotic metals commonly used in medical equipment. The design also increases the power, accuracy and weight-handling capability of the machine. The grinder itself is configured with a high degree of modularity, allowing customer-specific machines to be manufactured quickly and easily.

The Ultragrind machine is built with a one-piece bed that combines rigidity, stability and stock removal rates whilst maintaining high precision. It incorporates mechanical, electrical and software features that were developed based on user research.