Fea

ture

“First, do no harm.”it’s been the guiding principle of

medicine since the days of ancient Greece. And it’s at the heart of the business model at Sterimedix Limited, based in Redditch, Worcestershire, in the UK.

“We are one of the world’s leading manufacturers of single-use ophthalmic

surgical devices,” says Richard Walker, Sterimedix’s sales and marketing director. “We are constantly developing new single-use devices to meet new surgical needs and single-use replacements for existing reusable devices. Sterimedix makes only single-use devices, including cannulae, irrigation and aspiration handpieces, phaco choppers, and

other highly specialised products, because the firm believes it is best for patients,” Mr Walker says. “Using single-use devices that are manufactured and sterilised in controlled factory conditions greatly reduces the risk of surgical mishaps like toxic anterior segment syndrome, infections, and blocked cannulae that can result from faulty cleaning and sterilisation of reusable devices,” he adds.

That added safety margin is especially important in ocular surgery, even compared with other kinds of surgery. Because the eye interior is so sterile and sensitive, even minute contaminations can result in sight-threatening complications. “We believe that single-use instruments should be the standard of care,” Mr Walker says.

he’s far from alone in that assessment. indeed, the EU has directed that single-use surgical instruments should be used

whenever such devices are available. Other countries around the world have adopted similar standards. As a result, use of single-use instruments for ophthalmic surgery now exceeds use of reusable devices in the UK, Mr Walker says.

Despite the global recession, Mr Walker expects 2009 sales to grow 25 per cent or more. The firm is seeing increased demand in Europe and Asia. Recently, Sterimedix gained approval for its products in Japan. The firm also has a distributor in the US. “We are constantly expanding into new territories, and our business has doubled in the last three years,” he notes.

Such rapid global growth would not be possible without two things – impeccable manufacturing quality and a constant stream of new instruments to meet evolving surgical needs. Sterimedix is constantly working with ophthalmic surgeons, pharmaceutical companies, and device manufacturers to develop new products, Mr Walker says.

Among recent innovations are single-use scleral markers for marking injection points for intravitreal drugs for treating age-related macular degeneration and other retinal diseases. To keep up with advances in cataract surgery, Sterimedix is continually developing handles and irrigation and aspiration cannulae of very small diameters with varying tip angles, shapes, and sideports for microincision bimanual and coaxial surgery. Specialised cannulas for capsulorhexis, hydrodisection, nucleus removal, and capsule polishing are available. A wide variety of cannulae and handpieces with different tip angles and gauges are made for vitreoretinal surgery.

Sterimedix also supplies sterile cannulae to pharmaceutical manufacturers for use with viscoelastics, and to other firms that distribute surgical instruments under their own brands. “That is an important part of our business,” Mr Walker says.

Often, new instruments are developed from concepts presented by surgeons. “Sometimes they have detailed plans drawn up and sometimes it is just an idea we work with them to develop. it is core to our success that we recognise the need to innovate and keep up with the trend toward smaller incisions and development of new treatments, like injecting Lucentis,” Mr Walker says.

Manufacturing single-use surgical instruments to the increasingly precise tolerances required for microincision surgery presents technical challenges to maintain flow rates. Sterimedix is more than up to the task.

Founded in 1989, the firm resides in the traditional heart of the needle-making industry in the British Midlands. “The Quakers settled here and began making needles after being driven out of London,” Mr

Walker says. Sterimedix’s technical director and co-founder, David Bailey, has extensive training and background in the design and manufacture of intricate steel tubing. Ronnie MacFarlane, managing director and co-founder, has an extensive background in the medical device industry.

Building on this foundation of fine metal-working expertise, Sterimedix has invested heavily in technology. The goal is two-fold, Mr Walker says. First, high-tech manufacturing and quality control equipment ensure a highly standardised and uniform quality product. in the second quarter of this year the firm is moving to 100 per cent automated camera inspections of all products.

Second, automation allows Sterimedix to keep its manufacturing completely in the UK without adding prohibitive labour costs. “We are very much a manufacturer, not an importer. We make all of the goods we ship,” Mr Walker says. The firm has not increased prices in more than eight years, and does not expect to do so in the next few years due to the competitive nature of the market. “With automation we can potentially increase production without increasing the size of our facility.” As volume grows, unit production costs and capital costs drop, he notes.

Sterimedix also works to keep shipping and packaging costs down by reducing packaging to the smallest possible size. Devices are shipped either in sterile blister packs or in bulk to be sterilised and packed as surgical kits by other firms.

All of this means that single-use instruments will be increasingly cost-competitive with reusable devices. They may even already be more economical, Mr Walker says. “if you use eight or 10 instrument sets in a day, that is eight or 10 you have to clean, sterilise, inspect, and store. That takes a lot of effort and a lot of energy. The comparative cost difference between single-use and reusable devices is very hard to determine due, often, to the fragmented costing methods in hospitals. however, there is no doubt in my mind that the potential risks, which the World health Organization has highlighted, with the reuse of surgical instruments is a compelling argument for the use of single-use products.”

Mr Walker believes Sterimedix’s commitment to innovation, manufacturing quality and protecting patients with single-use devices will give the firm an edge in competitive global markets. “There are many firms making cannulae, but we do it to a very high standard of quality. We have taken what we have learned and moved on to innovating with other devices within the ophthalmology sphere. This brings the safety and benefits of single-use devices to more patients and surgeons every year.”

Richard@sterimedix.com

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Outlook on Industry

Sterimedix sees the future in single-use instrumentsReduced risk of cross contamination and infection driving move to disposables

by Howard Larkin

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