Prepared for medical needs of tomorrow

The medical device market continues to grow, boosting demand for sterilisation services. The introduction of technically enhanced instruments has increased the need for advanced sterilisers that are compatible with such devices, marking a shift away from steam sterilisers to technologies such as ethylene oxide, vaporised hydrogen peroxide, hydrogen peroxide gas plasma, and ozone gas-based sterilisation

The medical device sector is growing at a healthy rate in some regions but high product failure rates, regulatory changes and a poor economic climate mean Europe is having to battle for a share of the action. Susan Birks reports.

The medical device sector is predicted to have some of the better growth rates among manufacturing industries, according to Clearwater Healthcare Team’s latest publication, Medical Equipment and Supplies Report 2013.1 Revenues for the US production market for medical equipment and supplies is estimated to be in excess of £66bn, and this is projected to grow at an annual growth rate of 4.1% to £81bn by 2017. With more than 16,400 businesses in the medical equipment manufacturing industry, the US has one of the largest markets; Canada meanwhile boasts 1,000 firms and generates $2.3bn in exports.

Europe’s largest medical device markets are Germany, France, the UK, Italy and Spain. According to the Outlook for Medical Device Markets in Western Europe,2 published by Espicom Business Intelligence, these medical device markets will be affected by the current eurozone crisis in the short term. In the three-month period between August and October 2012, medical device exports increased by only 0.6% in Germany and fell by 4.4% in the UK. However, beyond the current recession, the countries of western Europe are expected to return to growth with an average annual growth rate of 1.6% between 2014 and 2018.

The German medical device market is ranked the third largest in the world, behind the US and Japan. In 2012, it was estimated at US$23.3bn, equal to $285 per capita. The French market is the second largest in Europe, with consumption of medical equipment and supplies valued at $13.3bn in 2012, equal to $209 per capita. And the UK was valued at $8.9bn in 2012, equal to $142 per capita, and is projected to increase by a CAGR of 6.0% until 2017.

The European market sector faces some legislative changes too; in the wake of the PIP breast implant scandal, Europe has seen the revision of the EU Medical Devices Directives (MDD) to improve patient safety. In September 2012, the European Commission published what the new legislation on medical devices should look like and member states and the European Parliament are now negotiating and agreeing the final legislation.

Sterilisation market builds

Any growth in the medical device market brings with it a rise in demand for medical device sterilisation services. Major players in the sterilisation equipment market include: Steris Corp (US), Getinge (Sweden), Advanced Sterilization Products (US), and Belimed (Switzerland). Key players in the contract sterilisation services market are Synergy Health (UK), Steris Isomedix (US), Sterigenics (US), Medivators (US), and Nordion (Canada).

According to the report Infection Control Market – Global forecast to 2017,3 the introduction of technically enhanced instruments in the market has increased need for advanced sterilisers that are compatible with such devices. This has brought about a shift from steam sterilisers to low temperature sterilisers with technologies such as ethylene oxide (EtO), vaporised hydrogen peroxide (VHP), hydrogen peroxide gas plasma, and ozone gas based sterilisation.

The provision of contract sterilisation services is also growing, but in the near future, the report says, in-house sterilisation is expected to compete more strongly with contract sterilisation services, mainly due to the advent of hydrogen gas plasma and VHP that are preferred to be used in-house. These technologies also offer better quality assurance with a just-in-time facility for sterilised products, it says.

The report also forecasts gamma and electron beam (E-beam) sterilisation services will see better growth than EtO in the near future due to their wider application with respect to sterilisation of medical devices and other products.

Irradiation is on the rise as a method of sterilisation due to its competitive pricing and compatibility with commonly sterilised medical equipment, packaging and devices

For example, Vancouver’s Isotron Industries, which owns the IMPELA E-beam technology, and has been servicing the medical device industry for more than 20 years throughout North America, believes irradiation is on the rise as a method of sterilisation due to its competitive pricing and compatibility with commonly sterilised medical equipment, packaging and devices. In addition, the E-beam method is promoted as an environmentally-friendly process, harnessing electricity as its sole power source and, unlike the other alternatives, E-beam processing does not produce or use hazardous or radioactive materials.

Tino Pereira, CEO of Iotron Industries, says: ‘IMPELA electron-beam technology prevents the spread of harmful micro-organisms as the beam penetrates the device completely to ensure that every surface on the outside, as well as the inside of the device, is sterile.’

Following US-based Noxilizer’s recent asset acquisition of Saian Corporation of Japan, the two companies have been involved in developing nitrogen dioxide as a sterilisation solution for medical device, pharmaceutical and biotech companies, as well as hospitals. The acquisition is intended to strengthen the global effort to promote acceptance and growth of nitrogen dioxide sterilisation as a powerful and less-expensive alternative to current sterilisation methods.

Market investment

SteriPack, a global leader in manufacturing medical packaging solutions, meanwhile, has opened a new in-house testing laboratory, providing package testing services to facilitate its growing customer base worldwide. This new opening is a significant step in expanding SteriPack’s operation. It conducts its testing at the headquarters in Ireland.

‘Expanding into package testing services enables us to continue to deliver on our strong reputation of providing quality work and customer service to our growing client base and is a tremendous boost to SteriPack’s production capabilities,’ says Group Sales Director Barry Moore.

Synergy Health’s site at Thorne, near Doncaster, UK, offers EtO sterilisation plus associated laboratory services to the healthcare sector in the UK, Ireland and Scandinavia. In operation since 1998, two chambers are being added to the existing facility, doubling site capacity from March 2013 onwards.

Focused on surgical instrument sterilisation, US company Restore Medical Solutions has closed a $2.5m Series A round of funding that will assist the medical device start-up in fulfilling already substantial demand for the company’s debut product.

Founded in Atlanta, by Ryan Ramkhelawan and Shawn Flynn, Restore Medical Solutions specialises in increasing efficiency and productivity in the estimated 6,000 hospitals and 5,000 surgery centres in the US that reprocess re-usable surgical instrumentation.

The Memphis-based company’s patent-pending technology is said to have shown up to a 60% improvement in efficiency on surgical instrument reprocessing times, while providing reduced potential for surgical site infections, increased instrument/asset accountability, decreased breakage due to poor care and handling, reduction of disposable wraps and accessories and standardisation of terminal sterilisation packaging, which will reduce poor outcomes associated with processing variability.

Restore Medical Solutions has generated significant interest from more than a dozen hospitals across Atlanta and Memphis, five of which are looking to place orders.

Our product will allow hospitals to get life-saving instruments into the hands of their surgeons faster, not only saving costs, but patients’ lives as well

‘Our product will allow hospitals to clean and re-sterilise surgical instruments in a more efficient and safer way,’ said Ramkhelawan, Restore Medical Solutions’ CEO. ‘This will allow hospitals to get life-saving instruments into the hands of their surgeons faster, not only saving costs, but patients’ lives as well.’

SteriBeam Systems, of Kehl in Germany, is one of the companies developing the market for pulsed UV, PEF and MW LP plasma sterilisation technologies. It recently introduced fully automated in-line pulsed UV sterilisation tunnels for medical device and other product pilot and production lines.

The tunnels are equipped with Intense Pulsed UV flash lamps, have UV transparent conveyors and are capable of sterilising the entire product surfaces with the reduction from bacteria and spores for up to 6 log (1:million). The pulsed UV exposures can be set as required and it can sterilise surfaces of open products as well as products wrapped in UV-transparent foils at the rate of up to 1,000 products an hour, sterilising it both from the top and bottom (360° UV exposures).

With growth in the medical device sector set to continue, more packaging, plastics moulding and sterilising companies look likely to benefit.

References

1. www.clearwatercf.com/documents/sectors/Medical_Equipment_Supplies_final.pdf

2. www.espicom.com/medical-devices-outlook-western-europe

3. www.marketsandmarkets.com/Market-Reports/infection-control-market-1084.html

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STERIS (more information, website)

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