Recent years have seen little innovation in med-tech or OEM medical device sterilisation methods, but with today’s up and coming technologies, there could be a more appropriate solution for the modern needs of manufacturers on the horizon.
Over the past 50 years, there has been a significant change in how medical devices are manufactured, principally, from the use of metal and glass to medical grade polymers for single-use and disposable products. This shift, combined with more stringent regulations to more accurately address issues related to infection control, prompted the previous major change in sterilisation from steam autoclaving to a requirement that products are delivered sterile by the manufacturer.
“Terminal sterilisation” of medical devices requires the manufacturer to ship products by truck, rail or air freight, and have the final critical production step performed by a third-party. These products must then be returned to the manufacturer so that they can verify that the process has been performed, and only then can the products be sent to distributors & end customers. This adds significant time & costs to the overall production process, taking up to 2 weeks or more to complete at an average annual cost of around £120K per company excluding inventory holding costs.
Today, the size of the global market for medical device sterilisation stands at £1.2Billion annually, with large 3rd party incumberments reluctant and without incentive to change. These large conglomerate organisations utilise large capital intensive systems that comprise whole buildings, and require significant volume throughput to achieve economies of scale.
Currently, approximately 40-50% of disposable medical products manufactured in developed countries are sterilised using some form of ionising radiation, but the growth in market share has been limited by the cost and environmental impact of existing sterilisation methods, which in turn has created an attractive market opportunity for new entrants with a clear entry point and regulatory pathway in the OEM Medical Device sector.
With continuing industry changes, including new regulatory initiatives such as Unique Device Identification (UDI), and additional cost pressures, such as the 2.3% medical device sales tax imposed by the Obama administration in the US, medical device manufacturing would benefit from a new approach to sterilisation that addresses manufacturers’ needs and fits with their workflow processes.
Enxray have developed a strategy for the rapid market adoption of their technology to exploit this opportunity and radically change the way medical devices are sterilised on-site and on-demand, initially focusing on companies using Gamma and other forms of ionising radiation. Enxray was founded in October 2012, based upon the inventions of Dr Sergey Mitko and Dr Yuri Udalov, two of the company’s co-founders who had proven the ability to generate low energy x-rays in a novel method. The 3rd co-founder, Edward Cappabianca, had knowledge & experience of the medical device manufacturing industry, and together saw that there was a significant opportunity to sterilise equipment at the point of manufacture.
The technology works through their patented method for generating high voltage – low energy x-rays to achieve the required kilo-gray dosage of ionising radiation to ensure that the bacterial load is reduced to a level that is deemed to be sterile – typically defined by demonstrating a reduction in the bacterial load to a Sterility Assurance Level (SAL) of Log 10-6.
The Enxray product has the potential to overhaul this stagnating market sector, and has significant implications throughout the entire value chain for healthcare systems. By enabling sterilisation at the point of manufacture, companies will be able to significantly reduce time to market, and free up inventory holding costs that are currently imposed on them by their 3rd party sterilisation service providers. Importantly, hospital systems must also maintain higher average inventory levels, as periodically, bottlenecks in the sterilisation plants can cause systemic delays. Other disruptive characteristics include:
- A compact design that will enable sterilisation on site, eliminating time-consuming & costly logistics.
- Very affordable Technology compared to existing technologies, with significant indirect cost savings (inventory holding cost).
- Individual product sterilisation & labelling will provide greater traceability, reducing the likelihood of broad product recalls.
- EnXray will lease its technology to OEM medical device companies on a 5-year term with an annual minimum + per unit sterilisation charges, removing cap-ex decisions.
The LEXR technology itself is unique in several ways, including the emitting head source of the X-rays, which is covered by Enxray’s first patent, as well as proprietary designs around the power supply & cooling systems. This patent gives them a strong position relative to other companies seeking to generate LEXRs for a wide range of industrial applications. “Maintaining ownership of our technology by leasing it to customers, combined with our patents & know-how, will help create barriers to entry for OEM on-site sterilisation” said Edward Cappabianca in a recent interview for the Med-Tech awards 2015. Large incumbent players will find it difficult to respond as their current business and pricing models are based on large volume pallet-load batch processing and maintaining existing facilities at these high throughput rates. Although these large organisations already have the business relationships in place with medical institutes, Enxray’s low cost alternative for smaller “rush orders” will help them penetrate the market, giving direct control back to OEM’s for their own sterilisation processes, paying dividends in gaining industry acknowledged credibility and fostering quicker market adoption.
Enxray’s initial prototype will be developed and manufactured on an outsourced basis through their development partner Tharsus Group, who will then foster the ultimate commercialisation of their game-changing med-tech product by ramping up to scaled production for a timely market deployment. Tharsus, are an award winning UK development and manufacturing organisation that specialises in the commercialisation of high-value electro-mechanical products, and early adopters of the OEDM platform that will enable Enxray to take their product from initial concept right through to scaled production along a path of least resistance.
Tharsus will tackle the complexities that come hand in hand with the realisation of Enxrays’ latest innovation, mitigating risk and generating commercially successful innovations by further exploring and expanding on the technology building blocks housed within Enxray’s IP. Tharsus adopt an agile and knowledge based approach to new product introduction that enables their engineering design teams to leverage Enxray’s extensive insight to unlock distinct advantages like; reduced time to market and the ability to achieve strict commercial objectives – amortising attractive financial returns over the coming 5 years.
Work has already begun on this project, the preliminary challenges have been centered around the commercial viability of the high voltage power supply and the rate of sterilisation.
Tharsus have been working collaboratively with the technical team inside Enxray’s business to appreciate the technical constraints and critical performance parameters that will lower the barriers to commercial realisation. “We’ve applied our knowledge and skills in design for manufacture and produced a functioning production prototype” – Tim Iceton, Electrical Engineering Lead at Tharsus.
“We’ve faced particular challenges around the packaging of the specialised high-voltage pulse power electronics” – achieving a compact space envelope while maintaining the required insulation and clearances necessary for the high voltage (100kV), high dV/dt (1ns rise time) output. We’ve overcome this by utilising up to 60% of the latent space within the unit and distributing the electronic payload evenly across the product’s design.
The LEXR product has been a brilliant opportunity for Tharsus to flex our automation and control knowledge base – applying our embedded systems competencies to “produce a microprocessor based control system that co-ordinates conveyor speed, pulse magnitude and the rep-rate from multiple power supplies along with facilities for dosimetry monitoring and feedback”. The exploratory approach we’ve taken to develop the prototype has allowed us to add new and improved functionality at every point in the technical build – so when it comes to defining the specification of the production unit we can include things like additional interfaces and create a route map for the full automation, remote monitoring and data logging of the resolved product.