Breathing life into medical development partnerships
09 February 2011
When there is so much complexity in business arrangements, it’s refreshing to see a clear example of two organisations combining their skills.
Surrey-based Anaxsys developed and patented advanced sensor intellectual property capable of profiling moisture levels in inhaled breath. Based on their medical background and thorough market research, a demand for this technology was clearly identified. Following the initial concept generation, Anaxsys went in search of a development and manufacturing partner to undertake design, prototype and then manufacturing in order to make its specialist capabilities a reality for patient care.
It was at this point that Anaxsys engaged in discussions with Kent-based instrumentation design consultancy and manufacturer, Integrated Technologies Limited (ITL).
In early 2008, an anaesthetist voiced his view that there was a real need for respiratory rate monitoring in perioperative surgery. Up until now, nurses have primarily observed or felt for chest movements to identify breathing, but if a patient suffers a blockage or there is another reason for chest movement not associated with breathing, then such movement does not necessarily mean that the patient is breathing safely. Significantly, respiratory rate is the least often recorded vital sign, but is one of the most sensitive to problems, so could in many cases be the first one to indicate that something may be wrong with a patient.
With nothing available on the market to automate the process of directly measuring respiratory rate, delivering a product that applies moisture sensor technology to a standard oxygen mask would be an ideal and highly saleable solution.
However, having the sensor in the mask introduced new challenges because it is essential that no cross-infection between patients can occur at the interface of the connector and mask-mounted sensor.
With this challenge in mind, Anaxsys engaged in hospital studies with nurses in post operative care and opened discussions on the first product concepts with a Cambridge-based consultancy.
From this work, there was an overwhelming preference for one particular design approach, both for the breath rate sensor and the visible/audible monitor and alarm. User trials with an early prototype also confirmed this preference and identified the need for continuous monitoring of respiratory rate, and for both upper and lower respiratory rate alarms.
After early user trials and identification of what additional features were required, Anaxsys held a design review of the user-requirement specification. As the company had limited electronics and software development resources, ITL’s skills were engaged. Initially taking over on sensor housing, alarm functionality and the digital interface, the ITL team later took on all aspects of algorithm development, prototyping and design for manufacture.
From the commercial perspective, volume revenue comes from the sensor being fitted in the mask; one sensor per mask and one mask per patient delivers high volumes but at a relatively low margin. The re-usable high quality monitor is manufactured in lower volumes but at higher cost and higher margins.
With the research complete, the business model in place and the engagement of ITL, ‘respiR8’ was born.
The respiR8 solution consists of a low cost, disposable, specially adapted oxygen mask fitted with a sensor and a robust re-usable electronic monitor that can be used throughout the duration of a patients’ stay, and provides a clear digital display of real-time respiratory rate.
Any significant change in respiratory rate trips an integral alarm, allowing health care professionals to make an immediate intervention. The high-low alarm conforms fully to EU regulatory and safety standards. Respiratory history is stored in a memory bank and can be viewed using a second display mode; identifying the trend of respiratory rate over the monitoring period.
One of the major factors appreciated by users in the concept trials was the clear AMOLED screen, legible from almost any angle around a patient and observed as making ‘respiR8’ one of the easiest medical devices to read. This technology was adopted in the design with special attention to its procurement, as this is a relatively high cost display option. respiR8 is mains powered, uses a rechargeable battery that allows patients to be monitored whilst they are moved, and can be rapidly deployed for use with any existing bed-head array system.
“Although progress has been excellent and we are on schedule with our planned customer deliveries, the project was of course not without its difficulties and it was at these times that the benefits of such a close relationship with ITL really came into its own,” said Barbara Lead, Commercial & Development Director of Anaxys. “To solve the cross-infection potential identified in the risk analysis, the sensor housing had to be completely re-designed and this was achieved after a lot of work by ITL. Also, due to the low signal levels involved, we did have a real problem with ‘noise’ pick-up in the screened connecting cable between the mask mounted sensor and the monitor unit. We needed an affordable solution and the ITL team really put the hours in when it counted and came up with a digital solution, with the development of a dedicated and very low cost analogue to digital converter incorporated into the cable connector to the mask.”
It was also identified that the future of the chosen AMOLED screen was in question as the 2.8in screen chosen was to be discontinued and replaced with a 2.4in version. As a result, ITL has put design contingency in place for different sized screens and may seek another 2.8in screen.
Anaxsys has gone from concept design to a product launch in just two and a half years. Lead commented: “We would never have achieved this without the support and commitment of ITL, and in particular, its knowledge of the relevant regulatory processes and requirements were fundamental to our achievement in this timeframe.”
In addition to being the sole manufacturer of sensors and monitors, ITL provides Anaxsys’ full supply chain and all product distribution. Anaxsys will place orders on ITL’s logistics organisation, which will ship directly to the end customer.
Lead added, “Development with ITL was serendipity and it is an absolutely brilliant design and manufacturing partner. It has a fantastic team that excels when it comes to handling issues in real time as they arise and their team worked very well with Anaxsys’ own team. Whenever problems were encountered, ITL has committed quality resources to them. All members of the team are very capable, easy to work with and have very good project management skills. Not only did they re-design the software, electronics, sensor housing and tooling for the sensor housing, but also project managed, outsourced and secured all regulatory approvals for the monitor.”
ITL shipped the first 100 pilot production monitors to Anaxsys in September 2010 with an order for a further 1000 units in place to start a planned production ramp in Q1 2011. The strong working relationship has also encouraged strategic thinking such as advanced procurement of key and long lead-time components to ensure a successful roll-out to lead customers.
Anaxsys is now looking to ITL to implement its logistics support, quality management, field support and product returns processes, further extending ITL’s involvement in the major activities of the business. Alongside this, Anaxsys has two more products planned, with which it hopes to make a significant impact in the areas of lung cancer screening and patient management for asthma and COPD (Chronic Obstructive Pulmonary Disease).
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