ITL & Anaxsys – breathing life into Medical Development Partnerships
These days, when there is often so much complexity in our business arrangements, it’s refreshing to see a clear example of two professional organisations combining their skills to deliver a quality, ground-breaking product, on an aggressive schedule, to receptive customers. This study is an example of just such a case when a successful design, prototyping and manufacturing house forged a strong and fruitful partnership with a medical devices company to deliver the world’s first ever continuous respiratory rate monitoring system for use in perioperative surgery.
Surrey-based Anaxsys has developed and patented advanced sensor intellectual property capable of profiling moisture levels in inhaled breath and based on their extensive 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 manufacture in order to make its specialist capabilities a reality for improved patient care.
It was at this point that Anaxsys engaged in discussions with Ashford-based instrumentation design consultancy and manufacturer, Integrated Technologies Limited (ITL).
‘Bringing Instruments to Life’ is what ITL does. It has been doing so with great success for 35 years and its strength lies in its ability to support customers throughout every stage of the concept, design, development, prototyping and manufacturing cycle. Its involvement with Anaxsys is no exception and Commercial & Development Director Barbara Lead describes ITL as “a vital partner in Anaxsys’ entire development, manufacturing and delivery process”.
We look at how challenges in the process were dealt with and the value of the deep involvement of ITL’s skill set from initiation of the design process to point of delivery. How they have enabled a successful, regulatory qualified and profitable solution to be delivered into a demanding customer base, ahead of schedule. With the ability to develop such strong partnerships, we also see that the future looks healthy for ITL with another satisfied customer onside for the long term.
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 the patient is breathing safely. Significantly, respiratory rate is the least often recorded vital sign, but is also one of the most sensitive to problems, so could in many cases be the first one to indicate 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 likely 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.
Anaxsys took on these and many other challenges to apply its specialist sensor IP to solving this problem and to delivering a reliable and safe graphical- & alarm-based monitoring system.
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 & 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 Anaxsys had limited electronics and software development resources, it was at this point that ITL’s broad and specialist 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 & one mask per patient delivers high volumes but at relatively low margin. The re-usable high quality monitor is manufactured in lower volumes but at higher cost and higher margin.
So, with the research complete, the business model in place and the engagement of Integrated Technologies Limited, ‘respiR8 - an innovative new product for the continuous monitoring of respiratory rate’ 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 memory 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 extremely 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, utilises 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 as we speak we are now 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.
“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 all credit to the ITL team, they 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 convertor, 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 2.8” screen chosen may be discontinued and replaced with a 2.4” version. As a result ITL has put design contingency in place for different sized screens & may seek another 2.8” screen. Either way a re-design around the monitor screen is in future plans for the product.
The results of ITL’s proactive approach speak for themselves and the pre-production prototypes, now being produced in low volumes are proving highly successful during field trials.
Anaxsys has gone from concept design in April 2008 to a product launch in October 2010 – just 2.5 years. Barbara 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”
ITL manages all outsourcing, regulatory approvals and BSI testing for Anaxsys and has successfully completed the final stages of CE certification.
Also, in addition to being the sole manufacturer of both 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 direct to the end customer.
Barbara Lead added, “Development with ITL was serendipity and ITL 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”. Much credit was given to Steve Hope, ITL’s R&D Leader and his team. “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.
As an aside, Anaxsys will also offer Training Modules for Nurses for Vital Signs Monitoring indicating where intervention would be suggested and what the intervention might be.
The future for ITL
So what comes next for the partnership between these two companies? Well, firstly 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 up its sleeve with which it plans to make a significant impact in the areas of lung cancer screening and patient management for asthma and COPD (Chronic Obstructive Pulmonary Disease).
Anaxsys has every intention to once again engage ITL in all stages of concept, design, development, manufacturing and delivery of these future products and fully expects a similar level of support and success. ‘Partners for Life’.