Medical Software

January 30 2012

 

 

 

Developing Medical Device Software

Medical software design standard IEC 62304 came into force in June 2010 and is now regulatory. Triteq Technical Director Ken Hall, was asked to share his views by emdt magazine and his article describes how this change will impact on the software development process for medical device manufacturers.

 “Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical product by the Medical Devices Directive. This has now changed. A new regime is in force governing all medical device software development for all classes of device. ”

 

Triteq offer a comprehensive advice and regulatory service and look forward to meeting with potential and existing clients to discuss requirements, please contact Ken Hall on 01488 684554.

 

January 30, 2012

Eykona in USA

January 27 2012

 

 

Eykona, a medical technology business which spun out of the University of Oxford, is heading to America with its 3D imaging products that enables doctors to accurately measure whether wounds are healing. Triteq have worked extensively with Eykona on this project and are delighted that the project is receiving such positive recognition.

Eykona, which spun out of the university in 2007, has opened an office in North Carolina as it aims to break the US market with its handheld camera that allows clinicians to take pictures of a wound, such as a bedsore or a diabetic ulcer, and measure how it is healing by turning it into a 3D image.

The move to open an American base comes after Eykona won more than £500,000 of funding from the Small Business Research Initiative, a competition organised by the Technology Strategy Board to allow companies to work with the public sector to tackle specific problems.

Winning the grant allowed Eykona to raise a further £2.5m from investors, such as venture capitalists, and develop a product which it trialed with 15 NHS centres in the final three months of 2011.

In 2011 Triteq were delighted to be notified by IET that they had been shortlisted in the Healthcare Technologies category for their work on Eykona’s Unique Dermal Imaging System, which transforms wound management in hospitals , this is the first wound care system of its kind. The IET Awards programme includes awards to reward and celebrate individual excellence and innovation, undergraduate and postgraduate engineering scholarships and this year Triteq were delighted to be notified that they had been shortlisted in the Healthcare Technologies category for their work on Eykona’s Unique Dermal Imaging System, which transforms wound management in hospitals , this is the first wound care system of its kind.

  

 

  

 

 

 

Triteq Partners with RFI for ElectronicTrtrTR

 

 

 

 

January 30, 2012

Arab Health

January 30, 2012

Oxford Science Park 

January 30, 2012

Open Innovation 2012 

January 30 2012

 

 

Opening the Doors  

After a journalist described our company as one of the "best kept secrets in the Thames Valley, we decided it may be a good idea to open our doors and showcase our capabilities. On the 19th January we welcomed over eighty clients, over three sessions to our new offices at The Innovation Centre in Hungerford. Guests were taken on the journey from concept to production with demonstrations and opportunities to meet the Triteq team. Triteq is a growing business,working with existing and emerging technologies to help customers get their products to market on time and within budget. To meet with a Director at Triteq to discuss our expertise and technologies please call our Head Office at The Innovation Centre in Hungerford, Berkshire on 01488 684554 or email. 

January 30, 2012

Artificial Pancreas Project

Artificial Pancreas Project

 

 

AP@Home

Triteq is part of a consortium of academic and industrial partners in an EU project called AP@home, which aims to develop an artificial pancreas (AP).  Triteq will be at the AP@Home Conference in Barcelona from 6th to 10th February, which is being held at the CCIB in Barcelona.

Steve Lane, Commercial Director at Triteq explains, “The first phase of the project was extremely successful in developing software algorithms.  Triteq’s role now is to apply our electronic design expertise to develop a system for suitable clinical trials.  This will bring together the CGM and insulin infusion pump into a single device, with the ultimate aim of having a single access point through the patient’s skin.  Different software algorithms will be built into the system to interpret the data gathered by the CGM and automatically control insulin dosage and delivery.  We are delighted to be working with European partners on such an exciting project, which promises to make a ground breaking development in patient care.” 

The pancreas produces insulin which regulates blood glucose levels, but in diabetics, insulin production is reduced or stopped and diabetics must inject themselves with insulin to regulate their blood sugar.  AP@home aims to produce an AP device that will continually monitor the blood sugar levels of diabetics and automatically regulate insulin delivery into their circulation to maintain correct blood sugar levels. 

The AP system will use a Continuous Glucose Monitor (CGM) and an insulin infusion pump, and along with a software algorithm, the system will calculate how much insulin to deliver at any time in response to blood glucose levels.  The system could not only improve the quality of life for people with insulin treated diabetes, but also reduce the escalating healthcare cost burden.

In the final year of the 4-year project (ending 2014), the performance of the newly created AP system, including remote monitoring facilities, will be compared with standard intensive insulin therapy in daily life in a multinational controlled trial.

“The aim of this project is to let Europe lead in the development of AP systems”, said project coordinator Lutz Heinemann of the Profil Institut für Stoffwechselforschung GmbH. “Simplified care and improved quality of life for patients with diabetes will diminish related complications and health costs in the long run”, added Heinemann.

The AP@home consortium brings together world-leading experts in the fields of medical device development, clinical studies and modelling & control algorithms, including seven academic partners (Universities of Cambridge, Padova, Pavia, University Hospitals of Amsterdam and Montpellier, Medical University Graz, EPF Lausanne) and five industrial partners (Profil Institut für Stoffwechselforschung GmbH, Sensile Medical AG, STMicroelectronics, 4a engineering GmbH, as well as Triteq).  The project is funded with a €10.5M grant from the European Commission’s Framework Programme 7.

 

January 29, 2012

New Quality Manager

 IET Awards

November 07, 2011

New Quality Manager

Medica 2011

November 07, 2011

New Quality Manager

Medelec 2011

November 07, 2011

Triteq shortlisted  

September 02, 2011

Product Development

Product Development Process

The development process for medical electronic devices follows a tightly controlled procedure.  There are several key stages to ensure that the design complies with the highest medical standards applicable to the product.  Triteq supports clients at all stages and these are outlined below.

 

Research

Triteq often carries out research into new medical device technologies and produces proof of principle prototypes to prove their suitability for the proposed application.

 

Specification

Specification and planning are crucial for a smooth product design process.  Triteq has proven techniques to extract design data.  We produce detailed requirements and design specifications, well in advance of the design commencing.

Once the specifications have been agreed and signed off, a fully detailed and accurate development plan is produced.  This is then used as the baseline for product development.

 

Risk analysis

Working with our customers, a detailed analysis is carried out before the design begins.  This helps identify any possible risks associated with the medical device being developed and the product development process.  Throughout the design and development cycle this risk analysis is revised and updated.  This process should continue for the life of the product and Triteq can help support clients with this ongoing task.

 

FMEA analysis

Triteq’s FMEA analysis of a design is used to identify likely failure modes and their effects.  The probability of an occurrence, an assessment of severity, and methods of detecting a failure can then be made.  Based on this information, the risks can be prioritised and actions taken to reduce any potential failures.

 

Industrial design

Triteq has a specialist industrial design team, which advises on mechanical and material elements.  See the Industrial Design section for further information.

 

Electronics hardware design

One of Triteq’s greatest strengths is its electronic design expertise.  Electronics can be designed for all applications from high volume disposable devices to low volume highly complex multi-processor platforms.  See the Electronic Design section for further information. 

 

Software Design

We offer structured design techniques conforming to EN/ISO62304 when designing safety critical single fault tolerant code.  These techniques are employed for all medical device software development, irrespective of the application, because they guarantee fault free code.  This is compliant with software design requirements and ultimately shortens the development lifecycle.

 

Verification

Our team carries out design verification to a scheduled test plan throughout the development process.  At the end of the development, a final product acceptance test (PAT) is conducted on fully functional pre-production units.  This is a final check for compliance with the product specification.  Further formal testing by an approved external test house is usually carried out and this will ensure that the device conforms to the requirements of international standards for medical products.

 

Validation

Although it is usual for our clients to carry out the formal device validation, Triteq will provide the appropriate documentation and support this process. This process usually entails a clinical or user group trial of some sort.