Medical Device Connectivity
We specialise in providing quality connectivity solutions for healthcare initiatives around the world.
End-to-end support for Connected Medical Devices
Whether you’re looking to bring connectivity to a device that’s yet to go to market or need connectivity solutions to be implemented or improved on existing lab or point-of-care systems, our team can offer end-to-end support. With developers, designers, product managers and compliancy officers to hand, we can provide strategical or regulatory consultation, as well as solution planning, development, and delivery. Our team can also support in testing or hosting your connected medical device solutions, and maintaining them long-term through development support, infrastructure, and cybersecurity services.
Providing effective solutions for Connected Healthcare
We’ve worked with governments, charities, and health organisations across the globe to develop connectivity solutions that have helped save lives.
The Early Infant Diagnosis programme saw us work with Alere to improve workflow efficiencies through connected diagnostics, to lower infant mortality rates from HIV by reducing times to treatment. Existing methods used paper-based systems and had treatment times of up to 12 weeks in some countries, which would be too late for many.
We developed a platform that enabled diagnostic devices located at strategic hub clinics to connect and transmit patient results to a centralised data store. Data was then routed on to SMS-enabled printers at remote locations. This provided a fast, accurate and cost-effective means of aiding clinical decisions.
The connectivity solution had an enormous impact, taking time from testing to diagnosis down to just 3 days. Infants with HIV were moved promptly onto anti-viral treatment programmes with great success.
How can we support you?
Lab and point-of-care device connectivity can make the diagnostics and testing process more efficient and reliable, driving patients on to treatment and prevention programmes. We are dedicated to providing connectivity solutions that support these strategies. Some of the standards and protocols we work to include:
We are more than just your digital health team.
You’ll be working with specialists in this area who care about the quality of the end product. Our digital health team work to a programme of continuous development and best practice to ensure that you get the solution you need. We’ll customise platforms for enhanced functionality, investigate and fix issues, and build new components and apps as part of an ongoing development cycle.
SSDLC
Security is critical to ensuring your connected medical device meets compliancy mandates, as well as protecting clinical data and mitigating risks of device downtime due to malicious attacks. Our expertise in the secure SDLC guides our comprehensive approach to integrated security in every development phase of your connectivity project.
We prioritise threat modelling, robust coding practices, and thorough testing to fortify your medical device connectivity solutions against vulnerabilities. With a commitment to compliance and continual improvement, our SSDLC framework ensures a resilient software ecosystem, elevating your security standards and instilling confidence in your final product.
Why us?
We’ve been working on global health projects since 2012. The research, planning and development that has gone into our work has given us a real understanding of the challenges facing countries and healthcare organisations, and has made our team passionate about connectivity.
We’ve been involved in global health for over 10 years, and have the knowledge required to implement connectivity solutions for a range of protocol, compliance, and performance needs.
It’s essential that your final solution works as expected. With an accredited and experienced test team, we know how to qualify connected medical devices through efficient and thorough testing procedures.
We work to the quality standards you need and expect. We are ISO-13485, ISO-14001, ISO-27001 and ISO-9001 accredited, and we implement these QMS for all projects, products, and solutions.
Third-line support is available for every platform and solution we create, so that you can get assistance whenever you need it. With our developers, testers, and cybersecurity experts you can maintain your device’s connectivity with a lifecycle approach.
IEC 62304
A core aspect of providing solutions for connected medical devices is medical software development. We are well-versed in navigating the intricate requirements of IEC 62304 regulatory standards, ensuring the safety and efficacy of the software-based solutions we provide.
We are experts in risk management, software development processes, and documentation practices that align with IEC 62304. Trust us to ensure that your healthcare software meets this crucial regulatory framework, providing assurance of adherence to international standards, and delivering safe and effective medical device connectivity solutions.
Tell us about your project
To find out more about our services and how we can help your business, please get in touch.