Apps and websites

Medical device software development is expensive and slow, and can be risky

Creating new medical software is very different to most commercial software development. Special practices are mandated for safety because failures in software used to diagnose and treat patients can cause serious harm.

Medical quality and software standards are mandated worldwide to minimise risks introduced through inadequate design, development and deployment.

Software engineers are required to be trained to work in compliance with these standards. This increases costs and makes recruitment challenging.

To evidence compliance with these standards, formal design patterns with copious volumes of precise documentation are mandated. Non-compliance carries the risk of serious penalties.

Camgenium's platform has been built to work around these problems

Quite simply, it enables STEM engineers to build regulatory compliant products in a small fraction of the time needed for bespoke coding by using validated, compliant pre-built components. This radically simplifies the creation of new medical device grade products.

Camgenium's platform automates aspects of compliance

Built-in design tools allow complex applications with exciting user interfaces to be built using drag and drop design methods with minimal need for bespoke coding. The platform allows reuse of years of expertise gained in the development of quality systems and medical products to ensure immediate compliance with regulations and laws. It automatically documents changes, allowing affordable iterative product development that results in more usable products. Prototypes built on the platform maintain a full, auditable design history.

The platform performs referential verification of all calculations in all pages of an interconnected application at design time. As a page is changed the system will flag any broken content (UI, workflow and calculations) in other pages.

Overall development and deployment times are a small fraction of those that would be required for bespoke product.

Developing the AOS system on the Camgenium platform shortened the timeframe by about 70%. This product allows patients at home to take photos of their eyes. These photos are examined by clinicians using automated routines to check for eye health and ensure it is safe to issue contact lens prescriptions. The AOS system has been deployed in three continents.

One logical design runs correctly both in the web and on multiple device types

The design tool uses drag and drop to create a ‘what you see is what you get’ WSYWIG application that includes UI, calculations, logic, verification and logging (time date and signature). This includes the smart layout functions that guarantee that layouts render correctly on different screen sizes (not scaling) and for different target user groups. Multiple views can be created through drag and drop. All share the same logic and workflow.

Mobile apps run locally and share the same calculations and logic as the web screens (run locally) ensuring simplified verification. Differences between platforms (web browsers, mobile operating systems and makes of devices) is managed by Camgenium. Where necessary, we have created new verified libraries to gain identical performance across devices.

Designs are automatically rendered using native code for the web, Android and iOS mobile devices. This means that native controls (i.e. the controls that are standardly used on a particular device like an iPhone) are automatically used when an app is running on that device. For example, if a date control or combo box is placed on the design page it will appear as the native Apple, Android or web control depending on the device it is running on. Relative size, appearance and transparency are all correctly displayed.

Mobile apps synchronise with the web and can operate off line. Mobiles can be used off-line and will securely synchronise the data they hold with websites ensuring that data can be entered on the web aormobile devices and viewed anywhere. Special functions have been implemented to resolve data conflicts that can occur when two different people input data to the same record.

Platform is mature and richly featured

The platform has reached a state of maturity that allows a wide range of medical products to be built, ranging from remote ophthalmology systems to AI driven patient waiting lists to pacemaker monitors. The platform is used in frontline medical applications in multiple countries.

As an example of the range of functionality supported by Camgenium's platform, it includes configurable image processing controls as part of the drag and drop suite. This allows new applications to be developed that leverage modern image processing.

Similarly, AI models can be included in applications created by the drag and drop editor. This makes it possible to accommodate changes very rapidly.

The platform also supports complex triggers from both web and mobile controls that will send alerts, messaging and force conditional navigation through an application. This allows alerting like Email, PUSH and SMS notifications to be set up generically.

The platform also supports sophisticated and highly granular group functions, which allows highly sophisticated applications to be set up, for example applications with patient apps and specialised clinician, researcher and administrator web sites.

Data entry complies with medical device standards and GCP for clinical trials

Full version control with rollback is included for all designs, making documentation of changes trivial. The version control allows the way the screen looked at every revision to be viewed and tested. It ensures that all builds can be tracked and makes it easy to determine when breaking changes were made and document fixes.

All pages are uniquely identified and monitored giving full traceability of all designs. The About pages in products built on the Camgenium platform list the page UIDs, precisely defining the versions of each page released. This is needed for medical device regulation.

Applications can be set up to collect real-time information about patient behaviours from interaction with mobile clients that can simplify patient questionnaires and avoid the need to ask unnecessary questions. This innovation was conceived from working with mental health patients where it may be difficult to engage patients to collect the answers to standard questions. About twenty screen actions were determined and are sent back to the server automatically as the application is used (requires patient permission). An example would be to determine where a patient clicks for content (during a game or video) to determine left / right side predominance after stroke. This is a standard feature of the drag and drop platform.

All data input by users is not only stored time, date and user stamped, but with information about the screens and database schemas to enable formal review, showing what the page looked like and how it worked at the time the user interacted with it. This can be directly exported as objective evidence for regulatory submission and clinical investigation.

Ensuring accessibility

The platform provides a range of features to ensure that apps and websites are accessible. Camgenium works to international UX standards, including those mandated for medical device design.