As a highly regulated industry, medical device production requires clearance and approval by a governmental regulator before devices can be sold commercially.
To attain this approval, medical products need to be developed and tested in accordance with the harmonized standards that govern medical device software, namely ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
Only companies with quality management systems (QMS) in compliance with ISO 13485 are eligible to develop these products.
Increased regulations and process compliance are now required for in vitro diagnostic products and are now at a level similar to the regulations affecting Medtech and Medical Device companies over the past two decades.
Software product development and engineering service offerings must therefore come intertwined with deep regulatory expertise.
Over the last few years, the Medical Devices industry has seen exponential growth in the category of Software as a Medical Device (SaMD) mobile and cloud systems. SaMD applications are becoming more commonplace within medical device systems, either as systems of care applications or medical device accessory applications (e.g., diabetes insulin dosing).
Engineering firms that have only limited skills with embedded systems or lack the resources needed for developing software for newer mobile and/or cloud-based systems will need to find a way to bridge that capabilities gap.
Medical Device Software Development spans embedded software systems for:
External and implantable cardiac defibrillators
Insulin pumps / glucose monitors
Spinal cord simulators
Pain management systems
SaMD products are also regulated under ISO and IEC standards and include:
Patient engagement applications on mobile devices that are associated with diagnosis or therapy
Patient and healthcare clinician applications deployed on healthcare networks and clouds used for making patient treatment decisions
From an industry perspective, we consider Medical Device Software to be embedded software encapsulated within a medical device (including an in vitro diagnostic instrument), or any software that is standalone used for diagnosis and treatment of an individual
patient, as SaMD software.
One of the major challenges medical device companies face is around the issue of customer and product support.
Unlike with traditional embedded applications, where the manufacturer had a high level of control of the product environment, with mobile phones, when applications are released, global regulators expect the manufacturers to have a robust, sustainable product support plan in place.
This is necessary to deal with the weekly or monthly changes and updates for commercial mobile operating systems and the potential impact of these on the SaMD application, and creates a resource and financial burden for manufacturers since they are not experts in this area.
Medical device companies will require access to mobile OS (iOS/Android) expertise combined with experience with relevant regulations.
Human factors engineering has been a major challenge for medical device manufacturers for years.
The ISO 62366 standard has multiple elements to make sure applications are safe and effective, so these important attributes generally receive ample attention.
However, most medical device groups fail to adequately leverage experience design as a system-design driver — to use human interaction as a baseline for the “efficiency and effectiveness” described in FDA guidance materials.
As manufacturers embrace mobile devices, patients (i.e., consumers) are much more critical of these interfaces.
The lack of priority on interface and visual design quality is impacting the medical device manufacturers’ image on the market (and could even be affecting stock price). Changes in the digital landscape have led to a greater emphasis on the individual digital experience for patients and trial subjects.
Higher quality standards for interaction efficiency have been set by leading digital solutions providers — think of offerings in the Apple App Store and Google Play marketplaces — as well as the ISO standards.
More than ever, therefore, a lack of interface efficiency can significantly decrease a medical device app engagement score — to the point where most users will toss it into the same “unenjoyable necessity” category to which so many poorly performing government services apps are condemned.