Software as a Medical Device Development
In this age of technology, software has penetrated and gained relevance in almost each and every field.
From education to transportation to housing & construction to postal services, you will now find the rampant usage of software no matter where you go.
This goes without saying that even the healthcare industry could not resist the temptation and has now adopted a plethora of cutting-edge software to fulfil various functionalities.
In fact, the number of software used in and around the medical devices has enhanced dramatically over the past few years.
The emergence of the IoT or Internet of Things and its corresponding parts like Wireless connectivity, smartphones, cloud computing, AI & Big Data has further accelerated this process.
This technological revolution that is now dominating how healthcare is being administered and delivered, has influenced the usage of highly sophisticated software to fulfil various requirements
Medical device software are of 4 types –
a) SaMD or Software as Medical Device – a complete software that serves as a medical device by itself
b) SiMD or Software in a Medical Device – a part of the medical product like AI in a medical device
c) Usual Purpose Software (not a Medical Product by itself)
d) Software as an accessory to medical device
Now let us understand what a Software as a Medical Device (SaMD) is!
What is Software as a Medical Device?
International Medical Device Regulators Forum (IMDRF) defines the term Software as a Medical Device as a software designed in a way to be used for the operation of one or more medical purposes that perform these functions without being part of a hardware or medical device.
SaMD as Software as a medical device is being used more and more with every passing day and SMD developers are also trying their best to cater to the rising demand. A huge range of technology platforms use this including the medical device software, virtual networks and others. This can at times be with other software types.
The defining feature of SaMD is that it performs a variety of medical functions without the requirement of a hardware. This is used along with non-medical computing platforms which can be connected to virtual networks or general-use hardware.
What Qualifies as an SaMD?
This SaMD is used alone or in combination with one or more medical purposes.
Here are some of the qualifying points suggested by software as a medical device companies that can be used to detect whether a software is an SaMD or not-
a) There is always a medical perk to use this.
b) There is patient risk involved if it is used incorrectly or it malfunctions.
c) It does not achieve its primary intended action by immunological, pharmacological or metabolic means
d) It can bring forth patient data and healthcare providers also get informed about ways or options to treat, diagnose, prevent or mitigate an ailment
e) This can be used to inform, diagnose, prevent, inform, monitor, alleviate or treat disease
Benefits of SaMD
SaMD tools assist to accelerate the discovery, management and treatment of a variety of medical issues and automate certain aspects of care to save time.
SaMD can collect massive amount of SaMD data and can solicit user feedback because of its availability across multiple devices.
Two of the greatest perks of SaMD include enhanced health outcomes through more accurate data as well as quicker feedback and production leading to faster innovation.
Businesses using or developing SaMD can enable fast feedback loop for driving faster innovation, faster production iterations and thus getting to market at a quicker pace.
This also makes the collection of data quick and simple providing high-quality data leading to better health outcomes. Some of the SaMD platform applications can be seen as below –
- Diagnosis & Screening
- Alerting and Monitoring
- Disease Management and Chronic Condition
- Digital Therapeutics
In comparison to other software while this can be a bit confusing, but SaMD has displayed some exclusive features that you won’t get in other medical hardware or device.
Unlike other devices, SaMD can leverage connectivity and technology to people and devices which can monitor continuously safety, performance and effectiveness.
Inspite of the exclusive nature of the standalone health apps, medical software developers should prioritise the clinical evaluations and risk-based criteria.
Although not all companies will decide to go for developing SaMD, it is always advisable to understand the best practices for creating safer and better practices.
Companies therefore can either ignore the IoT (which will halt or disrupt their progress), acquire companies who have the talent pool to tackle this or construct their capacity internally.
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