Healthcare services can be transformed immensely just by monitoring the data generated by them every day. This can be achieved through software.
There are three types of software in medical devices:
- Software that is integral to a medical device.
- Software used in the manufacturing or maintenance of a medical device.
- Software as a medical device which on its own is a medical device.
This article focuses on software that is categorized under Software as a Medical Device (SaMD).
What is Software as a Medical Device (SaMD)?
According to the International Medical Device Regulation Forum (IMDRF), Software that is developed to serve one or more medical purposes without being a part of a hardware device is defined as Software as a Medical Device (SaMD). Software is not SaMD if its intended use is to drive a hardware medical device. SaMD is a medical device, and it can be used in conjunction with other products including medical devices.
As the use of the software as a medical device is growing significantly, to ensure the safety of the patients, regulatory bodies are working on regulations and guidelines.
The Manufacturer used assessment and analysis of clinical data of a SaMD to verify the clinical safety, performance, and effectiveness of the device. The Evaluation process has below 3 parts:
1. Valid Clinical Association - This evaluation refers to the extent to which the SaMD’s output (concept, conclusion, measurements) is clinically accepted and corresponds accurately within the world to a healthcare situation.
2. Analytical / Technical Validation - It measures the ability of a SaMD to generate the intended technical output accurately, reliably, and precisely by processing the input data.
3. Clinical Validation - Assessment relates to finding out if the SaMD’s output data achieve the intended purpose accurately, reliably, and precisely in the target population during a clinical trial.
Basic Model of SaMD
A SaMD uses an algorithm (results, set of rules, or processes) that operates on data input to produce data output that can serve necessary medical purposes. Figure-1 describes the basic model of SaMD which specifies inputs to the algorithm and outputs of the algorithm.
Real World Performance of SaMD
FDA believes organizations can show excellence in continuous improvement by proactively monitoring the real-world performance (RWP) data of their SaMD products. RWP can continuously monitor for improvement as illustrated in the below figure.
All organizations would need to demonstrate the capability to collect and analyze the post-launch RWP data, whether by instrumenting their SaMD products to generate the needed data or by leveraging alternative data sources. Software Pre-Cert Program which is a component of the real-world performance (RWP), is designed to use post-launch RWP data analytics to verify against the pre-defined standards. If RWP data meets the intended purpose, then we follow the pre-certification process. The Precertification process further follows the process of identification of emerging safety and cybersecurity risks, providing critical feedback to the other components of the Program and supporting the appropriate use of post-market data in clinical evidence.
SaMD can be used across all the platforms like, technology, medical device, commercial and virtual networks. This was previously referred to as "standalone software," "medical device software," and/or "health software". This leads to the total product lifecycle (TPLC) database which will present an integrated record of pre-market and post-market activities for the medical devices. The Regulatory framework promotes the manufacturers for continuous monitoring of their SaMD with respect to the safety and effectiveness, this results in increased benefits to patients and providers.
Nowadays, Healthcare decisions are widely dependent on the information provided by the output of the SaMD, where these decisions can impact clinical outcomes and patient care. Hence the global regulators expect that performance of SaMD should adhere to the risk and impact of the SaMD to demonstrate assurance of safety, effectiveness, and performance.
Decos as a software solution and services provider for medical devices manufacturers, follow all the FDA, EU MDR standards, compliances, and regulatory approaches in terms of remediation, system engineering and development of the medical devices. Our dedicated Systems Engineering Group can assist you in the clinical evaluation of SaMD and related regulatory activities.
To know more about the regulations and submission process of SaMD for approval to FDA and EU MDR, please check the below articles: