From Classification to Compliance: A Comprehensive Guide for SaMD Development

Developing Software as a Medical Device (SaMD) requires a well-structured approach that begins with classification and extends through a complex certification process. This blog post explores key steps and considerations for SaMD development, from understanding regulations to navigating compliance.

How Medical Devices Get Classified: A Brief Overview

Understanding SaMD classification is crucial for adherence to regulatory frameworks. SaMD manufacturers and providers have to learn about core international standards like IEC 62304 and their role in defining life cycle processes for medical device software. According to IEC 62304, standard devices are classified on the risk basis as:

• Class A: No injury or damage to health possible;
• Class B: Non Serious injuries are possible;
• Class C: Death or serious injuries are possible. 

Nonetheless, now we see how SaMD and medical devices are classified under the EU MDR. There are several different routes of assessment to obtain CE marking for your product, and the path you undertake depends on the risk class of your device under the MDR.

• Class I: Devices within Class I represent the lowest level of risk. They cannot be invasive and must not have direct patient contact;
• Class II: Class II is further subdivided into Class IIa and IIb. Class IIa encompasses devices of moderate risk, while Class IIb involves those with moderate-to-high-risk profiles. Devices in Class II can be used directly with patients and serve diagnostic, therapeutic, or monitoring purposes;
• Class III: Devices categorized as Class III carry the highest level of risk. This category includes devices that directly interface with the Central Circulatory or Nervous System or incorporate a medicinal product, such as a pacemaker or joint prostheses.

SaMD Development Roadmap: Vital Steps for Success

Embarking on SaMD development entails making critical decisions, from the “Make or Buy” dilemmas to readiness assessments. MedTech companies have to evaluate carefully the kickoff of projects related to SaMD development and weigh the trade-offs between building from scratch and purchasing solutions. They gather information about available off-the-shelf products and evaluate time-to-market limitations and market positioning.

Navigating a SaMD development from scratch can be notably costly due to potential deficiencies in risk classification and compliance expertise. Misidentifying the appropriate SaMD classification or neglecting to determine a target classification early in the design and development phases can result in severe financial implications.

Outlined below are essential guidelines to ensure accurate SaMD classification and sidestep hazardous pitfalls:

1. Evaluate Organizational Readiness: At the organizational level, evaluate which classifications your company is well-equipped and experienced enough to pursue. Higher SaMD classifications require more extensive documentation, validation, and quality management systems (QMS);
2. Assess Time-to-Market: Consider the urgency of your market entry and the priority to gain a competitive edge. This means opting for a less stringent classification or seeking exemptions from the SaMD regulations to help simplify the regulatory burden;
3. Analyze Market Positioning and Competitive Edge: Thoroughly comprehend your product fit within the market and capitalize on your unique selling points. Analyze your customer’s needs, motivations, habits, and behavioral patterns to align your SaMD development with their requirements. 

Embracing Composable Application and Agile for SaMD Success

Agile methodologies establish a conducive framework for software development, enabling teams to prioritize incremental and swift delivery. While this approach offers significant benefits, aligning it with the stringent regulations governing medical device software introduces certain challenges. Particularly, harmonizing an agile environment with the multifaceted demands outlined by IEC 62304, ranging from risk management to problem resolution protocols, poses distinct complexities.

Moreover, leveraging Composable Architecture enhances the concept of modularity that suits perfectly the certification stream that any MedTech working with SaMD has to undertake. New modules can be added and existing ones can be updated, without compromising the rest of the system, and features that have become obsolete can be removed, all with ease. 

This system relies on the concept of a microservice-based development platform that supports cloud-native applications by combining and assembling different modules to support multiple business processes. By focusing on development logic related to business requirements, Feature Teams can create customized solutions quickly and securely, with the assurance that they can control their scalability over time. 

Mia-Care steers to secure-certification process for SaMD

To successfully launch a SaMD, you need a compliant product and documentation supporting quality approved by the appropriate regulators.

Based on the previously established goals, it is clear that there is no definitive list of steps required to achieve certification. Rather, the quality process can be incorporated into an Agile environment to accommodate frequent changes in requirements. To leverage the capacity to quickly respond to software changes and build software components ready to be certified as SaMD, organizations can leverage the Mia-Platform Console, an internal development portal, and the Mia-Care Marketplace, a broad service catalog of reusable compliant software modules. 

The Mia-Care software suite helps you to master:

1. Version control system, improving consistently software components and items traceability;
2. Risk Management, with secure control procedures that facilitate risk management during the product life cycle;
3. Agile Software development life cycle methodologies, allowing customization and scalability in a regulated environment;
4. Technical documentation management, though automated processes embedded in Mia-Care’s software suite.

Conclusions

Embarking on the journey of developing Software as a Medical Device (SaMD) demands a well-structured and strategic approach. As we’ve explored the key steps and considerations, it’s evident that the path to certification is both intricate and essential. The challenges of building SaMD from the ground up or transitioning from monolithic systems to microservices architecture are significant, often resulting in delays and complexities related to certification processes and agile implementation.
Mia-Care technology emerges as a pivotal solution, offering MedTech companies a certified and regulated environment that streamlines software development, empowers comprehensive product feature traceability, automates recurrent processes, and enables rapid and secure scalability. As we navigate this dynamic landscape, embracing innovative technologies can pave the way for SaMD’s success, ultimately benefiting patients and healthcare providers.