What are the five phases of Medical Device Software Development?

From dealing with detailed paperwork and timelines, to following strict rules set by the regulatory bodies, medical device software development can be highly complex. It’s essential to understand these challenges to make the SaMD journey smoother and more effective. Below, there are some examples of common SaMD challenges that each manufacturer should be aware of.

• Design & Medical Device Software Development process: Regulatory bodies require SaMD developers to adhere to specific processes. Standards like IEC 62304 outline lifecycle requirements for medical device software. Integrating these requirements into the design and development process can be technically complex.
• Risk Management for Medical Device Software: It is required to apply comprehensive risk management activities throughout the SaMD lifecycle. This involves following standards like ISO 14971, which provides a detailed process for managing risk and a deep integration of risk management activities into design, development, and post-market surveillance.
• Regulatory Navigation: The regulatory framework surrounding SaMD is complex. Constant updates from governing bodies like the FDA mean that manufacturers need to keep their products aligned with the latest guidelines.
• Quality Assurance: Beyond basic functionality, the emphasis on quality cannot be overstated. Rigorous testing and quality checks ensure the software’s reliability, accuracy, and overall performance.
• Healthcare Expertise & Collaboration: Understanding the clinical landscape is key. Whether it’s for diagnosis, monitoring, or treatment, the software should align with healthcare objectives.
• Validation and Verification: FDA requires that medical device software goes through rigorous testing to ensure it performs as intended. Given the diverse range of devices and operating systems they may run on, comprehensive testing can quickly become difficult.

• Rigorous FDA standards: The FDA sets high standards for documentation, aiming to ensure patient safety and product reliability. This makes thorough documentation a non-negotiable aspect of SaMD development.
• Design Controls and Traceability: SaMD developers must maintain a clear trail of their development process. From initial design to final product release, traceability ensures that every step can be accounted for, validating the product’s safety and efficacy.
• Quality Management System (QMS): Most SaMDs require a sophisticated QMS, as per standards like ISO 13485, which is often beyond the scope of those newly beginning their SaMD journey. This QMS has to encompass all processes, from design and development to post-market surveillance and ensure continuous improvement.

• Regulatory Pathway Assessment: Before diving into the submission process, it’s crucial to do a detailed regulatory pathway assessment for the Software as Medical Device (SaMD). This foundational step involves a comprehensive evaluation of the device’s intended use, potential risks, and classification. By determining the best approach for FDA approval from the beginning, manufacturers can set a clear roadmap, saving both time and resources and laying the groundwork for a smoother journey ahead.
• FDA Submission: Building on the insights from the pathway assessment, the next task is navigating the FDA submission process. With the proper pathway identified, companies go through a strict FDA submission process. With such rigorous examination, it is helpful to have regulatory experts on the team or collaborate with seasoned consultants. Their expertise can significantly streamline the submission, ensuring all regulatory standards are met.

The rapid expansion of the Software as Medical Device (SaMD) landscape brings new challenges, which underscores the need for a well-structured, phased approach to SaMD development. Next, we’ll delve into the five phases of medical device software development, providing a roadmap to navigate this complex space successfully.

The first phase of SaMD development focuses on planning, research, and documentation. Recognizing the complexity of the product development process and the benefits of collaborations, partnerships, or expert consultations will ensure success.

During this phase, it is essential to:

• Strategize funding approaches: At this stage, manufacturers evaluate different financing options. Whether it’s seeking venture capital, government grants, or self-financing, a solid financial roadmap is crucial to carry the project through all development stages.
• Identify target markets: It’s not just about identifying where the product will be sold but understanding the specific needs, preferences, and challenges within those markets. This insight ensures that the SaMD products are tailored for optimal market reception.
• Understand the regulations and challenges of that target market: Every market has its unique regulatory landscape. Taking care of regulations from the beginning ensures that the product aligns with specific regional requirements.
• Conduct market research: Knowing what’s already out there helps strategize better. Identifying existing devices and their functionalities can provide a clear direction on product differentiation and market positioning.
• Document all findings: This isn’t just a procedural step, but a proactive measure to ensure that all initial findings and decisions are traceable, setting a clear path forward.
• Setup Quality Management System (QMS): ISO 13485:2016 is the widely recognized standard adopted by most medical device companies, providing a solid foundation for controlling all activities related to SaMD, therefore it is highly recommended to implement your QMS accordingly.

Phase II, at its core, is about transforming an initial idea into a tangible concept and verifying its feasibility. It serves as a foundational stage where teams test the waters before delving deep into intensive medical device software development and large-scale funding. Let’s break down the activities below:

• Project plan and timeline: This step involves crafting a detailed project roadmap, outlining the sequence of activities, key milestones, and estimated timelines. A clear plan ensures that the project stays on track, all activities are sequenced logically, and stakeholders remain informed about progress.
• User interviews: Engage potential users or stakeholders through surveys, interviews, or focus group discussions to gather their needs, preferences, and expectations in regards to what you’re hoping to develop. Direct feedback from the end-users ensures that the software is developed in alignment with actual market needs and enhances user satisfaction.
• Customer prototype valuation: Once an initial prototype is developed, it’s shared with a selected group of potential users for hands-on testing and feedback. This real-world evaluation offers insights into how the software performs in practical scenarios and highlights areas of improvement.
• Prototype analysis: The feedback and data obtained from the prototype evaluation are analyzed to identify areas of enhancement or modification. It ensures that the software undergoes refinements based on actual user experiences before proceeding further.
• Initiate and maintain a Design History File (DHF): Begin the documentation process, which contains all design decisions, changes, and validation efforts throughout the software’s development. A DHF is a regulatory requirement and serves as a comprehensive record, ensuring traceability and transparency in the design process.
• Initiate risk management: Start the process of identifying, assessing, and strategizing how to mitigate potential risks associated with the medical device software. Proactively addressing risks ensures patient safety and regulatory expectation alignment, along with preventing costly corrections later on. In this step it’s also very important to comply with all the FDA cybersecurity guidelines.
• Intellectual (IP) landscape review: Examine the intellectual property landscape by identifying potential patent opportunities and ensuring the software as medical device doesn’t infringe on existing patents. This safeguards the project from legal challenges and helps in establishing a strong IP position in the market.
• Initial regulatory strategy: Perform the regulatory pathway assessment. Draft a preliminary plan detailing how the software will comply with regulatory standards and requirements of the targeted markets. Early strategizing streamlines the FDA submission process and ensures that SaMD development aligns with compliance standards.
• Initial reimbursement strategy: Plan how the software as medical device (SaMD) will be priced, reimbursed by health insurance providers, or integrated into healthcare payment systems. This strategy ensures that once the software hits the market, there’s a clear financial plan that aligns with healthcare industry practices.

In conclusion, Phase II is a pivotal stage in SaMD development. By ensuring each of these activities is done well, teams can set a solid foundation for next phases, minimizing potential challenges and streamlining the journey from concept to market-ready product.

As we transition into the third phase, conceptual stages to tangible design and testing. This phase not only shapes the software but also confirms its ability to function optimally within its intended environment. During this phase, the SaMD begins to take shape, the design & development must undergo rigorous verification and validation to ensure its readiness for real-world scenarios. Its important to define acceptance criteria for each test, through a design traceability matrix that aligns customer & user requirements with engineering specifications. Now lets list and explain activities that should be done during third phase of SaMD development:

• Product design & development: The product design & development activity is a fundamental stage in the SaMD lifecycle, where the theoretical aspects and insights gathered from preliminary stages are turned into a real software blueprint. This process is governed by various international standards to ensure the software is safe, effective, and user-centric. Product design & development activity, when guided by the standards like IEC 62366, IEC 62304, and ISO 14971, ensures that the SaMD developed is not just functional and efficient, but also safe, user-friendly, and compliant with international regulatory requirements. This holistic approach helps in creating software that truly aligns with end-user needs and meets all the regulatory requirements.
• Design verification & validation:  Verification confirms the software design meets its specified requirements, while validation ensures the software accomplishes its intended purpose. These processes ensure that the SaMD is both correctly built (verification) and built correctly (validation), guaranteeing its reliability and effectiveness.
• DHF and project timeline maintenance: Continuously update the Design History File with new information and changes, and adjust the project timeline based on development progress and any occurred challenges. Regular maintenance ensures regulatory compliance and provides stakeholders with a clear and updated view of the project’s progress.
• Risk management activities: This involves continually identifying, assessing, and mitigating risks related to the software’s design, production, and potential misuse. Continuous risk management ensures patient safety and successful regulatory approval.
• Regulatory strategy update: Review and adjust the regulatory strategy based on evolving insights from the design and development phase. Keeping the strategy updated ensures alignment with current standards and increases the chances of smooth regulatory submissions.
• Regulatory submission: Prepare and submit the necessary documentation for regulatory approval, which might differ based on the targeted markets and their specific requirements. This is an important step towards launching the Software as Medical Device (SaMD) in the market.

During this phase, HTD development teams follow the Compliant Agile methodology which is the optimal choice for medical device development due to its iterative and collaborative approach, allowing for continuous feedback, adaptation to changing requirements, and accelerated time-to-market. By embracing Agile, SaMD development teams can foster innovation, improve product quality, and effectively manage risks throughout the development lifecycle.

In the next article of the SaMD series, I will dive deeper into compliant Agile that accelerates SaMD development while ensuring compliance with all the regulatory requirements. If you do not want to miss the next article, make sure to sign up to our SaMD Newsletter and get all the latest information sent directly to your inbox!

As the SaMD product journey transitions into Phase 4, it moves from a state of design and development completion to ensure that the product is ready for the market, both in terms of performance validation and in the strategic launch plan.

A common pitfall during this phase is the realization of unfinished testing due to an inadequate understanding of regulatory requirements or attempts to take shortcuts. Gathering data for validation and verification tests, and completing technical documentation are essential tasks. Here’s a closer look at the key activities within this phase:

• Product branding: Branding is more than just a logo or a catchy name; it’s about creating a distinct and recognizable identity for the SaMD. This involves understanding the target audience, the product’s unique selling points, and ensuring consistency in branding materials. A strong brand can help build trust with users, differentiate the product in the market, and set the tone for all subsequent marketing efforts.
• DHF completion: The Design History File (DHF) serves as a comprehensive record of the design and development process. Finalizing the DHF ensures that all documentation – from initial concept to final design validation – is organized, complete, and compliant with regulatory requirements. This not only helps in regulatory inspections but also ensures that there’s a clear traceability of design decisions throughout the product lifecycle.
• Market launch plan: This strategy involves detailing how the SaMD will be introduced to the market. Key considerations include target demographics, marketing channels, pricing strategies, and post-launch support. A well-executed launch plan can significantly impact the product’s initial acceptance and ongoing market success.
• Risk management update: As the product moves closer to market release, it’s crucial to revisit and update the risk management files. This ensures that all potential risks have been adequately addressed, and any new risks identified during the latter stages of development are appropriately mitigated.
• Obtain regulatory clearance: Before the SaMD products can be released to the market, it must obtain the necessary regulatory clearances or approvals, depending on the jurisdiction and risk classification of the software. This involves submitting the required documentation, including the DHF, to regulatory bodies and addressing any queries or concerns they might raise.
• Finalize reimbursement strategy: A reimbursement strategy details how the medical device software will be paid for by insurance providers or government health schemes, which is especially important in the medical field. Finalizing this strategy involves understanding the reimbursement landscape, ensuring the Software as Medical Device (SaMD) meets the necessary criteria, and setting up processes for claims and payouts.

In summary, Phase 4 is a critical step in the SaMD lifecycle. It’s about finalizing design and development activities and preparing for the product’s market introduction. By carefully navigating each of these activities, manufacturers can ensure a smooth transition from development to successful market launch.

In the fifth phase of the life cycle of a Software as a Medical Device (SaMD) manufacturers transition from the design and testing phase to real-world use of the device. Even as the product enters the market, the dedication and attention of its developers and manufacturers remain crucial. Here’s a comprehensive breakdown of the activities and considerations of this phase:

• Risk management update: As the SaMD interacts with real-world scenarios, it’s possible to encounter risks that were not previously taken into account. Continuously updating the risk management files is important. Emerging risks can be identified, documented, and managed in a timely fashion, further enhancing patient safety.
• Post-market surveillance: This proactive approach involves closely monitoring the performance of the SaMD post-launch. Gathering data from various sources, including customer feedback, reported incidents, and clinical data, which helps in assessing the product’s safety and efficacy.
• Update reimbursement strategy: The healthcare landscape is constantly evolving, with changing reimbursement policies and criteria. Post-launch, it might be necessary to adjust the reimbursement strategy based on real-world data, feedback from healthcare providers, and changes in reimbursement policies.
• Process improvements: Continual improvement is at the heart of medical device software development. Based on post-launch feedback and operational challenges, some processes may need refining. Whether it’s the way software updates are rolled out or how customer support is provided, it’s important to stay flexible and adaptive.
• Update design documentation: As the product matures and potentially undergoes updates or modifications, its design documentation should evolve as well. Ensuring that all design records, user manuals, and other documentation reflect the current state of the product. This is not just good practice—it’s often a regulatory requirement.
• Quality audits: Regular internal and external quality audits ensure adherence to quality management systems, compliance standards, and manufacturing best practices. Audits can uncover areas of non-compliance or inefficiency, offering an opportunity to improve and ensure the product continues to meet both user needs and regulatory requirements.

In summary, Phase 5 is more than just the moment a product meets its audience. It represents a commitment to the SaMD’s efficacy and safety in the market. By being compliant manufacturers can ensure their product doesn’t just launch successfully but also helps improve patient outcomes while prioritizing safety.

Embarking on a Software as a Medical Device (SaMD) journey requires not only technical knowledge but also a deep understanding of a regulatory landscape, market dynamics, quality assurance, risk management and more. Going through the five phases of development can be overwhelming, with each stage presenting its unique challenges. This is where expertise matters. Engaging with a SaMD expert from the beginning can bring to the table a wealth of experience, insights, and strategies tailored to navigate these complexities, ensuring that your SaMD project is not only compliant but also positioned for success.

HTD is your trusted SaMD partner specializing in software as medical device design and development with a focus on quality and patient safety. We support our partners from product ideation, discovery, intended use definition, through design and development all the way to the FDA submission process. Our SaMD experts accelerate product development and innovation and help you optimize resource efficiency.  If you are looking for the best medical device software partner, reach out to info@htdhealth.com and set up a free consultation to discuss your future SaMD product.