When done well, prototyping de-risks medical device software development by validating user workflows and design assumptions before engineering investment scales up — particularly important for medical device companies preparing for clinical study or commercial release.
Getting an MVP for your medical device is not as complex a process as it may seem. With five simple steps, Sequenex helps our medical device clients create an iterative, market-ready MVP by turning their Software Requirements Document into an effective prototype that informs the features and functions required for successful MVP software.
The process of developing a Minimum Viable Product for your medical device may seem complex. But the truth is, this process follows a logical set of steps that even the greenest tech startups can easily follow. From creating your Software Requirements Document and prototyping to developing the actual MVP, the most important aspect is having the right software partner to work through the steps with you.
Below, we’ll take a closer look at what MVP software is and the five steps every medical device company should go through to create their MVP software. We’ll also share some of the specific tactics Sequenex uses with our clients to ensure we create the most useful and effective MVP software, helping you get to market sooner.
What Is an MVP?
Minimal Viable Product is a development strategy and product management concept popularized by Eric Ries in his book “The Lean Startup.” An MVP is the simplest version of a product that can be released to the market to validate assumptions, gather feedback, and test hypotheses with minimal resources.
In the context of medical device software, an MVP is the earliest version of the software that includes essential features to address a specific healthcare problem or need. This version of the software is designed to be functional, albeit with a minimal set of features, and is intended for initial testing and validation.
MVPs are often developed and deployed to gather feedback from healthcare professionals and end-users. This allows the development team to validate assumptions, identify potential improvements, and iteratively enhance the software.
How Is Having MVP Software for Your Medical Device Beneficial?
By focusing on the minimum set of features required for functionality and usability, the MVP software approach enables early validation while reducing cost and time to market. It also allows for iterative improvement and helps to mitigate risk.
- Early Validation. An MVP allows you to validate your medical device concept early in the development process. By releasing a basic version of the product, you can gather feedback from users, healthcare professionals, and other stakeholders. This feedback helps validate assumptions, identify potential issues, and refine the product before investing more resources into its development.
- Cost Efficiency. Developing an MVP requires fewer resources compared to building a fully-featured product. By focusing on essential functionalities, you can reduce development costs and minimize financial risk. This cost-efficient approach is particularly beneficial for startups and small companies with limited budgets.
- Reduced Time to Market. MVP software enables you to bring your medical device to market faster. By prioritizing core functionalities and releasing an initial version of the product, you can start generating revenue and establishing a presence in the market sooner. This early entry into the market gives you a competitive advantage, especially with novel and innovative products.
- Iterative Improvement. As you gather feedback from users and stakeholders, you can identify areas for improvement and prioritize features for future iterations. This continuous improvement cycle ensures that your medical device evolves to meet the needs of users effectively.
- Risk Mitigation. By testing your medical device with real users early on, you can identify and mitigate potential risks before they escalate. Addressing issues and refining the product iteratively reduces the likelihood of costly mistakes and regulatory setbacks later in the development process.
How to Get MVP Software for a Medical Device
Having an MVP for your medical device is a smart way to reduce costs and improve your product before launch. But how do you go about building an MVP for your medical device idea?
With the right software partner, you can easily create MVP software in just five simple steps.
Step 1: Create a Software Requirements Document
Before your software partner can create an MVP for your software, you first need to create an SRD.
A Software Requirements Document (SRD) outlines the functional and non-functional requirements of a software system. It serves as a blueprint for software development, detailing what the software should accomplish and how it should behave. This should be written in non-technical language from the end user’s point of view.
SRDs for medical devices typically include:
- An Introduction – Provides an overview of the document, including its purpose, scope, and intended audience.
- Functional Requirements – Detailed descriptions of the software’s functional capabilities, including specific features, functionalities, and user interactions. Outline what the software should do to meet the intended purpose and address user needs.
- Non-functional Requirements – Includes performance, reliability, security, and regulatory requirements. Non-functional requirements specify how the software should perform and behave, such as response times, error handling, data security measures, and compliance with relevant regulations and standards, such as FDA regulations, GDPR, and HIPAA.
- User Requirements – Describes the intended users, their roles, and their needs. Outlines user scenarios, workflows, and any user interface considerations to ensure usability and user satisfaction.
- System Requirements – Technical specifications for the software, including hardware and software dependencies, operating environment, compatibility requirements, and integration with other systems or devices.
- Data Requirements – Specifications for data input, output, storage, and processing. Includes data formats, data sources, data validation rules, and any requirements related to data privacy and security.
- Interface Requirements – Specifications for user interfaces, including graphical user interfaces, command-line interfaces, and application programming interfaces. Defines how users interact with the software and how the software interacts with external systems or devices.
- Quality Assurance and Testing Requirements – Consider criteria for testing the software to ensure its quality, reliability, and compliance with regulatory standards. This will be discussed more in depth with your software partner.
- Documentation and Training Requirements – Requirements for user manuals, technical documentation, training materials, and support resources to facilitate the safe and effective use of the medical device software.
- Regulatory Compliance – Compliance statements and evidence demonstrating adherence to applicable regulatory requirements, standards, and guidelines. This should include references to relevant regulations, standards, and guidance documents.
- References and Appendices – Additional information, references, and supporting documentation relevant to the SRD, such as industry standards, regulatory guidance documents, and technical specifications.
Your SRD provides a clear and comprehensive understanding of your proposed software’s scope, features, and constraints. It serves as a reference for developers, designers, and stakeholders throughout the development process. Most importantly, it should provide perspective from the end user’s point of view and be written in language users can understand.
Step 2: Review SRD with Software Development Partner
Once your SRD is complete, it’s time to go over it with your software partner.
All stakeholders, including representatives from both the device company and the software development partner, should be present to offer their perspectives and ensure a mutual understanding.
This review entails meticulously examining each section of the SRD, clarifying any ambiguities, and validating that the documented requirements accurately reflect the project’s objectives and needs. Identifying assumptions and potential risks associated with the requirements is vital to proactively address challenges. Feasibility assessments are usually conducted to gauge the practicality of implementing the outlined requirements within the given constraints of time, budget, and technology.
Collaboratively discussing implementation approaches, technology choices, and development methodologies is paramount to establishing a shared understanding and strategy. Establishing clear acceptance criteria for each requirement, documenting action items, and defining communication channels ensure ongoing alignment and help facilitate successful collaboration between the client and the software development partner.
Step 3: Develop Prototype
The completed SRD will serve as a foundational guide for creating a prototype or visual representation of the device platform, application, or other software.
Drawing on the shared understanding of the SRD from the previous step, the software partner begins prototyping by translating the documented requirements into tangible design elements, user interfaces, and interactive features. This iterative process involves close collaboration between the medical device company and the software partner, with frequent feedback loops to refine the prototype based on evolving insights and requirements.
The prototype serves as a visual representation of the intended product, allowing stakeholders to visualize key functionalities, user interactions, and design aesthetics. Through this collaborative effort, the two parties can iteratively refine the prototype, incorporating feedback and making adjustments as necessary.
One of the most commonly used software prototype creators, and the one we at Sequenex trust to help make our products, is Figma.
This versatile design tool facilitates the creation of prototypes and visual representations of medical device software products. It allows both parties to work collaboratively in real-time, regardless of their physical location.
One of Figma’s key strengths is its ability to support iterative design and rapid prototyping. Designers can quickly create multiple design variations and interactive prototypes, allowing stakeholders to visualize different concepts and provide real-time feedback. Equally important, Figma’s cloud-based platform ensures that all project files are stored centrally and accessible to team members at any time, eliminating version control issues and enabling seamless collaboration. This centralized approach also facilitates the easy sharing and presentation of design concepts to key stakeholders, including regulators, clinicians, and end users.
Step 4: Design MVP Software Features and Functions
Once the prototype is developed, it serves as a blueprint for designing the features and functions of the MVP software. Here, the device company and the software partner engage in an iterative process to further refine and expand upon the initial design. They begin by reviewing the prototype to identify key features and functionality essential to addressing users’ core needs and achieving the product’s objectives. Through collaborative discussions and feedback sessions, they prioritize these features based on user requirements, market demand, and regulatory considerations.
Designers and developers then work closely to translate the identified features into actionable design specifications and technical requirements. This involves breaking down each feature into smaller, more manageable components and defining their functionality, user interactions, and technical implementation details. Throughout this process, the prototype serves as a visual guide, helping to ensure consistency and alignment between the design and development teams.
As the design and development of the MVP software progresses, the prototype continues to evolve in parallel, reflecting the latest changes and enhancements. At Sequenex, we insist on regular review meetings and feedback sessions with our partners to evaluate the progress, identify any challenges or roadblocks, and make necessary adjustments to the design and development approach. This iterative and collaborative process allows both parties to stay aligned, address issues promptly, and ensure that the final MVP software meets user needs, complies with regulatory requirements, and delivers value to the market.
Step 5: Development MVP
Drawing on the refined design specifications and feature priorities established during the prototype phase, developers diligently implement the core functionalities and features identified for the MVP software. They follow an iterative development approach, breaking the process into manageable sprints or iterations, each focused on delivering specific features or functional increments.
Throughout the development process, Sequenex maintains open lines of communication with our device partners, collaborating closely to address any challenges, provide feedback, and make necessary adjustments to the development plan. Rigorous testing procedures are also employed to verify the functionality, reliability, and usability of the MVP software, with any identified issues promptly addressed and resolved.
As development progresses, the MVP software takes shape, gradually incorporating essential features and functionality to address the core needs of users and stakeholders. Once the development milestones are met and the MVP software is functional, it undergoes thorough testing and validation to ensure readiness for market release. This may involve beta testing with select users or pilot deployments in real-world settings to gather feedback and validate assumptions.
Upon successful validation and acceptance, the MVP software is prepared for market launch, with both parties working together to execute a strategic go-to-market plan. This may involve marketing campaigns, sales efforts, and regulatory compliance activities to ensure a successful product launch. Following the launch, the device company should continue to gather feedback from users and stakeholders, iterating on the MVP software based on real-world usage and evolving needs, thus driving continuous improvement and innovation.
The Road to Successful MVP Software
The journey from ideation to the creation of a Minimum Viable Product for medical device software involves a strategic, collaborative process. By following a logical sequence of steps, medical device companies and their software partners can efficiently navigate through the complexities of MVP software development while ensuring alignment with user needs and regulatory requirements.
The result of the simple five-step process Sequenex takes with our device partners is a market-ready product that addresses user needs, reduces time to market, and lays the groundwork for future enhancements.
With the right software partner and a strategic approach, medical device companies can successfully navigate the complexities of software development and bring innovative solutions to market, ultimately improving patient outcomes and advancing healthcare innovation.
Frequently Asked Questions About Medical Device Prototyping
Common questions from medical device companies starting their prototyping work — what tools to use, how long the process takes, and how prototyping relates to MVP software development and regulatory readiness.
What is medical device prototyping?
Medical device prototyping is the iterative design and validation of a medical device’s software interface, workflow, and feature set before committing to full MVP development. The prototype is typically a clickable, interactive visual representation built in tools like Figma — used to validate user workflows with clinicians, surface design issues early, and refine the feature set that ultimately drives MVP engineering.
What tools are used for medical device prototyping?
Figma is the most common medical device prototyping tool — cloud-based, collaborative, and well-suited to iterative design with remote teams. Sketch, Adobe XD, and InVision are also used. For prototypes that need to demonstrate clinical workflows or device-app integration, higher-fidelity tools like Axure or ProtoPie may be appropriate. Tool choice depends on prototype complexity, team workflow, and the level of interactivity required for clinician validation.
What is the difference between a medical device prototype and an MVP?
A medical device prototype is a non-functional visual representation used to validate design and workflow decisions — typically built in design tools like Figma. An MVP (Minimum Viable Product) is functional software with the minimum feature set needed to validate the product in the market. The prototype precedes the MVP in development: prototyping de-risks the design; MVP development de-risks the engineering and market fit.
How long does medical device prototyping take?
Medical device prototyping typically takes 4-12 weeks, depending on the complexity of the workflow being prototyped and the depth of clinician feedback required. A simple prototype that validates a single workflow can be completed in 4-6 weeks. A complex multi-screen prototype with multiple stakeholder review cycles can extend to 10-12 weeks. The Software Requirements Document review and stakeholder alignment typically take 2-3 weeks of that timeline.
Do I need a Software Requirements Document before prototyping a medical device?
Yes. A Software Requirements Document (SRD) is the foundation that guides medical device prototyping. The SRD defines functional and non-functional requirements, user roles, regulatory compliance needs, and data flows — all of which the prototype then visualizes and validates. Starting prototyping without an SRD typically produces design that doesn’t survive stakeholder review or regulatory scrutiny later.
