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5 Steps to Get MVP Software for Your Medical Device

Getting MVP software for your medical device is not as complex a process as it seems. 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 necessary to create successful MVP software.

The process of getting a Minimal Viable Product for your medical device may seem like a complex one. But the truth is, this process follows a logical set of steps that even the greenest tech startups can easily follow. From the creation of your Software Requirements Document to prototyping to the development of 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. We’ll also share some of the specific tactics Sequenex takes with our clients to ensure we create the most useful and effective MVP software to get you 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 refers to the earliest version of the software that encompasses essential features necessary to address a specific healthcare problem or need. This version of the software is designed to be functional, albeit with a minimal set of functionalities, and is intended for initial testing and validation purposes.

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 in subsequent iterations.

How Is Having an MVP for Your Medical Device Beneficial?

By focusing on the minimum set of features required for functionality and usability, the MVP 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. An MVP 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 MVP software for your medical device is a smart way to reduce costs and improve your product before launching it. But how do you go about getting MVP software 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 point of view of the end user.

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 act as a foundational guide to create a prototype or visual representation of the device platform, application, or other software. 

Drawing upon the shared understanding of the SRD gained in the previous step, the software partner begins the prototyping process 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 and iterate on 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 are able to 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 feedback in real time. 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 easy sharing and presentation of design concepts to key stakeholders, including regulators, clinicians, and end-users.

Step 4: Design MVP Features and Functions

Once the prototype has been developed, it serves as a foundational blueprint for designing the features and functions of the MVP. 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 functionalities that are essential for addressing the core needs of users and achieving the product’s objectives. Through collaborative discussions and feedback sessions, they prioritize these features based on factors such as 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 progresses, the prototype continues to evolve in parallel, reflecting the latest changes and enhancements made to the software. 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 any issues promptly, and ensure that the final MVP software meets the needs of users, complies with regulatory requirements, and delivers value to the market.

Step 5: Development MVP

Drawing upon the refined design specifications and feature priorities established during the prototype phase, developers work diligently to implement the core functionalities and features identified for the MVP. They follow an iterative development approach, breaking down the development process into manageable sprints or iterations, each focused on delivering specific features or functionality 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 the essential features and functionalities needed to address the core needs of users and stakeholders. Once the development milestones are met and the MVP software reaches a functional state, it undergoes thorough testing and validation to ensure its readiness for release to the market. 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 and collaborative process. By following a logical sequence of steps, medical device companies, and their software partners can efficiently navigate through the complexities of 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.

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