Managing Medical Device Manufacturers as Software Development Subcontractors

This content provides a step-by-step overview of how we, as software development subcontractors, successfully partner with medical device manufacturers in the development of innovative smartphone applications.

Our approach focuses on understanding their unique requirements and working together to create tailored solutions that introduce new features for medical professionals, ultimately enhancing efficiency and quality of patient care. By leveraging our extensive experience in software development for various smartphone operating systems and our commitment to complying with the IEC 62304 standard, we ensure top-quality products are delivered within agreed-upon timeframes.

Through this collaborative process and our expertise in the medical device industry, we strive to establish strong partnerships with leading medical device manufacturers seeking a reliable subcontractor for their software development needs.

Pre-Contract Considerations: Laying the Foundation

Before diving into the development process, it’s essential to lay a strong foundation by understanding various classifications and regulations governing medical devices. The pre-contract considerations chapter focuses on determining software classification according to IEC 62304 and medical device classification according to government regulations such as FDA Class III or CE Mark Class IIb. A solid grasp of these classifications helps establish appropriate strategies and resources allocation before entering into a contractual agreement.

Classify the medical device according to government regulations

• FDA Class III: Devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or have potential unreasonable risk.
• CE Mark Class IIb: Implantable devices that interact with the human body and pose a higher risk than Class IIa devices but lower risk than Class III devices.

Determine software class according to IEC 62304

• Class A: Lowest risk; no injury or damage to health is possible.
• Class B: Moderate risk; non-serious injury is possible.
• Class C: Highest risk; death or serious injury is possible.

Strategize accordingly based on classification before signing any agreements:

• Understand the additional requirements and documentation needed for different classifications.
• Allocate resources and time to address specific needs depending on the software class.

Specification Alignment: Navigating Expectations and Priorities

A successful partnership between software subcontractors and medical device manufacturers requires aligning expectations and establishing priorities. In this chapter, we discuss how to outline project specifications, navigate revisions during discussions, and prioritize risk mitigation. These aspects are crucial for preventing miscommunication, managing change requests effectively, and ensuring that both parties are on the same page regarding project goals.

Outline clear project specifications

• Develop a detailed list of features, functionalities, and expected outcomes.
• Define the scope, timeline, budget, and other project constraints.

Be prepared for revisions during discussions

• Keep an open mind when negotiating with clients regarding feature requests or changes.
• Communicate effectively about the feasibility and impact of these changes on project goals and timelines.

Prioritize risks mitigation

• Identify potential risks associated with software development for medical devices.
• Develop strategies to mitigate these risks while maintaining product quality and adhering to industry standards.

Establish mutually agreeable solutions for additional feature requests or changes

• Understand client needs while balancing project scope and budget limitations.
• Propose alternatives or compromises that meet both parties’ objectives without derailing the project.

Design Process: Building a Robust Blueprint

As you embark on designing software for medical devices, it is imperative to create detailed design documentation that caters not only to your client but also regulatory reviewers. This chapter highlights the importance of developing comprehensive architecture design charts, components breakdowns, and explanations of frameworks and libraries used in the project. A well-documented design ensures compliance with industry standards while providing clear explanations to diverse audiences.

Create detailed design documentation, including:

• Architecture design charts: Visual representations of the software structure, illustrating relationships and dependencies among components.
• Components breakdown: Detailed descriptions of each component’s purpose, functionality, and interactions with other components.
• Frameworks and libraries usage explanation: Clarify the choice of specific technologies, their benefits, and implementation approaches.

Ensure thorough explanations of design concepts to prevent potential issues during regulatory reviews by FDA or EEC reviewers:

• Make design documentation accessible to non-expert audiences by using clear language and visual aids.
• Address any potential concerns related to software safety, reliability, and compliance with industry standards.

Coding Phase & Risk Management: Balancing Progress and Risks

The coding phase is pivotal for bringing your software concept to life while continuously assessing potential risks. This chapter delves into maintaining regular communication with clients during coding, verifying risk mitigations, assessing new risks throughout the process, and conducting unit tests or code analysis as needed for high-risk Class C projects—ensuring that development progress is balanced with effective risk management practices.

Maintain regular communication with your client throughout coding:

• Schedule periodic progress meetings to discuss development status.
• Share intermediate milestones or prototypes for early feedback and alignment.

Verify risk mitigations and assess possible new risks during coding:

• Continuously monitor risk management measures throughout the development process.
• Update risk assessments based on any changes in requirements or technology choices.

For high-risk Class C projects:

• Conduct unit tests: Test individual components or modules in isolation to ensure their correctness and reliability.
• Perform code analysis: Use static code analysis tools to identify potential issues related to code quality, security vulnerabilities, or maintainability.

Testing Strategies: Ensuring Quality and Compliance

A thorough testing process is vital for delivering high-quality, reliable software that meets client specifications and addresses risk mitigation requirements. The testing strategies chapter outlines a three-phase approach—factory tests, customer tests, and end-user tests—to ensure comprehensive coverage of all aspects of the software. It also emphasizes the importance of developing a well-structured software test plan to facilitate smooth and efficient testing.

Divide testing process into three sub-phases:

• Factory tests: These are conducted at your premises under customer supervision. Prepare test scenarios that demonstrate software functionality according to specifications. Allow customers to provide feedback during this phase.
• Customer tests: Offer support during customer-led tests at their premises by setting up the necessary testing environment and providing guidance as needed. Encourage customers to conduct tests representing real-world usage scenarios.
• End-user tests: Provide assistance during your customer’s end-user testing phase. Be available for clarifications or troubleshooting issues as they arise. Collect feedback from end-users to refine the software further.

Test all aspects of the software and user documentation:

• Ensure it meets specifications: Verify that the developed software aligns with the agreed-upon project specifications.
• Address risk mitigation requirements: Test and validate implemented risk mitigations to ensure their effectiveness in reducing potential risks.

Develop a comprehensive software test plan, detailing:

• Test organization: Outline the structure and sequence of testing activities.
• Roles and responsibilities: Assign specific tasks and deliverables to relevant team members.
• Platforms for testing: Identify suitable hardware, software, or infrastructure required for testing purposes.
• Required data: Determine any necessary input data or test cases needed for successful completion of tests.

Delivery & Support: Bringing Your Project to Fruition

This chapter focuses on transferring the developed software’s property to your customer while continuing to provide support during their end-user tests. We discuss the importance of offering problem resolution services and ongoing maintenance according to your contract’s warranty period. By defining bug severity levels and response times, you can effectively manage post-delivery support while ensuring customer satisfaction.

Transfer the developed software’s property to your customer:

• Prepare a delivery package containing all project artifacts, including source code, design documents, test results, and user documentation.
• Sign any necessary legal agreements to formalize the transfer of ownership.

Continue support during their end-user tests:

• Offer technical assistance during end-user testing phases as needed.
• Provide prompt responses to questions or concerns raised by clients during this period.

Offer problem resolution services and ongoing maintenance as per your contract’s warranty period:

• Implement bug fixes or enhancements based on client feedback.
• Regularly update clients on progress and timelines for maintenance activities.

Define bug severity levels and response times:

• Blocking: Critical issues that prevent usage of key functionalities; provide patches within 24 hours.
• Major: Significant issues that impact overall usability; provide patches within 7 days.
• Minor: Cosmetic or low-priority issues; address these in the next service pack release.

In Summary

Developing software for medical devices requires adherence to best practices in development while considering unique constraints faced by medical device manufacturers. Each chapter in this guide provides insights into essential aspects of successful collaboration—from pre-contract considerations through project delivery and support. Familiarizing yourself with industry standards like IEC 62304, understanding risk management protocols, and maintaining open communication lines will result in a satisfied customer and a successful partnership.