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5 Green Flags: Hiring a Medical Device Developer

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Hiring a medical device developer for your device can be daunting, however, there are a few things that you can look for to help focus your search. These are the top 5 green flags to look for when you’re talking to contract developers about partnering with them to design and develop your medical device.

1: Transparency in Budgeting and Fees

You’ve worked hard to secure your funding – it’s important that you know where it’s going when you work with a contract developer. A reliable developer will provide a clear and detailed breakdown of costs when presenting your project proposal. While long-term projects can go through many changes, there are key financial aspects should be understood upfront, such as:

  • Hourly labor costs
  • Expected material and equipment expenses
  • Expense mark-ups
  • Project plan detailing tasks
  • Clear indication of deliverables

This transparency helps prevent misunderstandings and ensures that there are no hidden fees, allowing you to plan your budget effectively and avoid unexpected expenses. Look for developers who offer comprehensive quotes and are open about their pricing structure from the beginning.

While giving a proposal, the development company should also tell you how often you can expect formal project updates. We’ve learned that weekly formal updates that include: budget, timeline, and technical updates are best for both us and our clients. Of course, more frequent touchpoints are likely throughout the week but make sure you ask about the minimum number of formal updates you can expect.

2: Open Communication About Your Proposal

When hiring a medical device developer, look for those who actively seek your feedback on their proposal and engage in open dialogue. This way, the developer can ensure mutual understanding of your project’s goals and requirements, preventing miscommunications and setting a solid foundation for a successful partnership.

A developer who asks for your input on their assumptions and adjusts their proposal based on your feedback demonstrates flexibility – an important aspect of working with startups.

Discussing the proposal in detail allows both parties to identify potential challenges or areas of concern early on. Addressing these issues upfront can help develop a realistic and achievable project plan. Setting clear expectations regarding deliverables, timelines, and responsibilities through open communication ensures a smooth workflow and timely achievement of project milestones. Open communication at this stage also helps build trust and confidence both ways.

3: Quality and Certifications

Certifications such as ISO 13485:2016 for medical devices signal that the developer adheres to industry standards and best practices. A benefit of working with a developer that hold this ISO certification is that it requires comprehensive documentation and traceability of the development process. This can be crucial for auditing, regulatory submissions, and addressing any issues that arise during or after the development phase. Proper documentation ensures that all aspects of the development are transparent and can be reviewed or inspected as needed at any stage.

By choosing a developer committed to quality and holding the right certifications, you mitigate potential risks and project delays through the product lifecycle. Certified developers are required to identify, evaluate, and mitigate risks associated with medical device development, ensuring a safer and more reliable end product.

4: Flexibility and Adaptability

Startups often operate on tight schedules and pivot quickly to adapt to new opportunities, market demands, or unexpected challenges. A flexible contract developer ensures they can work with an evolving schedule without compromising on quality or deadlines.

In the dynamic environment of a startup, project goals and requirements can change rapidly. An adaptable developer adjusts their approach to meet these needs. This adaptability might involve incorporating new features, changing project scope, working with deadlines for low-volume manufacturing needs, or shifting priorities to address immediate concerns, all while maintaining the integrity and progress of the project.

This trait is particularly crucial for startups aiming to innovate and grow quickly, as it allows for a responsive and resilient development process that can support your business’s growth and success.

5: Relevant Experience and Skillset

Many developers focus on specific areas such as catheters, wearables, neurology devices, and more. Finding a developer whose expertise aligns with your specific type of device can significantly enhance the quality and efficiency of your project.

A developer with relevant experience brings a deep understanding of the unique challenges and requirements associated with your type of device. For example, a developer specializing in catheters will likely be well-versed in the necessary regulatory standards, material specifications, and functional requirements specific to that field.

We’ve found that startups with first-of-kind devices sometimes have a hard time finding a development company that can meet the requirements of the device. In this case, looking for a developer that has experience working with innovative devices with similar parts or requirements can work just as well.