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How to choose best partner for medical device software development?

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May 09, 2024

12 min read

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

Medical device software development is a specialized field that combines the rigor of medical science, and regulatory requirements with the innovation of technology. Choosing the right development partner in this niche is critical—not only for the compliance and functionality of the products but also for the success of the business itself and what’s most important is patient safety. The process involves complex and meticulous engineering that must adhere to strict regulatory standards, making the selection of a capable and reliable partner a crucial decision for any medical device company.

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Understanding the field of medical device software development

Medical device software development, often referred to as software development for medical devices or medical device software engineering, plays a crucial role in the healthcare industry. It is the process behind the design and creation of software that is either embedded in medical devices or standalone applications known as Software as a Medical Device (SaMD). These solutions are integral in diagnostics, treatment, monitoring, and management of health conditions, each requiring a high level of precision and reliability.

The importance of choosing the right development partner

The stakes are high when it comes to developing software for medical devices. A well-chosen partner helps ensure not only that product development timelines and budgets are met but also that the final product is safe, effective, and compliant with international health regulations.

Additionally, the right partner understands the internal pressures and influences that managers face when making executive decisions, offering support that goes beyond technical expertise to include strategic business insights.

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The basics of medical device software development

Key concepts

Software development for medical devices encompasses a range of applications, from software that controls the device itself to software that acts independently as a diagnostic or therapeutic tool.

This development must integrate robust design, strict testing protocols, and adherence to global medical software standards and practices, such as ISO 13485 for medical devices and ISO/IEC 62304 for medical device software lifecycle processes. If you want to learn more about SaMD development, make sure to read our article “5 phases of medical device software development”.

Overview of SaMD development

Software as a Medical Device (SaMD) refers to software solutions that perform medical functions without being part of a traditional hardware medical device. SaMD development demands a deep understanding of clinical environments, as well as the regulatory requirements specific to the jurisdictions where the software will be used. Developers must focus on software performance across different platforms and devices, ensuring reliability, security, and user-friendliness.

I. Preparation: How to select a medical device software development company

Define your project requirements

Before initiating the search for a software development partner, it is vital to clearly define your project requirements. This includes outlining the scope, objectives, and specific challenges of the project, such as user interface complexity or data security needs. A clear project brief will help potential partners assess their capability to meet your needs and set the stage for effective communication throughout the development process.

Criteria for Choosing the Best Partner

Technical Expertise and Experience

When choosing a medical device software development company, technical expertise and industry experience are paramount. Look for a partner with a proven track record in developing medical software that not only functions seamlessly but also adheres to all regulatory standards. Experienced developers will have a deep understanding of both the technical and regulatory landscapes, which can significantly accelerate the development process and ensure product safety and efficacy.

Regulatory Compliance and Quality Assurance Practices

A good medical device software development partner will demonstrate robust quality assurance practices and a strong commitment to regulatory compliance. This includes following best practices in documentation, testing, and validation processes. The ability to navigate the complex regulatory environment, particularly in diverse markets, is crucial for the timely and successful launch of medical software products.

Additionally, it is highly beneficial if the partner holds an ISO 13485 certification. This certification is a mark of a quality management system that is specifically designed to meet the stringent requirements of medical device and software development, providing further assurance of the partner’s dedication to maintaining high standards throughout the development lifecycle.

Usability Engineering and Human Factors in Medical Software Development

In addition to technical expertise and regulatory compliance, the importance of usability engineering and human factors cannot be overstated in the development of medical device software. Usability engineering focuses on ensuring that the software is designed with the end-user in mind, facilitating ease of use, minimizing user errors, and enhancing overall safety. Incorporating human factors into software design is crucial for creating intuitive interfaces and interactions, particularly in high-stakes medical environments where user mistakes can have serious consequences.

A development partner skilled in these areas will be able to conduct thorough user research and usability testing, integrating these insights into the software’s design and development process. This not only meets regulatory expectations, such as those outlined in the FDA’s guidance on human factors and usability engineering but also ensures that the software meets the practical needs and constraints of healthcare providers and patients, ultimately leading to better health outcomes.

II. Searching: Steps to find a reliable software development partner

Conducting Thorough Market Research

Begin by conducting detailed market research to identify potential partners who have the capabilities and expertise you need. Look at their past projects, expertise in similar technologies, and reviews or testimonials from previous clients. This research will help you shortlist companies that are most likely to meet your project’s specific requirements.

Evaluating case studies and past projects

Review case studies and past projects to understand how prospective partners have tackled challenges similar to those you might face. This evaluation will give you insights into their problem-solving abilities, innovation in design, and ability to deliver projects on time and within budget. Past performance can be a reliable indicator of future success.

III. Assessment : How to evaluate potential software development partners?

Checking if potential partner meets our criteria

When assessing potential partners, consider their technical abilities, regulatory knowledge, and the scalability of their solutions. It’s also important to evaluate their project management methodology, transparency in communication, and experience. Ensuring that they have sustainable operations and a stable team can mitigate risks associated with long-term projects.

Importance of cultural fit and communication

The cultural fit between your team and the software development partner is often overlooked but is essential for a successful collaboration. A partner who shares similar values and work ethics will facilitate smoother interactions and a better working relationship. Effective communication, especially in a field that involves complex and technical details, is critical for the alignment and success of the project.

Long-term partnership considerations

Evaluating long-term reliability and scalability

Choosing a medical device software development partner is not just about project-specific needs but also about considering long-term reliability and scalability. A partner that can scale with your growth and adapt to changing technology and market demands is invaluable.

Strategies for building a sustainable partnership

Building a sustainable partnership goes beyond the initial project. It involves ongoing communication, regular updates, and a mutual understanding of goals and challenges. Establishing a structured feedback mechanism and regular checkpoints can help maintain alignment and foster a positive and productive relationship.

IV. Making the final decision

Tools and techniques for effective project management

Utilize advanced tools and techniques for project management to ensure transparency and consistency throughout the development process. Tools like JIRA, Github, eQMS or custom software that provides real-time project tracking and communication can enhance project oversight and outcomes.

Maintaining Ccommunication and transparency

Continuous communication and transparency are key to navigating the complexities of medical device software development. Ensure that your chosen partner values open dialogue and provides regular updates to avoid misunderstandings and align project objectives with business goals.


Choosing the right medical device software development partner is a strategic decision that impacts not only the immediate success of your project but also your company’s position in the market. By carefully evaluating potential partners against these criteria, you can establish a fruitful collaboration that promotes innovation, compliance, and growth in the competitive field of medical technology.


HTD is your trusted technology partner that has a proven track record and an experienced team to help you get your medical device software to market quickly and securely. Reach out today to discuss your project and make a difference together!

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