In the ever-evolving landscape of the MedTech industry, agility and efficiency are paramount. Agile Development and Continuous Delivery are two methodologies that have transformed the way software is created, delivering high-quality solutions in less time. But these processes do not translate seamlessly to software as a medical device (SaMD) development without the inclusion of Continuous Compliance.
Today we invite you to learn more about Agile Development, Continuous Delivery, and Continuous Compliance and how Sequenex uses these approaches to ensure its customers receive safe, high-quality SaMD delivered faster and for less money.
What Is Agile Development?
Agile Development is an iterative and flexible approach to software development. It prioritizes collaboration, customer feedback, and the ability to respond to changing requirements.
Agile approaches involve breaking down a project into small, manageable increments and continuously delivering functional software. This incremental approach allows teams to adapt, refine, and improve the product over time. Agile methodologies, such as Scrum or Kanban, focus on delivering value quickly.
This makes them well-suited for industries like MedTech software development, where a rapid, ever-evolving market requires an approach that can adapt and change in an instant.
What Is Continuous Delivery?
Continuous Delivery (CD) is a software development and deployment approach that focuses on automating and streamlining the process of delivering software updates and improvements.
In CD, code changes are continuously integrated, tested, and made ready for production deployment through automated build, testing, and deployment pipelines. This ensures that software can be released to production at any time, in a controlled and reliable manner.
This development approach aims to reduce the manual effort required for software release and increase the speed and frequency of software delivery. It does this while maintaining high quality and minimizing the risk of introducing defects or errors into production systems.
What Is Continuous Compliance?
Continuous Compliance (CC) in medical software development refers to the ongoing process of ensuring that a software product adheres to relevant regulatory standards and requirements throughout its development lifecycle.
CC involves integrating compliance activities seamlessly into the development process from the very beginning and maintaining compliance at every stage of development. It includes thorough documentation, rigorous testing, validation, and verification procedures to ensure that the software meets the necessary regulatory standards set by authorities such as the Food and Drug Administration in the US and the European Medicines Agency in the European Union.
In the context of the medical field, which is highly regulated and governed by strict quality and safety standards, Continuous Compliance is crucial for ensuring patient safety and the reliability of medical devices and software. It is also necessary to avoid a lengthy and costly compliance phase at the end of development. Despite the many advantages of CC, many MedTech companies and software developers do not employ this technique when developing SaMD.
The Benefits of Combining Agile Development, Continuous Delivery, and Continuous Compliance in SaMD Development
Agile Development, Continuous Delivery, and Continuous Compliance are the optimal development processes for creating software as a medical device (SaMD).
The MedTech industry is evolving rapidly and requires an approach to software development and deployment that can keep up with constant advancements. Combining these three approaches for building medical device software has many benefits from rapid iteration and innovation to reducing costs and delivery time to providing unparalleled predictability and transparency.
Agile Development allows for frequent software updates and improvements. This enables quick adaptation to evolving medical standards, regulatory changes, and emerging technologies.
Agile also encourages cross-functional teams, including developers, testers, and regulatory experts, to collaborate closely. This ensures that the software meets the needs of the end-user and complies with regulations.
Agile emphasizes continuous user feedback, ensuring that the software is user-friendly and tailored to the specific needs of the end-user, be that healthcare providers, patients, or consumers.
Agile’s iterative development and CD’s automated testing help identify and address issues early, reducing the risk of software defects that could compromise patient safety or regulatory compliance. These bugs are identified earlier in the process and removed immediately, negating the need for lengthy testing and cleanup after the product is completed.
Compliance and Documentation
Integrating CC into Agile and CD allows proactive developers to facilitate compliance with stringent regulatory requirements, such as those put forth by the FDA, by integrating documentation and validation activities into the development process. By incorporating these steps from the first feature release, developers can ensure they are complete by the time the product is finished. This means that no time needs to be allocated to this process between completion and launch, which has the potential to reduce the total development time of SaMD by weeks or months.
By combining Agile and CD, developers can effectively implement Continuous Integration (CI) practices. CI involves integrating code changes from multiple developers into a shared repository several times a day, enabling early detection of integration errors and facilitating the rapid development of high-quality software.
Scalability and Flexibility
Both CD and Agile can accommodate changes in project scope and scale, allowing MedTech projects to adapt to new research findings, market demands, and emerging technologies. This adaptability remains in place long after launch, extending the lifespan and usability of devices and software far beyond their initial design.
Agile prioritizes delivering the most valuable features first, helping to reduce cost. Meanwhile, CD reduces manual testing efforts, leading to cost savings over the course of development. CD also results in fewer bugs which means fewer expenses and less time wasted between planning and launch.
Agile and CD’s rapid development and deployment cycles can expedite the delivery of innovative MedTech solutions to the end user. Not only does it take less time and money to complete the software build, but the end result is much less likely to require debugging. This removes a lengthy step from the end of the process. Additionally, CC ensures compliance with every feature launch, removing the need for prolonged documentation efforts after the product is complete.
By combining Agile, CD, and CC, developers ensure that every feature release is clean, functional, and compliant. If changes are made to the scope of the project or if restrictive deadlines require that additional features must be cut, the completed features will still form a usable product that can be released without additional steps to confirm functionality or compliance.
Agile practices, such as daily stand-up meetings and regular progress reporting, provide stakeholders with transparency into the project’s status. This not only fosters an environment of trust and alignment, but it opens the floor to discourse that helps to ensure the customer receives the product they expect.
CD’s automated testing and Continuous Integration help maintain high software quality, which is crucial for patient safety and regulatory compliance in MedTech.
Timelines in traditional software development are difficult to predict because the lengthy debugging and compliance phases can vary significantly based on unpredictable parameters during development. When software is created using CC, CD, and Agile, each feature is bug-free and compliant at the point of release, which negates the need for these unpredictable post-development phases. Moreover, the timeline for each feature release can be easily predicted, allowing developers to confidently forecast completion dates for projects regardless of scope or size.
How Sequenex Uses Agile, CD, and CC to Deliver Better Software
The use of Agile and Continuous Delivery in software development has become more prevalent in recent years. Because of their benefits, these practices are especially useful for developing medical software. Many MedTech companies employ these methodologies when building software for medical devices and connected apps.
What many of these companies do not realize is that Agile and CD are not enough to create reliable software for medical use in a timely and cost-effective manner.
SaMD must meet regulatory guidelines that require strict documentation, including validation and verification documents and design history files (DHF). Agile and CD alone do not account for this extra development requirement in SaMD. When software for medical use is developed in this manner, companies must complete a prolonged documentation process after the product has been completed. The length of this process can be unpredictable, making it difficult to meet launch deadlines and accurately forecast project costs.
In order to take full advantage of the cost-savings, flexibility, and other benefits of Agile and CD for SaMD, developers must also utilize Continuous Compliance in their workflows.
Why Sequenex Is Different
At Sequenex, we’ve fully embraced Agile Development, Continuous Delivery, and Continuous Compliance methodologies, enabling us to deliver high-quality software solutions to our customers faster than other development companies. Our unique approach starts with a customer conversation where we work closely with you to understand your software system’s goals, whether it’s solving specific use cases, creating a tailored app, or addressing a particular problem.
This initial conversation results in a comprehensive set of epics and user stories, forming the foundation for our development process. We provide you with a detailed scope estimate and basic architecture, so you know what to expect in terms of project duration and cost.
What sets Sequenex apart from other MedTech software development companies is our commitment to Agile practices and continuous development, integration, and compliance.
This means we avoid extensive upfront design work, recognizing that software requirements can evolve. Instead, we collaboratively design and implement features as we go, ensuring that we fully understand the technical aspects before implementation begins. Our highly collaborative environment and quality-first culture guarantee that we retain only highly skilled engineers who produce impeccable results.
Our development process is meticulously structured, starting with a user interface phase, if needed, followed by design collaboration, risk assessments, feature and system-level architecture, and, finally, implementation. Each feature progresses through design, implementation, automated testing, and client demos. We repeat these steps until all features are complete, ensuring a final product that meets your expectations, adheres to regulatory requirements, and is ready to go to market without additional steps.
This unique approach saves you time and money in several ways. Unlike traditional methods where issues often linger and lead to delays and extra costs, we address and resolve potential problems as they arise, ensuring smoothly functioning increments for a bug-free final product. Collaboration between developers and testers and the use of simulators that test not only individual increments but the device as a whole, ensure our software is fully vetted and ready for deployment.
We use this same continuous process approach to meet documentation and validation requirements as the software is built. Each feature release includes the full DHF and documentation required to meet regulatory guidelines. This eliminates the need for an extensive and time-consuming documentation effort at the project’s end, which saves weeks of development time and reduces expenses. Furthermore, this allows for impressive flexibility in project scope and deadlines. Because all features are fully functional, integrated, and compliant, deployment can be completed at any time.
Additionally, we hold ISO 13485 Certification for our quality management system. This highlights our dedication to adhering to stringent quality standards and regulatory requirements. It is just one more feature that separates us from the competition and underscores our commitment to delivering high-quality software solutions.
Sequenex Project Success Stories
Here at Sequenex, we have used our expertise and unique development process to help countless connected medical device companies plan, develop, and launch their products. Below are some of our most recent project highlights.
Remediation of Software for Smartwatch-Based Lifestyle Device
A startup wearable device company came to us with incomplete, non-functional code developed by another software development company. Significant gaps existed in the testing of this code and the features contained numerous bugs that compromised functionality.
We immediately implemented automated integration and system tests to cover most functionality. In just two months, we were able to increase code coverage from 0% to 50%. We also executed a device simulator to reproduce the smartwatch features and functionality over Bluetooth. Additionally, we were able to create a testing app for use by the manufacturer to verify the integrity of newly built smartwatches.
New Build for Medical Device Startup with an NFC-Based Device
We implemented a device simulator to reproduce all device functionality over near-field communication (NFC). We built native mobile applications and software development kits (SDKs) for both iOS and Android with over 80% code coverage.
Additionally, we implemented fully automated system tests to verify the functionality of all components, including the mobile phone app, web services, and infrastructure.
Startup Developing BLE Medical Sensor
For this complex project, we had to integrate the manufacturer-provided development kit used for testing the device hardware into our Appium-based system testing harness.
We integrated these testers in order to ensure that the software worked with the sensor device, eventually creating a set of tests that checked the entire system, including the hardware, mobile app, and backend services, to make sure everything worked together smoothly.
Fortune 1000 Medical Device Company
For this project, we provided several quality assurance engineers to work directly with the internal teams at the company. These engineers worked as team leads to provide principle-level expertise and knowledge to build automated tests and frameworks across mobile applications and web services.
Sequenex Has the Expertise to Bring Your SaMD to Market
At Sequenex, our commitment to Agile, Continuous Development, and Continuous Delivery methodologies ensures that we provide you with high-quality software, on time and within budget, while minimizing risks and delays. Your success is our priority and our unique approach reflects that commitment.
To learn more about how our approach to software development can benefit you or to discuss your diabetes or connected device SaMD project with our team, connect with us today.