Welcome to a new era of MedTech innovation!

Are you facing challenges in product development due to unnecessarily slow processes in both software development and quality assurance? You’re not alone! A very common situation is that the requirements within medical technology products (from ISO 13485, IEC 62304, IEC 82304, MDR, 21 CFR Part 820, etc.) and software development are not easily compatible. Modern software development processes are expected to be agile with short releases, high flexibility, and extensive automation, while quality assurance processes typically rely on defined procedures with clear requirements and checkpoints, generating comprehensive documentation.

To deliver revolutionary products in this rapidly growing industry, work practices must be redefined and shaped around access to new, modern development and testing tools used in the software development field. Industry standards such as GAMP5 2nd edition and TIR45 support new approaches that can significantly reduce costs and development time while maintaining quality standards. Through continuous integration and continuous delivery (CI/CD), we not only shorten software development lead times but also pave the way for a more efficient and agile workflow.

Software development in Medtech can be complex and resource-intensive. Lemontree understands these challenges and has a standardized approach to develop new methodologies, offering tailored solutions to streamline and enhance efficiency. While concepts like CI/CD, DevOps, and associated automation are familiar in software development environments, their application in regulated settings is less straightforward. Continuous integration/continuous delivery (CI/CD) aims to streamline and accelerate the software development lifecycle. We see this as an area with significant potential to streamline and reduce costs in software development, benefiting both companies and patients.

Effectively applying agile work/CI/CD in conjunction with regulations requires deep expertise in both domains, while considering the technological stack to ensure smooth process integration.

There is nothing formal preventing companies in the medical technology industry from implementing agile approaches with updates to their QMS (Quality Management Systems); however, it often requires a change process that includes people, technology, and expertise in both compliance and technical tools. Tangible benefits such as improved time to market, best practice workflows, and reduced costs can be the desired outcomes. With an agile methodology, we gain more opportunities to control, review, and improve our workflows.

There have been significant developments in methodologies and standards in recent years that allow for agile development and automation within MedTech. For example, GAMP5 2nd edition and TIR45 support automation and even advocate for agile development. However, the work must be conducted in a structured manner with defined processes and still in compliance with applicable regulatory requirements.

Here’s how Lemontree can assist:

We leverage our unique expertise in both software development and Life Sciences to help our clients transition to agile methodologies while maintaining requirements for product quality, patient safety, and data integrity. Our extensive experience includes successful engagements across various industries, including Fintech, where we have helped companies develop top-quality software. We support our clients throughout the entire journey, possessing the specialized skills needed for each step of the process. Each transformation journey is unique, but we have developed a concept designed to simplify and streamline the process as much as possible.

The transition from waterfall principles with extensive documentation to agile work and automation with digitalized documentation will require a change process. Quality assurance functions must become integrated into development work, not just a post-check where both sides understand how to work. Ideally, the work is conducted in a structured manner, starting with low-hanging fruit to demonstrate effectiveness, followed by adaptation and broader rollout across the organization.

Lemontree has ready-made models and concepts to assess the efficiency of the development process as needed, while also preparing for adaptation by evaluating existing regulations and their applications in your organization.

Lemontree begins with a review involving relevant parties at your end, typically the CTO/Head of Development and/or QA function. Together, we set common goals for the upcoming work. In the initial phase, we conduct a feasibility study with a review of the current state and identify low-hanging improvement opportunities that can be easily achieved. For example, this could involve introducing common tools for certain functions, automating simple tasks, or streamlining testing processes that are currently cumbersome or redundant. After completing the feasibility study, a joint decision is made on the next steps, typically involving a pilot, Proof of Concept (PoC), or further investigation. A combination of these approaches is also possible. The aim is to quickly define actions that will impact the development process and pave the way for changes in work practices. The goal is to enable agile processes and automation while complying with applicable regulations.

All of this follows Lemontree’s project model for implementation, which includes reporting, monitoring, and execution. This is usually complemented by various expert skills and evaluation models we use to assess maturity levels in CI/CD, development processes, and applied quality assurance regulations.

Does it sound simple? It isn’t, but embarking on a journey of change towards agile work and automating software processes can significantly increase release speed, enhance competitiveness, boost employee satisfaction, and create conditions for increased profitability.