SaMD Team at Mediwhale is at the heart of our software-based medical device development.
They handle everything from backend and web frontend to operational tools and cloud infrastructure, while also ensuring our products meet strict regulatory standards. Working closely with other teams, they focus on creating safer, more reliable products and finding smart, efficient ways to solve challenges.
In this interview, we hear more about their work, their approach, and the values that guide them.
Please introduce the work of the SaMD Team.
From a development perspective, the SaMD Team is responsible for the backend, web frontend, operational tool development, and cloud infrastructure management for our SaMD products. On the regulatory side, we handle the preparation and maintenance of the technical documentation for our products.
Our work mainly involves collaborating with the Solution, Sales, and Regulation teams, with close communication with the Solution Team to exchange a wide range of ideas from a development perspective.
Although we do not directly face hospital IT environments and therefore lack extensive experience in that area, we play a key role in ensuring our products are delivered reliably across various settings.
What types of problems does the SaMD Team primarily deal with?
The SaMD Team focuses on solving two major questions: What is a safer, more verifiable design? And how can we solve more problems with fewer resources? To deliver value to patients and hospitals, we believe we must create safer, verifiable products, and we continually explore how to achieve that.
Personally, I believe developers should approach various tasks through systemization and automation. With that mindset, I consider different ways to solve more problems with fewer resources.
Could you share a particularly memorable challenge or achievement?
We completely redesigned a legacy system to create a new one. The old system had been built in a way that made verification impossible in many areas. We analyzed the old requirements and re-designed the system to be verifiable, resulting in a much more trustworthy system. This was a particularly memorable accomplishment.
I believe that thanks to the SaMD Team’s work, hospitals and patients can use medical devices that are safer and more reliable. Some might think our product is simply about receiving retinal images, running them through an AI model, and showing the results, but in reality, productizing an AI model involves much more. The system must remain stable even under heavy usage, protect and store patient data securely, guard against various cybersecurity threats, and undergo thorough testing to ensure no issues occur after updates. Thanks to the SaMD Team’s efforts, hospitals and patients can use our products in a safe and trustworthy manner.
What technology stack and domain knowledge will new team members encounter?
Our main tech stack includes Python, React, AWS, and Jenkins. In terms of domain knowledge, new members will become familiar with medical device standards for SaMD products, mainly the IEC 62304 standard for the software life cycle of medical devices and the ISO 14971 standard for medical device risk management.
Working in the SaMD Team offers the opportunity to gain diverse experience in creating reliable software. Reliable software development is an essential skill in any company and domain, and I believe our team is the best place to build that capability.
What kind of people make up the SaMD Team?
We are a team that doesn’t just rush to handle problems in front of us; instead, we aim to solve them in better, more sustainable ways for the long term. While this may seem slower at times, we believe it ultimately benefits the company and the team.
Our colleagues don’t blindly follow established methods — they consider whether there might be better ways and raise questions when necessary. Knowing we still have room to improve, we don’t settle for the current system but constantly seek better approaches.
Is there a culture of sharing knowledge and promoting learning within the team?
When someone joins, we assign them small issues so they can analyze the codebase while solving real problems. We also encourage new members to actively ask questions, helping them quickly understand, adapt, and make contributions.
What tasks or projects is the SaMD Team currently focusing on?
We are currently focusing on establishing our internal technical documentation framework and optimizing the process from design to implementation. Our aim is to reduce unnecessary overhead while adopting only the processes we truly need, so that a systematic process supports software stability without hindering development performance.
In what direction do you plan to grow the SaMD Team, and what qualities do you expect from new members?
We aim to grow into a team that delivers rapid product development through systematic design and development processes. We want to be a team that applies the regulatory requirements of medical devices while still enabling fast product improvements, ultimately becoming an influential presence across the company.
In addition to solid development skills, we value those who are not afraid to learn new things and who can work with us to improve underdeveloped systems and processes.