About the company

Ascilion specializes in the design, development, and manufacturing of products utilizing hollow microneedles for the extraction of dermal interstitial fluid (dISF) from the skin. Leveraging advanced MEMS (micro electromechanical systems) technology, the company provides a unique microneedle based sampling solution.

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  • Application Specialist
  • Start: 1 January, 2024
  • Currently ongoing

Integration of dISF extraction tool in customer applications

Work description
After three years of R&D work at Ascilion, my role evolved to focus on integrating our innovative dISF extraction tool into diverse customer applications. This transition demanded a high level of customer interaction, requiring me to understand and address customer needs while providing technical support. I was also involved in the developing the regulatory framework for the medical device.

Regulatory compliance
I managed the compliance process for IEC 60601 (electrical safety) and IEC 62304 (software life cycle processes). I maintained continuous dialogue with testing bodies to ensure meeting of regulatory standards, which required learning about compliance of electrical components within the MDR (medical device regulations) framework. I was also responsible for creating a plan for compliance for the medical device software according to IEC 62304, which required in-depth knowledge of software development according to the standard.

Applications engineering tasks
My role in applications engineering focused on visiting customers to demonstrated and teach correct usage of our medical device. I trained customers on our device and also played an important role in understanding their unique needs and adapting our product to their applications. My strong understanding of both the hardwaree and software involved in our product, ensured that I was able to answer customer questions with precision, and I was also able to quickly judge whether their requests were feasible or not. It occasionally involved on-site improvisation of customization of the product.

What I learned in this role:
This role developed my knowledge in medical device regulations and complex product design projects within medical device development. I gained an understanding for the product lifecycle, from development to market integration. The experience of participating in projects honed my leadership skills and ability to managed complex projects. My communication skills were greatly enhanced, as I learned to effectively convey complex technical information to diverse audiences, from regulatory bodies to potential clients. Another key experience in this role was that I learnt how to independtly organize and execute meetings with customers, and I learned a lot about how to listen to customer needs. This experience has made me more capable of handling customer interactions in complex settings.

Skills developed:
  • Knowledge of medical device regulations (MDR, IEC 60601, IEC 62304)
  • Project management in a regulatory environment
  • Applications development and customer feedback integration
  • Customer relationship management
  • Technical training and support
  • Regulatory documentation
  • Development Engineer
  • Start: 1 February, 2021
  • End: 1 January, 2024

Development of medical device for extraction of liquid dISF

Work description
In my initial years at Ascilion, I played an important role in transforming a prototype medical device into a market-ready product suitable for clinical applications. My contributions were in both hardware and software development. This role required me to rapidly acquire new skills and knowledge, often venturing into unfamiliar territories of medical device development.

Hardware development achievements
I developed test setups for various components, ranging from mechanical testing of silicon features to inspection systems. The interdisciplinary nature of my work required me to improvise and be creative in developing and using various hardware solution for development of the product. I was also involved in development of electronic component design and pneumatic solution, which required me to quickly learn new design tools. This work demonstrated my ability to apply theoretical concepts in practical, real-world applications and to quickly learn new skills when necessary.

Software development innovations
My software development efforts were used to advance our lab capabilities and product functionality. I developed a suite of software tools using SQL, C#, C++, and Python. These software applications not only facilitated data acquisition and analysis but also integrated with physical systems, teaching me important skills in hardware-software integration. Many of the tools were used for automation to improve the workflow and facilitate development.

Additional key contributions:
I also made contributions to experimental design, particularly in microfluidics, optimizing the application of our technology. These experiments improved our device's performance sufficiently to make it ready for use outside of the lab. I also contributed by using inspection techniques such as SEM to investigate and maintain a high product quality. Beyond technical development, I took on tasks in product design, documentation, and customer support, developing my ability to manage multiple aspects of product development and R&D.

What I learned in this role:
This role was a transformative experience, significantly expanding my technical and professional skill set. I gained comprehensive knowledge in medical device development, from initial concept to market-ready product. My skills in software development were significantly enhanced. I also gained insight into the world of manufacturing, which taught me a lot about trade-offs between product design and production. Working in a startup environment honed my ability to manage multiple responsibilities efficiently and make decisions in a fast-paced setting. I learned to prioritize tasks effectively, balance short-term deliverables with long-term goals, and adapt quickly to changing project requirements. This role also deepened my understanding of medical device development and the associated regulatory requirements. I learned to effectively communicate and collaborate with professionals from diverse backgrounds, including engineers, biologists, regulatory experts, and researchers. This experience has made me a more technically skilled engineer.

Skills developed:
  • Medical device development and testing
  • Software development (SQL, C#, C++, Python)
  • Hardware-software integration
  • Automated QA systems
  • Microfluidics experiment design
  • Advanced microscopy techniques (SEM, LOM)
  • CAD design and 3D printing
  • Technical documentation and regulatory compliance
  • Customer support and training for complex technical products
  • Rapid prototyping and iterative design processes