James Hamerslag is a Senior Systems Engineer at Siemens Healthineers, where he has spent the last 40 years developing and implementing product, process, and manufacturing systems. In this interview, he shares insights into the industry’s greatest challenges, the skills he has honed over his career, and the importance of cross-functional teamwork in the Diagnostic Device Manufacturing field.
HCP: Hi, Jim. Could you introduce yourself and tell us about your role and experience?
Hamerslag: I’m James Hamerslag, a Senior Systems Engineer at Siemens Healthineers. I’ve been working in engineering for 40 years. My journey began at DuPont Medical Products, where I entered the Diagnostic Device Manufacturing industry as an engineer. Throughout my career, I’ve focused on product, process, and manufacturing systems development, contributing to various advancements in the field.
You have a background in microelectronics. How did you transition into medical devices?
After completing graduate school, I started in microelectronics with a company that specialized in wire and die bonding equipment. I later transitioned to developing products and manufacturing systems for laser transmitters and receivers used in fiber optic applications. During this time, I developed expertise in thick film technology, which ultimately became crucial in the development and commercialization of a medical device designed to measure electrolytes in bodily fluids. This was my entry point into the medical device industry, and I’ve been working in this field ever since.
What types of medical devices do you work with now?
I currently focus on Clinical Chemistry and In Vitro Diagnostics (IVD). For instance, when a doctor orders lab tests, the blood sample is processed through an analyzer located in a hospital laboratory, testing company lab, or doctor’s office. Much of my work revolves around the packaging and manufacturing systems to produce consumables used in these analyzers.
Having spent four decades in the industry, what changes stand out most in your career?
The biggest change has been the advancement of engineering and manufacturing tools, especially the personal computer. When I first started, I used a Digital Equipment Corporation (DEC) PDP-11 for computational work. Then, in 1981, the IBM PC revolutionized the way engineers work. Today's personal computers are far more powerful, offering faster processors, vast memory and storage, advanced graphics, and the capability to run resource-intensive applications. They’ve truly transformed how engineers approach their job.
In packaging, how do you balance sustainability, cost reduction, regulatory compliance, and customer usability?
When designing packaging for medical devices, we must consider both product and regulatory requirements. Key factors include ensuring the product is user-friendly and compatible with the customer’s workflow. It’s vital that the packaging not only meets regulatory standards but also provides a seamless experience for the end-user. For example, does the packaging support easy integration into the customer’s environment, and does it ensure the product is easy to handle and use?
Is sustainability a growing concern in your field?
Absolutely. There is constant pressure for sustainable packaging, especially as our products are sold globally. For instance, the European Union has more stringent environmental regulations than the U.S. As a result, sustainable packaging materials are an integral part of our product requirements.
You’ve mentioned the importance of collaborating with packaging, manufacturing, and automation teams. Could you expand on that?
Collaboration between the product development, manufacturing, and automation teams is crucial, especially during the product development phase. It’s common for product development teams to focus primarily on the product itself and overlook the practical aspects of manufacturing. If manufacturing and automation constraints aren’t addressed early on, you may find yourself in a situation where the design is incompatible with existing manufacturing equipment or difficult to automate. Engaging these teams from the outset ensures that the product is both manufacturable and scalable, avoiding costly and time-consuming delays later in the process.
What are the biggest challenges and opportunities in packaging within the industry?
The main challenges lie in meeting product specifications while adhering to stringent regulatory standards. Packaging must be designed to work within the customer’s operational environment, which may include considerations like refrigeration requirements. Regulatory hurdles also play a significant role, especially as the Clinical Chemistry and In Vitro Diagnostics (IVD) industry is governed by multiple regulatory bodies, such as the FDA in the U.S. and regulatory authorities in other countries. Navigating these varying regulations can be one of the most challenging aspects of packaging design.
Switching gears a bit… What skills have been most essential in your career?
Several skills have been pivotal in my career. First and foremost, statistical analysis of manufacturing data has been invaluable. By analyzing data, you can identify areas for improvement and make informed decisions. I’ve found that automation of data collection is critical, as manual data collection is prone to human error, often leading to questionable results. Another essential skill for me is being able to comprehend process control software. While I’m not a software engineer, I can write and understand process control software, which has been a vital tool in my work.
What advice would you give to someone just starting in medical device development?
My advice would be to, as early in your career as possible, find a mentor who is passionate about teaching and guiding you. It’s important to leverage existing knowledge and focus on solving new challenges. I often encounter young engineers who hesitate to explore the work of others. Gaining insight into their successes and failures allows one to build upon their experiences and avoid common pitfalls. Don’t fear failure – view it as a learning opportunity and a necessary step toward finding the right solution.
Watch the video interview at Healthcare Packaging to learn more about medical device packaging best practices.
