What special requirements do systems engineers face in medical technology? Are there differences compared to other industries? As a systems engineer in medical technology, I would like to share my experiences in this blog post.
Regulatory requirements, processes, standards and approval
Hardly any other industry has such restrictive regulations as medical technology. Here, a systems engineer requires in-depth knowledge to successfully manage projects. On the one hand, it is important to know the regulatory requirements in medical technology and understand the resulting processes. On the other hand, compliance with standards and overseeing the approval of a medical device are key tasks of a systems engineer in medical technology. Experience in this field is very important.
A systems engineer in medical technology has to create, read, and approve a lot of documents. Anyone who has a problem with documents should probably look for another field :-)
Basic knowledge of medicine
An engineer is not a doctor! That's a good thing. However, basic knowledge of medicine is very helpful and important for the development of products in medical technology. I attended lectures on anatomy and physiology during my studies and am also interested in medical topics in my free time. This helps me to better assess the background of products. A systems engineer must have an overview of medical products and know the market and the competitors. When developing a product, a look at competing devices is often taken. This allows you to identify good or bad concepts and improve your own product accordingly. But for this, it is necessary to be familiar with competitors' devices. Ideally not just from user manuals, but also from actual devices. Dissecting and analyzing competing devices is very interesting and sometimes instructive.
Complexity and distributed teams
With a few exceptions (CT scanners, MRI scanners, radiotherapy), the complexity of medical technology products is not as high as in the automotive or aerospace industries. However, due to the increasing interconnectedness of products and rising performance requirements, complexity is now increasing noticeably. In my observation, team sizes have quadrupled in the last 10 years. This is also due to the fact that teams are no longer located at one location. Distributed teams are also becoming increasingly common in medical technology. This situation has existed in the automotive sector for some time. Therefore, we can benefit from their experience and avoid "beginner mistakes" with distributed teams. Especially with increasing complexity and distributed teams, the system engineer plays an increasingly important role as a central contact person. In my opinion, the system engineer in medical technology must deal with distributed teams and communication.
Special features in medical technology
A special feature of medical technology is the usually low unit volumes. Here, sales volumes like those in the automotive or consumer electronics markets are only a dream. Of course, manufacturing costs are also an important factor in medical technology, but not as much as in price-driven products and products in very high quantities. If a product is sold several million times, then a few euros are already a lot. If, on the other hand, only a few thousand products are sold, the costs are not as significant.
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| Dipl.-Ing. Goran Madzar, Partner, Senior Systems Engineer E-mail: madzar@medtech-ingenieur.de Phone: +49 9131 691 240 |
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Do you need support with the development of your medical device? We're happy to help! MEDtech Ingenieur GmbH offers hardware development, software development, systems engineering, mechanical development, and consulting services from a single source. Contact us. |
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The role of systems engineer is not as widespread in medical technology as one might think. But this is increasingly changing. Within development teams, individuals often take on multiple roles. For example, a systems engineer (if this role has been explicitly stated) in medical technology is often a jack of all trades, taking care of requirements, system architecture, project management, and, most importantly, managing the various disciplines (hardware, software, design, systems, and testing). The job of a systems engineer in medical technology is therefore very varied. "T-shaped skills" are essential for this job! This concept is about combining broad knowledge and specialized (in-depth) knowledge in one person. Broad knowledge is the focus. The development engineers bring the specialized knowledge. However, if necessary, the systems engineer must also be able to go into depth.
As is probably the case in all industries, nothing beats experience in medical technology! The more experience you have gained in development as a systems engineer, the better for the project.
For anyone interested in the topic, I recommend the two blogs System architects – why we need them and what they should be able to do? and Introducing system architects into the companyIn it, I delve deeper into what systems engineers should be able to do and how to develop systems engineers within a company. In my opinion, systems engineers are a rare breed and difficult to find on the market. Therefore, it makes much more sense to develop systems engineers within a company than to spend a long time searching for suitable people.
If you need help, please feel free to contact me. I'm happy to answer any questions you may have.
What are your experiences? I'm very happy to receive feedback and engage with you. Feel free to leave a comment on this article. If you know someone who might also be interested in the blog, I'd be very happy if you would recommend it.
Best regards
Goran Madzar