What is Medical Assembly?

What is Medical Assembly?

Medical device assembly is only one important part in the manufacturing of life-saving medical devices. The challenges involved in the production of medical goods are high and range from intense regulations to difficulties in finding skilled assembly workers, which is why automated solutions are on the rise, not only in medical assembly lines. 

In this article, we will take a closer look at medical assembly and medical manufacturing assembler as a job description. Further, we will delve deeper in the challenges manufacturers have to face and how flexible automated solutions can help to overcome them.

Medical Assembler: Job Description

Medical assembly jobs are in high demand for skilled workers. However, staffing medical assembly jobs in specific areas is not easy for many producers. Assembly operations require a lot of attention to detail in order to guarantee safety for the patient and consistent product quality. 

Especially in regard to medical device manufacturing, which has to comply with a broad range of regulations and is held to high quality standards, the assembly process relies on the expertise of manufacturing assemblers. 

The tasks of medical assemblers include the building, maintaining and customizing of medical products. In most job descriptions, a high school diploma is one of the certifications that are required, some medical assembly jobs also require a post-secondary education and several years of assembly experience. Further, there are different job types in the assembly process, ranging from entry-level posts at mechanical assembly lines to advanced assembly technician jobs like electronic assembly that often require skills like soldering and ultrasonic welding.

Especially in the area of personalized medical devices or HM/LV productions, high problem-solving and troubleshooting skills are important. After successful application, employees receive on-site training1 on how to handle the required assembly equipment and follow GMP guidelines and ISO regulations. . 

Medical Device Assembly: Definition

The U.S. Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”2

Examples include autoinjection PENs, syringes, catheters, defibrillators and a lot more. The national healthcare authority of the USA separates different types of medical devices into three different risk classes, which require different regulation sets. These range from quality controls to labeling specifications and productions in cleanroom environments. 

Medical device assembly is regarded as one important part of the highly regulated manufacturing process of medical devices. 

Automated Manufacturing in Medical Device Assembly

By using automation in medical device assembly and subassembly, production quality and efficiency can be boosted. Strenuous and monotonous tasks like assembly, for instance, are more prone to human error and the risk for product loss. With the appliance of automated solutions in these areas, the risk for human errors can be significantly reduced. 

Another critical factor that speaks for the use of automation in medical device assembly is the change in demographics, the industry is experiencing. Many medical manufacturing companies have trouble finding skilled workers and move assembly to contract manufacturing companies to prevent bottlenecks.3

By integrating robotic solutions in the process or automating it completely, it gives manufacturers the freedom to act more independently, while improving their production numbers and increasing production speed.

Medical Assembler vs. Automation in Medical Assembly

Automated solutions have long found their way into large-scale productions of identical medical devices, where they replace human workers in strenuous and monotonous tasks like assembly4. Even though robotics have often proved themselves as more efficient and quicker in the enactment of these tasks5, the integration of automation is more complicated for personalized medical device productions, which are only produced in smaller numbers6

The need for human intervention when switching between different recipes and for regular quality controls was still necessary in many cases, and the initial cost too high for smaller-scale productions. 

However, with the rise of innovative, flexible solutions like the ESSERT MicroFactory that are highly adaptable to changing demands in production lines, automation has found its way into High Mix Low Volume productions. While the need for human intervention could be minimized, leaving workers time to concentrate on more interesting tasks, the option exists. 

This helps workers stay flexible and make quick and easy switches between the production of different items via a simple control panel and minimal physical intervention. With this technology, assembly lines can easily be changed from syringe assembly to autoinjectors or PENs. 

Medical Device Assembly Line: ESSERT MicroFactory

The ESSERT MicroFactory was developed to support manufacturers in making their medical assembly line more efficient. Our automation solution is highly flexible and modular to cater to the changing demands in High Mix Low Volume productions of syringes, PENs and autoinjectors. The minimal set-up and rearrangement time help to save time and easily change production recipes. 

It is possible to produce multiple devices in one assembly line, by quickly adapting the individual modules. For example, syringes and autoinjectors can be produced at the same production line with the highest grade of precision and accuracy. 

The ESSERT MicroFactory saves your staff time for other important activities and relieves them from strenuous and monotonous assembly tasks. At the same time, speed can be increased due to less down-time and consistency can be improved. Automated controls help manufacturers to keep up their quality standards and comply with GMP guidelines and cleanroom requirements to ensure patient safety.

  1.  “Medical Assembler”. JobHero. https://www.jobhero.com/resume/examples/medical/assembler#:~:text=Medical%20Assemblers%20are%20in%20charge,to%20order%2C%20and%20handling%20repairs.. Accessed: 21 March 2024. ↩︎
  2. “How to determine if your product is a medical device”. Food and Drug Administration. https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device. Accessed: 21 March 2024. ↩︎
  3. “Four of the medical device industry’s most pressing challenges and how to solve them”. Medical Device Network. https://www.medicaldevice-network.com/sponsored/four-of-the-medical-device-industrys-most-pressing-challenges-and-how-to-solve-them/. Accessed: 21 March 2024. ↩︎
  4. Rania Gihleb, Osea Giuntella, Luca Stella, Tianyi Wang. “Industrial robots, Workers’ safety, and health, Labour Economics”. Volume 78, 2022. DOI: https://doi.org/10.1016/j.labeco.2022.102205. ↩︎
  5. Morgan AA, Abdi J, Syed MAQ, Kohen GE, Barlow P, Vizcaychipi MP. Robots in Healthcare: a Scoping Review. Curr Robot Rep. 2022;3(4):271-280. doi: 10.1007/s43154-022-00095-4. Epub 2022 Oct 22. ↩︎
  6. Johnson KB, Wei WQ, Weeraratne D, Frisse ME, Misulis K, Rhee K, Zhao J, Snowdon JL. Precision Medicine, AI, and the Future of Personalized Health Care. Clin Transl Sci. 2021 Jan;14(1):86-93. doi: 10.1111/cts.12884. Epub 2020 Oct 12. ↩︎