At Unitron two main disciplines get together: electronics and life-science. Life-science devices are medical devices and all devices intended to be used in the laboratory (mostly for in vitro diagnostic analysis). Electronics is basically anything with a power plug or a battery.
When developing and marketing a life-science device, there are three questions that need thorough consideration:
- What does the device’s technology look like, is it safe and reliable?
- What is the (clinical) interface between the life-science device and the user or operator?
- What regulatory requirements are applicable and how to address them?
Each of these questions has its own challenges, for which we offer a total solution package.
Question 1: What does the device’s technology look like, is it safe and reliable?
Imagine a customer comes to Unitron with a (mostly) great life-science device idea, that needs to be turned into a product. What they bring to the table is for example an indication of what the device is intended to do and what it may look like. Unitron’s R&D department explores and analyses the product’s requirements, its use cases, the technologies that can be used, and which technical standards are applicable. We also consider biomedical aspects, like biocompatibility and clinical features. Often the medical device contains an applied part, which is in direct contact with a patient. It is important that the device does not pose risks that are unacceptable when using the device. All this information is then used, in a highly regulated development environment, to develop a prototype of the product, for safety and reliability testing, user validation and clinical validation.
When the development of the life-science device is finished, and the design of the device is validated, a design transfer process is followed to ensure a smooth transition of the design into manufacturing, aiming for high-quality and reliable series production. Often a process validation method called IQ/OQ/PQ is used to validate the production process. Our products are manufactured in-house, at our manufacturing location in IJzendijke, where we have two production halls.
During the past 30 years we have specialised ourselves in areas like lung ventilation, measuring and control systems, optics, heating, and printed electronics.
Question 2: What is the (clinical) interface between the life-science device and the user or operator?
The second question introduces the clinical/medical aspect of the life-science device. What is the intended clinical benefit of the device, and what is its mode of interaction with a patient? In order to answer this, a thorough understanding of both the technologies used and the clinical performance are needed. There are many ways a life-science device can be in contact with a patient or patient derived material. For example, often laboratory equipment intended for In Vitro examination gets in contact with patient material. An example is a device that modifies cells of individuals using gene therapy. After treatment of the cells, they are returned into the individual’s body. It is very important to understand the interface between what happens inside the cells and what is the risk of introducing the cells back into the individual.
Question 3: What regulatory requirements are applicable and how to address them?
Recently two new European laws for medical devices were published: the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. These regulations demand a lot of documentation on a medical device’s design, use, and manufacturing, for example in the area of risk management, clinical evaluation, post-market surveillance and quality management. We are experts in selecting, interpreting, and applying these regulations, combined with international safety standards, throughout the life cycle of a medical device.
Both our regulatory team and R&D department have their office in Hengelo (Overijssel). Visit our websites to get more information:
www.unitron.nl for R&D, design transfer and production information
www.unitronregulatory.nl for information on our regulatory services.
Check out our vacancies or send an open application to Unitron’s HR manager Gillian Jones, at firstname.lastname@example.org.