We believe in a simple statement: medical devices should help people and protect the lives of patients. They can improve quality of life and give a starting point on some reflections about health status and wellbeing goals to achieve. For that reason medical devices are getting smaller, less invasive, more efficient and most importantly – remote. Since two decades we see a global digital transition and medical device manufacturing methods have developed to meet connected world demands.
What is medical device manufacturing?
Medical device manufacturing somehow is similar to producing electronic gadgets yet there are significant differences in terms of quality management, regulations and do’s and don’ts. A typical medical device manufacturing process includes all aspects of the fabrication of a medical device, including designing a manufacturing process to scale-up and ongoing process improvements to sterilize and package for shipment.
A most beneficial model to work on a new medical device is to start cooperation with a one-stop medical device development company. The term one-stop in this case means that one organization joins manufacturing services with the ideation, conceptualization, and prototyping phases of product development and even regulatory consulting. Usually this type of Medtech partners cover the entire process and is a focal point even when a product outsources components or entire devices assembly to contract manufacturers.
They vary in size and expertise, as well — some comprise small, precise operations specializing in particular materials or components, while others are massive cleanroom facilities equipped for large-scale production.
Processes used to manufacture medical devices
Medical device manufacturers strive to be faster and more efficient, but they also need to meet standards and quality management system requirements. As a result of eco-friendly policies, new devices use more renewable resources, sustainable materials, and equipment is more energy efficient. In addition, companies implement methods to reduce waste creation. To deliver these, the Medtech sector is improving processes, seeking technological advances in machines or equipment components, or safer/more reliable materials. The same principles apply to the packaging process.
Because medical devices have direct impacts on public health and quality of life, their safety is imperative. We trust doctors, and so we trust the devices they use. Don’t we? To create desirable outcomes for all parties and prevent device recalls, companies must follow relevant medical device manufacturing standards from industry-specific to general:
- ISO 13485 – quality management system specifically for medical device manufacturers
- OHSAS 18001 / ISO 45001 – outlines requirements for occupational health and safety management systems
- ISO 27001 – tools to assess and manage cybersecurity
- ISO 50001 – standardized system for energy management
- ISO 14001 – standard for environmental management system compliant
- ISO 9001 – general standard for quality management
These standards help ensure that a manufacturing or design process can consistently produce the quality required to serve patients and healthcare professionals.
What to consider when manufacturing medical devices?
Still, while speed and cost-savings are vital to successful manufacturing, quality control is of the utmost importance — particularly as medical device market demands shift toward a more value-driven landscape. Medical device manufacturers are required to implement and maintain Quality Management Systems in their organizations to ensure that their practices provide for the safety of their medical devices. It is not necessary to obtain an ISO 13485 certificate, but medical device manufacturers are advised to do so, because nothing confirms compliance with a standard as well as the assessment of an independent body such as a notified body. For some companies, quality management system certification also brings a number of benefits and ensures that the essential requirements described by MDR are met.
The EU Medical Device Regulation (MDR) has four device categories and five risk-based classifications. The categories are: non-invasive devices, invasive medical devices, active medical devices, and special categories (this includes contraceptive, disinfectant, and radiological diagnostic medical devices).
The risk classifications are:
Class I – Non-sterile or no measuring function (low risk)
Class I – Sterile and a measuring function (low/medium risk)
Class IIa (medium risk)
Class IIb (medium/high risk)
Class III (high risk)
The Medical Device Regulation assigns risk classifications to each medical device. The classification depends on the amount and depth of data required to support an application for approval. Adverse events must also be reported. Each device class has its own suite of testing requirements (unlike under FDA where only Class III devices require clinical testing).