Various kinds of medical devices can be spotted in hospital or medical organisations. For example, infrared thermometers and surgical masks used nowadays to combat COVID-19, the equipment in hospitals like hospital beds, medical imaging systems (X-ray, CT, MRI), and rehabilitation units. Behind every medical device being used in hospital, clinics or at home, tons of resources, time and efforts are required for preparing all the work for saving people’s lives.

You may want to know:

• the path that a medical device needs to walk through before being used by patients or healthcare professionals;
• the considerations that medical device manufacturers will focus on; and
• the challenges that medical device manufacturers will face.

Despite your concept in mind on how your designs work, there are elements from different areas that you may need to consider, develop, verify, and validate before finalising your products. 

When it comes to product commercialisation, regulatory compliance is undoubtedly a crucial part of product design. Subject to the target countries and locations, your products, from circuit and mechanical design, manufacturing, packaging, marking and labelling shall fulfil all the requirements stipulated in local regulations. For example, in the United States, manufactures are required to comply with Federal Drug Administration (FDA) pre-market approval requirements. In the European Union medical devices have to comply with the Medical Device Regulation (MDR) or In-vitro Diagnostic Medical Device Regulation (IVDR), whichever suits.

Especially for medical devices, safety and efficacy shall be the primary focus of the design and the core of the entire product. In order to minimise all the risks that may cause harm to users and patients, risk management is an effective tool for identifying and evaluating all the potential risks deeply embedded in the product. Designers and manufacturers should be aware of the risks and implement change or measures to eradicate these risks, or, at least, alleviate the harmfulness of such risks to a certain extent.

Whenever there is a need to amend product/process design, manufacturers are required to conduct a risk assessment on the change to product safety, usability, and reliability, whilst every change should be documented properly. In case that major changes are required, re-validation/re-verification of the change will be essential in order to ensure that the safety and efficacy of the product are to be maintained.

Formed with a group of experts from different backgrounds, from mechanical, electronic, software, and biomedical engineering, professionals come together to evaluate the risk and come up with appropriate solutions to each problem.

Taking one more step forward that brings about an enormous difference and solid consideration of ergonomics may turn a product into a masterpiece. You may find out how prominent it is if you are dedicated to designing the best piece of work in the market. After considering all the features based on customers and regulatory needs, usability and ergonomics are somehow prominent factors of contemplating how well your final design will be. Thoroughly considering how the device will be used, experts may provide hints about what should be amended for improving the product for better storage, easier operation, or even enhanced conformity to handling devices. Never underestimate this final touch as it helps a great deal with the efficiency and effectiveness during operation, especially in a world where every second counts.

With all the strings and bits being put together, it is about time they were to be put to the test and we were brought design verification and validation. Verification is an evaluation of specification on individual parts of the product, from circuit board testing to functional test, etc. In addition, validation is an evaluation of the performance of the product as a whole and how it matches the intended usage as defined at the beginning. Bear in mind that, for better information management, it is good practice to keep records of all data and results from verification and validation throughout the entire design and development process.

The manufacturing site is where wonders are done. Before mass production, you need to design and validate a series of procedures in order to allow production lines to assemble parts and components together with no technical or cosmetic defects. When everything is set, each production line is capable of manufacturing a massive number of devices per hour.

A risk-based approach is adopted to qualify assembly and testing stations, and to define and confirm a range of process inputs so as to assure that the process produces conforming products.

Usually process validation contains 3 steps: IQ, OQ and PQ.

• IQ stands for Installation Qualification. This is the first step in the validation process to ensure that the manufacturing process will live up to its expectations. In this phase you should verify the equipment’s design features and make sure it is installed correctly.
• OQ stands for Operational Qualification. In this phase, you should verify that the manufacturing process is achieving its operational requirements.
• PQ stands for Performance Qualification. It is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be tested.

Traceable product identification is one of the most important measures for ensuring the safety of medical devices. As a medical device manufacturer, we need to establish and maintain device master records (DMR) including operation procedures, material incoming inspection records, process records, and testing records. Unique Device Identification (UDI) is one of the emerging requirements around the world to standardise the traceability of medical devices which comprise a UDI-DI (device identifier – specific to a manufacturer and device) and a UDI-PI (production identifier – identifying units of device production).

Similar to other products, medical devices require a pre-market approval process before product launches. Depending on product categories, risk and invasiveness, and specific requirements of target market countries, testing includes electrical safety, biocompatibility, and connectivity, etc.

Certain higher-risk products may require clinical evaluations or even clinical trials. They aim to verify the clinical claims made about the device, including the application of the device (eg the target treatment group, the site of applications to/in the body, methods of contact with human bodies, indications, severity and state of the disease, application requirements and operation environment, etc), methods of applications, contraindications, precautions, and warnings, etc. 

With loads of supporting documents, samples will be submitted to compliance and certification testing laboratories, which are the final gatekeeper of product compliance, for carrying out respective compliance tests. Meanwhile, representatives from regulatory bodies may request for visiting the manufacturing sites for factory inspection, checking all the documentation, manufacturing procedures, quality control and other critical areas to see whether they fulfil the regulatory requirements of the country. After overcoming all the difficulties along the way, with the approval of the regulatory bodies and customs, medical devices may be eventually shipped to their destinations for duties.

The beauty of product realisation is not about initialising an evolutionary product that no one has ever invented; it is the close and interdisciplinary collaboration, and the hard work of intelligent minds that sculpture something meaningful in society.

By Ir Karon LO and Mr Clarence NG from the Biomedical Division of the HKIE