Medical Device Engineering
Medical device engineering is a set of activities that employ engineering concepts to create a useful and safe medical device for patients. We can even say that everything that stands between an exceptional idea for a medical device and its readiness for market approval can be termed medical device engineering.
Each future product should have defined functional product requirements. Furthermore, the hardware and software must meet the relevant standards, and mechanical design must comply with the appropriate protection classes. The regulatory approvals for medical products include, among others, CE, FDA and UL markings.
As the medical device company, you should carry out the verification and validation efficiently and automatised, usually in a specialised department.
Answer the preliminary questions
Before drawing up a detailed plan of medical device development, you, as the device developer, should answer several questions that may not all be technical, such as:
- Is the use-case for the medical device clearly defined?
- and are anticipated market needs satisfied by the device (market research)?
- How do we define an essential strategy for gaining market approval?
- How can the design, development, manufacturing, certification and post-production processes be comprehensively determined?
- What system must be in place to fully monitor and document the manufacturing process from base components to a product in clinical use?
- Which strategy and information will lead to market approval?
- Which design setup allows all users, such as patients, clinicians, nursing staff assistants, to have the most benefit from the device?
- What are the human-factors engineering features for the device that guarantee a baseline of user-safety and efficiency of use?
- Will the manufacturer conduct all the necessary medical device engineering activities himself, or will he need outside help?
- How do we set up a process and quality assurance system that enables all the engineering steps to be documented, so we meet all medical regulatory demands?
- How will verification & validation be carried out efficiently, in an automated fashion with a unified software solution?
- Which regulatory approvals and markings will you seek, such as CE for medical products, UL and FDA?
- What system will you put in place to gauge the device’s clinical performance and its uptake in the market?
Every medical device manufacturer should possess the skills and knowledge of medical device engineering basics, such as design, manufacturing, quality assurance, regulatory compliance and medical market awareness. Medical device engineering must meet the demands of medical regulators agencies, such as the Food and Drug Administration (FDA) in the USA, the European Commission (EC) or the National Medical Products Administration (NMPA) in China.
Safety and Effectiveness in Medical Device Engineering
Medical device engineering must take into account procedures for complying with regulations regarding safety and effectiveness.
Medical devices can vary hugely in complexity. But the same holds for each of them: the distance from the design laboratory and the hospital ward is immense – especially in paperwork and hours spent documenting the management, development and quality process. Namely, every medical device needs to fulfil two distinct and equally important aspects:
- (1) it must be safe and
- (2) it must be effective.
That is why the laws regulating medical devices’ market take care of both of the aspects mentioned above. But they are addressed in different ways.
As the medical device company, you must demonstrate that you have engineered your device so it is safe and effective, as required by the country where you will sell the device. To prove safety, you must provide lots of documentation: extensive test reports, detailed design documents, compliance with applicable standards, and so forth.
In contrast, effectiveness is proven either by doing clinical trials and investigations involving animals or humans, or by claiming that the device in question is similar to other devices already being used, and demonstrating it by pointing to scientific articles or other literature.