Skip to 0 minutes and 12 seconds The rapid product development and technology advancements using 3D printing has really meant that it’s an open field, as far as the regulatory environment’s concerned. The regulators I’m not sure are really prepared for 3D printing and what it stands for in the future. Most of the regulatory bodies around the world do have allowances, or do have a regulatory system, that accounts for custom-made devices. And I think, as we progress with more technology, with greater advancements, with bioactive products being printed from 3D printers, it’s going to be an area that we need greater regulation, so that we can make sure that patients are covered and surgeons have good outcomes.
Skip to 1 minute and 2 seconds The design stage is critical for us to start thinking about regulating the product. In all of our cases, we start thinking about the regulatory requirements on day one. So whenever we get a new case, we start thinking about what are the risks associated with that product? And then, how can we mitigate those risks associated with it? Any risks that we have, we try and look towards the clinical data, the clinical published literature, and see what’s available there to support the use of that product in humans.
Skip to 1 minute and 32 seconds We then start and look at what additional tests can we do to mitigate some of those risks, whether it be mechanical testing, or even computer modelling, or having a look at maybe some preclinical studies in animals. In that risk analysis, we’ll try and engage a surgeon, maybe we’ll involve sales people, nurses, end-users, anyone who’s involved in the process who can really add something and think outside the square. We should never let the regulatory requirements stifle our innovation. We should always pioneer innovation. However, during that innovation phase and the design phase, we should always consider the regulatory requirements.
Andrew Batty, CEO of Anatomics (2014)
Andrew has what he terms as the essential principles, a set of guiding requirements that specify characteristics to assist the manufacturer in producing safe, effective, and high-quality medical devices.
Part 1: General principles
- Use of medical devices not to compromise health and safety
- Design and construction of medical devices to conform with safety principles
- Medical devices to be suitable for intended purpose
- Long term safety
- Medical devices not to be adversely affected by transport or storage
- Benefits of medical devices to outweigh any side effects
Part 2: Principles about design and construction
- Chemical, physical and biological properties
- Infection and microbial contamination
- Construction and environmental properties
- Medical devices with a measuring function
- Protection against radiation
- Medical devices connected to or equipped with an energy source
- Information to be provided with medical devices
- Clinical evidence
© University of Wollongong, 2020