Designing a product in any discipline has its challenges; but perhaps none is more challenging than the pursuit of creating a medical device.
The road to a fully realised concept that aids someone in the medical field is pathed with red tape and regulations. And rightly so. Without stringent regulatory requirements, it’s easy to imagine a situation where a faulty product causes harm to the one operating it, or – worse still – harm to a vulnerable patient being treated with it.
Preventing the worst
Only the year before last the Health & Safety Executive (HSE) put out an urgent safety notice warning all hospitals that they should immediately cease using any KN95 labelled face masks. KN95 is a self-assessed Chinese certification. This means that KN95 facemask quality was not able to be properly regulated. Through scientific testing, the HSE showed that KN95 masks varied drastically in performance. And were ultimately deemed to not provide adequate levels of respiratory protection for healthcare providers. Subsequently, the HSE took action and ceased their sale on the UK market.
While this action was absolutely necessary to help limit the spread of COVID and protect frontline healthcare workers, it also meant that many companies who had invested in thousands, if not hundreds of thousands, of KN95 masks were now sitting on unusable product. A situation that could have been avoided had
The challenge of a global market
As seen in the example above, regulatory matters don’t just need to be considered for the country of origin. But for any country you intend to sell the product in.
If you’re UK based, for example, this means not just complying with UKCA regulations. But potentially CE/EN marking, NISOH and FDA approvals too.
For many companies, regulatory compliance can be a real stumbling block for bringing their product to market. Causing unexpected delays, if not permanently derailing the project altogether.
But that’s where we come in.
We’re here to help
As an industrial design agency specialising in the medical, safety and consumer markets – we’ve helped hundreds of companies, big and small, realise their product’s potential and turn their Designs into Reality.
Whether your product is still a concept, or almost ready for mass-production, we’re here to help.
As specialists in the field of medical device design, we are fully ISO 13485 certified. The international standard for medical device quality management.
Working with an ISO compliant partner like Design Reality enables you to minimise the time and cost associated with integrating an external development programme into your own quality management systems. It also means that the design process can proceed more rapidly. And that quality management can be seamlessly integrated throughout every stage of the process.
Our team of experienced designers, engineers and quality control specialists can help advise, guide and prepare you for the various regulations your product design will need to comply with for sale in your target markets.