Anyone who watched the recent BBC series The Dropout about the Theranos scandal cannot fail to realise that trying to circumvent medical device regulations can only end in disaster.
The medical device sector is one of the world’s most highly regulated and rightly so. You cannot gamble with patient’s health. Get it wrong and the results can be fatal.
First, do no harm not only applies to the medical profession but is a watchword for developers of medical devices.
Having worked in this field for 18 years, we have not only found it exciting but extremely challenging.
When we are approached by an inventor with an idea for a new medical device, it’s our job to turn it into a commercial reality.
Three things are essential for success – time, money and patience. This article looks at how to successfully turn a medical device idea into a commercially viable product.
Firstly, you may have a brilliant idea for a new medical innovation but is there a market for it and what is the scalability of that market.
It is essential to do your initial market research to establish if there is a need for your device and find out what the competitive landscape is like.
Does your product improve upon what already exists or is it a brand new invention?
Dr Euan McBrearty
A great example is our work with TidalSense.
We are working with them to develop a handheld device to measure the health of a patient’s lungs in cases of COPD and asthma.
The existing technology (the spirometer) was developed in the 1800s so clearly there was room for innovation.
Also, diseases like COPD are the third largest cause of deaths world-wide so the device will be solving a major health problem.
The technology will lead to quicker and more accurate diagnosis which will save health services considerable amounts of money so there is a commercial case.
Secondly, you need to design and develop with manufacturing in mind.
Design of the product will need to conform with the strict regulatory framework governing medical devices.
Partnering with a design firm with experience in the field can pay dividends in terms of saving time and money on designs which are unlikely to be approved for use.
Next carry out extensive testing using clinical and user trials to prove safety, effectiveness and usability.
This will mean producing a number of prototypes which can be assessed for potential flaws and ensure patient safety and comfort.
The certification and regulatory framework can be a nightmare for the unprepared.
We have seen examples of companies being tied up for years of negotiation with the relevant authorities as their device is deemed not fit for purpose.
It also essential that your IP is protected properly otherwise your idea could be stolen. This may require engaging with a specialist patent attorney.
Once the device is approved for use, think carefully about who to use for manufacture. We always recommend using a ISO-certified (ISO 13485) or FDA-registered manufacturer.
What quantities of the device will be required low, medium or high? Do you have a supplier and component supply chain that can scale up as necessary?
The choice of materials is becoming more crucial, and the pressure is mounting to improve sustainability and reduce the use of single use plastics in the medical field.
Working with a specialist medical device manufacturer can reduce costs, speed up your time to market and ensure high quality standards.
A specialist manufacturer will also have the correct protocols in place to provide full audit and traceability reports on parts should there be any problems further down the line.
The medical device field is exploding. There is increased funding for medical research and technical innovation. More and more talented engineers and scientists are choosing to specialise in this field.
Moreover, there have been quantum leaps in the fields of electronics and computing, particularly in Artificial Intelligence (AI),which means there many more tools to employ in the medical device field.
This has led to unprecedented advances in the fields of new drugs, surgical procedures, medical devices and telemedicine.
The medical device field is very wide ranging from simple tools like bandages and tongue depressors to complex machines such as pacemakers and MRI.
We have been working with our client MR Coiltech over a number of years to develop the next generation of MRI scanners which will provide unprecedented levels of detail for brain scans which will lead to better diagnosis and treatments for a number of brain-related disorders such as degenerative diseases, schizophrenia and developmental disorders, including autism spectrum disorders.
