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Do you have a medical device to launch?
Well I have good news for you and I have bad news for you.
Here is the bad news first:
Medical devices are not easy to launch and are masked with layers of regulations. There are several reasons for launching a new product into the market.
It may be due to a healthcare practitioner wanting life to be easier for them during a medical procedure which involves the innovation of a new device. It may be a completely new device that will save thousands of lives or improve the quality of lifestyle of those with health issues.
Whatever the case, there is benefit which will ultimately lead to patient safety. With this in mind the focus is to benefit others, and in doing so keeping patient and user risk at a minimum.
With reported incidents on the rise, authorities have tightened up regulations over the past few years, hoping that manufacturers will build quality in, while taking risk out (as far as possible) of a device.
So, what’s the good news?
Firstly, there are experts out there who are born out of necessity. Over years and years of being in the industry they have seen the good, the bad and the ugly.
Medical device experts can help hold your hand and make sure you get your product to market and explain the regulations bit for you. Medical device experts are almost lawyers these days, with the amount of legislation involved there is a tonne of legal language that can bore and scare you, and make you think – do I really want to do this?
So the take home point here is, if you have done your research and there is a market for your device, then yes you want to do this, but taking a slice of the global market can not only be profitable but also make you a philanthropist. However, trying to walk the journey alone can cost you heavily, so seek advice.
How to do it?
I call the following flowchart “Concept to Market” diagram, which I often put in front of start-ups, or those about to embark on developing a new Medical device.
There are several ways to plan, which is why I call it “an example” of what is required. At each end of phase, have a checklist and review you have completed what you set out to do.
The steps and stages are not set in stone; however they are a clear indication of the following –
Well congratulations! If you have made it through all the phases involved, you have received regulatory clearance and your device is now gaining sales, does the vigilance stop?
Not at all, now when you thought the journey ended, the journey has just begun.
Your device is in the market, in the hands of users so be ready for feedback, improvements and continuously reviewing your internal systems. Make sure you have a robust internal quality auditing system to review your records and ensure you are:
Making a medical device can be both financially rewarding and solve complex day to day health problems. By no means should the process be rushed as the authorities will be watchful for vigilance, following regulations and complying with standards as necessary.
If you have followed the path indicated in figure 2.0 you will have a good chance of getting a product to market safely and successfully.
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Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through...