So, you’ve started development on a new product, and it looks like it’s going to come under the very large umbrella of "medical device". Anyone with experience in this field will know that understanding the product’s likely classification early, and the required level of effort, is crucial to success. Overestimate, and the device will arrive on the market late, over-budget and over-documented. Underestimate, and the device won’t even reach the market without costly retrospective evidence building. So, how do you find the sweet spot and deliver exactly what is required?

Firstly, get to know your product. Who is it for? What will it be used for? What impacts could it have? Understanding these factors early will not only help you develop the right product but will also build the foundations for classification.

Next, get to know the market regions. Where will it be sold? Do they have their own classifications, or do they defer to global standards? Whilst the exact title of classification may differ, generally the requirements are the same around the world.

Finally, get to know the competition. Are there similar products already available? How are they classified? This sort of information is publicly available on regulatory body websites, although it might take a bit of digging.

onducting these assessments of the environments that surround your product might feel like a step backwards, but as the article “For success in product development – start at square zero” (https://www.med-technews.com/medtech-insights/latest-medtech-insights/for-success-in-product-development-%E2%80%93-start-at-square-zero/) explains, it will be invaluable to the project moving forwards.

Now you have everything you need to determine what classification your product will fall under. The most important thing to bear in mind is that this decision will influence the amount of effort required to get your product to market. There is a tendency within the medical industry to overestimate the classification level “just to be safe”, and make sure that more than enough evidence is created during product development. However, this can lead to massively inflated project budgets and timescales, which can be the death of a product before it ever reaches the market.

Think of the development process as a tree. For every increase in classification level, more branches are added to the trunk, and more twigs are added to the branches. If every endpoint adds time and cost to your development process, you can see how quickly budgets can spiral out of control. This is why understanding your product and its classification is so vital to the success of a project and the delivery of a device to market.

At OPD, we use our wealth of experience to help determine the size of your tree and provide a realistic assessment of the development scale. We also recommend involving a 3rd party regulatory consultant, as their expert advice and impartial opinion can be vital to challenging assumptions and keeping everyone focused on reality.

Ultimately, the most important outcome of any medical device development is that a product that can change lives for the better gets onto the market in the right way, at the right time. This ethos is at the heart of what we believe in at OPD and shapes everything we do – making things better by making better things.

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