The Business Market Assessment tool to helps you understand the initial investment and recurring regulatory compliance costs you’ll face. The guide walks you through the revenue vs cost modeling calculations to help you judge the market viability of your product and see if a specific market makes sense.
Did you know that regulatory submission fees can run as high as $100K per product and may exceed five-year revenue projections for new products?
It’s true – not every market may make sense for every product.
Ask any medical device startup or small biotech company about their go-to-market plans and you’ll hear the cold, hard truth about the costs associated with launching a product in certain locations.
Regulatory compliance is a critical investment regardless of target market. However, even a quick, cocktail napkin calculation can demonstrate that for some products, certification and/or submission fees can quickly outpace the sales projections.
Take MDR certification, for example. There are many initial costs to consider, such as the application fee to the notified body, preparation of the initial QMS procedures and technical documentation, audit costs, validation testing costs – just to name a few.
Then there are the annual “maintenance” costs incurred every year for the duration of the certificate – the periodic safety update reports (PSURs), annual surveillance audits, the annual notified body fees, and more.
And remember – each of these fees applies to each product.
Of course, for larger, well-established companies with deep pockets, MDR certification or FDA submission is a no-brainer, a strategic business decision that will prove well worth the substantial investment.
But for companies with smaller bankrolls, the decision to pursue something like MDR certification is not quite so straightforward.
Needless to say, this new paradigm has upset the market-entry plans of more than one company, and it will require more than a little cocktail napkin math to inform a solid business decision.
That’s why leanRAQA created the Business Market Assessment Tool to help you understand the initial investment and recurring regulatory compliance costs you’ll face. The guide walks you through the revenue vs cost modeling calculations to help you judge the market viability of your product and see if a specific market makes sense – before you commit.
Don’t leave your commercialization strategy to chance. Download our free assessment tool and see which markets make the most sense – and promise the most rewards – for your products.
This guest post was provided by leanRAQA.