Short answer: from about €100.000 for a basic medical device up to several million for an advanced medical device (about €500.000 for implants).
Long answer: that depends on several factors: the type of device, what data is already available for example if we can use already established validations (BAAT has several for you to use), which market(s) you want to get approval for, how much risk you are willing to take, what lead time until market approval you have in mind, experience in medical product development.
Generally you can say, that there are three major pillars that determine a project: Budget, Quality and Lead-time. Quality is mostly dictated by the Medical Regulations which means that you have 2 pillars left to play with. If you aim to shorten your lead-time to get market approval in the fastest way ever possible, the budget goes up.
What will this investment bring you and your customers?
And what will be the return on investment for you?
About 1.5 years on average until submission at the competent authority. The shortest lead-time that we have accomplished for developing 7 spinal implants from concept to obtaining FDA approval was 10 months. For CE, the review time at a Notified Body generally takes longer when compared to the review time of the FDA, especially now with the MDR (the new medical device regulations). For an explanation on why this review time is increased, see our explanation at the next question.
You need to guarantee that your device is safe and effective for its whole lifetime. With device we mean all its aspects that also includes e.g.: tray, packaging, labels, IFU, surgical technique, instrumentation, accessories, manufacturing processes, end-user training and transport to get it to the end-user.
Besides Engineering your device (Engineering is usually the easy part), you need:
Check also our latest interview ‘tips for medical startups’
What would it mean to you if we can handle all these aspects for you,
so you can focus on the technology and sales of your device?
This depends on the classification of your device and if there are already similar devices with adequate data on the market that you target for. For implants and class III devices you will have to do a premarket clinical study unless:
If you need to do a pre-market clinical study, on average you need to account for €10.000 per patient and about 40 patients per study. This number can vary and depends mostly on the ‘to be tested’ outcome variable(s). To calculate the exact number we would perform a Power Calculation so you know how many patients should be included in this premarket clinical study.
What would you do if you knew the most efficient regulatory route to get market approval for your medical device?
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