Question 1

When should we get quality, regulatory or clinical input for our idea?

Accepted Answer

Medical devices operates in a highly regulated environment.  To understand the scope of your project – as an in put to how much money will be needed and how much time it will take to get to market, early advice about regulatory classification, quality requirements and if you’re likely to need clinical data is really important for early-stage planning.

Question 2

When should we start think about talking to the FDA?

Accepted Answer

As soon as possible!  The majority of start up companies look to the US market first because generally the regulatory pathway is clearer than it is for Europe at the moment.  While it is clearer, that does not mean it is easy!  By their nature, most start-ups are working on novel devices or new treatments.  Talking to FDA early means that you can clarify if your device is a 510k or could get converted to a DeNovo.  Having written feedback from FDA is compelling when trying to get investment to move forwards.  Did you know that there is no fee to talk to the FDA about device classification?

Question 3

What about Europe?

Accepted Answer

For novel devices, and with some device types reclassified, there is an increased need for clinical data for a CE application.  There is great progress on the establishment of the Expert Panels under the MDR, but the pathways are fully available yet.  There are pilots running at the moment, and we will know more when the outcomes of those pilots (pilot expert panel for clinical data, pilot orphan device designation).  Triskele Consulting has applied for and been accepted to participate in both of these pilot programmes.  Contact us to find out what we’ve learnt.

Question 4

How soon do I need to have a Quality Management System?

Accepted Answer

During the early stage of concept development work, lots of exciting activities are progressed – typically at speed – and with lots of clinical input.  Unfortunately, in all the enthusiasm, most of the activities are not documented, and your hard work and information gathered gets lost.  Document everything – even if it is in a laboratory notebook.  Your interactions with surgeons/clinicians represents the beginning of customer requirements gathering and early (formative) usability work – remember – if it’s not written down, it never happened.  You need the basic elements of a QMS like design control, risk management and document control right from the beginning.

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