Good day Anon,
This can be done a number of ways depending on type of the device, whether professional use only, or over the counter/patient use. One way is to "estimate" the population based on market information, sales knowledge, or extrapolating from the sales information you currently have. There are also external sources like trade organisations or marketing groups which conduct research into market segments. It helps to identify the potential patient population not just for the PSUR, but including clinical evaluation process, and risk management. To be honest, your sales and marketing persons should have a good idea of the potential market for your device including the population who could use the device and frequency of use.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Nov-2020 03:44
From: Sarah Tait
Subject: PSUR
Hi, would it be possible to extract more detail from your sales data? For example by including sales volume plus the number of customers over the same time period and their geographical spread. This would distinguish between 100 devices sold to a single customer in a single European country, and 100 devices sold to 50 customers in multiple different European countries.
Thanks,
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Sarah Tait
Birmingham
United Kingdom
Original Message:
Sent: 01-Nov-2020 14:33
From: Anonymous Member
Subject: PSUR
This message was posted by a user wishing to remain anonymous
Hi,
For a PSUR the requirement is to estimate the size and characteristics of the population using the device. How do you estimate size of the population? I have sales information, but the population size is in addition to volume of sales.
Thanks.