Formative studies – more important than summative?

20th February 2017

A provocative thought – I think formative studies are essential in the process of developing safe and effective medical devices. In fact I think they are more important than summative studies. Why? Well, we all know that the final validation study is aimed at getting your product approved by demonstrating that it can be used […]

FDA new draft guidance: Human Factors Studies for a generic product in an ANDA

13th February 2017

The FDA have produced a new draft guidance, published on the 13th January and distributed for comments. See http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm536959.pdf for a copy. The draft guidance focuses on combination products and in particular the design of the delivery device part (for example an autoinjector or a dry powder inhaler). It gives some very specific recommendations about […]

Human Factors Testing Summit report

12th February 2017

Just got back from the 2nd Human Factors Testing Summit, in San Francisco. Around 50 senior HF specialists from Pharma and Medtech engaged in two days of extremely high quality talks and discussions about the latest thinking on this rapidly expanding field. I met with senior managers from Merck, Roche, Abbvie, Ferring, Allergan, Becton Dickinson […]

What’s the most ergonomic position for self-injection?

3rd February 2017

We have recently been doing a lot of research into the body positioning of patients when they self-inject and the impact it has on the forces they exert in their fingers while injecting. It’s surprising that there is virtually no published research into key questions such as: Should patients use an arm rest while injecting? […]