From prototype to product


Let me do this newbie question. I Know That a lot of Regulatory exists in this field, so my question is to understand better what is the real benefit That OBM Initiative can bring to people.

What’s the problems in transforming a prototype to a product? Can this devices be effectively used for the less fortunate?

I would expect a large amount of bureaucratic and regulatory barriers as well as problems arising from the market of these devices.


Good morning Mario,

I think it’s a very interesting question. I asked myself the same thing many times, trying to understand the limits and possibilities of the project.

Working in the medical device sector (from concept to certification) know very well the activities necessary for their qualification and relevant standards and Medical Device Directives.

I think it’s a good discussion to outline the potential of the project with a more general vision, compared to more technical topics.


Thanks for the very interesting question @marsac.
Europe in general is far away from a standardized regulatory system on Open Source biomedical devices or 3d printed biomedical devices.
OBM Initiative is contributing to some regulatory aspects (for example we try to offer some technical documents of our projects), but we decided to stop us before the regulatory line. Our project are spreaded online as work in progress projects, so people can download them and understand how they work. Clinicians can download them and apply them to patients at own risks or certifing it.

@Cristian_C can better explain all the process :slight_smile: