Response to Marco
Thanks @Noemi for helping me out on responding @markomanka.
I’ll try to go through the points
* The transformation of cronic patients into makers is scientifically documented. Something like 50% of patients have been creating an innovative solution for their health problem (SocialMediaWeek Milan 2016) but, either I don’t understand what you mean by ‚stimulus to personal studies’ or I strongly disagree. Production of the device should simply be a joyful and possibly a beneficial process. Avoiding personal defeat is ethical top priority.
- Lets make it clear: Quality is one thing, safety is another. Quality depends on the maker = participant. Safety is ensured by facilitator and mentors. Safety is a relative issue. Walking is risky – you may fall, therefore the neurologist may advice stop walking and use a wheelchair instead (a real casestory). As when we do clinical trials, the participant must be guided through a ‚risk assessment’
* What you say about ‚bypassing’ is actually the reason for hacking - for opencare. Once you certify your product is ‚frozen’. Yes it’s about bypassing >100k euro of CE marking expenses of a product which the user has to pay (https://edgeryders.eu/en/fes-for-foot-drop). You can’t meet individual requirements because youll lose certification.
However you have a point. Help us to find a way to ennsure that this is legal and how participants can be ensured in case of accidents. Please?
- don’t get your point about IP??? We are in open context, free,
* Responsibility and lawsuits. I can see you are a lawyer mind so please help out on this point? (Yes the idea is that the paricipant is fully responsible) How does the makerspaces go about this issue (@Costantino)?
* ‚Disabled ones’ are in this case people, the participants, looking for a alleviation for lack of body function. In contrast to established health care ( were the patient is often a passive receiver patiently waiting for …), the WeHandU (see above reply) philosophy is NOT to decide what is best for a patient. Rather a person living with an impairment is looking for a way to resolve that HE/SHE considers a problem and hopefully resolve/alleviate it in a creative environment (I am often contacted by such people). The ‚not-patient’ but participant is… a participant. People not ‚wanting any aid’ (and they are most) will not come in WeHandU. (BTW. Disabled people is not existing in the modern vocabulary)
* Solutions not marketed is a complex one. As graduate student I believed (was taught) that if it works it will be sold. That’s not the way of business. Healthcare is business. Hard cold business. A businees where 90% of the healthcare budget is spend on a solution that does not work. 90% (EU data) is spend on treating cronic diseases. Why are they cronic? Because the cure we are paying is not working… ok I’m being cheeky here 
If you study the dropped foot stimulators, invented 50 years ago, there is a ton of scientific work that demonstrates efficiency. Its provided by NHS in england, but not in the rest of europe. Why?
* Optimistic research. No, rather pragmatic - If something does not work try something different. The different is to eliminate the last variable (confounder is the term) not yet controlled in 50years of research: FAILING INSTITUTIONS (article on edgeryders).
What would you suggest as a cut off for a clinically relevant change?
How many people regaining some hand function? How many people walking yet some years before they end in a wheelchair? Would 10 suffice or do we need 100.mio (A cervical spinal cord injury cost society approx. 1mio$/year)
What if one of them was you? Would the existence of WeHandU space be justified it it could preserve you some personal independence?
We have a choice here: continue spending millions on research refining (reinventing) technology (http://www.eurekalert.org/pub_releases/2016-01/kf-kfa010716.php). Promising technology that has not been marketed or clinically relevant for many years?
H0: We can demonstrate that it is useless by testing the last hypothesis (which is that OpenCare approach can solve the ‚marketing’ problem).
What do you propose?