This Thursday, May 11th, we will present the same question to the cohort. On July 13th, for our 3rd monthly check-in, we will have a work session to discuss which items will be locally manufactured in Ghana, Kenya and South Africa.
I have played with a foldscope. The licenses is such that you cannot make your own locally. They may be able to be assembled locally. Foldscope’s can be bought here:
The project is an interesting one for me, I think we have in general with OpenFlexure tried to be very careful not to over-promise on our capability. For the WHO malaria diagnosis you need to be able to reliably count malarial parasites across multiple fields of view of the microscope. Foldscope have always been one of those projects that in my mind has promised and promoted far more than it is actually capable of delivering. It is incredible for the size and simplicity, but when you think about the medical uses they are promising it has significant distortion and aberrations. I see it as an educational microscope, with perhaps some use for larger parasites where qualitative rather than quantitive metrics are needed.
I have to say I feel significant damage is done by this form of over-promising from academic groups. They regularly claim use for malaria diagnosis, and make these sort of videos.
These are fold scope red-blood images. I see no way you could reliably count parasites living in these cells.
Notice the clarity of the central sections of the image, yet the images still blur to the edges. To combat this we use an automated stage to take multiple images that overlap and stitch them together to make one large high quality composite image using the centre of 100 different images:
The resulting composite image is about 170 megapixels, and is then used for analysis. Is this good enough for malaria diagnosis? The answer is we think so, but testing is ongoing.
My thoughts on the trials
I think that making some items in a distributed way and distributing them is locally is a great idea. However, I would be very hesitant about producing for clinics unless you know there is a need, and you have expertise and procedures in place to check the items quality and compliance, and that you are making items which do not count as medical or in-vitro diagnostic devices without having license to do so. One way around this is finding clinical partners for testing whether devices are fit for purpose, but there are significant ethical and safety considerations before doing that.
If we are simply testing manufacturing repeatability, I would opt for non-medical uses and distribution.
That’s definitely several elements that we will need to take into account to make choices (recapping your points below)
expertise and procedures in place to check the items quality and compliance
items that don’t need a license that the manufacturers don’t have
Some of the thoughts around the ethical questions for testing “fit for purpose” could be to have a different purpose: making materials for health partners that are not medical materials. Could be around lighting for example, or quality of the space for visitors and patients, rather than medical care itself.
I agree that focusing on using healthcare as opposed to medical (which connotes diagnostic purposes) is an important distinction that provides a bit more flexibility for distribution. That being said, the more pressing issue, as I see it, is the “fit for purpose” part of this thread.
Discussing here at length what we all think may be a good product fit is interesting in the ideation phase for generating ideas. It will ultimately depend on what what the localized needs of the healthcare facilities are, and that is a question that needs to be asked of the partner organizations. This may require an additional survey tool to gather that information - though, that is something for discussion perhaps, during the next checkin meeting on June 8 @Jessicang.
This is a very interesting thread providing great insights into the factors that need to be considered in selecting each of the three items. Another set of dimensions to add to the “assessment matrix” (I’m using that phrase figuratively for now) for selection is the capabilities of the maker spaces. The items need to be ones that all nine spaces have the capability to produce in terms of processes, machines, tools, materials, and skills.
@schutton can speak more to this, but unavailability of suitably skilled makers might be mitigated by provision of training in some cases, but would need to be verified.
Perhaps unavailability of materials is less critical if the required materials can be shipped to any marker spaces that don’t have them locally, although again that would need to be verified (eg cost and logistics).
However, if any maker space doesn’t have the process/machines/tools needed for making any of the items then that might mean excluding it from selection.
I agree that it is something we should discuss with the whole cohort on our next monthly check-in meeting, June 8th. It is important to start talking to the nearby healthcare facilities to understand their needs and inform them on the donations.