It’s relatively easy. Just put off compliance with regulatory requirements, adherence to a quality system, leave out nice-to-have product features, and omit the infrastructure for customer support, sales, training, etc.
I admire what this inventor is doing. He’s trying to meet an important need for an endoscope in developing countries. I don’t believe, however, that it can be considered the same product as commercially available endoscopes sold in the USA, EU, and other developed countries. In that respect, the Wired headline is misleading.
This innovation has the potential to have a large beneficial effect on public health in developing nations. It will be interesting to see if this design shift becomes “disruptive” technology and challenges the market in developed countries.
“Traditional endoscopes cost anywhere from $30,000-70,000, but by making different design choices and cutting out extraneous “nice-to-have” features, the price can be reduced dramatically. The EvoTech team found that off-the-shelf camera modules, only slightly better than the ones used in smartphones, could provide pictures crisp enough to meet clinical standards for just a couple hundred dollars. “The EvoCam is basically a webcam you put in your body.” says Zilversmit. Most endoscopes come with dedicated computers and complex image processing hardware. The EvoCam replaces all those expensive extras with software running on a standard laptop, using solar power if necessary, and soon hopes to have a version for tablet. Instead of sending a team of technicians to train doctors, EvoTech distributes training documents and video over the web.”
Read more: How Do You Design a Medical Gadget That Costs 95 Percent Less Than Before? | Wired Design | Wired.com.
Yet another smartphone medical device, this time a portable eye exam for use in developing countries. Very cool. There is enormous need and potential for inexpensive, portable diagnostics in the developing world.
I’m particularly impressed with how the current generation of entrepreneurs has decided to avoid costly custom technology solutions and instead leverage the multiple billions of dollars previously invested in IT. This device connects to the web and not only does the diagnosis but it shows the patient eyeglass stores.
Read more: Vinod Khosla-backed smartphone diagnostic creating portable eye exam raises $2M | MedCity News.
Another example of the astonishingly rapid convergence of mobile technology and medical applications.
“Here’s another example of the trend: a spectrometer that costs as little as $200. An iPhone cradle, phone and app, it has the same level of diagnostic accuracy as a $50,000 machine, according to Brian Cunningham, a professor at the University of Illinois, who developed it with his students (see video).”
“In the future, it’ll be possible for someone to monitor themselves without having to go to a hospital. For example, that might be monitoring their cardiac disease or cancer treatment. They could do a simple test at home every day, and all that information could be monitored by their physician without them having to go in.”
Those slabs in our pockets are so much more than phones.
Read more: A Smartphone Spectrometer Diagnoses Disease At A Fraction Of The Price | Co.Exist: World changing ideas and innovation.
A couple of interesting facts from this article and from my experience with a client:
Did you know that condoms are medical devices? (Class II = 510k)
We don’t hear or read much about it but there is a raging AIDS epidemic in sub-Saharan Africa. Millions of men, women, and children are afflicted. Among others, the World Health Organization, the Bill and Melinda Gates Foundation, and the U.S. Department of State are heavily involved in AIDS treatment and prevention in Africa.
One of the most effective HIV prevention methods is adult male circumcision, proven in several large randomized clinical trials in Africa. The substantial reduction in HIV susceptibility demonstrated in the clinical studies is described as providing the equivalent of vaccine-level protection, about a 60% reduction in HIV susceptibility.
The PEPFAR program (President’s Emergency Plan for AIDS Relief) was started by President George W. Bush and continued by President Obama. PEPFAR has spent more than $50 billion on AIDS and other infectious disease prevention and treatment to date. While not a panacea, PEPFAR estimates voluntary adult male circumcision will save $15 billion in HIV treatment and care expense, prevent more than 3 million HIV infections, and save hundreds of thousands of lives over the next 12 years.
BBC News – Ghana seizes ‘faulty Chinese condoms’.