: In 2011 my childhood friend and my current co-founder of MobileODT, Dr. David Levitz, approached me with an exciting insight: thanks to the trillions of dollars invested by the mobile phone industry, the core electronic components that are required to build powerful optical imaging devices have dropped to cents on the dollar — which meant that many of the expensive systems he used as a researcher in biomedical optics could be built for less than a thousand dollars. At the time I was the Global CEO of my previous venture, the PresenTense Group, a social venture accelerator network I founded back in 2005 with startup accelerators in a dozen cities around the world, but the more we spoke, the more I fell in love with the idea of working with him to significantly reduce the cost of medical devices so as to make powerful diagnostic imaging available to the general public.
We filed a few patents, and as we started to build our business model we kept stumbling upon the mind blowing fact that nearly every person on the planet can now access a mobile phone – and yet five billion people have access to phones and not to physicians. That irked us on two levels: first, if a person can get their hand on a mobile phone, and the mobile phone had many of the same components as a medical device, why shouldn’t they be be able to use those phones to save their lives or a life of a loved one? Second, on a business level: if the mobile phone industry and the carriers and the content providers could make a fortune in those markets, why weren’t we seeing more medical technologies taking advantage of those same channels?
And so we set off in October 2012 to do two things: first, build a more mobile, more powerful, and less expensive medical device using the increasingly powerful and inexpensive components available to mobile phones. And second, to close the gap between phones and physicians so that any person in reach of a phone could be in reach of a powerful medical device that can save their lives.
To do these two things hand in had, we decided to start with cervical cancer, because cervical cancer is a leading cause of death for women in remote and rural areas worldwide — from the southwest of the US to southeast Asia — and that is despite the fact that if you catch the cancer in the first five years from HPV infection, a newly trained medical technician can generally treat it, on the spot, for less than $28. If we can succeed in cervical cancer, we decided, we not only will be moving the needle on one of the largest health challenges facing humanity, we also will be proving out our technology in some of the harshest environments on the planet — and thereby setting the foundation to scale the company so that it becomes the standard for visual-based diagnosis, for any condition, for every person on the planet.
Medgadget: How does your product fare when compared with conventional colposcopy?
: Our product begins with our mobile colposcope, but it is much more. The Enhanced Visual Assessment (EVA) System is a full end-to-end that supports the entire health system approach to cervical cancer screening in those areas where visualization is part of the primary screen, and follow-up visualization in those areas where laboratory testing is possible. The most tangible part of the system is EVA’s mobile colposcope, which is, in essence, a medical grade mobile phone case that extends the optical capabilities of the mobile phone so that it can image the cervix at colposcopic resolution.
From an optical perspective, our EVA’s mobile colposcope enables a qualified health provider to view an object at the same magnification and resolution as the popular video colposcopes on the market. It also can capture at the same – and sometimes better – image quality than many of the video colposcopes currently being used by our clinical partners, or optical systems that have a digital camera attached to it.
While imaging is the most visible part of the system, the deeper value to the practitioner and the health system is in the network effect that our cloud-based platform provides. While a traditional colposcope is essentially a long-range magnifying glass, EVA’s mobile colposcope is a tool that enables health providers to consult over questionable cases, capture and direct referrals, and conduct quality control and quality improvement exercises so that they can provide a higher quality of care to their patients.
And we’re only getting started. Our system learns from those interactions – with devices in the field, we’re capturing thousands of images per month, including the pattern of the image, along with the diagnosis and annotations and notes, and we’re using that to improve a model that will soon help us provide an immediate risk assessment to the provider to flag areas of concern. So while conventional colposcopy (or similarly any other visual-based diagnosis) depends on the provider’s own skill and experience, EVA’s users will have the guidance of tens of thousands of similar cases to help them identify risk factors and, we believe, eventually enable any provider to make the same diagnostic decision that the best specialist in the world would make.
Medgadget: What would you say is the typical cost difference between your mobile colposcope versus the traditional version?
Ariel Beery: Most video colposcopes in the US range between $10,000 to $14,000, depending on the system and its viewing technology. Low-cost colposcopes can range between $3,600 – $6,000. Ours is currently selling for $1,500 for the hardware, with an annual subscription to the online services of $200.
Medgadget: How has the feedback been from users of your product?
Ariel Beery: We took a partnerships-based approach to product development, which means that we have worked hand-in-hand with a number of health providers and clinical institutions around the world to build and improve our product until its current commercial iteration. And we are especially grateful to those who were willing to jump in with us when we had nothing more than a 3D-printed prototype with off-the-shelf lenses!
In the early stages, with version 1.0, we received a lot of constructive feedback, a lot of things the providers loved and a whole lot they hated. As we moved through 1.4, we stabilized the system, and the feedback got better. By 1.5 we understood that we had the product design wrong, and we expanded our capacity. It wasn’t until 1.6 that we figured we had something – and that led us through 2.0, when we received CE mark and started selling.
The best feedback we’ve gotten comes from our orders — since we received regulatory clearance, the majority of those first partners who took our big blue 3D-printed prototypes into the field have ended up purchasing our systems, and in the past five months we’ve sold over a hundred systems, which have been used in 11 countries by those organizations. At the moment our backlog has vastly outstripped our inventory for the next six months, so we are moving quickly towards mass manufacturing to meet the demand.
Medgadget: How has the Medtech Innovator competition/accerator affected your company/product?
Ariel Beery: We are so, so very grateful to the MedTech Innovator program for the support, and especially to Paul Grand and his extraordinary team who gave us unbelievable opportunities to learn and grow through the program. The mentorship by BD’s Ryan Callaghan has been invaluable, as were the many open calls MedTech hosted, and the in-person events where we were able to learn a tremendous amount about the field and where medical technologies are heading.
Winning the MedTech Innovator competition at AdvaMed was another huge boost. When we started the company, we weren’t sure how the medical device industry would think about a company such as ours – focused on emerging markets as our first beachhead. What we realized at AdvaMed, and has been strengthened through conversations with some of the biggest players in the field since, is that the leaders of the industry have set their sites on the two things we do well: first, building appropriate technologies for emerging markets, which represent billions of potential patients and customers whom traditional medical technologies may not reach. Second, building connected, networked technologies which can bring the power of Big Data into the hands of the physician.
Medgadget: Have you had any regulatory challenges with your company/product?
Ariel Beery: No – although we did go through a multi-stage conversation with the FDA as all of us explored the intersection of a mobile phone and a class II medical device (colposcope). It was a fascinating experience, to be on the cutting edge as the FDA clarified for itself the conclusions of its guidance on devices that are traditionally seen as medium risk. We are now clear, and are submitting our 510(k) in the coming weeks.
Medgadget: Can you describe a major obstacle you faced taking a concept and turning it into a tangible product/service?
Ariel Beery: One of the greatest challenges in building a medical device for remote and rural areas — and especially for remote and rural areas in emerging markets — is that the traditional formula for building and commercializing a medical device is discordant with the needs in the field. As we studied the space, we found there were maybe a handful of products that started their lives in remote and rural areas, and even less that sought to deliver the same level of diagnostic quality as that which was available on significantly more costly and complicated equipment in higher resource settings.
Because we did not have many models to learn from, we adapted what we knew from our shared experience in multiple different disciplines and employed an agile, iterative approach to product development. We have an amazing team which brought their myriad experiences to bear on the problem – and it is a testament to their abilities that we were able to go from idea to company formation to prototyping to regulatory clearance to commercialization in less than three years.
Medgadget: We have many aspiring medtech innovators who read the site. Do you have any advice for them as they set out to make their mark on the world of healthcare?’
Ariel Beery: It’s a big world out there. Build something for those parts of it who deserve the access to quality health care that the rest of us are getting.