Over the following month xRapid will be holding internal interviews in order to provide fresh perspectives on the progress and impact of our diagnostic tool. This week we spoke with Dr Charlyn Belluzzo. Charlyn is the clinical director at xRapid and is a key part of our senior structure. In interview she gave some important insights into the challenges of regulation for medical devices and how xRapid is well placed to overcome such obstacles. The interview follows below:
Thank you for joining us for this interview Charlyn. To start, can you tell us about your professional background?
Healthcare has always been my professional pursuit. During my 30-year career, I have worked across the spectrum; clinical care, bio-medical and pharmaceutical research and some global health roles that particularly address population health.
I hold a doctorate in public health and tropical medicine and an MBA degree. The purpose of the MBA was to conduct the business of healthcare, a really important part of global healthcare these days.
I also received graduate degrees and post-graduate training from LaSalle University, the University of Colorado School of Business, Georgetown University School of Medicine and Tulane University of Public Health and Tropical Medicine.
I am speaking to you from my office here in San Francisco, USA and it is a glorious California morning.
Can you explain a little about your role at xRapid?
I serve as the Global Clinical Director of xRapid. I am tasked with coordinating all medical affairs; interfacing with clinicians and healthcare authorities worldwide. I co-author and manage the clinical research and oversee and manage the regulatory processes. I also interface broadly with the Global Health community from xRapid’s perspective. A perspective which includes a view of modern technology and how it my be applied to make healthcare more accessible, more cost effective and also learning and informing on how we use the data that we collect from the diagnostic procedure.
What was it that first attracted you to xRapid? What made you want to get involved?
Intersecting cutting edge technology and healthcare, particularly in the developing world, has long been a hallmark of my career. xRapid is highly appealing to me as it is creating a valuable shift in population health around the globe, utilizing common mobile technology to deliver rapid, accessible diagnostic testing at a trifling cost.
What are the primary obstacles for xRapid in terms of regulation?
Regulatory in itself sounds like to would be full of obstacles and a very difficult and arduous process. That it is; but the guidelines and the neccessary criterea are well spelled out and very possible to achieve by following strict process. By international definitions, we consider xRapid to be a “class two,” medical device. There are strict guidelines that govern the manufacture, testing, and sales for devices in this classification.
The guidelines specify two overreaching criteria; is the method and device safe for patients and is it effective as a diagnostic tool, as compared to the current standards of care and diagnostic methods currently used for the same purpose.
At the present time, xRapid is developing, testing and preparing to market an indication for diagnosing malaria with the use of an iPhone for worldwide use.
In this particular procedure, the safety standard is well documented; a common finger prick for a blood specimen. This is very much a standard procedure used all over the world, and will be very simple for xRapid to comply with.
The « effectiveness » is measured against current standards of diagnostic reliability. When testing in the field, xRapid is compared to traditional microscopy with human interpretation and Rapid Diagnostic Tests (RDT) which is a “dipstick” type of tool.
There are two questions to be addressed here; is the pattern recognition scanning method as reliable as other current accepted forms of diagnoses and is it possible to accurately conduct the specimen collection, slide preparation, and transition of image from the field?
Responsibility for the first stage of xRapid’s global regulatory pathway lies with the International Clinical Investigators, conducting early research and testing in the field. Scientists and medical professionals from London School of Hygiene and Tropical Medicine and other highly respected academic institutions have begun the testing process in a few regions in Africa. Feedback from these early field trials are informing and supporting our regulatory process, laying the foundation for our applications to the World Health Organization (WHO) and later the Federal Drug Adminstration (FDA) in the US.
It is a lengthy but fairly straight forward process to regulatory approval and diagnostic method acceptance for future sales.
What does the future hold for xRapid? Where do you think it can help people most?
Into the future, xRapid is well positioned for impact across the world and transverses the spectrum of healthcare and economic variances.
In Malaria, xRapid has several huge advantages over current methods of malaria diagnoses; xRapid costs per test are far below current methods, diagnoses are achieved in a fraction of the time, there is no waste, field personnel can easily be trained to perform this highly reliable method, and the technology evolves organically with the advances in smart-phone development. As Apple and other developers of smartphones move forward, we ride on their backs and apply these methods of pattern recognition and diagnostics to increase the breadth of opportunity for our diagnostic tool and our company.