MToday’s news that Elizabeth Holmes, the founder and CEO of Theranos, has been convicted of three counts of wire fraud and one count of conspiracy to defraud investors is making headlines.
But these headlines make it easy to lose sight of what is most important in this story and who was hurt: people reluctant to undergo diagnostic tests who could have benefited from Theranos’ alleged innovations that lowered the barriers to testing. . They are now left to the status quo and have yet another reason to question the medical innovation establishment that claims to want to help them.
The company’s transgressions cast a shadow over biomedical innovation, particularly in the area of diagnostics and blood testing. Established players and entrepreneurs are facing a more in-depth public scrutiny of the claimed benefits of their innovations, which is healthy. For investors, Theranos ‘story is a cautionary tale, a reminder to be more careful and to ensure that technologists’ claims are backed up by real science.
This scandal must serve as a call to action for the health technology community. It is extremely important that he learns from – and goes beyond – Theranos so that patients benefit from new technologies, approaches and care. Change begins by rebuilding trust with patients and providers and taking a non-negotiable position on three principles.
Caring for patients above all else
A woman testified that a Theranos blood test falsely indicated to her that she had miscarried. Other people have testified to inaccurate results for blood disorders and cancer.
Quality care cannot be provided without reliable and accurate test results, and poor testing puts people at risk, both physically and psychologically. Seventy percent of medical decisions depend on diagnostic laboratory tests. If test results are not accurate, providers can give their patients bad advice and patients can make potentially disastrous choices.
Consumers are drawn to new drugs, diagnostic methods, drug delivery systems and medical devices that offer the hope of better treatment and care, more convenient and less expensive. But Silicon Valley’s ‘go fast and break things’ approach doesn’t work when lives are on the line.
Always lead with science
In healthcare, the drive to innovate and bring new products to market is intense, and the growing demand for convenience and ease is pushing businesses to scale faster than ever. This is good, but there is a danger in forgetting that in supporting people’s lives, real shareholder value results from real value for patients.
To create this value, everything must be based on science. Even in this supercharged environment, it is possible to innovate with rigor and integrity, linking in-depth scientific knowledge and the know-how of the technological ecosystem. Taking a systematic approach can address some of the biggest challenges in healthcare and ensure that patients and providers get the most out of innovation.
The Covid-19 pandemic has underscored the need to expand access to testing so that individuals can make informed decisions regarding their health and well-being. As consumers increasingly engage in managing their health, they are looking for brands they can trust.
Ensure transparency and understanding
Demand is strong for new healthcare offerings to meet the growing need for disease detection and chronic disease surveillance. The Centers for Disease Control and Prevention estimates that 6 in 10 Americans are living with at least one chronic disease. These diseases, such as asthma, diabetes, heart disease, are the leading cause of death and disability in America, as well as the main driver of health care costs.
Yet a 2018 survey found that 40% of Americans said they ignored a recommended medical test or treatment, numbers that have remained consistent with the advent of Covid-19. The result is a medical system focused on caring for the sick instead of rapid diagnosis and early intervention.
Since blood tests can be a predictor of disease trends, an easy way to help people is to provide them with easily accessible and affordable testing options. Yet a flood of new options and promotions to consumers without clarity on proper use, performance, and quality can be confusing at best and misleading at worst. Truth in communication is essential. It is essential that clear information about diagnostic tests is conveyed to patients and that they know that in diagnostic testing – and in any other area of innovation – clinical monitoring is a must, not a “nice to have”. “.
In the excitement of inventing new things, innovators must stay grounded in these three key values. Lives are on the line. There is no “pretend until you do” in health care. Scientists and innovators must learn the lessons of the Theranos debacle so that people truly benefit from the new technologies and approaches to blood testing and the quality care they provide.
David Stein is CEO of Babson Diagnostics, a healthcare technology company focused on the transfer of lab tests to the pharmacy counter.