The story of Theranos remains one of the most infamous cautionary tales in medical innovation. Once valued at $9 billion and hailed as a revolutionary step in blood testing, the company’s downfall revealed deep cracks in the culture of secrecy, marketing hype, and scientific misrepresentation.
Today, as the biotech industry continues to evolve, with legitimate advancements in microsampling and diagnostic innovation; Theranos serves as a reminder of why transparency, validation, and collaboration are not optional; they are essential.
The trial attracted attention from those in the medical device and biotechnology industries, particularly regarding Theranos' purported miniaturized testing device, "the Edison," aimed at making blood tests cheaper and more accessible through finger-prick samples.
Although Holmes and her company failed to change the world with their Edison technology, the idea they were aiming for was a good one: to replace painful, expensive and inconvenient venous blood draws with a less painful, more mobile and user-friendly alternative that could deliver robust data to researchers and healthcare professionals.
Between 2003, when she founded Theranos as a 19-year-old college dropout, and Q4 2014, her company was valued at around $9 billion, Elizabeth Holmes claimed that Theranos was changing the world.
Edison, Theranos’ proprietary laboratory device, could replace venipuncture with a finger prick and test for hundreds of diseases from a single drop of blood just as accurately as traditional blood testing methods.
As we now know, the Edison lab device from Theranos never delivered on this promise, despite Holmes’ claims that it did.
Had the technology worked as advertised, Holmes could indeed have changed the world. Had the company more deftly and appropriately managed expectations for investors and customers (and followed a more realistic product launch timeline), it could have been tremendously influential.
Instead, the CEO unloaded her personal shares and tried to fend off litigation after a well-reported exposé from investigative reporter John Carreyrou lifted the veil on the inner workings of a healthcare startup that couldn’t deliver and whose secrecy and “fake-it-till-you-make-it” approach posed potential harm to countless patients.
The Theranos catastrophe left the rest of us with a few valuable lessons learned.
Theranos claimed to perform hundreds of diagnostic tests using only a few drops of blood. However, the company consistently avoided independent validation and regulatory scrutiny. The results were disastrous: unreliable data, compromised patient safety, and ultimately, federal prosecution.
While Homes courted media attention and worked overtime to spin the story of her company’s concept, mission and technical approach to healthcare, she never provided much in the way of data or details to substantiate her claims.
To this day, it is still somewhat unclear what Edison technology is or how it works. Even her employees were forbidden to communicate with each other about their work.
And according to the Wall Street Journal healthcare reporter and author of “Bad Blood: Secrets and Lies in a Silicon Valley Startup” John Carreyrou, the Theranos business model and Holmes’ leadership style should not occur in any medical organization.
The free flow of information, at least internally, is a cornerstone of any groundbreaking technology – professionals working on all its components need to know what’s going on in different departments throughout the operation.
In contrast, modern companies advancing microsampling technologies, such as Neoteryx, understand that scientific credibility is built on transparency and validation. Every microsampling device and workflow must be peer-reviewed, independently verified, and compliant with international standards (like ISO, CLIA, and FDA guidance).
Innovation without validation is speculation. Ethical companies publish data, submit to regulatory oversight, and collaborate with the scientific community to ensure that novel tools deliver accurate and reliable results.
One of Theranos’s greatest failures was its disregard for data integrity. Internal results were manipulated or hidden to satisfy investors, while patients and clinicians were misled by inaccurate reports.
The consequences were devastating! Not just financially, but emotionally, as patients received false health information. This failure underscores why data transparency and reproducibility are the lifeblood of medical science.
A thorough peer-reviewed scientific analysis is critical for any medical technology before it is offered to subjects in research settings or patients in routine medical practice.
Validated microsampling technologies are supported by independent studies and are designed to yield consistent, reproducible results across diverse users and sample types. Researchers can verify data accuracy through open protocols and standardized workflows—something Theranos actively resisted.
Scientific integrity cannot be faked. Trust is earned through reproducibility, transparency, and rigorous data governance.
Elizabeth Holmes, was convicted of wire fraud and conspiracy in 2022 and began serving an 11-year prison sentence in 2023. Her story continues to make headlines, but the real lesson is broader: overpromising and underdelivering destroys public confidence in science.
A real lesson here is never to compromise on patient safety, especially if your aim is to achieve positive change with technology that is designed to benefit people. Regulations exist for a reason.
True innovation means working within the constraints of the med-tech industry and following the rules of the regulatory agencies that ensure medical and biotech companies introducing disruptive technology will put people first, and not make up their own rules and hope for the best.
That means communicating clearly about what their technology can do (and its current limitations), while continually investing in research, validation, and regulatory compliance.
Responsible innovators don’t rush to market—they build for longevity, accuracy, and trust.
Since the fall of Theranos, the diagnostics industry has become far more vigilant. Regulators, investors, and clinicians now demand proof before promises. The rise of microsampling exemplifies this shift, showing that small-volume, decentralized sampling can transform healthcare, but only when developed with rigorous scientific and ethical oversight.
Neoteryx’s Mitra devices with VAMS technology have undergone extensive validation by independent laboratories and global research institutions, demonstrating reproducibility and stability even under variable conditions. This transparency ensures that microsampling is a credible, ethical evolution of blood collection—not an unverified shortcut.
Leaders in the microsampling industry emphatically state that it should not. A few hours after the verdict of Holmes’ fraud trial made headlines on January 3, 2022, Trajan CEO Stephen Tomisich posted this message on his LinkedIn page:
“There is no place in science to 'fake it till you make it'! While Theranos may now be in its grave, the damage of this episode continues with many incorrectly concluding what is and isn't possible with blood microsampling. Today there are many enterprises pursuing decentralized healthcare systems, including blood microsampling strategies [that, like Trajan’s,] are science based and driven to deliver better health outcomes for society."
Regardless of the questionable actions of Holmes and the outcome of her fraud trial, the value of remote specimen collection technology that simplifies specimen collection and delivers precise and reliable data should not be overlooked.
If medical device and biotechnology companies maintain a high ethical code and comply with regulatory requirements during all phases of development, microsampling will continue to thrive as scientific specimen collection method and may indeed change the world.
The Theranos case was not the end of innovation in blood diagnostics—it was a turning point. The next generation of microsampling technologies are proving that progress is sustainable only when founded on science, transparency, and ethical leadership.
At Trajan, we believe innovation means doing things the right way, not the fastest way. The lessons from Theranos continue to guide our mission: advancing reliable, validated microsampling solutions that empower both researchers and patients worldwide.
Learn more about validated microsampling technologies that are reshaping clinical research and diagnostics. Contact Neoteryx to explore compliant, reliable, and patient-friendly blood collection solutions.
About Trajan Scientific and Medical
Trajan is a global developer and manufacturer of analytical and life sciences products and devices founded to have a positive impact on human wellbeing through scientific measurement. Trajan enables scientific solutions that are more selective, sensitive and specific for biological, environmental or food related measurements – where analytical measurement quality can impact human wellbeing. Trajan focuses on emerging technologies that offer portability, precision, miniaturization and affordability, for the greatest benefit to society. To learn more, visit www.trajanscimed.com.
Image Credits: Getty Images, Wikipedia, The Orange County Register
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