When It Comes to Medical Devices, Patents Rule
Gain Inspiration from These International Medical Inventors
Medical device innovation is continuous, leading to the development of new medical devices that change patients' lives for the better. These devices come in many shapes and sizes, from new surgical technologies to devices intended for home use.
Some are minimally-invasive and operate externally to the human body; others slipstream the latest advances in nanotechnology or “smart pharmaceuticals” to give us a future glimpse of where medical device innovation is heading.
In particular, I have identified seven international medical device entrepreneurs who recently released patented inventions that are changing the face of medicine. As can be expected, technology – integrating both hardware and software – influence their inventing journey and ultimately move us towards a more affordable and streamlined healthcare arena.
But first let me set the stage for this enterprising field by highlighting some recent events and trends that impact medical device inventing.
Successes & Failures in the Medical Device Arena
It’s notable that many of these medical devices are diagnostic in nature, using microanalysis to identify blood anomalies or measure its flow through the human body. This final observation is important because it also reminds us of some spectacular failures within this field, including the meteoric rise and fall of Theranos, headed by the cultish and misguided inventor, Elizabeth Holmes.
At one point, she claimed her medical startup could run over 240 blood tests, including cancer and cholesterol, using a single drop of blood. This was considered a revolutionary concept and a massive achievement. Many, including Holmes herself, saw her as the next Steve Jobs suggesting her proposed “miniLabs” (later called Edisons) blood-testing devices were comparable to Apple’s iPhone revolution.
While she had crafted an elegant medical device patent while still a student at Stanford, several insurmountable challenges crept into the prototyping, manufacturing and testing procedures that were swept under the floor before being unmasked in a hard-hitting Wall Street Journal expose.
Adopting a Silicon Valley approach to revolutionizing medical devices through software innovation has its advantages, but when it comes to a patient's health every effort needs to be made by medical inventors to underpromise and over deliver during product development. In Holmes case, the opposite was true: Theranos was attempting to "fake it until you make it," which eventually lead to one of the biggest scams ever uncovered in the medical device industry. This example also shows us the increasing drive towards smaller medical devices or miniaturization which is indicative of the broader technology field. Where Theranos failed, others are making tremendous headway.
And, despite this hailstorm in the medical diagnostic inventing arena, several small startups and inventors quietly perfected similar, albeit more limited devices, promising to transform the lives of patients across the world. Some of these are highlighted below along with other enterprising medical inventions that make life easier and simpler for both the doctor and the patient. It's a rich field filled with talented men and women who truly want to make healthcare safer, more affordable and cutting-edge.
1. Kourosh Kalantar-zadeh: Gas-sensing Capsule
With the help of co-inventor Dr. Kyle Berean, Professor Kourosh Kalantar-zadeh developed and patented an electronic gas-sensing capsule capable of measuring gases in the gut, which can aid in the diagnosis of gut disorders.
Gut disorders affect up to 20 percent of the population at some point during their lifetime, and many of these conditions remain undiagnosed. This medical device invention has the power to increase the accuracy and frequency of diagnosis, thus improving the lives of many patients.
Atmo BioSciences claims this it's underlying patent is a world-first and believes its 2-cm long ingestible capsule will revolutionize this field.
2. Aadil Diwan: Ear-Cleaning Headphones
Aadil Diwan applied for a medical device patent for his invention, the OtoSet device. This device resembles a pair of headphones and is designed to remove impacted ear wax from a patient's ear safely and easily.
With this device, doctors who once spent a large amount of time removing impacted ear wax can focus their efforts on more important tasks, allowing them to treat more patients and reduce wait times.
Diwan and his colleagues were initially concerned that their device would be lost among a sea of other devices available for this purpose. However, because their device offers specific advantages, they applied for a patent to protect the uniqueness of their design. The device caught the attention of the medical community, allowing them to be named as one of the winners of the MedCity INVEST conference's Pitch Perfect Contest.
3. Alex Gomez: Surgical Medical Device Patent
When a young Alex Gomex came to see me years ago to patent a surgical device used in hospital operating rooms, he barely had a penny to his name. What he did have in spades was determination, conviction and vision. He explained that during his time at medical school he often moonlighted as an assistant to surgeons performing laparoscopic surgery in a New York hospital.
Since these rooms are notoriously cold it would cause the camera lens to fog up as the surgeon pushed the device scope into the warm body of the patient. To Alex’s surprise the surgeon would then dip the scope into a warm bucket of water to de-mist the lens. The more Alex thought about it, the more he realized the annoying insanity of this approach.
He would eventually drop out of medical college to pursue D-HELP a surgical anti-fogging medical device that quite literally revolutionized the science of surgery across thousands of hospitals in the United States. His masterstroke was acquiring early utility patent protection drawing the attention of a medical giant who eventually purchased his startup for $100 million.
His device, which incorporates a solution used to clean burns, is marvelously simple and elegant. Small, independent medical inventors across the world draw inspiration from Alex’s inventing journey which all started with a very simple idea.
4. Fabien Beckers: Blood Flow Devices (and Oncology AI)
Fabien Beckers is the co-founder and CEO of the medical innovation company Arterys. This company's goal is to create new technologies that help change the way medical professionals quantify blood flow in the body. So far, this company has released medical imaging devices that can be used in the heart, lungs, breast, and liver. Beckers and his team are continuing their medical device journey to develop technologies that work in other parts of the body as well.
Although Beckers already has an established history in this market, every new technology developed must be patented in order to protect the company's claim on the invention and its profits. His company is putting a tremendous focus on artificial intelligence to transform how patients are diagnosed.
In a recent press release, the company stated that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for its Oncology AI application suite. The patented medical software will help clinicians measure and track cancer according to radiological standards. My patent law firm has seen a tremendous increase in software-related patent applications that cover machine learning, AI and other areas of emerging software technology, including the blockchain (and related virtual cryptocurrencies). The medical industry is absorbing many of these new technologies in some form or another. Watch Arterys closely for new developments in this field that will pivot off the underlying medical intellectual property.
5. Joel Gibbard: Medical Bionic Assistive Devices
Joel Gibbard is the founder of Open Bionics, a company that first opened its doors in 2014. The company produces patented assistive devices designed to aid people with specific disabilities. One of the company's most notable devices is the Hero Arm, which is a 3D-printed multi-grip bionic hand.
Gibbard has been working with robotics since he was a teenager. Despite hundreds of failed prototypes, he continued his quest to create useful prosthetics and is now operating a successful medical device company. Families have renewed hope for their children deprived of limbs with the new range of bionic limb options.
In wonderful marketing move, the company teamed up with Mark Hamill, the iconic actor who played Luke Skywalker in the movie Star Wars. Remember the dramatic scene where Darth Vader severs Skywalker’s arm with a light saber?
Hamill delivers a heartwarming message to kids around the world highlighting the super cool nature of new bionic limbs, including the one engineered for him in Stars Wars.
6. Stefano Valenzi: GlucoScanner for Diabetes
Stefano Valenzi is a medical device inventor who is responsible for the GlucoScanner, a non-invasive device used to monitor blood sugar levels in patients with diabetes. At the time of this device’s creation, no other external glucose monitoring technologies existed.
Once he knew he had created something unique and useful, Valenzi was quick to apply for a patent to protect his intellectual property.
Thanks to the development of Valenzi’s machine, patients no longer have to stick themselves with needles multiple times throughout the day. Instead, they can rely on the GlucoScanner to monitor their blood sugar continuously using external sensors, which are connected to software applications.
7. Shireen Khan: Cholestech Medical Device
Shireen Khan, along with fellow inventors Suyue Qian, Jeff Shindelman, George E. Withers, III, Eileen Gee, William H. Chapman, Jr., Greg Bennett, Thomas D. Schaa, are the inventing masterminds behind the patent and development of the CLIA-waived Alere Cholestech LDX® Analyzer used for point-of-care lipid profile, cholesterol, and glucose testing.
CLIA is an abbreviation for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulation that allows certain devices to be used for home testing (or other lab procedures that have low risks to the human body).
Cholestech is used in several hundred hospitals around the world under the Abbot Brand. Doctors use it to quickly measure cardiovascular and diabetes health risks in tests that take less than 5-6 minutes to perform.
The device is also notable because of its connection to the Theranos debacle mentioned at the beginning of this article. Elizabeth Holmes brought over Tony Nugent from Cholestech to help fix some of the engineering and microfluidic problems that were cropping up in the Edison devices used to test tiny blood samples. Nugent suggested to the Theranos team that microfluidics was not realistic in blood diagnostics because the amount of blood being measured was far too small.
Nugent radically adapted the company’s approach to build a robot-in-the-box that would automate all the complex steps previously reliant on complex blood handling, distribution and analyzation .
While Theranos would eventually crash and burn, Cholestech’s specialized focus on developing an assay device (and method) for measuring lipoproteins associated with cholesterol, continues to win kudos in the medical device arena.
The Final Analysis
None of these medical device inventors found success overnight. Instead, they spent many days or even years honing their ideas through a process of trial and error. However, all of these entrepreneurs have one thing in common: perseverance.
These inventors kept working until they had their "eureka" moment, even when they were faced with challenges or encouraged to give up on their dreams.
These inventors also took the initiative to protect their medical device intellectual property by securing a patent at the appropriate time, which may come even before the device has been perfected.
It must be remembered, however, that while patents are vital for ensuring commercial success, inventors must rigorously adhere to FDA medical device guidelines when manufacturing and testing their product or face the consequences.
In the case of Theranos, its flawed lab procedures and risky testing procedures incurred the wrath of the FDA who concluded that the medical startup had been shipping its tiny blood-collecting vials—”uncleared medical device[s],” between states. “They also found that Theranos kept poor records, mishandled complaints, failed to conduct quality audits, and was ‘unable to produce documented supplier qualifications,’ among other observations,” said the Wall Street Journal.
However, where Theranos failed and fell so short, the other medical inventors listed above can proudly say that they have made a positive, lasting impact on the field of medicine.
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