Applied Biotechnology

Among my childhood phobias, a fear of needles is the only one that continues to haunt me in adulthood. So I was interested to read that researchers at the Massachusetts Institute of Technology have developed a new gadget capable of delivering a tiny, high-pressure jet of medicine through the skin without the use of a hypodermic needle.

Popular Science reports:

It’s similar to a normal syringe, except instead of a needle plunger, it uses a Lorentz force actuator, made from a magnet surrounded by a conductive coil. When a current is turned on, the magnetic field interacts with the current to produce a force. That force kicks a piston, which ejects a drug that has been embedded inside the capsule. The speed of the ejection and the depth it will reach can be controlled by altering the current.

To penetrate the skin, the ejection happens at ultra high speeds, almost equivalent to the speed of sound through air. The drug flows through an opening that’s about as wide as a mosquito proboscis, according to MIT News.

Researchers led by Ian Hunter and Catherine Hogan tested a prototype device with two different velocities: One can breach the skin and reach deep into tissue, and another can deliver drugs more slowly, so they can be absorbed by the skin. Different people would need different piston velocities …

While the device won’t be ready for the upcoming flu season, I take some comfort in knowing that the research on making injections less painful is progressing.

Previously: Researchers turn to mosquito to design painless needle
Photo by Indiana Public Media

As has been widely reported today, paralyzed patients for the first time have moved a robotic arm using only their brain activity. In a small clinical trial described in a Nature paper, two patients each used a tiny device implanted in their motor cortex to move robotic limbs to reach, grasp and drink coffee from a bottle.

In an article from The Atlantic, writer Jessica Benko tells the story of one of the study participants, a woman who enrolled in the trial after a stroke left her paralyzed and unable to speak:

The study’s codirector, a conscientious young neuroscientist named Leigh Hochberg [MD, PhD], was blunt with Cathy: Whatever the failures or successes of the study, she could not hope that the results would assist her in her lifetime. “There are no expected benefits this early on in the research,” Hochberg told me. “What we’re doing, and what Cathy knew when we were starting and what she enthusiastically joined, is an endeavor to test and develop a device we hope will help other people with paralysis in the future.”

Cathy’s device was implanted in 2005, and the researchers first target was for her to control a computer cursor. As Cathy concentrated on moving her hand, her efforts unspooled on screens in front of the researchers, who tried to use the information from her brain as a sort of virtual mind-controlled mouse. When the researchers turned control of the cursor over to Cathy’s neurons, the cursor immediately began to move haltingly across the screen. Cathy couldn’t believe her eyes. “I was numb with shock and disbelief,” she wrote to me, “so I moved the cursor all over the screen.”

An article and video published by Nature News describe how Hutchinson smiled when she first used the robotic arm. “We’ll never forget that smile,” Hochberg commented.

Hochberg and his team are continuing their work in this area, and last fall Stanford announced it was collaborating with the group by serving as a trial site for BrainGate2. Jaimie Henderson, MD, is lead investigator of the Stanford branch of the trial.

Scientists here have developed an innovative retinal prosthesis that may someday restore sight to those who have lost their vision due to certain types of degenerative eye disease.

While similar devices require coils, cables or antennas inside the eye to transmit power and information to the retinal implant, the Stanford device uses near-infrared light to deliver images making the device thin and easily implantable. As described in our recent release:

This device — a new type of retinal prosthesis — involves a specially designed pair of goggles, which are equipped with a miniature camera and a pocket PC that is designed to process the visual data stream. The resulting images would be displayed on a liquid crystal microdisplay embedded in the goggles, similar to what’s used in video goggles for gaming. Unlike the regular video goggles, though, the images would be beamed from the LCD using laser pulses of near-infrared light to a photovoltaic silicon chip — one-third as thin as a strand of hair — implanted beneath the retina.

Electric currents from the photodiodes on the chip would then trigger signals in the retina, which then flow to the brain, enabling a patient to regain vision.

A study, published online May 13 in Nature Photonics, shows how scientists used rat retinas to assess the photodiode arrays in vitro, and how the diodes produced electric responses that are widely accepted indicators of visual activity. The scientists are now testing the system in live rats, taking both physiological and behavioral measurements, and are hoping to find a sponsor to support tests in humans.

Previously: First results of human embryonic stem cell trials for blindness, Developing a prosthetic eye to treat blindness and The blind can see
Photo by the Daniel Palanker lab

As part of the National Science Foundation’s “Big Data” initiative (.pdf) UC Berkeley was recently awarded a $10 million grant. There, researchers will create an open-source platform to collect, organize and make sense of vast amounts of data, including information recently made public by the Centers for Disease Control and Prevention and several other federal agencies.

In a new iHealthBeat report from Deirdre Kennedy, health-care experts, including Stanford’s Atul Butte, MD, PhD, discuss (.pdf) the UC Berkeley project and the opportunities and challenges of mining big data for health care and scientific research. About the potential of using electronic health-care records for research purposes:

Butte says it’s possible to mine EHR without violating patient privacy. Stanford did just that. The university released a widely publicized study this year that found women reported higher levels of pain than men. Researchers gleaned that information from thousands of patient records by just combing through one piece of data — how they rated their pain when nurses asked them.

“It was the largest study ever for pain. That data was just sitting there in the repository waiting for someone to do something with it,” [says Butte.] “It didn’t even have to be publicly available. Data is on its way to getting more and more public. I actually think the new challenge is what do we want to ask of that data?”

Previously: New project will help people donate their data to research and Women report feeling more pain than men, huge EMR analysis shows

Thank you for taking the time to share your questions on health-care innovation and entrepreneurship using the hashtag #AskSUMed or the comment section on Scope. Here are my answers.

@NBBJCommunity asks: How can medical technology be integrated with tools like LEAN, architecture etc. to create holistic solutions?

Let’s take LEAN as an example. LEAN has its roots in the Toyota production system and process re-engineering. One of the key insights from the Toyota production system is that each handoff, when an item changes hands between individuals or departments, in a service system or production process is a potential point of failure.

In health-care, many preventable problems and medical errors occur at handoffs between staff members or during shift changes. You can use technology to make those handoffs work more seamlessly. You can start with things like electronic medical records to help reduce workflow failures. But you can also envision medical technologies that can be used to radically redesign the process of care delivery to eliminate handoffs. For instance, consider devices that could be used by a patient to perform activities and collect data that would otherwise be gathered and managed by a health-care provider. If we can integrate that information in a way that works seamlessly with the provider’s workflow, we can minimize the back and forth between the provider and patient that creates room for error.

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I call it the ultimate “blue light special:” an oral cancer screening tool that costs just a few dollars and can be used in rural regions of developing nations to help with early detection of a disease that kills more than 270,000 people a year.

Developed by a Manu Prakash, PhD, and his Stanford bioengineering team, this elegantly simple device, called OScan, attaches to any smartphone’s built-in camera, allowing anyone to take a high-resolution, panoramic image of a person’s complete mouth cavity. Illuminated by the device’s blue fluorescent light, malignant cancer lesions in the oral cavity can be easily detected as dark spots, by dentists or oral surgeons receiving these images wirelessly.

As I wrote in this Inside Stanford Medicine article, one thing I found shocking was how serious the epidemic of oral cancer is in India, due to the widespread use of chewing tobacco and the scarcity of dentists:

Although oral cancer stands as the sixth-most frequent type of in United States, it accounts for more than 40 percent of cancer-related deaths in India, not surprising considering that nearly 57 percent of males and 11 percent of women consume tobacco in that country.

OScan, which leverages the camera technology in ubiquitous smartphones, is a clever solution to the growing global problem of oral cancer. Today the device won first and second place, respectively, for the mHealth Alliance Award and the Vodafone Americas Foundation Wireless Innovation Project.

Photo by Steve Fisch

It will take more than a Band-aid to fix the medical device market. This was the message delivered by Alex Gorsky, future Johnson & Johnson CEO, to an auditorium full of students and entrepreneurs at the Stanford Biodesign From the Innovator’s Workbench event last week.

Gorsky, who in a few weeks will take the helm of the world’s largest health-care corporation, discussed challenges and opportunities in medical device market, as his company navigates through a turbulent world economy and a string of product recalls.

“It’s a difficult market,” he said. “The days of incremental innovation are over.”

And, while Gorsky thinks population growth will drive up worldwide demand for health care, it’s unclear who will pay for it.

Gorsky sees a fundamental shift in the way medical devices are purchased, which may change the innovator’s design approach. In the United States, buying decisions will shift from surgeons to cost-conscious hospital buyers. And that may create demand for keep-it-simple medical devices – designs that provide 50 percent of the bells-and-whistles of current devices for 15 percent of the cost. In addition, he cited the need for more clinical information on efficacy and safety, to help hospital administrators justify medical device purchases.

As the U.S. struggles to stem rising health care costs, his company will look to emerging markets – especially China – for growth. He predicts that these health care markets will grow at 4 to 5 times the rate of the domestic market.

He also sees opportunity in products that combine medical devices with pharmaceuticals, such as test strips, wound closures and drug delivery pumps. And he’s optimistic about the trauma market, which includes sports medicine, orthopedics, and surgical devices.

Finally, Gorsky recognizes that big leaps in medical technology are easier said than done in the current economic climate. As venture capitalists flee capital-intensive, long-lead medtech markets, he acknowledged that companies with broad product portfolios will need to be more proactive about early stage start-up acquisitions and university technology transfers to fill their product pipelines.

See Stanford Biodesign’s Innovator’s Workbench website to register for future biomedical leader events, or to watch videos of past interviews.

Photo by Kris Newby

Earlier this week on the Stanford campus, medical technology entrepreneurs shared advice and commented on the challenges faced by young companies in the biotechnology, medical device development and healthcare fields. KQED reports:

As part of the university’s Entrepreneurship Week, StartX, Stanford’s student-run startup accelerator program, hosted a panel where former students and company founders now working in the medical technology sector offered insight into all angles of the startup struggle.

All seven speakers agreed that funding problems are the largest roadblock but not wholly detrimental to the creative process.

“Due to the volatility of the FDA, most investors won’t invest until the later stage” of development, said Lily Truong, chief executive of ClearEar. The company’s total ear-care tool safely and quickly removes severe earwax buildup. “This causes the problem that if investors want late-stage companies, how does a startup get to that stage without help in the beginning?”

Previously: FDA begins to revamp approval process for medical devices, Stanford physician-entrepreneur discusses need to change FDA approval process, Stanford Biodesign Program releases video series on the FDA system, Is the United States losing ground as a leader of medical innovation?

Stanford inventors have developed a new sensor that uses a clever combination of antibodies, magnets and laser light to count white blood cells in tiny samples of blood and other body fluids. The device is so small and inexpensive that it could be used nearly anywhere: at doctors’ offices, disaster relief sites, battlefields or patients’ homes. (In the photo at right, the portion of the sensor that holds a blood sample is shown next to a researcher’s blue-gloved fingertip to give a sense of scale.) The inventors, who are now seeking a partner to commercialize the invention, hope it will some day be as ubiquitous as the portable glucometers that diabetics use to test their blood sugar.

A press release I wrote about the invention, which is described in a new paper in the journal Biomicrofluidics, gives details of the sensor’s potential:

“A low-cost way of counting cells could provide point-of-care diagnosis and monitoring for immune disorders, allergies, infections, AIDS, cancer and other disorders,” said Manish Butte, MD, PhD, who led the team of inventors.

…

The body has many types of white blood cells, each with different disease-fighting roles. White blood cell counts already help doctors diagnose some diseases and monitor treatment of others, including cancer and AIDS, but current cell-counting methods require fairly large blood samples and costly, slow equipment that can be operated only by trained laboratory technicians.

One possible application of the new sensor would allow doctors to solve a common, vexing problem: determining the cause of a runny nose. Instead of using the current trial-and-error method for diagnosing the problem, doctors could take a mucus sample from the patient in their office and measure the white blood cells present. Elevation of one type of white blood cells could implicate allergies, another cell type could point to a sinus infection and a third type of elevated cell count could suggest that the runny nose was simply due to the common cold.

Read the whole release for more details, including a description of how the sensor works.

Photo courtesy of Manish Butte

I guess you could say that the Stanford Biodesign Program “wrote the book” on how to teach medical technology innovation to multidisciplinary teams. The U.S. Food and Drug Administration recently acknowledged the effectiveness of this training program by signing a “memorandum of understanding” with Stanford, which I discuss in today’s Inside Stanford Medicine.

The agreement lays the groundwork for the FDA and Stanford to collaborate on a number of initiatives, including educational outreach, cross-training of scientific personnel, and the development of new biostatistical methods for more accurately evaluating the safety of emerging medical technologies.

The biodesign program, which is in its 11th year, trains teams of doctors, engineers and business students — in an intensive one-year program — to identify a medical need, develop an invention to fill it, create a business plan, navigate the regulatory process, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.

Previously: Stanford Biodesign Program releases video series on the FDA system, FDA walks line between innovation and safety, Stanford physician-entrepreneur discusses need to change FDA approval process, and New biomedical device textbook gets early praise