The Smart Magazine About Medical Technology Innovations
FIME 2016: A Taste of the Americas
It describes itself as the “largest medical trade fair on the biggest medical device marketplace,” serving North, Central and South America. For its 26th year, the FIME exhibition was held August 2-4 at the Miami Convention Center in Florida, attracting about 1,500 exhibitors from 38 countries and 20,000 attendees.
MedicalExpo e-magazine is publishing a special issue on the event for the occasion. You’ll have a taste of some of the most innovative devices showcased at FIME. You’ll also learn about the Latin American market, why the city of Miami is a hotbed for medical innovations, and about the biggest social network for U.S. physicians: Doximity.
A keynote speaker at FIME, Richard Vincins is vice president of quality and regulatory affairs at Emergo. The Texas-based consulting firm assists and advises medical device companies from the quality system implementation perspective to the regulatory requirements such as submissions and registrations. Vincins shared...
Miami has hosted FIME for many years. It may be far from the big-name hospitals and medical schools of New York, Boston and Washington, but the southern coastal city is still a hotbed for innovation, particularly when it comes to technologies and surgeries that improve patients’ quality of life.
One of Florida’s leading urologists, Dr. George Suarez, worked for years to bring a prostate cancer treatment known as high-intensity focused ultrasound (HIFU) to the United States. It works by using sound waves to heat and destroy tissue at a precise focal point, at temperatures of up to 90 degrees Celsius.
Suarez likens the procedure to using a magnifying glass to focus the sun’s rays and burn a leaf. For patients with localized prostate cancer, the procedure can be done on an outpatient basis without any surgery, cutting, suturing or radiation. Suarez, who is medical director of the Prostate Cancer Institute of Miami, explained to us:
There is no pain. There is no bleeding. It is completely non-invasive.
Although this technology was first researched in the United States in the 1950s, nothing became of it for decades. HIFU gained approval in Europe in 1995. “I realized the importance of this technology. And I had the foresight to say, how do I get my hands on it and how do I make this happen?”
Suarez was the medical director of the clinical trials in the United States for HIFU. It was initially rejected by the U.S. Food and Drug Administration, but HIFU for prostate tissue ablation eventually gained FDA approval in 2015, when the U.S. federal agency approved the Sonablate 450, developed by SonaCare Medical.
Dr. George Suarez, urologist (Courtesy of International HIFU Centers)
Suarez said the procedure’s risk of impotence and incontinence are far lower than the standard therapies of radical prostatectomy or radiation. HIFU can be repeated, and studies have also shown that HIFU does not risk spreading the cancer, unlike procedures such as uterine morcellation, he added.
Suarez has performed well over 2,000 HIFU surgeries—more than any single doctor in the world—and often travels internationally to train physicians in the procedure. “Living in south Florida, I should be fishing or boating or doing something else,” joked Suarez, 60. “I often tell people, ‘If you see me at a golf course, come and get me because I am lost.’”
Improving Gallbladder Surgery
Dr. Tushar Barot, a general surgery resident at Mount Sinai Medical Center in Miami, saw a problem with gallbladder removal—namely a high complication rate due to bile duct injury. This potentially dangerous or even fatal mistake can happen when the bile duct gets cut or pinched during surgery, leading bile to leak into abdomen or blocking its regular flow. It often happens when the operating doctor cannot see clearly the area around the gallbladder and bile ducts.
Barot’s research showed that Mount Sinai’s complication rate for laparoscopic cholecystectomies was 5.7% —which he felt was too high. Some 750,000 of these operations take place annually in the United States. “So we implemented a six-step protocol in our hospital to see if we could do something to reduce this complication and essentially create a culture of safety where we could make this procedure safer for everybody,” Barot said.
Dr. Tushar Barot presenting his research (Courtesy of Mount Sinai Medical Center)
The first step involved clearing fat and fibrous tissue from an area known as the hepatocystic triangle, then separating the lower one-third of the gallbladder from the liver. “Two and only two structures should be seen entering the gallbladder,” he explained.
Then, surgeons allow for an intra-operative timeout, followed by extra attention to any aberrant anatomy. The fourth step of the protocol allows for “liberal use of intro imaging” followed by identifying the danger zone. Barot’s final step: Get help from another surgeon. A total of 173 patients were enrolled in the nine-month study from 2014 to 2015 to see if these steps could reduce complications. They did. According to Barot:
We dropped our complications from 5.7 percent to 0 percent using that protocol.
Larger, long-term follow-up studies are needed, he added. Eventually, Barot hopes that others will take advantage of the six-step protocol in their hospitals.
New Generation Disc Replacement
Another innovation that was dreamed up in Florida is a lumbar disc replacement known as ActivL. It is the first FDA-approved spine surgery technology in a decade. For patients with lumbar degenerative disc disease or lumbar disc herniations, it offers an alternative to spinal fusion surgery, which involves fusing vertebral bones together and can lead to more stiffness and pain.
The technology was co-developed by Dr. Rolando Garcia, who was the first surgeon in Florida to perform a spinal disc replacement back in May of 2000 and was the co-lead investigator of the FDA trial for ActivL.
The ActivL artificial disc (Courtesy of R. Garcia)
ActivL has chromium endplates with spikes that affix to the patient’s vertebrae and an ultra-high molecular weight polyethylene core that enables natural forward and backward movement of the lumbar spine. Garcia, an orthopedic surgeon with Orthopedic Care Centers in Aventura, Florida explained:
One of the greatest advantages is that ActivL recreates the motion of a normal spine by allowing the plastic inside of it to move and mimic the motion of the human spine.
“It also offers advantages in terms of its shape which allows the surgeon to better fit the implant to the patient,” he added. Since ActivL was FDA-approved in June of 2015, he estimates he has performed about 100 surgeries using the disc replacement.
FIME is a good occasion to talk about how American physicians communicate with one another. Over half a million U.S. healthcare professionals are members of the social network Doximity. Launched in March of 2011, it became the most popular network for physicians in the United States in just five years. Its co-founder,...
HD Medical has revealed at FIME its HD Steth: a digital smart auscultation device that looks and feels like a regular stethoscope. Almost 200 years after French physician René Laennec invented the first stethoscope, this smartphone-connected innovation is likely to be one of the most revolutionary advancements in auscultation.
Since 2005, California-based company HD Medical has been working on designing medical products to detect heart conditions early. Their first-generation devices, such as the ViScope MD,enable healthcare professionals to observe heart signals on a screen attached to the device.
“We were working with world famous cardiologist Dr. Nelson Schiller, and jointly assessed that auscultation is becoming a lost art. For example, it is difficult to hear certain sounds—especially for older doctors. In order to make diagnoses bullet-proof, we added a real-time visual component to our devices,” Kristi Furrer, senior director of marketing at HD Medical, explained the story behind their technology to us.
With HD Steth, HD Medical is taking things one step further. The device aims at integrating seamlessly into existing clinical workflows, thereby following a general design trend of connecting digital experiences with familiar manual elements. “HD Steth is based on the same technology as the ViScope, which is already FDA-approved and CE-certified. However, it has a brand-new form factor, which is much more like a traditional stethoscope,” said Kristi Furrer.
This early stethoscope belonged to Laennec (Courtesy of Science Museum, London)
On the earpiece end of HD Steth, users can listen to the internal sounds of the body in high-fidelity audio. The chestpiece has a digital readout of the heart rate on the front side, and three gold-plated ECG (electrocardiogram) leads on the reverse. Users can transfer the patient auscultation data via Bluetooth to their smartphone, where the HD Steth app displays and analyzes ECG and PCG (phonocardiogram) signals in real time.
A Relevant Tool for Tele-Health Initiatives
“There are algorithms embedded in the application, which interpret the heart wave forms and indicate whether there is a murmur. According to our clinical trials at UCSF and in India, the heart murmur algorithm has 96 percent accuracy,” Kristi Furrer told us. The app can also store patient data, andsend it to specialists or EMR (electronic medical record) systems, making HD Steth likely to become a relevant tool for tele-health initiatives.
The HD Steth (Courtesy of HD Medical)
HD Steth is being announced worldwide, starting with the U.S. during the FIME Conference in early August with general announcement planned for early Q4. The worldwide rollout will then be moving on to Germany, the Middle East, and Japan. “We see HD Steth as a device for all kinds of medical personnel and healthcare organizations. Eventually we will also have a version called HD Scope for consumers,” said Kristi Furrer. HD Steth will retail for $400.
However, healthcare professionals are able to have the device quickly paid for itself, as HD Steth meets Medicare reimbursementrequirements for ECG and reporting. The company is currently negotiating similar reimbursement plans for markets outside the U.S.
Also presented at FIME, the Licetec V-Comb is a chemical- and allergen-free comb designed to eliminate lice infestation. Developed in Australia by TwoLife Technologies, and patented internationally as a Class I medical device, the V-Comb provides immediate feedback to the user as they comb, eliminating any uncertainty about the treatment’s effectiveness.
To satisfy international regulatory standards, the V-Comb has undergone vigorous testing and it is certified and registered with leading international health regulatory agencies, including the FDA, CE and Australian Therapeutic Goods Administration.
The V-Comb has stainless steel metal teeth for the removal of lice and eggs, while the body is made of robust ABS plastic. Its built-in vacuum assists with drawing head lice and eggs that are removed by the teeth into a disposable capture filter housed within the unit.
The V-Comb’s teeth remove adult lice, hard-to-see nymphs and eggs from the hair during combing. As the hair is combed, it breaks the head lice life cycle and prevents re-infestation. The V-Comb then removes head lice and eggs from the teeth into disposable capture filters that can later be removed and sealed for hygienic disposal.
It is safe, simple and user-friendly for regular treatment on multiple children at home. The V-Comb is easily dismantled for cleaning and the combing head can be soaked in hot water. Used regularly, the V-Comb can also be used for early detection of head lice activity and prevent a full-blown infestation.
The V-Comb (Courtesy of Licetec)
If an outbreak is suspected at school, TwoLife recommends using the V-Comb over a 14-day period. In the first four days, the company recommends combing daily to get rid of all lice and eggs in the hair. Using it consistently the first four days helps ensure that all the lice are picked up, in case any are missed in the first day.
In the next five to 10 days, TwoLife recommends using the comb two to three times to catch any eggs that might have hatched, or new lice that could have been picked up at school or daycare. On the 11th through the 14th days, use the comb once or twice after school or day-care to check for new lice activity. After the 14-day period, check the hair with the V-Comb once or twice a week for any new activity. It costs $64.99, according to the company’s website.
Serology detects IgM and neutralizing antibodies that develop towards the end of the first week of illness (≥4 days post-illness onset). The test is currently approved for marketing in India, the Philippines, Thailand, Indonesia and Guatemala. According to Jatin Mahajan, managing director at J. Mitra, test results can be obtained within 15 minutes and the test offers excellent sensitivity of 97.5% and a specificity of 99.10%.
The assay uses a sandwich principle, in which the test sample of sera from the patient is introduced and flows laterally through an absorbent pad where it mixes with the conjugate. The complex then migrates through the nitrocellulose membrane by capillary action. When the complex reaches the line of immobilized capture reagents, it generates a pink purple line that indicates that the sample is reactive. The assay also uses a procedural control, an additional control line that has been immobilized at a distance from the test line on the strip. If the test is performed according to protocol, a pinkish purple line will form at the control region upon contact with the conjugate.
The Helps Support Clinical Findings
The rapid test permits early diagnosis and avoids problems in patients who aren’t able to follow up appropriately. Patients can be told of their diagnosis and get symptomatic treatment.
The rapid test permits early diagnosis and avoids problems in patients who aren’t able to follow up appropriately.
There is no vaccine or medicine to prevent chikungunya virus infections. Also, many countries where chikungunya virus is endemic lack specialist equipment and laboratory skills. An anti-chikungunya IgM detection kit helps support clinical findings in the assessment and differentiates the virus from other pathogens, including dengue fever.
The Advantage Chikungunya IGM Card requires no instruments and is a qualitative and visual test. Its shelf life is 18 months at 2 to 30 degrees Celsius. The kit is a biohazard free, see-through device, and it comes in a 10-test and 25-test pack size.