Karanjit Kooner
Orlando Auciello
Walter Voit
Yanliang Zhang
University of Texas Southwest Medical Center, Dallas, TX

Glaucoma is the second-leading cause of blindness, affecting 80 million patients globally, including 3 million patients in the United States. Elevated intraocular pressure (IOP) is an important risk factor in the pathogenesis and progression of glaucoma. It is caused by gradual blockage in the eye’s drainage channels that drain the aqueous humor (AH) from the eye’s anterior chamber (AC), resulting in pressure increase in the AC, optic nerve damage, and blindness. Currently, a glaucoma drainage device (GDD) is implanted after medical treatments fail to control IOP by providing a conduit to drain AH from the AC to the sub-conjunctival/sub-Tenon space. Unfortunately, current GDDs have major drawbacks.

Back: Haafiz Hashim and Monica Patel; front: Irina Kim, Karanjit S. Kooner, and Priya Mekala; University of Texas Southwest Medical Center, Dallas, TX.

Large sizes require lengthy and extensive surgical dissection. Large volume of AH is released abruptly causing serious vision threatening complications. Prolonged inflammation and fibrosis leads to 50 percent premature device failure over five years. By comparison, the proposed Squid Glaucoma microShunt (SGS) will be 90 percent smaller and will provide a slow and controlled release of AH through a narrow tube. The AH is then further slowed by a channel placed between the chambers. Thus, the SGS would require minimal surgical dissection, and the AH will be released in a slow sprinkle-like fashion, minimizing inflammation, fibrosis, and complications. Two built-in retainers would provide stability, eliminating the need to suture the device to the sclera.

Schematic of microforceps.
The novel Squid Glaucoma microShunt.

Current GDDs are made of materials that provoke inflammation and fibrosis, often leading to intense encapsulation and elevated IOP. The SGS device will be coated with a patented low-cost ultrananocrystalline diamond (UNCD) film, which exhibits super-hydrophobicity and superb biocompatibility. Finally, a pair of patented microforceps would facilitate quick and easy insertion of the SGS promoting a 50 percent reduction in surgery time, enabling surgeons to perform faster and more efficient surgeries.

In the United States alone, direct costs related to glaucoma reached $5.8 billion annually according to a 2013 report. The global glaucoma surgery market was valued at $818 million in 2020, projected to reach $6.5 billion by 2030 with a compound annual growth rate of 24.6 percent. Currently, due to the complexity of the procedures, complications, and invasiveness of the bulky GDDs, only 40 percent of glaucoma patients undergo surgical interventions. The less-invasive SGS implant would make early surgical intervention an option available to wider sections of the glaucoma population with presumably better outcomes, thus preventing blindness.

Schematic comparison of Ahmed and SGS shunts.

Preliminary in silico fluidic simulation has shown that the SGS has the potential to significantly reduce IOP by 50 percent. Additionally, the efficacy of the UNCD coating on reducing fibrosis has been tested and confirmed.

A SGS prototype will be manufactured in collaboration with world-renowned material scientists and engineers with extensive experience in micromedical devices at the University of Texas at Dallas and at the University of Notre Dame. Two fabrication processes, hybrid lowcost 3D conformal printing and photolithography, will enable the SGS to be cost-effectively produced.

A video of the technology is available here .

Honorable Mentions

Wearable Continuous Blood Pressure Monitors

Xina Quan, PhD
Zhenan Bao, PhD
Keith Drake, PhD
Doug Halperin
Weyland Leong
Junjun Liu, PhD
Art Muir, MBA
Peter Noymer, PhD
Dave Richardson
Thomas Roxlo, PhD
Will Sutherland
PyrAmes Inc., Cupertino, CA
The wearable devices provide a comfortable and easy-to-use alternative to intermittent cuff measurements.

PyrAmes is a digital health company focused on fundamentally transforming healthcare delivery through continuous blood pressure (BP) monitoring that is accurate, wireless, and noninvasive. The devices’ comfort and ease-of-use will enable better BP management for patients from newborns to seniors. The wearable devices provide a comfortable and easy-to-use alternative to intermittent cuff measurements with the timeliness and accuracy of invasive arterial catheters (IALs), at reduced cost, and at reduced risk of pain and complications.

BP is a critical biomarker for many medical conditions affecting the lives of hundreds of millions of people. Tighter BP control can lead to better outcomes for the 116 million American adults suffering from hypertension. Frequent BP measurements are needed for critical or emergency care, home medical management for stroke or cardiac patients, and monitoring of pregnant women at risk of hypertension disorders of pregnancy such as preeclampsia.

To measure blood pressure, standard BP cuffs only provide spot measurements and can be time-consuming and difficult to self-administer. While frequent measurement with automated cuff devices (ABPMs) is recommended by the American Heart Association, the cuffs are inconvenient and uncomfortable (and painful for some) and carry risk of tissue damage. ABPMs are prescribed for fewer than 1 percent of suspected hypertensives; patients generally are unwilling to use them for more than 24 hours. Most important, intermittent cuff measurements may not be sufficient for critical care where the status of a patient can change from minute to minute.

Continuous BP can be monitored using an IAL inserted into the artery to directly measure changes in BP, but carry risk of serious complications such as infection, bleeding, blood clots, nerve damage, and amputation, particularly for children with smaller arteries. Requiring highly skilled medical staff and equipment, they are generally only used in ICU settings.

PyrAmes’ technology has been used successfully on patients ranging from newborns to adults 89+ years old. The device provides timely data to treat patients at risk of rapid changes in BP that can lead to stroke or multiple organ failure, while removing the pain and risk of the current standards of care at lower cost and increased patient compliance. It also offers the possibility of remote monitoring for caregivers.

The wearable device uses paper-thin capacitive sensors to capture pulse waveforms processed with neural networks to produce BP values that meet the FDA’s accuracy guidelines. Its passive measurements with a comfortable band and an easy-to-use app will improve compliance, thus providing more effective care.

In volume, the devices can be manufactured using roll-to-roll processes and could be integrated into smartwatch bands. The electronics costs will be similar to low-end fitness bands, encouraging adoption of PyrAmes’ technology across a broad range of applications.

The company’s go-to-market strategy is to launch products in multiple markets, including noninvasive alternatives to arterial lines, emergency medical monitoring, noninvasive ambulatory monitoring, and home health monitoring. The first product for neonates is in pilot production and a multi-site pivotal validation study for 510(k) submission to the FDA. Products for adult inpatient and outpatient applications, including home monitoring, are under development.

A video of the technology is available here .

Continuous Predictive Respiratory Monitoring

Richard Hughen, CEO
Ronen Feldman, CTO
Linshom Medical
The device delivers continuous predictive respiratory monitoring to the patient bedside and home.

Linshom (which means to breathe) is first to deliver continuous predictive respiratory monitoring to the patient bedside and home. Compared with current responsive systems used today, this predictive respiratory device eliminates the morbidity, mortality, and cost associated with unrecognized respiratory compromise in healthcare.

The patented, FDA-cleared device provides an operating room quality respiratory profile including respiratory rate (RR), tidal volume (TV), minute ventilation (MV), inspiratory-expiratory ratio (I/E), and apnea detection, which are all delivered continuously and in real time.

Current technology is too large, complex, and expensive for the patient bedside or home. Linshom is the only device, outside of the OR and ICU, capable of practically delivering TV to the patient bedside. TV is the volume of air moved with each breath or the quality of respiration. Respiratory rate alone is inadequate to predict respiratory decline, but RR plus TV can predict respiratory decline events 12–70 minutes prior to an emergency.

The device enters a $1.9 billion (U.S.) market via an IRB-approved study in partnership with Brigham & Women’s Hospital (Harvard) in Q3 2022. Linshom holds issued patents (in 10 countries) with new filings ongoing. Linshom’s CPRM solves the problem of unidentified respiratory depression events (RDE) and can intercept these catastrophic problems before they occur and result in codes, intensive care unit (ICU) transfers, and sometimes death.

The value of continuous respiratory monitoring has been proven and published by Dartmouth demonstrating a 65 percent reduction in rapid response team deployment and a 48 percent reduction in ICU transfers. This resulted in a $58,000 savings per patient not transferred to the ICU and a $1.5 million savings annually in a small, 33 bed, orthopedic surgery (hip, knee) unit. Extrapolated to more (post-surgical) beds, the savings are dramatic. However, this solution is not deployed universally because the equipment is large and expensive, and training is intensive and not practically deployable on a large scale. Linshom has solved this with a small, inexpensive respiratory sensor that can be deployed on a large scale. Wide deployment of an inexpensive sensor to the patient bedside will save lives and reduce morbidity and expense.

Unlike alternative technologies (pulse oximetry and capnography), the Linshom sensor is not compromised by motion, light, or supplemental oxygen administration making it a robust solution for respiratory monitoring during medical evacuation (civilian or military).

There are 48 million operative cases and 28 million ambulatory surgery patient cases in the United States annually. These 76 million patients require anesthesia and most have no postoperative respiratory monitoring post-surgery. This translates to a $1.5 billion potential market where $466 million is served with the company’s first product (FDA cleared) and $1.1 billion is served with the second product. There are 137 million ER visits with 39 million due to injury and 12 million resulting in hospital admission. Respiratory monitoring is appropriate for ~half of this population or a potential market of $1.3 billion where $400 million is served with the first product and $900 million with the second.

A video of the technology is available here .

AI-Supported Robotic Diagnostic Treatment System for Vertigo

M. Haluk Ozkul
Tarik Ozkul
Burhan Ozmen
BSYG Medical, Istanbul, Turkey
An AI-enhanced precision maneuvering system is designed to assist physicians in diagnosing and treating BPPV patients in a single session.

BPPV type vertigo affects 8 percent of the population, and every year 1.6 percent of the population visits an emergency room for BPPV attacks. The misdiagnosis rate of BPPV in the ER is reported as 74—81 percent. Every year, 5.5 million patients visit the ER in the United States, and the cost of BPPV to the healthcare system is $4.4 billion annually. According to statistics, BPPV patients visit the hospital seven times, and getting a cure takes 70 months on average. BPPV is one of the illnesses that reduce quality of life significantly.

BPPV is the only type of vertigo that is cured only by maneuvers. It is caused by loose crystals inside the vestibular (balance) organ. The diagnosis is done by watching involuntary movements of the eye called nystagmus. But the loose crystals can appear in any one of the six vestibular canals, and each canal causes a different type of nystagmus.

Because of these conditions, the nystagmus movements can be quite complicated, and diagnosis can be quite difficult. This is proven by the 74–81 percent misdiagnosis rate reported in ER. The treatment is done by maneuvering the patient in 3D space in such a way that loose crystals are deposited in a harmless location in the vestibular organ.

The Robotic Maneuvering System (RMS) is a precision maneuvering system enhanced by AI, which is designed to assist physicians in diagnosing and treating BPPV patients in a single session. In a recent official clinical trial published on clinicaltrials.gov, the device’s success rate was 94 percent, and the average time of treatment was 20 minutes. Among patients, some visited the hospital 14 times before, and some patients had been suffering for 3.5 years. All patients were all cured in a 20-minute session.

The patented AI system is designed to diagnose multi-canal patients as well as those patients who show no nystagmus at all. These are traditionally the hardest BPPV cases to treat.

BPPV affects all age groups but the elderly are likely to be affected five times more than younger groups. BPPV in the elderly is especially troublesome due to falls and associated fracture risk. Recovery of the elderly from fractures is difficult, and one out of five dies due to complications within one year.

The study proved that training ER physicians for BPPV may reduce costs and expedite recovery. The ultimate aim is to place the RMS with Decision Support in ERs and help ER physicians handle BPPV patients as soon as they visit the ER.

The RMS system is designed to be user friendly. Even elderly patients with fractures in their spine, and overweight patients were very comfortable with the RMS system during treatment.

A video of the technology is available here .

Smart Orthopedic Implant to Enhance Bone Growth

Ben Hertzog, PhD
John Zellmer
Martin Larsson
Erik Zellmer
Rory Murphy, MD
Intelligent Implants, Houston, TX

There is an urgent need for more effective treatments for patients suffering from degenerative disc disease. Specifically in spinal fusion surgeries, incidents of nonunion — when the bones of the spine fail to fuse correctly — are high risk and can severely impact patients’ quality of life.

One of the most expensive and invasive medical procedures, spinal fusion surgery is the only option for a large population of patients suffering from chronic back pain. After many decades of progress, roughly 18 percent of 1.5 million worldwide annual spinal fusion surgeries still fail, leading to devastating complications and immense healthcare waste. A failed fusion impacts the patient, payer, and hospitals through the continued poor quality of life, radiation overexposure, expensive revision surgeries with poor outcomes, and lengthy hospital stays.

The smart implant incorporates a regular orthopedic implant connected to wireless antennae for controlling electrodes that graft fresh bone tissue into the body.

The nonunion rate is at least 18 percent. Despite this significant unmet clinical need, there has been shockingly little transformative innovation in the field of orthopedics, specifically, devices for spinal fusion. Intelligent Implants developed the SmartFuse implant, which is designed to minimize the risk of nonfusions, increase bone volume, and accelerate growth driving better outcomes and quicker recoveries for spinal fusion patients.

Studies have shown conclusively that electrical stimulation techniques can lead to bone cell proliferation. Intelligent Implants has conducted preclinical studies, and results demonstrated that SmartFuse active simulation can increase the quantity and quality of new bone growth.

What sets Intelligent Implants apart from its competitors is that the SmartFuse technology platform combines a therapeutic benefit (i.e., accelerated bone growth and healing) with sensor technology to measure the amount of new bone growth … remotely. The smart implant incorporates a regular orthopedic implant connected to wireless antennae for controlling electrodes that graft fresh bone tissue into the body. The bone graft allows the natural bone to grow into place over time.

Combined with the SmartFuse Cloud (including a physician portal and patient app), the SmartFuse System provides unprecedented control and real-time monitoring of the patient throughout the entire duration of healing. The vision is to ultimately improve outcomes for spinal fusion patients by accelerating bone growth, reducing healing times, improving compliance, and enhancing clinical decision-making with real-time data.

Operating at the intersection of digital medicine and orthopedics, SmartFuse represents the future of medical devices that industry has been talking about for many years now: smart implants that use technology to improve patient outcomes by providing a therapeutic benefit and data to support real-time clinical decision making.

A video of the technology is available here .

The 20th annual “Create the Future” Design Contest for engineers, students, and entrepreneurs worldwide, sponsored by COM-SOL, Inc., and Mouser Electronics, drew nearly 600 innovative product ideas from engineers and students in countries from around the world. The Medical category itself received 61 innovative entries from 17 countries. Analog Devices and Intel were supporting sponsors, and Zeus sponsored the Medical category. The contest, which was established in 2002, recognizes and rewards engineering innovations that benefit humanity, the environment, and the economy.

Winners were selected from the seven categories: Aerospace & Defense, Automotive/Transportation, Consumer Product Design, Electronics/Sensors/IoT, Manufacturing/Robotics/Automation, Medical, and Sustainable Technologies/Future Energy.

In addition to product ideas at the concept or prototype stage, contestants could submit designs for commercial products introduced to the market within the last 12 months.

The grand prize winner receives $25,000, while the first-place winner in each category receives a Hewlett-Packard workstation computer.

This article introduces the Medical Category winner and four Medical Category Honorable Mentions. Congratulations to all who entered. All of the entries can be seen here .

See the rest of this year's winners: