The 14th annual “Create the Future” Design Contest for engineers, students, and entrepreneurs worldwide, sponsored by COMSOL and Mouser Electronics, attracted more than 1,100 innovative product ideas from engineers and students in more than 71 countries. The Medical category itself received 88 outstanding entries from 32 countries. Analog Devices and Intel were supporting sponsors. The contest, which was established in 2002, recognizes and rewards engineering innovations that benefit humanity, the environment, and the economy.

Winners were selected in late September from the seven categories: Medical Products, Consumer Products, Electronics, Machinery/Automation/Robotics, Sustainable Technologies, Automotive/Transportation, and Aerospace & Defense. 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 $20,000, while the first-place winner in each category receives a Hewlett-Packard workstation computer. The top 10 vote recipients also receive prizes. The most popular vote recipient receives a GoPro® camera. The others receive a Sphero® BB-8™ Droid™ or robotic gaming system.

In addition to the winner and honorable mentions listed here, there were winning entries in other categories with medical applications. In the Consumer Products category, the X-Drive Powered Wheelchair Conversion converts conventional wheelchairs into powered ones. In the Machinery/Automation/Robotics category, the 3rd Arm – A Wearable Robotic Limb for Augmenting Human Abilities is a wearable robotic assistive device designed to be used to restore lost functions or add functionality to amputees or to patients diagnosed with brain stroke, multiple sclerosis, or Parkinson’s disease.

This article introduces the Medical Category winner as well as four Medical Category Honorable Mentions. The top prize winners will be honored at an awards reception in New York City this month. Congratulations to all who entered. All of the entries can be seen at http://contest.techbriefs.com/2016/entries/all .

MEDICAL CATEGORY WINNER

Continuous Wearable Blood Pressure Monitor

Fig. 1 – Wearable wristbands continuously measure blood pressure and a smartphone application uploads a report into the patient medical record for clinician review.

Sean Connell, Kyle Miller, Jay Pandit, and Jung-En Wu, Bold Diagnostics, Evanston, IL

High blood pressure affects 1 billion individuals globally and more than 80 million in the United States. Hypertension is the leading risk factor for coronary artery disease, stroke, heart failure, and chronic kidney disease. Nearly 70 percent of all healthcare expenditures ($170 billion) in the United States are spent managing complications resulting from uncontrolled blood pressure. Notably, high blood pressure is a modifiable risk factor that can be managed with adequate monitoring.

Despite the overarching implications, blood pressure monitoring remains limited by poor diagnostic solutions like the traditional blood pressure cuff that provides inaccurate and infrequent measurements confounded by procedural limitations. The only solution to circumventing these limitations is the ambulatory blood pressure monitor. Current ambulatory monitors consist of a blood pressure cuff programmed to inflate every 15 minutes for a 24-hour period to take repetitive discrete measurements. Despite the benefits, ambulatory monitoring remains limited because of logistical constraints, expense, and poor patient compliance as a result of discomfort.

There remains a clinical need for a noninvasive, unobtrusive monitoring system that can acquire accurate blood pressure measurements with greater frequency to properly manage hypertension.

Bold Diagnostics has addressed the unmet need by developing an innovative low-cost diagnostic platform that consists of a set of wearable wristbands that continuously measure blood pressure and a smartphone application that uploads a report into the patient medical record for clinician review (see Figure 1). The solution provides accurate measurements with greater frequency, which enables clinicians to positively impact clinical outcomes with proper blood pressure management.

The wristbands calculate blood pressure based on Bold’s patent pending Differential Pulse Arrival Time (DPAT) technology. DPAT states that the pulse wave generated by the heart contracting arrives at the right before the left arm because of an inherent delay created by the anatomy of the aortic arch. Bold has further discovered that the difference in arrival times is an indicator of blood pressure.

Bold has developed a working prototype and conducted preliminary clinical studies under an approved IRB protocol that demonstrate proof of concept. The clinical study (n=15) demonstrated (i) a consistent difference in pulse arrival times between the right and left hands and (ii) a strong correlation between DPAT and blood pressure (±5 mmHg) in comparison to control measurements. Study results suggest DPAT is a viable method for continuously measuring blood pressure.

The company has developed a strategy focused on direct distribution to tertiary care centers for a price between $155–$195 at cost of goods sold at $25–$40. Following the prescribed monitoring period, the physician will review the report and charge insurance providers for reimbursement with established CPT codes for ambulatory monitoring. Bold anticipates a 510(k) application for market entry by 2018.

The company aims to redefine the way blood pressure is measured with its wearable wristbands to empower clinicians to effectively manage hypertension and improve clinical outcomes.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/6724 .

HONORABLE MENTIONS

Infant Care System — A Therapeutic Wearable for Babies

Fig. 2 – The device wirelessly integrates pulse oximetry with data gathering and a rescue stimulus. The device consists of a glove that houses the sensor and the stimulus circuitry, a pulse oximeter sensor, controlling logic, and low-energy Bluetooth for communication.

Diego Delia, Clinton Allen, and Omar Mohammed, Apnosystems, Buenos Aires, Argentina

The Apnosystems Infant Care System (ICS) device is a life-saving medical intervention that can cause a sleeping infant who has ceased breathing to stir and resume breathing. This wearable device will change the way we care babies, both in the hospital and at home.

Premature, low birthweight babies, postoperative babies, and those with congenital defects are at higher risk. Such infants may suffer critical situations during sleep resulting in temporary brain damage, permanent brain damage, or death. The device can also help to protect babies with diagnosed unstable airway conditions. If an airway obstruction results in low blood oxygen saturation, the device detects the hypoxia and provides an intervention stimulus.

Anesthesiologists agree that when a patient is in trouble, the problem must be addressed in a matter of seconds or minutes. The ICS is a device that acts automatically and within seconds. The ICS helps in three ways: by monitoring, intervening, and gathering new and valuable data. This device, which is a first of its kind, wirelessly integrates pulse oximetry with data gathering and a rescue stimulus. The device consists of a glove that houses the sensor and the stimulus circuitry, a pulse oximeter sensor, controlling logic, and low-energy Bluetooth for communication with smartphones, tablets, and PCs (see Figure 2).

If a baby experiences a dangerously low heart rate or blood oxygen saturation episode, and after the device’s algorithm determines the need, the device provides a brief transcutaneous electrical nervous stimulation (TENS) to rouse the wearer. The algorithm was based on a Collaborative Home Infant Monitoring Evaluation (CHIME) study to reduce false alarms. The rescue stimulus is minimal and cannot cause undue distress. Caregivers can adjust the intensity of the therapeutic stimulus to a lowest effective dose for each individual (high, medium, or low stimulus).

The Apnosystems ICS device may be produced for as little as $25 per unit. The tested technologies utilize low-cost components. As sales volumes increase, efficiencies can further reduce unit production cost. The ICS garment can be made of all natural fibers, making it environmentally friendly. The ICS’s batteries are internal and rechargeable. The device can be recharged from voltage sources that include solar arrays. The ICS can be assembled almost anywhere in the world.

It is the only device that delivers a therapeutic, life-saving intervention using accepted and reliable detection of health parameters. Data are gathered in realtime on infants wearing the ICS through caregivers’ smartphones and other devices. In emerging economies, the device is particularly useful. Premature babies are more common and high-risk babies are more likely to be sent home without a sufficient level of security because of lack of space in the nursing care units.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/634 .

The Cervia System — Automated, Accurate, And Accessible Cervical Cancer Screening

Fig. 3 – The cerVIA integrates a custom camera scope with a unique cervical cancer lesion detection algorithm in a point-of-care device.

Ritish Patnaik, Stephanie Yang, Olachi Oleru, and Jahrane Dale, Luso Labs, Plano, TX USA

The cerVIA system, developed by Luso Labs, integrates a custom camera scope with a unique cervical cancer lesion detection algorithm in a point-of-care device (see Figure 3). Fitted for speculums and operated with any Android smartphone, the cerVIA system offers automated, accurate, and accessible cervical cancer screening for women in “low- and middle-income” countries worldwide.

Cervical cancer continues to devastate millions of families in these countries. Of the 528,000 cases and 266,000 deaths due to cervical cancer in 2012, 90 percent occurred in low- and middle-income countries. The cancer’s prevalence in these countries can be partly attributed to late-stage diagnoses. Clinics in high-income countries use cytology screening of pap smears to find abnormal tissues before they progress into precancerous lesions. However, cytology screening requires laboratories and trained scientists, neither of which is readily found in low- and middle-income countries. As a result, a lack of appropriate screening tools contributes to cervical cancer causing the projected deaths of 447,000 women in these countries in 2030.

Visual inspection with acetic acid (VIA) testing has emerged as the standard for cervical cancer screening in these countries because of its accessibility and affordability. Clinicians perform VIA by applying diluted vinegar to the patient’s cervix and inspecting it for whitened precancerous lesions after a few minutes. Unfortunately, VIA shows poor diagnostic accuracy due to the inherent subjectivity of visualizing precancerous cervical lesions, the inconsistent lighting conditions in clinics, and the inadequate precancerous lesion detection training typically provided.

The cerVIA system solves these clinical issues in a manner that seamlessly integrates into standard VIA procedures. After applying vinegar to the cervix, the clinician inserts the cerVIA device into the speculum and takes an image through the companion Android application. The device contains a custom lighting system that standardizes input images, consistently capturing images with similar brightness, hue, and saturation values. These images feed into an algorithm on an Android application that uses pixel-intensity processing and machine-learning processes to detect precancerous lesions. The algorithm then outputs heat maps to highlight problem areas that clinicians can examine to make more-informed diagnoses, providing a more objective assessment than conventional VIA.

While competitors look to supplant VIA with resource-intensive methods or supplement VIA with expensive mobile colposcopes, the cerVIA system’s potential lies in its simple operation that complements standard VIA testing with objective, accurate analyses at a competitively low price of about $1.10 per patient. In preliminary diagnostic testing, the algorithm increased testing sensitivity and specificity to 91.7 percent and 88.6 percent, respectively, demonstrating an approximate 23 percent improvement over conventional VIA.

Luso Labs is planning a pilot study of the cerVIA system this winter in India where 432 million women are at risk for cervical cancer and 80 percent of cervical cancers are detected at stage 3. After obtaining regulatory approval in India, the company will mass-manufacture cerVIA devices via injection molding and bring the systems to clinics through in-country partners.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/7288 .

Disrupting Severe Sepsis With An Innovative Filter

Fig. 4 – The SeptiFlux hollow fiber hemofilter incorporates an innovative membrane filtration spectrum designed to control destructively amplified inflammation.

Chris Jaynes and Jim Matson, Immunocept Medical Products, Denver, CO

Immunocept Medical Products (IMP) is an early clinical-stage healthcare company committed to saving and dramatically improving the lives of those with acute inflammatory-related disease by providing innovative medical products that significantly improve organ and patient survival.

In U.S. hospitals, more than 1 million patients are admitted annually with sepsis, making it the most expensive disease treated at $20.3 billion. Sepsis causes nearly half of all inpatient deaths for both adults and children and more than half of sepsis survivors are left disabled and chronically ill. These “survivors” do not improve, but they do not die. Instead, they linger on life support in ICUs or special care units. This recently recognized problem is known as chronic critical illness; the sepsis component is estimated to generate $17 billion in additional hospital-related costs. The total cost in the United States of failing to control destructive inflammation exceeds $45 billion annually, including the cost of acute care, repeat hospitalization, and chronic critical illness. These combined costs of treating sepsis patients and survivors represents an enormous burden on the healthcare system.

Inflammation is one of the body’s first and best defenses against injury and/or infection. Quiescent inflammatory cells distributed throughout the body keep quiet vigil for tissue injury or invading germs. When injury or infection occurs, local inflammatory cells rapidly respond, secreting chemical signals (inflammatory mediators) to attract more activated cells to the site; this amplifies the intensity of the inflammatory attack to the scale of the threat. Invading germs and damaged tissues are destroyed and healing is promoted. In most cases, inflammation confines and then eliminates the threat.

However, with severe tissue injury or aggressive infection, local inflammation can be massively amplified. Inflammatory mediators can become so abundant that they spill out of the local site into the bloodstream and circulate throughout the body. These circulating mediators can trigger undesired inflammation, damaging vital organs, degrading their function and causing failure. There are over 100 individual molecules involved in the inflammatory cascade ranging in size from 8 to 100 kDa (kilodalton). Current treatments for sepsis focus on one or two of the prominent molecules, which is like placing a Band-Aid on the problem, temporarily alleviating symptoms, but not reversing the underlying organ damage.

Backed by 11 U.S. patents, the SeptiFlux™ hollow fiber hemofilter incorporates an innovative membrane filtration spectrum designed to control destructively amplified inflammation, which is the root cause of organ failure in both brain-dead organ donors and severe sepsis patients (see Figure 4). The Septiflux is designed to work with all currently existing hospital hemofiltration machines, decreasing the barriers to entry. The company’s strategy is to leverage its unique regulatory and market relationships in the organ donor field to launch this unique product and then use those results to drive development of the severe sepsis market for much less money and time than it would otherwise cost.

For both organ transplant recipients and severe sepsis patients, this means rapid reversal of organ failure, much better survival, much less cost, and much higher quality survivorship.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/6549 .

Contact Lens — Wearable Health Monitor

Fig. 5 – The contact lenses continuously and noninvasively monitor health biomarkers.

Harry Gandhi, Huayi Gao, and Maarij Baig, Medella Health, Kitchener, ON, Canada

Medella Health is a wearable technology start-up based out of Waterloo, Canada. The company is developing contact lenses that continuously and noninvasively monitor health biomarkers and transmit the data to a mobile phone, so patients can better manage their health (see Figure 5). The company is starting with diabetes management, but can expand this technology to many other health indicators, such as heart disease and mental health.

In its two years of operation, the company has grown the team to include a variety of engineers, scientists, and designers, and has built a mid-stage prototype that can detect glucose (and other protein biomarkers) in the eye and transmit the information to an external device. By connecting this system with a mobile device, patients will get push notifications each time their blood glucose goes into the “warning zone” (drops too low or climbs too high). In addition to this, healthcare providers can directly receive data from their patients and with the relevant analytics, better under stand and diagnose the condition.

Diabetes is one of the quickest growing diseases in the world, affecting 371 million patients worldwide. In North America, it costs a diabetic $1,500–$4,500 a year to monitor his or her glucose levels, leading to a staggering $25 billion in spending on diabetes monitoring. Unfortunately, the majority of diabetics struggle with managing their conditions, partly due to the invasive and painful nature of current blood sugar monitoring systems. This ultimately leads to their health declining further and, thus, a greater drain on healthcare budgets.

The contact lenses will introduce innovative and relatively low-cost technology to the market that allows diabetics to live their lives without regular interruptions. To do this, Medella plans to integrate with existing diabetes management apps and communities (such as the Bant app), develop a Medella app, and partner with doctors and optometrists to promote the product to diabetic patients as well as garner a base of key customers through direct sales to drive future referrals.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/6272 .


Medical Design Briefs Magazine

This article first appeared in the November, 2016 issue of Medical Design Briefs Magazine.

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