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www.insightscare.com September 2018

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MOST INNOVATIVE

MEDICAL DEVICES C O M PA N I E S H

2018

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Brianna Wronko CEO

Group K Diagnostics:

Transforming Patient Care with Accurate, Fast, & Affordable Diagnostics


We use more data. More data means better solutions.

www.thinkdatasmart.co m


From the

Editor Artificial Intelligence: Bringing about a Paradigm Shift in Patient Care

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nnovation in technology always comes with a promise of future development possibilities. A new technology today, is old news tomorrow. The healthcare sector is launched exception. Technologies like the Internet of Things, Artificial no Intelligence, or Additive Manufacturing, have had tremendous disruptive effects on how we treat patients. They have also influenced the ways we keep track of our health daily. AI has brought about a paradigm shift in the healthcare sector, powered by the increased availability of medical data & rapid development of analytics techniques. AI can be useful to process various types of healthcare data, structured and unstructured. Main disease areas that use AI tools consist of cancer, cardiology, and neurology. Diagnostic tools, genetics, electro-diagnosis, monitoring, physiology, disability evaluation, mass screening, and others are some of the prominent subsections that can deploy AI effectively. This technology is largely being used in diagnosis, since its early days. “We should think about AI the way we think about patient care- as a continuum, spanning care areas and disease states.”- Dr. Mark Michalski, MD, Executive Director of the Massachusetts General Hospital. AI can use erudite algorithms to ‘learn’ features from an enormous volume of healthcare data, and then use the acquired insights to assist clinical practice. This ability of AI can be further enhanced by equipping it with learning and self-correcting, so as to increase the accuracy of the feedback. An AI based system can assist the physicians; by providing informed medical information from previous literature, and clinical practices, to offer proper patient care. Additionally these systems can help reduce diagnostic and therapeutic errors. All these advantages and assistance is provided in real time, thus providing fast and calculated decisions to the physicians. In spite of AI attracting substantial attention in medical research and healthcare sector, the technology has been facing tangible issues while its implementation. The two major hurdles that AI is currently facing are the regulations that bind the technology, security concerns, and data exchange. The efficacy and safety of AI systems require standards for their assessment, which current regulations lack. AI based systems require a continuous training or upgrading by clinical studies that are published daily, in order for them to work well. However due to the deficit in data supply and sharing, the initially deployed training with historical data is all the systems have to offer. Tackling these issues is a must before the healthcare sector can use and unleash the full potential of Artificial Intelligence in providing state-of-the-art patient care! ane Sayali Sayali Rane


Editor-in-Chief Pooja M. Bansal Managing Editor Ashwini Deshmukh Executive Editors Sayali Rane Shane Gomez Contributors Aishwarya, Datta Visualiser David King Art & Design Director Amol Kamble Associate Designer Rahul Kavanekar Co-designer Priyanka, Shweta

Art & Picture Editor Paul Belin Jayant Khanna

Senior Sales Manager Amy Jones Business Development Manager Mark Williams Sales Executives Kelli Thomas, Bill Thompson, John Smith Technical Head Swapnil Patil Technical Specialist Amar, Vivek, Pratiksha Digital Marketing Manager Marry D’Souza

SME-SMO Executives Prashant Chevale, Uma Dhenge Research Analyst Chidiebere Moses sales@insightscare.com

Circulation Manager Robert, Tanaji SeptemberStella , 2018 Database Management Andrew Corporate Ofces: Insights Success Media Tech Technology Consultant David StokesMedia and Technology Pvt. Ltd. Insights Success LLC 555 Metro Place North, Suite Ofce No. 510, 513, 5th Floor, Rainbow Plaza, Shivar Chowk, 100, Dublin, OH 43017, United States Phone - (614)-602-1754 Email: info@insightscare.com For Subscription: www.insightscare.com

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Revolutionary Medical Devices Transmuting the Healthcare Space

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edical devices play a decisive role in the healthcare industry. To carry out the smallest of tasks in this sector, it is important to employ the right device and technology; from a major surgical operation to primary health monitoring, devices are present for everything.

Medical device companies develop a plethora of products such as wheelchairs, defibrillators, pacemakers, stents, infusion pumps, etc. The medical device industry is highly structured, and companies must continuously invest in research and development in order to preserve a competitive superiority. The future of the global medical device market looks bright with prospects in public and private hospitals. The worldwide medical device arcade is projected to reach an estimated $409.5 billion by 2023. Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.” These 10 are the bellwether medical devices companies, with diverse product ranges, strong performance, and significant revenues. On the cover we have showcased, Group K Diagnostics. The company manufactures a modular, point-of-care, paper microfluidic diagnostic device with a mobile app that reads the device’s outputs, and quantifies results for physicians to make informed diagnoses within 20 minutes of seeing a patient. Flipping through the pages you will find Motiv Inc. that excels in developing simple wearable devices that can make people’s lives better; Misceo, is a pioneer that provides cutting-edge real-time cardiac monitoring and analysis for Hospital and clinics; BioSerenity, it is a fast growing company which combines high tech engineering, innovative technologies, medical development, and big data analytics to provide wearable medical device solutions; Trexo Robotics, this company is a pioneer in delivering wearable robotics for children with disabilities to assist with mobility; Zenflow is developing an office-based, less invasive, long lasting, and easy to learn treatment to relieve the symptoms of BPH. We have also featured Oxitone Medical Ltd., Vascular Dynamics, Beyonics, and Lutech Industries; as some of the leading medical device manufacturing companies. We also bring you an expert’s view on a fiery topic namely ‘AI Is Starting to Change Radiology,’ written by Dr. Enhao Gong, who is the founder of Subtle Medical. Our in house editorial team has also put together interesting articles, on trending topics in the healthcare space. So, flip through the pages of our magazine and treat yourself with the technological innovations trending in the medical device industry!


Cover Stay

Group K Diagnostics: Transforming Pati ent Care with Accurate, Fast, & Afl ordable Diagnosti cs

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Telemedicine TelemedicineThe Fastest Growing Segment of Emerging Services in Healthcare Industry

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Organs-On-Chips Organs-On-Chips: A Potential Drug-testing Alternative Approach

Transforming Radiology

AI is Starting to Change Radiology, for Real

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18 BioSerenity: Technology at the Service of Healthcare

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Trexo Robotics:

Delivering Futuristic & Innovative Pediatric Wearable Robotic Devices

Misceo Grand Technology:

Ushering towards the Next Generation Telemedicine Technology

42 Zenow:

26 Motiv: Providing Subtle, Sleek & Sophisticated Wearable Devices

Driving the Future of BPH Relief with Innovative Solutions


When you deliver superior service, rely on

superior equipment. Ensure a comfortable birth day, every day.

www.gehealthcare.co m


Brianna Wronko CEO

We provide a revoluti onary applicati on of point-of-care diagnosti cs


Group Diagnostics: K Transforming Pati ent Care with Accurate, Fast, & Afl ordable Diagnosti cs


Cover Story

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he clinical decision making process is affected by a of sequential steps; lab testing series being one of the most vital ones. In spite of this, providers are struggling to effectively receive and manage lab test results, with a significant lag between patient appointments and results. During her time in a Philadelphia HIV clinic, Brianna Wronko saw a troubling case involving a pregnant mother diagnosed with HIV. Due to the delay in receiving the patient’s results, the patient remained on her medication, which was detrimental to both her and the fetus. She could not be reached by phone or mail, therefore making a change to her medication impossible until she walked into the clinic several months later. Without the necessary immediate action in response to her test results, the mother and child were left with the possibility of severe physical complications and a high cost of future care. This is an extreme case, but such setbacks can be avoided with immediate testing and results. That is when Wronko started working on a product with a thoughtful perception of the big picture. She focused on the manufacturing, ease of use, marketability, and adoption in the current healthcare infrastructure, and then scaling the big picture down until she developed the current design, and

platform to support those elements. That is when Group K Diagnostics, Inc. was born. Today the company is working seamlessly under Wronko’s guidance. She serves as the CEO of Group K. Group K manufactures a modular, point-of-care, paper microfluidic diagnostic device with a mobile app that reads the device’s outputs, and quantifies results for physicians to make informed diagnoses within 20 minutes of seeing a patient. The Journey of an Idealistic Organization Group K Diagnostics has developed from a research prototype to a reality. The company foresees bringing to market this transformative technology as early as 2019. Upon the opening of a larger wet lab space, separate manufacturing space, expanded administrative offices, and the completion of initial clinical trial testing by year end 2018, the company will begin scaling into the healthcare marketplace. Comprised of a seasoned team of engineers, operators and business executives matched with world class advisors, Group K Diagnostics continues to change the path within the diagnostics industry. The Young & Dynamic Leader Wronko brings seven years of research experience in microfluidics and

Our Multi -Diagnosti c Point-o f-Care test allows providers to take immediate therapeuti c acti on based on results

immunology to design and manufacture Group K’s paper microfluidic devices. Wronko has a BSE in Bioengineering from the University of Pennsylvania. Her experience with FDA and governmental approval processes from her time at Five Eleven Pharma and GSK has been instrumental for streamlining the pre-clinical, clinical, and FDA processes. Now, with a team of research engineers and technicians for device production and development, Wronko focuses on overall technological development and company vision. Discrete Services & Products Group K Diagnostics’ technology has two components, hardware and software: The Hardware Component- the paper microfluidic device is designed to support over 60 tests and counting. The design of the devices’ channels, sample deposition region, and detection regions—as well as the instructions for use—remain constant, while the reagents used in the detection regions change to support different diagnostic tests. This allows healthcare providers to learn one protocol for testing instead of having to remember several different ones. The device also features a QR code to note expiration date, test identity, and lot number; a barcode to associate the test with a patient and transmit results to the electronic health record; and a color panel for the computer vision feature of Group K’s mobile app to reference and normalize color based on ambient lighting. The Software Component- is comprised of several portals targeting various stakeholders in the healthcare system. The mobile app is used to walk the provider through the steps associated with using the device, collect results, inform diagnoses, and record patient data in the Electronic Health System. The flow of the app includes a login page and patient confirmation followed


by image acquisition. A picture of the device’s detection regions is acquired, and through computer vision, image processing, and AI- analysis it produces produce quantified measures that inform diagnoses and are recorded in the EHR. Through the company’s patient app or patient portal login, patients can access their results and transfer them from hospital to hospital. Finally, combining everything together, there is an additional portal available to hospital administrators. Group K Diagnostics’ hospital portal also has epidemic tracking and hospital preparedness applications with anonymized patient data. By analyzing the type of tests being ordered, and the corresponding results, hospital systems can identify epidemics and better prepare with optimized inventory purchasing and staffing. With big data analysis, Group K Diagnostics can track the severity and geographic location of disease and predict where disease will spread. This information can be used to increase hospital’s preparedness for epidemics and general disease.

We ofl er a paper-based diagnosti c tool, to cut down the cost of lab diagnosis

For example, Group K’s Liver Function Test (LFT) results in a measurement for ALT (amongst five other metabolites) in terms of units per liter which is used to evaluate one aspect of liver function. The web app would display anonymized data for providers, for example to see if a Liver Clinic was effectively managing medication switches for liver disease patients. The mobile app has patient and provider portals. With 36% of abnormal results never communicated to patients, the app eliminates this miscommunication and allows the patient to have their full diagnostic test history stored in their app. The

provider portal organizes the diagnostic tests, and immediately transfers the results to the EHR so information is never lost. Group K’s technology can be used in specialty and primary care centers. The clinical use of the company’s technology does not impose any additional training on nurses and physicians, so these personnel can easily adopt its technology into their workflow, while eliminating the existing time they spend at the end of their day calling patients or release results to their patients.


Vision & Mission of Group K Diagnostics Group K Diagnostics offers a clever, simple solution for the slow, inefficient, and costly laboratory testing that sets today’s standard for 77% of all patient diagnoses. Iterating about Microfluidics in the diagnosis laboratory Wronko says, “We admit that applying microfluidics to the laboratory testing problem is not novel. Research labs have designed and implemented prototypes but fail to make cost effective manufacturing processes and complimentary software.” Group K intends to revolutionize diagnostic testing by having solved the age old problem of adapting microfluidics to laboratory diagnostics by a streamlined, patient and physician suitable diagnostic. Capturing Markets with Innovation Having started out in a strong research vertical, Group K Diagnostics is blazing a new path forward, in point of care diagnostic testing. The immediate markets the company is

addressing, include LFTs ($972 million), comprehensive metabolic panels (CMPs, $5.4 billion), and complete blood counts (CBCs, $4.1 billion). The most important facet of Group K’s technology, driving its value, is the time it takes for diagnostic testing. On average, existing laboratory testing results take 10 days to return to a provider, despite 77% of diagnoses are only completed with lab results. This delay loses patients, transforms acute cases to chronic cases, and increases patient costs. Additionally, this testing procedure costs patients $15-100 per test unless they follow strict insurance guidelines. The current standard for diagnostic testing and laboratory testing takes too long, during which patients are lost to follow-up, acute cases, can become chronic, thus increasing patient costs. Relative to the market, Group K Diagnostics is unique in that its product is low cost, requires less than 20 minutes for


results, does not require training or refrigeration, can be completed in o ffice, and supports multiple tests. The company states, “Our biggest competitorAbbot’s iStat- requires training and refrigeration and cannot be completed in office.” Matchless Solution to Point-Of-Care Diagnostic Testing Group K’s technology reduces the time to results from 10 days to 20 minutes for $8-12. The diagnostic test can be completed within a patient appointment, leading to patient retention, patient diagnosis and immediate clinical action, as well as reduced costs for patients. The technology improves patient care by lowering the cost of laboratory diagnostic testing, supporting immediate clinical action, giving patients the rights to their results, and better preparing hospitals to respond to epidemics or clinic wide issues. The cost of the device falls below that for laboratory testing reimbursement today, which makes Group K’s platform more accessible to low resource clinics and patients. The firm’s modular, microfluidic device, and mobile app with computer vision and AI revolutionize diagnostic testing by providing quantified results within minutes. This allows physicians to take immediate clinical action. This technological platform will support over 60 tests in the future with liver function, comprehensive metabolic panels, and complete blood counts as its initial tests. The fast response time of the technology provides results within a single appointment, allowing immediate clinical action to be taken, so that time sensitive and communicable cases are better treated as well as controlled. The distinct patient portal gives patients access to their result records, so all abnormal results are immediately reported, as well as overseen and given by a provider in the moment. Improving hospital preparedness for epidemics allows patient experience to improve, protecting patients against infectious diseases or outbreaks. Another intriguing feature of the product is that it is easy to use and does not require additional training. It also doesn’t require refrigeration, and can be completed in office. This gives patients’ direct access to their results, eliminating any miscommunications that might occur in the case of 36% of abnormal results that currently go unreported. All these elements have led to seamless integration of Group K Diagnostics’ product in to the physician, and nurse workflow. Instigating a Groundbreaking Change in Healthcare The numerous advantages of the product will ease payer demands, and allow the device to be used by physicians in specialty or primary clinics, without access to on-site labs, and needing urgent & frequent results. In addition to increasing accessibility to laboratory testing to low resource regions and patients, Group K’s product will improve time to diagnosis for all users. The need for immediate results and clinical action is crucial for improving treatment and preventing acute cases from becoming chronic. Another key feature of its software is the provider and patient portals. It will allow patients to receive and keep records of their results ensures that abnormal results are communicated and also transferred easily when a patient transfers providers. Group K Diagnostics’ platform prevents this miscommunication, and helps protect patients and providers. Another revolutionary application of the company’s software component is epidemic tracking using anonymized patient data. The medical diagnostics industry continues to change rapidly and with its revolutionary application of


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Company Name

Management

Brief

Scott D. Smith CEO

Beyonics is one of the leading precision parts manufacturers offering complex integrated manufacturing services such as precision metal stamping, innovative mold design and fabrication.

Pierre Frouin Founder & CEO

BioSerenity is a fast growing company which combines high tech engineering, innovative technologies, medical development, and big data analytics to provide wearable medical device solutions.

Brianna Wronko CEO

Group K Diagnostics, manufactures a modular, point-of-care, paper microfluidic diagnostic device with a mobile app that reads the device’s outputs, and quantifies results for physicians to make informed diagnoses within 20 minutes of seeing a patient.

Lutech Industries lutechmedical.com

Leanna Vachula President

Lutech Industries Inc. brings together innovative, cutting- edge technology with cost conscious strategies; by providing affordable, quality medical equipment that will allow providers to care for their patients effectively.

Misceo misceo.io

Mahesh Galgalikar CEO

Misceo Grand Technology is a pioneer that provides cuttingedge real-time cardiac monitoring and analysis for Hospital and clinics for both in-patient monitoring and Ambulatory out- patient monitoring using a single medical device platform.

Motiv mymotiv.com

Tejash Unadkat CEO Curt von Badinski Co-founder & CTO

Motiv is a company that excels in developing simple wearable devices that can make people’s lives better.

Oxitone Medical Ltd oxitone.com

Leon Eisen CEO

The Oxitone watch is the world’s first wrist pulse oximeter without a fingertip probe enabling comfortable patient monitoring of blood oxygen level and pulse rate anytime, anywhere.

Trexo Robotics trexorobotics.com

Manmeet Maggu CEO

Trexo Robotics is a pioneer in delivering wearable robotics for children with disabilities to assist with mobility; it provides state-of-the-art products at an affordable price.

Vascular Dynamics vasculardynamics.com

Ed Roschak CEO

Vascular Dynamics Inc. is pioneering endovascular baroreflex amplification (EVBA) to advance the treatment of hypertension to bring a better quality of life to patients who are resistant to conventional treatments.

Zenflow zenflow.com

Nick Damiano CEO

Zenflow is developing an office-based, less invasive, long lasting, and easy to learn treatment to relieve the symptoms of BPH.

Beyonics beyonics.com

BioSerenity bioserenity.co m

Group K Diagnostics groupkdiagnostics.com


BioSerenity:

Technology at the Service of Healthcare

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Pierre Frouin Founder & CEO

“We combine high-tech engineering, medical development, and analytics, to deliver full stack precision medicine solutions

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he rise in the global population has triggered an increase in healthcare costs and a number of unmet medical needs; technology offers solutions on a number of levels, reducing time, and space limitations. One such company that aids this problem by providing wearable medical device solutions is BioSerenity. Established in January 2014, the company is located within the Brain and Spine Institute, at the heart of the largest university hospital in France: la Pitié-Salpêtrière in Paris, with offices across France, China and the United-States. The company is internationalizing and expanding, with the workforce of more than hundred employees. It offers solutions for many applications in diagnosis, monitoring, and clinical trials. BioSerenity is a fast growing company which combines high tech engineering, medical development, and Artificial Intelligence to solve four key problems by: Ÿ Allowing long term recordings without increasing patient’s burden, while significantly reducing hospitalization costs. Ÿ Reduce diagnosis errors that are due to lack of data or misinterpretation errors. Ÿ Help patients to receive the appropriate treatment as fast as possible. Ÿ Reduce patient cohorts needed for clinical trial by providing more accurate data.

The company first started providing Smart Healthcare Solutions with the focus on Epilepsy and has since expanded to Cardiology, Sleep disorders monitoring, and Urology. BioSerenity’s solutions have helped diagnose over twelve thousand patients and it has recently raised 20 million dollars to support its growth. It tackles these challenges with the help of a rich ecosystem of partners. The company has collaborated with patient groups, academic centers, hospitals, and industry to come up with futuristic medical devices. Spearheading BioSerenity Bioserenity was instituted by Pierre Frouin, who is currently the CEO of the company. He holds a Master’s degree, in IT Engineering and a MBA from INSEAD, which he leverages to lead BioSerenity towards becoming one of the fastest growing medical devices company. Pierre has worked in the medical industry throughout Asia, Europe and North America, for almost his entire career. Pierre’s experience in the pharmaceutical industry and the medical diagnostics industry has helped him understand that point of care diagnostics was going to be critical for the development of personalized medicine. Distinctive Products and Solutions that BioSerenity Offer The Neuronaute is the first solution developed for the diagnosis of epilepsy based on the use of a smart textile, a


mobile application, and a cloud platform. The system is designed to make it possible to record physiological parameters continuously, including electroencephalography (EEG), and in an outpatient setting. The goal is to give neurologists a tool to get to the diagnosis of epilepsy faster by recording patients in their home environment or in any hospital bed on the long term basis. The signals are then parsed by an A.I. assistant to help identify digital biomarkers or anomalies. Its A.I., called Serena, learns from the interpretation of Neurologists (machine learning) how to identify critical elements in the EEG that are linked to a pathology. For each recording, the A.I. analyzes the signals, and helps neurologists focus on important periods of the EEG signals. The aim is primarily to save the physician’s time by not having to review lengthy periods of raw signal.

allows it to focus on what is most needed, instead of what is most trendy; to bring to the medical community the best tools possible that help patients. BioSerenity believes that this approach leads to faster adoption, and a leaner iteration process. It has also setup a strong regulatory team and culture; an expertise that is often missing in tech startups.

improvements. Ÿ Artificial Intelligence is assisting physician in their daily practice.

Profile-1

The company is now working on Cardiology, Urology, Sleep Disorders, and Pregnancy Monitoring. It has developed a Cloud platform that allows it to deploy Medical Device and Mobile Apps powered with A.I. across the globe. The company works closely with doctors and researchers; this

Awards and Accolades BioSerenity has Received With over twelve national and international awards, BioSerenity has received the support of doctors and patients from all around the world. The company is the recipient of the International Innovation Awards, the World Wide Innovation Challenge, Innovact Award, Connectitude Program, and many more. Technology Trends in the Medical Device Industry Currently there are two major technological revolutions undergoing that have the potential to change the landscape of Medical Device industry that include: Ÿ IoT (Internet of Things) is allowing for remote monitoring of devices and much shorter cycles of

IoT is already helping millions of devices being better maintained, while Artificial Intelligence is still in its infancy. Future Perspective of BioSerenity The medical device industry was historically separated and often in the shadow of the pharmaceutical industry. Now that the Medical device industry is in the spot light, the future will generate more cooperation between the two industries. BioSerenity’s next product launch is going to be in Sleep Disorders with an ambulatory polysomnography assessment solution. The Somnonaute is a medical device project aiming to allow a full polysomnography exam in a medical sleep analysis setting. In order to allow a full exam to be recorded, a connected cap, shirt, and pants are required. Recorded measurements include electroencephalogram, electrocardiogram, electromyograms, pulse oximetry, movement, positioning, and breathing.

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Misceo Grand Technology: Ushering towards the Next Generation Telemedicine Technology

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Mahesh Galgalikar

here is a growing demand for a system that can monitor all essential body vitals and activities of the patient usually monitored in ICU and help in Cardiac events prevention, diagnosis, postoperative care and ongoing management of patients through noninvasive monitoring. Silicon Valleybased Misceo Grand Technology is a pioneer that provides cutting-edge realtime cardiac tracking and analysis for Hospital and clinics for both in-patient monitoring and Ambulatory out-patient monitoring using a single medical device platform.

Founder & CEO

Misceo helps Hospitals to extend their services beyond their premises. It provides a connected healthcare solution to decentralize existing healthcare infrastructure and coordinate patient care services between clinics at remote locations and hospitals.

“We provide connected healthcare solution to decentralize existing healthcare infrastructure

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Misceo/The company first came into existence as a software analytics company for the diagnosis of congenital heart defects using acoustic analysis of heart but soon jumped into Healthcare IoT industry and started building its H/W product line for a tele-ICU market. Misceo is working to close the gap between inpatient and outpatient monitoring by developing a seamless medical device platform that could scale from hospitals to homes. The company intends to disrupt the home healthcare market and optimize

healthcare delivery with the help of its medical device solution and advance cloud analytics expertise. About the Leading Light and His Sight The company was incepted in 2013 by its visionary Founder and dynamic CEO, Mahesh Galgalikar. He holds a Master’s degree in Electrical and Electronics Engineering from Rochester Institute of Technology, NY and has more than eight years of vital experience in medical technology development. He is the pillar of strength for Misceo and the principal inventor behind its flagship technology. According to the CEO, today, everyone wants to reap quick benefits without understanding the harsh reality that this industry is one of the slowest moving sectors regarding product market adoption and especially in regulatory requirements. “Medical community is very rigid when it comes to adoption of new technologies. Due to rigorous standards laid down by FDA, it’s always a lengthy process to get the product ready for market,” asserts Mahesh. “Our focus is very straightforward and clear, build a product which is centered on the end users need and deliver the best quality possible in the least amount of time.” Significant Facets of its Product Company’s flagship product is a portable one that provides accessible and insightful details related to a heart


ailment in a technologically superior manner that too at low cost and in simple & accurate terms. Apart from this, their product is unique in much sense. It offers: Continuous Monitoring: Misceo Access is the only continuous longterm multi-sensor ambulatory monitor to be in the market EHR Integration: Misceo Unity infrastructure will seamlessly integrate with hospitals EHR systems to deliver hassle free solution Error-proof: The ergonomic design of Misceo Access eliminates common errors due to ECG patch misplacement Reusable: Misceo Access can be used time and again (Electrode patches are the only disposable element) Efficient Procedures: Monitoring device moves with the user, so transitions from one procedure or location to the next are seamless in Hospitals Multi-parametric Status Monitoring: Provides Continuous 6 Lead ECG, PPG, O2 Sat, Body Temperature & Activity Virtual Oversight: AI lead oversight for continuous patient monitoring reduces the burden on physicians,

cardiologists, and technicians in Hospital and thus assists in analyzing patient data and alert generation The Scenario of Medical Device Industry Hospital readmission is a primary concern these days. If hospitals don’t reduce preventable 30-day readmissions, they stand to lose a substantial amount of revenue as per Hospital readmission reduction program administered by CMS in 2012. An effective telemedicine service is the solution to this problem. Although, there are many MCT devices available, but none assist the hospitals in a way that can reduce financial losses. Thus there is a dire need for a system that would scale effectively from inpatient monitoring scenarios to outpatient monitoring and provide more clinical grade information to help cardiologist come up with a diagnostic solution rather than just alert creation. High cumulative consumer costs (due to non-reusability), dependence on the device company for raw data retrieval, the company technician’s accurate collection and reporting of raw data, and generation of a summary report are some of the numerous disadvantages which current medical devices possess.

To alter this scenario, Misceo developed its wireless solutions that continuously monitor multiple body vitals and therefore provide arrhythmia burden, but can also wirelessly send critical arrhythmic events in real time for timely diagnosis and treatment. Future Outlook There was a time when the medical device industry was more focused on curative measures and understanding the progression of a disease. Today, it is moving towards preventive healthcare as more and more emphasis is given on disease prevention. Soon, technology like AI will assist scientists to unlock many mysteries towards the cause of disease prevention. “We feel with the technology in development at Misceo, we would be able to have a better understanding of human cardiac conditioning and progression of various symptoms in various cardiac and COPD conditions which would help us prevent significant medical conditions,” concludes the CEO. “Company intends to scale the solution for simply hospital scenario to a full-fledged home healthcare solution for chronic patient management by 2019.”

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Telemedicin e The Fastest Growing Segment of Emerging Services in Healthcare Industry

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lthough initially considered by some of the critics as ‘far away in future’ and ‘still in experimental stages’, telemedicine is a living and thriving reality today. India, with masses of talented people, is a nation of underdeveloped physical infrastructure. Telemedicine provides a potential opportunity to leapfrog steep challenges faced by such existing inadequacies in physical infrastructure for healthcare services. Telemedicine is a system where doctors and patients can share information in real time from faraway locations one computer system to another. They can have patient’s check-up through medical devices and can also capture the readings for diagnosis. Telemedicine is widely applicable in patient care, public health, and administration, hospitals and education. System and Network Set-up Telemedicine technology comprises software and peripheral components such as web camera and dish antenna to receive the signals or a broadband connection. There is an interface created between hardware, software and communication channels with satellites or internet to ultimately bridge two people in different locations. Utilities for Patients Patients and doctors can interact via the webcam-based interface, and communicate for diagnosis and treatment. When patients need to consult with their primary care physicians, they can submit the request in the system. The physicians placed at a remote location are immediately notified and can respond by activating an audio-visual interface. Even if the concerned physician is not available the request is transferred to other doctors in the national network. Unlike in general hospitals where they may have to wait for an appointment, telemedicine provides instant access to doctors. The service can be made available to patients with

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medical consultation off hours. Especially with the critical necessity of specialist doctors who may not be available locally. They can help monitor the rare and chronic conditions of the patient. Telehealth for Common Man The terms telemedicine and telehealth are many times used as synonyms. But some of the experts are of opinion that telemedicine is the physician focused term and tele-health is used to refer all health professionals. Hospitals or healthcare organizations involved in implementing telehealth or telemedicine will be able to distinguish between the two as technology becomes advanced and popular for the common man. Benefits of Telemedicine The biggest benefit is the availability of expert specialist to all patients in remote locations if the need arises. Patients can avoid the cost of transportation or avoid wasting time in traffic with video consultations from the comforts of his home. Individuals engaged by their work can also schedule a consultation during a break or even after work hours and will not miss any day of work for the sake of minor health problems. As specialists are rare and short in supply, patients like children or elderly people can use telemedicine solutions without the struggle for their specific health concerns. Recent Trends for Adopting New Technology Patient self-monitoring was a big trend recently for using the medical records and health-related data with modern devices and smartphones available. For example, small digital devices are available today which can track patient ECG’s and send the report to doctors, providing an invaluable tool for healthcare professionals to monitor cardiovascular activity. Hospitals and insurance companies are using emerging cloud technology to store electronic medical records. These are accessible to patients also who can see their test results and medical reports online. One of the main reasons why it has enjoyed success is because of increased customer satisfaction numbers. Telemedicine and related mobile applications are much more efficient in data collection and making research much more reliable with the well-documented database. Implementing a Telemedicine Project Telemedicine program should be that helps in identifying the specific needs of a community. These needs can be susceptibility to certain ailments or nutritional deficiencies as a result of cultural or social bias. Geographical variations also communities may have a large number of citizens who need diabetes or nutrition related counseling. Training of Staff for Patients’ Acceptance Well-trained professionals, related to both technical aspects and health care emergencies, must be available with adequate knowledge, experience, and job-related skills. The team implementing telemedicine project should ensure that the standard procedure is followed while using the equipment. Patient’s acceptance is an important parameter where patients can feel comfortable using the facilities and that can save time for other social activities. In addition to connecting patients with a primary care physician, telemedicine can facilitate access to specialists and super-specialists and also to the team of experts in particular kind of disease. Telemedicine saves time and money by avoiding travel for both doctors and patients. It also allows patients to remain in their communities, which means they will fill prescriptions, purchase healthcare accessories etc. Emerging Frontiers in Telemedicine Telemedicine technology is emerging as one of the fastest growing segments in the healthcare industry. Many organizations are taking it as a preferred destination to park their money and investment is increasing steadily. The global telemedicine market has shown the growth by around 18% CAGR. Readily accessible care, reduced healthcare costs, productive workforce, and enhanced patient experience are some of the main reasons why telemedicine is becoming popular. A shifting economic background, developments within the healthcare industry, responsive and conducive legislative environment have already created fertile ground for telemedicine to grow. Smartphones and internet-capable mobile devices may be the driving factor behind the success of telemedicine. The gadgets and the growing popularity of artificial intelligence and the internet of things are taking the possibilities to new heights. Out of healthcare delivery methods intended to play a greater role in healthcare, telemedicine is the most promising one.

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Motiv:

Providing Subtle, Sleek & Sophisticated Wearable Devices

F

orm factor, durability, stylish design and the integration of leading-edge technology for precise data collection are some of the factors that define a superior wearable product. One company that considers these factors with precision and craft products that people want to wear is Motiv Inc.

Tejash Unadkat CEO

Curt von Badinski C o - fo u n d e r & C T O

“We provide subtle, sleek, and sophisticated wearable devices that are comfortable and people want to wear

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Motiv Inc. is a breakthrough wearable technology company designing products that fit seamlessly into people’s lives. Motiv Ring was announced in January 2017 at the Consumer Electronics Show and officially began shipping in September. Its debut garnered a terrific response and glowing reviews from a multitude of prominent media outlets. It has a user-centric design which is both comfortable and state-of the-art. Motiv Ring is not currently a medical device; however, the company considers this form a stepping stone to evolve as a true medical device company in the future. An Innovative, Accomplished, & Design Driven Company Motiv began when Co-founder and CTO Curt von Badinski had a lightbulb moment that convinced him to use his tech expertise for a small and lightweight fitness tracker that could make people’s lives better. Curt is a serial tinkerer, inventor, entrepreneur

and businessman. As a mechanical engineer, he worked on various projects and quite a few IT companies; it was during that time that he realized that his work-obsessed and sleepdeprived lifestyle was less than ideal. He wanted to get a device that could allow him to track his sleep and health better, he tried what was on the market and those options didn't work for him, and he was inspired to make a seamless experience for people in a ring form factor. “Innovation in wearables doesn’t happen overnight. Change is typically the result of a lot of research and development followed by difficult engineering challenges. Building an amazing and capable team is one of the best ways to get there,” says von Badinski. Progressive, Passionate, & Experienced Leader of Motiv Tejash Unadkat is the CEO of Motiv; he joined the company in 2017. He oversees all elements of the business including sales expansion, product development, people management, and company growth. Under his leadership, Motiv has expanded its operating system support (now on both Android and iOS), retail distribution channels (including Amazon and Best Buy), platform compatibility (Alexa, Apple Health and Google Fit), and a slew of health partnerships (including Pear Sports, Plus 3 and Lindora.) Tejash


believes in building products that are useful to the people twenty-four hours of the day, seven days a week — across the health, wellness, access, security, and payments spectrum. Idiosyncratic Features of Motiv Ring Motiv Ring is the first medical device that blends in; this smart ring tracks heart rate, activity, and sleep. Motiv Ring is waterproof up to 165 feet. At less than 0.1 inches thick, it is about as thin as a nickel and weighs less than a penny. The titanium-shelled ring holds a charge for three days, and connects to the Motiv App available on both iOS and Android. It is about one tenth the size of its competitors, which makes it a people’s choice. While the wearable space is a crowded one, Motiv’s two biggest differentiators are the form factor and sensor data. The company has spent a substantial amount of time and effort on the development of its form factor while working their way down to the technology. Its considerably small size makes Motiv Ring an engineering marvel. Motiv has developed a product with components that are smaller than

a grain of sand. Motiv Ring is entirely custom made, right from the sensors, circuit boards, and battery. Motiv has taken the technology of a wrist-worn device and miniaturized it into a 2.4mm-thick ring. Finding the components — batteries, sensors, titanium shells that could accommodate its small size — was a challenge. Despite the challenges the form factor posed, it is hugely resonant with Motiv's customers who appreciate that the minimal, not clunky look, and that their wrists are free once again for watches, bracelets, or nothing at all.

Additionally, Motiv Ring uses a benchmark of active minutes, rather than steps, to measure heart health. These active minutes are tracked any time one is active for more than 10 minutes. Thus, “cheater” steps - those back and forth to the fridge or to the couch - are not rewarded as activity. This benchmark keeps its users honest and their hearts healthy. Apart from this the ring is always with the user durable, stylish, comfortable, and lightweight; it’s motivation wrapped around one’s finger.

The Benefits of a Finger-Worn Device

Motiv is continuing to expand its functionalities, partnerships, distributions, and integrations on a monthly basis. This continued momentum is important for the company’s growth. Motiv just announced its Google Fit integration in July, and will be announcing a series of healthcare partnerships with leading health tech companies in the coming months. Later this fall, the company will be introducing another version of its beloved ring and will enter into the biometrics space.

As far as sensor data is concerned, Motiv Ring has advantages over wristbased devices. Tattoos or even arm hair can affect the quality of heart rate data while wearing a wristband. These problems are far less common on the finger and palms, which also helps with heart rate data collection. The company’s ring fitting process, with seven unique sizes, allows users to get the right fit. A proper fit is imperative for collecting the best data.

Motiv Inc.’s Future Perspective

/ September 2018 /

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Organs-OnChips

A Potential Drug-testing Alternative Approach

N

ew drugs, medications and therapies are discovered every day. Pharmaceutical companies spend enormous amounts of funds and time on the research and development of novel drug targets strategies. In spite of all the effort not all the medications and therapies make it to the market. There is a dire need of a solution to accelerate drug research. For quite some time now cell cultures in petri dishes have been used to test the efficacy of new therapy, but this method does not give us a full proof knowledge of the working of the therapy. Cell cultures in-vitro do not react to drugs in a way similar to how they would retort inside the human body. Moreover, animal testing is a time-consuming, expensive, and is not satisfactory enough to prove the efficiency of a treatment on humans. Numerous drugs and therapies pass the animal tests, but end up being proved detrimental to humans; because traditional animal models often do not precisely mimic human pathophysiology. More than $2 billion are spent on a single compound being clinically tested. Meanwhile, countless animal lives are also lost. For these reasons, there is an exigent need for alternative ways to fast-track the development of new drugs and improve personalized medicine. To address this pressing issue scientist have come up with a new technology “organs on chip.” These are Cell cultures, often in 3D, that use microfluidics to mimic the way a tissue or part of an

30 / September 2018 /


organ work. From breathing lungs to beating hearts, organs-on-chips are some of fieriest novel tools for human biology research. Although these devices may bear closer semblance to computer constituents than human body parts, scientists have now produced working models for a whole assortment of organs, including the lung, the liver, and even the female reproductive system. Scientists hope to use these devices to model disease and ease drug development. Organ on chip research has already permitted us to create numerous microfluidic chips that can partly mimic organ function. Multi-organs on chip might also allow us to observe the side effects of drugs on different organs, and not keep the study restricted to those organs that the treatment targets. The goal is to be able to link a maximum of parts in order to, allow one and all to have access to customized treatments by using their one’s own cells to test them, which is termed as personalized medicine. Functioning of Organ-on-Chip It is improved computer microchip manufacturing method to engineer microfluidic culture devices that reiterate the microarchitecture and functions of living human organs. These micro devices, propose a prospective substitute to traditional animal testing. Each organ chip constitutes a clear flexible polymer approximately the size of a computer memory stick that encloses hollow microfluidic channels lined by living human organ specific cells. These cells are interfaced with a human endothelial cells lined on an artificial vasculature; mechanical forces can be applied to this set up to mimic the physical microenvironment of living organs, which includes the peristalsis-like deformations in the intestine and breathing motions in lung. They are fundamentally three-dimensional, living crosssections of chief functional components of complete living organs. The translucent nature of the device, allows scientists to view the inner working of the human cells without invading the living body. With their capability to host and combine the diverse cells and tissues, organ chips present an idyllic microenvironment to study molecular and cellular activities that bring about human organ function and imitate human specific disease conditions, as well as pinpoint new therapeutic targets in vitro. This device, intended to mimic whole-body physiology, controls fluid flow and cell viability while simultaneously permitting real- time observation of the cultured tissues and facilitates analysis of the intricate connected biochemical and physiological responses across ten different organs. This complete “Human Body-on-Chips” method can be used to predict human pharmacokinetic and pharmacodynamics reactions of drugs in vitro. / September

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Heart on Chip Lungs on Chips Today the primary goal of the healthcare space is the development of novel solutions to treat pulmonary diseases. Studies have shown that lung diseases are the fifth largest cause of death, and are predicted to be the third by 2020, all around the world. To address this issue it is important to develop strategies and drugs that can be made available to the public quickly. In this circumstance, using lungs on chips to facilitate the development of new treatments has shown a potential way ahead. The device mimics a living, breathing human lung on a microchip. The device, about the size of a toffee, acts much like a lung in a human body. It is made using human lung cells and blood vessel cells. At present scientist are still unable to mimic the exact entire lung on a microfluidic chip. Nonetheless, researchers have succeeded to replicate the function of an alveolo-capillary membrane that is the tiniest functional unit in the lung. This organ is the most vital part when it comes to testing of new medicines, as it constitutes the vital physical barrier between the body and the exterior world. This device has the potential to become a valuable tool for testing, absorption of aerosolized therapeutics, effects of environmental toxins, and the safety and efficacy of new drugs.

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Speaking of serious health problems, heart disease certainly tops the list. The number of deaths due to heart failure is escalating day by day. Hearts-on-chips were developed, specifically because of the substantial differences between animal and human heart cells. Using this technology scientists aim to study heart diseases and cardio-toxicity of chemical treatments. In comparison with regular cell culture, microfluidic chips allow collecting more relevant data. The chip comprises of several wells, each with separate tissues and integrated sensors, permitting experts to study various engineered cardiac tissues at once. The chips have the potential to become the best tool to study new treatments against heart disease.


Organs-On-Chips

Gut on Chip

Brain on Chip Brain on chip research has helped to replicate a small part of the brain, ‘the blood-brain barrier’, on chip. This barrier has a crucial function: of protecting the brain from all the pathogens in the blood and only lets through the nutrients the brain needs. On the other hand, this barrier can be problematic for some drug treatments, because it bars selected active sites from accessing the brain such as the medication against Parkinson’s disease. These microfluidic chips permit experts to test the flow of a physiological fluid on the epithelium; this mimics the blood flow and allows the brain cells proper differentiation and maturation. In spite of the fact that research in the field of blood-brain barrier microfluidic chips is only starting out, several models already exist.

Another organ here is the gut on a chip. The gut is a crucial organ when it comes to absorption of medicine, and this breakthrough technology would help us comprehend these issues better; and fast forward research. Scientists have developed a two-layer gut on chip system, similar to the lung on chip discussed above. This technology, much like the lung on chip, has proved to be very important, since it has permitted to re-create the mechanical tension, simulating peristaltic movement. During a particular study using this technology, the researcher used stem cells from a patient, who was suffering from digestive disorders, and developed with a gut on chip tool. Using this, experts were able to study the responses of the certain types of food and new treatments. This illustration comes to show what personalized medicine could look like, using organs on chips.

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Organs-On-Chips

Multi-Organs on Chips In the near future if developing organs on chips proved useful for testing certain treatments, in order to absolutely replace animal testing or to simplify personalized medicine, it is essential to link these organs together. While developing a new treatment strategy or drug it is vital to check the eect of these on the entire body as a whole. This is where multi-organ on chips can help out. Most multi-organs methods have also permitted scientists to study absorption and metabolism. Multi-organs on chips have allowed experts to carryout tests on previously existing medicine, meanwhile also allowing the progress of anti-cancer research.

Promising Applications of the Technology Organs on chips can prove to be cheap and widely reproducible could be decisive. They could permit testing at a very low cost, minus years of waiting periods. They will also cut down on the present ethical concerns, which come with animal testing. This technology will provide increased access to personalized medicine. Organ on chips will help ďŹ ght the battle against cancer. Creating tumors on chips, would allow us to directly test the treatments on tumors. It will also allow us to determine the side eects of certain treatments in advance. However, many challenges need to be addressed in order to completely replace animal testing in the development of new medicine.

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Trexo Robotics:

Delivering Futuristic & Innovative Pediatric Wearable Robotic Devices

O

ver the years, various solutions have come up to aid the differentially abled; few were focused specifically for but children with disabilities. Today, children with mobility impairments spend a lot of time sitting, which has been shown to lead to negative health outcomes in the long-term. Without the ability to walk, many children have a hard time getting adequate exercise and staying active. M a n me e t Ma ggu CEO & Co-founder

Rahul Udasi C T O & Co-Founder

“We want to reach the point when every family that has a child with a disability, will have access to and use the Trexo device, giving children more options and independence

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The story of Trexo Robotics began in 2011 when its CEO Manmeet learned that his nephew Praneit had cerebral palsy and would not be able to walk. With a desire to help his nephew, Manmeet and his friend Rahul, CTO, decided to take the matters into their own hands. They both studied robotics at the University of Waterloo, so building a robot to help Praneit made a lot of sense. Thus Trexo Robotics was born in 2016. Trexo Robotics designs and builds pediatric wearable robotic devices to help children with mobility impairments experience walking. Its’ product, Trexo Plus, is the only fully mobile robotic gait training platform that is commercially available for children. Trexo’s vision is to make this technology available for home use so that every child is able to walk regularly. Through this vision, they are

looking to redefine mobility solutions for people of all ages and abilities, by building affordable and effective products that empower individuals to move and live a healthy life. Fundamentally, the company is driven by the belief that people should have access to empowering technologies. The Accomplished & Innovative Leaders of Trexo Trexo Robotics was founded in 2016, by Manmeet Maggu (CEO) and Rahul Udasi (CTO) as partners. They began experimenting with various robotics designs until the revolutionary Trexo device came to life. Today, the Trexo Plus is being prototyped and is set to be piloted in an upcoming trial with the Cincinnati Children's Hospital. Praneit’s story has shaped the company’s values and mission to strongly focus on the children’s experience and to learn from its end users, including children, parents, and physiotherapists in order to build enjoyable and affordable products. Feather in the Cap of Trexo Together, the Trexo team has experience bringing over 200 products to market, taking these products from ideas to mass production. These and the founder’s experiences have rooted Trexo’s culture in continuous innovation. Manmeet strongly believes that robotics has the potential for the


betterment of society. Rahul, on the other hand, is an enthusiast of innovative robotics and is driven by his curiosity.

machine learning to improve the gait training of each child as progress is made, ensuring that the child continues to benefit from the use of the device.

Technologically, the company is at the frontier of robotic design. The Trexo team frequently tests its prototypes with various children who could benefit from this technology and learns from their experiences. Recently, following its participation in the Canadian Technology Accelerator Boston program, Trexo Robotics, won a MIT Enterprise Forum Startup Spotlight Award for their life-changing innovation.

The designs are made with a child’s comfort and needs in mind, and children with various conditions are frequently invited to Trexo’s office to try out the device and provide valuable feedback. Ultimately, Trexo’s goal is to create a device that physical therapists trust, parents can afford and children love. There are currently no such devices available that can be used at home by children. This device may be used by children with conditions including cerebral palsy, muscular dystrophy, traumatic brain injury, spina bifida, spinal cord injury and other conditions which lead to mobility impairments.

Trexo Plus: Strengthening the Differentially Abled Trexo Plus is the only fully mobile robotic device designed specifically for children to walk independently. Its unique design allows it to convert a passive walker into a fully powered robotic device that can be used anywhere. While starting as a physical therapy device, Trexo’s goal is to make this device accessible to children and their families at home so that they can experience walking outside of a clinic.

They strongly believe that leveraging novel technologies can have a strong impact on the care of people with disabilities, as well as healthcare overall. For instance, 3D-printing has also allowed Trexo to test parts and identify potential sources of issues quickly, ensuring that when its device hits the market, it is of high quality. This type of rapid testing has also been essential in keeping the company sustainable and moving quickly. In the future, Trexo is considering integrating

Positive changes are happening, and care providers are appreciating the value of innovative technologies to improve the quality-of-life of their patients. At the end of July 2018, Trexo will be placing its first unit for clinical testing at the Cincinnati Children’s Hospital. Additionally, it plans on deploying four more units before the end of 2018 for further evaluation. Trexo is currently preparing for FDA submission as well.

Present & Future of Trexo & Medical Devices The sad truth is that there isn’t much innovation happening in the accessibility and mobility space. This market is still frequently overlooked because there are significant barriers to entry. Trexo hopes that by showing people that with the usage of advanced technologies like robotics, one can help people in improving their lives and create a profitable business.

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A I

is to Change Starting Radiology, for Real

T

Dr. Enhao Gong Subtle Medical

About the author: Dr. Enhao Gong is the founder of Subtle Medical. Dr. Gong graduated with a Ph.D. in Electrical Engineering from Stanford University in 2018, with research focus on applying Deep Learning to improve medical imaging reconstruction, analysis, and quantification. He has been awarded Forbes China 30-under-30 in 2018, and serves in the committee of Machine Learning Workshop of ISMRM. Subtle Medical Inc., is an AI+Radiology startup founded by Dr. Enhao Gong and Professor Greg Zaharchuk from Stanford University, it is the Winner of 2018 NVIDIA Inception Award and Minnie Semi-finalist of Best Radiology Vendor.

38 / September 2018 /

he AI transformation is remarkable for its speed. For example in conference such as RSNA (Radiology Society in North America) and ISMRM (International Society of Magnetic Resonance in Medicine), AI applications was still a niche area before 2016, but is the top-1 hottest topic right now. We have passed beyond the point that people doubted the applicability and potentials of AI in radiology. Machine Learning and Deep Learning algorithms have demonstrated good performance that can supplement and verify the imaging tasks for radiologists. Although still in early stage, variable AI algorithms have already started to be test in clinical environment. This year 2018 is also a landmark year for AI in radiology, since several AI+radiology products have received FDA’s nodding that they can practice in clinics for segmenting heart from MRI, make classification from CT, evaluate lung nodules, etc. Beyond Classification - AI Improves Entire Radiology Workflow Particularly, when talking about AI for radiology, most people think of an AI algorithm that can eventually “replace” radiologists and conduct diagnosis. When people talk about the possibility of “replacing” radiologist, it is important to recognize the complexity of radiology. Radiologists are imaging experts with more than 10+ years of medical training, who render diagnosis and clinical decision suggestion from interpreting medical images and correlating their findings from images with other exams and


Transforming Radiology

tests. Currently, most AI algorithms are often designed for simplified ImageNet-ish image classification tasks, to separate images from different categories such as with or without abnormality. It is clear that there are still huge gaps between predicting a classification label, which is well studied and achieved by AI algorithms, and rendering final diagnosis, which is much more complicated and requires both images and non-image information. Beyond image classification, however, AI actually has great potentials to improve entire imaging/radiology workflow. AI algorithms and products can supplement existing radiology solutions, with more e fficient and accurate imaging acquisition, reconstruction, analysis, detection, diagnosis, and prognosis, which goes way beyond predicting labels of normal and abnormal tissues. Several research works, including the works we have done at Stanford; recently demonstrate that Deep Learning can replace conventional iterative algorithms for more accurate medical imaging reconstruction from 10x faster MRI scan or even 200x lower-dose PET scans. In addition, a lot clinical research works in neuroradiology; showed AI algorithms can not only categorize current disease, but also predict how the disease will progress in the future. From faster exams to accurate prognosis prediction, the entire radiology workflow can be improved using AI. Different from other AI+radiology companies and startups focus on automating radiology diagnosis using AI, we at Subtle Medical chose a different route to integrate AI into clinical radiology. We provide hospitals and imaging centers software infrastructure for AI-empowered imaging workflow enabling at least 4x faster and safer MRI and PET exams. We believe these AI tools will help hospitals and imaging centers to improve their productivity, quality of the service and patient satisfaction. No Workflow Disruption from Disruptive AI Technology It is no doubt that AI is a disruptive technology that will reform the radiology practice and workflow. However, the innovation in radiology practice, as well as in healthcare in general, should never disrupt clinicians’ operation. There is a saying that if the change of workflow requires radiologists to move from their chairs, it is not going to works. AI is supposed to free clinicians from repetitive tasks, not to add more tasks to them. Therefore it is fundamental for an AI product to seamlessly integrate into the entire workflow. For example, at Subtle Medical, all the products are designed in a way to (semi-) automatically function between scanners and PACS, staying almost silent and invisible to technicians and radiologists. In general, we believe the best radiology tool should simplify, accelerate, and prioritize tasks for radiologists, making exams more accurate, efficient and personalized, and improve the productivity and satisfaction for both patients and clinicians. AI products have potentials to achieve all of these requirements. Super-human Capability of AI Several research works show state-of-the-art AI algorithms, such as Deep Learning, have great potentials in tasks human professionals are not good at as well. For example, in identifying diagnosis disease subtypes, similar to finegrained image classification of identifying two similar dog breeds in ImageNet challenge, AI algorithms can do better than human and resolve inter-reader variability. In addition, for all the repetitive and quantitative measurements in radiology, such as contouring, segmentations, measuring brain thickness, and recording tumor size changes, AI algorithm can not only free clinician from these time-consuming mundane tasks but also get more accurate results. In addition, quantitative biomarkers and quantitative parameter mapping is a new trend in medical imaging as it offers better objective criteria for clinical decision, where Deep Learning is shown to improve for MRI. Last but not least, new algorithms lead ways to correlate radiology with large scale genetic datasets, which is too complicated that human can never be good at but AI. All of these new advances from AI can contribute to personalized and precision medicine in future radiology.

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Still a Long Way to Go Although AI in radiology has achieved a lot progresses, there are still a long way to go until it is routinely used in clinics. In 2016, Dr. Geoffrey Hilton mentioned “it is quite obvious that we should stop training radiologists”. Later, several AI papers published on achieving “expert-level performance” in diagnosis add-up the concerns that radiologists should be worried about losing jobs. However nowadays we know there are definitely some hypes in “replacing” radiologists. As the developers of radiology AI, we also understand and appreciate more that radiologists are doing much more than image categorizing. Most AI/Computer-Assisted-Diagnosis products are still in their early stage for a closed-set of a few disease categories. AI, for a foreseeable future, will not be generalized. No human is better than a small calculator for accurate arithmetic, but that is all that the calculator can do. Given the long-tail e ffects and the lack of datasets for rare disease, it is unlikely AI can do everything for radiologists. But, as put by Dr. Langlotz from Stanford, “radiologists who use AI will replace radiologists who don’t.” AI in radiology, probably similar to AI in other popular areas such as manufacturing and autonomous driving, will keep improve its capability to change the entire industry. As quoted in a recent Forbes article on robotics: AI will replace tasks, not jobs.

40 / September 2018 /


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Zenflow:

Driving the Future of B P H Relief with Innovative Solutions

P

Nick Damiano Co-founder & CEO

“We aim to improve patient care by providing a uniquely safe and effective treatment for men with B P H symptoms

42 / September 2018 /

roblem-solving has long been at the center of entrepreneurship. The right solutions bring in the right idea and the right idea executed with the right set of skills, creates wonders. Today, the speed at which the technology has been developing is ineffable; and with it there have been continuous innovations in various sectors of countless industries. The healthcare industry isn’t aloof of this pattern. Yet the healthcare sphere, even after the digital revolution, has not seen the amount of development that it should have. There is a lot of scope to improve the health and subsequently the lives of people. All it takes is the will and expertise to do so. Zenflow is a company started out of the Stanford Bio design Fellowship in 2014 after witnessing the distress of many men who were frustrated with their symptoms of BPH (enlarged prostate), and unhappy with the treatments available. Zenflow is developing an office-based treatment to relieve the symptoms of BPH. It aims to develop a less invasive therapy with long-lasting effectiveness that can be delivered in the doctor’s office with minimal patient discomfort. While its clinical trials are still in progress, the results so far look very promising.

Conquering Challenges since the Very Start After establishing Zenflow in 2014, the main challenges were to build a device that could solve the identified need, to prove that the device worked, and to secure funding for the company. The founding team of Zenflow addressed that the funding had to come first, before the other challenges. Being resourceful, they pursued all available options, including investor funding, grants, and business plan competitions. One of the biggest early breaks for Zenflow was being funded by Y Combinator as a part of the winter 2015 batch. It turned out to be a great experience. Zenflow leveraged this program to build its first working prototype, collect chronic animal data, and raise a seed round. From there, a team was hired and Zenflow started making faster progress. It started a first-in-human study in mid-2016 and has collected some very promising data. Now, with a team of 15 full-time people, Zenflow is initiating large trials to prepare for commercial launch. Innovative Products and Services Zenflow is developing the Spring System, which involves a small Nitinol implant deployed through a flexible cystoscopic system under direct


visualization. It designed the implant to provide solution for long-term risk, while avoiding adverse effects like migration and encrustation, issues that plague prostatic stents. The designed device is uniquely made, so that it can push back the prostate while being deliverable through a small, flexible catheter in a simple procedure that is easy for any urologist to learn and perform. Zenflow is focused on the patients’ need above all; always innovating to improve safety, effectiveness, and patient experience. Compassionate and Zealous Leaders of Zenflow Nick Damiano, Co-Founder & CEO, is seasoned with his experience as an engineer and an entrepreneur, in both medical devices and digital health industries. He founded Zenflow along with Shreya Mehta, Co-Founder & CTO. She has an experience as a R&D engineer at large medical device companies and has spent four years as a lead reviewer at FDA. Both founders spent a year in the Stanford Bio design Innovation Fellowship. The founding team’s medtech background has given them the practical knowhow they needed to get their product to market.

Adding to it, their experience from outside the industry and from the other side of the regulatory table has brought new perspectives to their work at Zenflow. In particular, the team takes a collaborative approach in its interactions with regulatory bodies and other medical device companies, sometimes even competitors. With improving patient care at the core of their mission, Nick and Shreya are making their way to achieving that goal, as partners. Staying Abreast with Changing Trends Zenflow makes it a point to stay on top of changing conditions in the therapeutic space and market; and thrive to adapt quickly to a clinical need or changing landscape. In particular, its major strategy is keeping the communication lines open with customers – patients, providers, and payers. Addressing the clinical need as well as possible is Zenflow’s top priority. In terms of technological changes, Zenflow has adopted 3D printing for prototyping. With a passion for success, every day matters to the team of Zenflow; and 3D printing gives them an ability to cut

their iteration cycle time down to a fraction of what it would have been years ago. It has made Zenflow a faster, leaner, and more innovative company. In working towards their goal, Zenflow has not been afraid to question its assumptions and adapt if changing conditions or new information warrants doing so. Plan for an Avant-Garde Future As far as its long-term strategy is concerned, Zenflow likes to play its cards close to the vest. Its ultimate mission is to provide the safest, most effective, most worry-free treatment for BPH symptoms to all the patients suffering from the disease. Zenflow has some interesting concepts in its works, which may expand the patient population under treatment and produce even better clinical results. It also has some ideas that could allow Zenflow to branch out into other urologic areas.

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The 10 Most Innovative Medical Devices Companies 2018  

Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector...

The 10 Most Innovative Medical Devices Companies 2018  

Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector...

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