This webinar aims to attract entrepreneurs and corporations to license two technologies presented: the Mizzou BioJoint Flex knee range of motion device. The webinar will include 10-minute presentations on each technology and a question period. The BioJoint Flex addresses knee arthrofibrosis by providing a gentle, prolonged stretch at home or in a clinic. It has undergone initial clinical trials demonstrating benefits in flexion, function, pain and satisfaction over physical therapy. Further development needs include finding a licensing partner for manufacturing and marketing, finalizing the patient and pro versions, pursuing 510k clearance, and commercialization. The presentation provides details on intellectual property, development stage, clinical results, market opportunity, competition, and the development team.
High Performance IOL Power Calculation….at the push of a buttonMichael Mrochen
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
NFL-Supported Medical Device Gets FDA De NovoEMMAIntl
The FDA granted De Novo approval to Miach Orthopedics' Bridge-Enhanced ACL Repair (BEAR) implant, a bovine collagen implant placed between torn ACL ends to facilitate natural healing over 8 weeks. A randomized controlled trial of 100 subjects found the BEAR implant patients reported similar knee function scores to ACL reconstruction patients at 2 years. This less invasive option with quicker recovery attracted the NFL Players Association and creates a new regulatory pathway for similar devices.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
The invasion of mobile medical apps: A 5-Year OutlookNealda Yusof
Digital health is a fast-growing space and will shape medical technology innovation of the future. This is an overview about the trends in mobile medical apps today and in the next 5 years. The topics discussed in this lecture include:
http://semoegy.com
Peek is a portable eye examination kit that clips onto a smartphone to allow healthcare workers to easily perform eye exams and screenings. It functions as both an ophthalmoscope and retinal camera to diagnose conditions like cataracts and glaucoma. By making eye exams affordable and accessible anywhere via smartphone, Peek aims to help eliminate the 39 million cases of avoidable blindness worldwide, especially in underserved regions without traditional eye care equipment. The system was created by a team that includes ophthalmologists, engineers, and designers, and has been recognized with awards for its innovative approach to healthcare technology.
This webinar aims to attract entrepreneurs and corporations to license two technologies presented: the Mizzou BioJoint Flex knee range of motion device. The webinar will include 10-minute presentations on each technology and a question period. The BioJoint Flex addresses knee arthrofibrosis by providing a gentle, prolonged stretch at home or in a clinic. It has undergone initial clinical trials demonstrating benefits in flexion, function, pain and satisfaction over physical therapy. Further development needs include finding a licensing partner for manufacturing and marketing, finalizing the patient and pro versions, pursuing 510k clearance, and commercialization. The presentation provides details on intellectual property, development stage, clinical results, market opportunity, competition, and the development team.
High Performance IOL Power Calculation….at the push of a buttonMichael Mrochen
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
NFL-Supported Medical Device Gets FDA De NovoEMMAIntl
The FDA granted De Novo approval to Miach Orthopedics' Bridge-Enhanced ACL Repair (BEAR) implant, a bovine collagen implant placed between torn ACL ends to facilitate natural healing over 8 weeks. A randomized controlled trial of 100 subjects found the BEAR implant patients reported similar knee function scores to ACL reconstruction patients at 2 years. This less invasive option with quicker recovery attracted the NFL Players Association and creates a new regulatory pathway for similar devices.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
The invasion of mobile medical apps: A 5-Year OutlookNealda Yusof
Digital health is a fast-growing space and will shape medical technology innovation of the future. This is an overview about the trends in mobile medical apps today and in the next 5 years. The topics discussed in this lecture include:
http://semoegy.com
Peek is a portable eye examination kit that clips onto a smartphone to allow healthcare workers to easily perform eye exams and screenings. It functions as both an ophthalmoscope and retinal camera to diagnose conditions like cataracts and glaucoma. By making eye exams affordable and accessible anywhere via smartphone, Peek aims to help eliminate the 39 million cases of avoidable blindness worldwide, especially in underserved regions without traditional eye care equipment. The system was created by a team that includes ophthalmologists, engineers, and designers, and has been recognized with awards for its innovative approach to healthcare technology.
This document outlines the agenda for a conference on obtaining FDA approval for AI-based medical devices. The agenda includes presentations on paving the path for FDA approval of AI devices, an open Q&A session with the FDA's Digital Health Center of Excellence, how to align product development with FDA regulations for AI, best pre-submission practices, and an update on the 510(k) program. There will also be breaks and a summary session. The presentations will provide guidance on navigating the FDA approval process for AI medical devices and obtaining feedback prior to formal submissions.
The document discusses the medical device industry including key sectors, regulations, and the product development lifecycle. It notes that the global market size for medical devices is approximately $300 billion and lists common device types such as cardiovascular, orthopedic, imaging, and respiratory devices. Regulations for medical devices are outlined for the US, Europe, Japan, and India. The medical device product development lifecycle includes 5 phases from initiation to post-launch assessment. Human factors considerations and emerging areas in devices such as assistive technologies, telemedicine platforms, cardiac implants, and deep brain stimulation are also summarized.
This document outlines the requirements for commercializing and ensuring quality in biomedical wearable and implantable devices. It discusses the markets and applications for these devices, including diagnosing and treating patients. Regulatory requirements for devices approved by the FDA and EU are also covered, including classification, quality system regulations, and labeling. The document addresses new product development processes, intellectual property, reimbursement, and preclinical testing requirements.
Time and cost savings of using continua pw cJanna Guinen
The document discusses the benefits of implementing the design guidelines from Continua Health Alliance, an international non-profit organization that enables connectivity of personal health devices. A survey was conducted of Continua members to quantify the time and cost savings. Case studies found that following Continua guidelines reduced integration time for a device manufacturer from 9 weeks to 3 weeks, saving $130,000, and for a system integrator reduced time from 12 weeks to 2 weeks for a project, saving $140,000. Overall, using Continua guidelines was found to save significant time and costs across organizations.
What are leadership The simple definizion is that leadership - islorileemcclatchie
What are leadership? The simple definizion is that leadership - is the art of motivating a group of people to act toward achieving a common goal. In a business setting it can mean directing workers and colleagues with a strategy to meet the company's needs.
This leadership definition captures the essentials of being able and prepared to inspire others. Effective leadership is based upon ideas (whether original or borrowed), but won't happen unless those ideas can be communicated to others in a way that engages them enough to act as the leader wants them to act.
Put even more simply, the leader is the inspiration for and director of the action. They are a person in the group that possesses the combination of personality and leadership skills to make others want to follow their direction.
<To develop a new medical device for China market >
< PMGT 699 – Applied Project Management >
Prepared By
< Soumitra G Shilotri >
<02/11/2020>
1.Executive Summary 3
2.Project Overview 5
2.1 Project Description 5
2.2 Problem Statement 5
2.3 Goals 5
2.4 Project Background 7
2.5 Product Objectives 7
2.6 Assumptions, Constraints and Dependencies 7
2.7 Project Deliverables 8
2.8 Schedule and Budget Summary 9
2.9 Evolution of the Plan 10
2.10 Definitions and Acronyms 10
3.Stakeholder Register 12
4.Schedule Component 14
5.Resource Plan with RACI 18
5.1Overview/Purpose 18
5.2 Resourcing Strategy & Assumption 18
5.3 Resourcing Development 18
6.Risk Management Plan 21
6.1 Review of Risk Management Plan 21
6.2 Risk Identification 21
7.Communications Plan 24
8. Procurement 28
9. Cost…………………………………………………………………………………………..30
10. Integrated Change Control 341.Executive Summary
1.1 Introduction
Johnson and Johnson (J&J) is an American multinational company that develops medical devices, pharmaceutical drugs and consumer products. J&J is one of the largest medical device companies in the world. There are various subsidiaries of J&J, however the medical device business of J&J includes 3 global franchises; mainly Ethicon (surgical), Bio-sense Webster (Cardiovascular & Speciality solutions) and Depuy Synthes (Orthopaedics). J&J has a presence in over 100 countries worldwide and the medical device companies manufactures and does R&D on various different kinds of surgical devices, implants that are used by doctors in laparoscopic surgeries.
Current project that I will be working on is named as Project RoadRunner by the project team. The project is to develop a new medical device implant for China market. The implant is a sterile product that is used by surgeons during bariatric surgeries. This implant is used alongside a vascular stapler and will improve the staple line integrity, force to fire and staple performance during surgery. This will be a big boost in the existing line of stapling implants by improving performance reliability and decrease market complaints. So far for earlier legacy devices, we were using 2-D st ...
Program Presentation Advance Program In Clinical Trial, Research & Data Man...biinoida
The document summarizes an advance program in clinical trial research and data management offered by the Bioinformatics Institute of India. The 6-month weekend program provides theoretical and practical training in clinical trial design, conduct, analysis and regulation. It includes classroom lectures, guest speakers and a clinical site visit. The program aims to prepare students for careers in the growing field of clinical research.
PreScouter Internet of Medical Things: Industry Roundtable WebinarPreScouter
PreScouter, a company that provides corporate innovation leaders with the data and insights on which to base product development and R&D planning decisions, invites you to learn about how competitors are using Internet of Things (IoT) to disrupt the healthcare and pharmaceutical industries through an exclusive PreScouter webinar.
In this IoT webinar, PreScouter partners with guest speakers: Alok Tayi, CEO of TetraScience and Neil Schappert, CEO of PilotFish to specifically address how Internet of Things will impact pharmaceutical and healthcare through a series of questions.
The full IoT report, which is approximately 130 pages, includes an introduction to IoT, findings and adaptations. Moving from a broad overview of IoT, the report takes an in-depth look at Smart Homes, Smart Healthcare, Smart Retail and Smart Manufacturing with infographics. Each section has an overview and an in-depth analsysis on several key players in the IoT space.
The IoT report covers Smart Healthcare innovators including Microsoft, Samsung, Oracle, GE, PilotFish and Chrono Therapeutics among others.
In the Smart Manufacturing space, adaptations from Schneider Electric, Honeywell, and Siemens are covered.
In the Smart Homes space, Intel, Smartrac, and IBM are some of the key players covered.
Two of the IoT report authors presented in an IoT Webinar - Internet of Medical Things: Industry Roundtable with two CEOs from companies spotlighted in the report, TetraScience and PilotFish.
IoT has a total potential economic impact of $3.9 tillion to $11.1 trillion a year by 2025.
We understand that our clients need to become abreast of current trends and quickly discover the competitive landscape and the market potential of disruptive technologies.
Don't miss out on this special PreScouter IoT report. Email: aelliott@prescouter.com.
Learn more about the commercial context of clinical trials, and how to leverage international networks to provide input into clinical trial designs that will generate value beyond regulatory approval, and provide supporting data to cause the adoption of medical devices.
This document summarizes the experience and qualifications of Greg Browne as a medical device R&D manager and design lead. He has over 15 years of experience in product development for consumer and medical devices. Some of his key qualifications include expertise in design management processes, usability research, agile development methodologies, and familiarity with FDA regulations for medical devices. He has experience leading cross-functional teams and new product development from concept through commercialization.
This document provides updates on several collaborative health IT projects in New Zealand, including:
1) The e-Labs project which aims to enable electronic ordering and sharing of lab test results between primary and secondary care.
2) The Consumer Health Portal proof of concept which created a personal health record for patients that integrated various online health tools and services.
3) The announcement of a new "Collaborate 2 Innovate" initiative seeking proposals for innovative collaborative health IT projects in New Zealand.
The objective of project is to improve end-users’ Healthcare experience through its IoT-based Healthcare services and to support business incubation scheme with better
regulatory support
For EAS 546: Engineering Entrepreneurship II at Penn, my team decided to prepare a business plan for DEKA Bionic Arm. This is the final presentation we gave at the end of the course
A smart enteral feeding system with integrated reflux monitoring and prevention. The system comprises of both proprietary hardware and software. A
feeding tube (LifeSafe Tube™) with embedded sensors collects data continuously. Proprietary algorithms analyze the collected data, weighing multiple risk factors such as patient position and physiological functions (ie: sneezing, coughing) to predict when reflux will occur. This information is used to automatically calibrate a feeding pump and optimize feeding rate in order to prevent reflux.
Anteo Diagnostics ASX Spotlight Presentation March 2014Matt Sanderson
Anteo Diagnostics is an Australian biotechnology company that develops proprietary surface coatings called Mix&Go for use in diagnostics and life sciences. In 2013, Anteo achieved solid commercial progress including partnership agreements that are enhancing the prospects of becoming cash flow positive in 2014. Anteo is now focused on advancing near-term opportunities to generate licensing fees and royalties from Mix&Go and expanding into the large market for bioseparations.
Apidays Singapore 2024 - Blending AI and IoT for Smarter Health by Matthew Ch...apidays
Blending AI and IoT for Smarter Health
Matthew Chua, Assistant Professor, Biomedical Informatives - National University of Singapore
Apidays Singapore 2024: Connecting Customers, Business and Technology (April 17 & 18, 2024)
------
Check out our conferences at https://www.apidays.global/
Do you want to sponsor or talk at one of our conferences?
https://apidays.typeform.com/to/ILJeAaV8
Learn more on APIscene, the global media made by the community for the community:
https://www.apiscene.io
Explore the API ecosystem with the API Landscape:
https://apilandscape.apiscene.io/
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Clinical Biometrics, Inc. Executive Overview
Description Clinical Biometrics is an organization dedicated to enabling predictive healthcare and disease prevention with the IoT. We are working on the IoT (Internet of Things) wireless, biomedical patient monitoring and vendor agnostic integration, pioneering programmable biosensors, integration products and services to monitor secure clinical data in real-time and over time, for inpatient and outpatient environments. Our model enables predictive and preventative healthcare delivery. We are developing vendor agnostic middleware that will allow the integration of the various vendor's sensors and protocols into a common platform with rich data analytics capabilities. This technology will impact our healthcare paradigms and usher us into the future of healthcare delivery including real-time predictive healthcare and disease prevention.
- Tim Crammer, CEO
Whiteboard2Boardroom collaborates with more than 21 research institutions, hospitals and corporation to move technologies out of research labs into the marketplace.
Whiteboard2Boardroom collaborates with more than 21 research institutions, hospitals and corporation to move technologies out of research labs into the marketplace.
This document outlines the agenda for a conference on obtaining FDA approval for AI-based medical devices. The agenda includes presentations on paving the path for FDA approval of AI devices, an open Q&A session with the FDA's Digital Health Center of Excellence, how to align product development with FDA regulations for AI, best pre-submission practices, and an update on the 510(k) program. There will also be breaks and a summary session. The presentations will provide guidance on navigating the FDA approval process for AI medical devices and obtaining feedback prior to formal submissions.
The document discusses the medical device industry including key sectors, regulations, and the product development lifecycle. It notes that the global market size for medical devices is approximately $300 billion and lists common device types such as cardiovascular, orthopedic, imaging, and respiratory devices. Regulations for medical devices are outlined for the US, Europe, Japan, and India. The medical device product development lifecycle includes 5 phases from initiation to post-launch assessment. Human factors considerations and emerging areas in devices such as assistive technologies, telemedicine platforms, cardiac implants, and deep brain stimulation are also summarized.
This document outlines the requirements for commercializing and ensuring quality in biomedical wearable and implantable devices. It discusses the markets and applications for these devices, including diagnosing and treating patients. Regulatory requirements for devices approved by the FDA and EU are also covered, including classification, quality system regulations, and labeling. The document addresses new product development processes, intellectual property, reimbursement, and preclinical testing requirements.
Time and cost savings of using continua pw cJanna Guinen
The document discusses the benefits of implementing the design guidelines from Continua Health Alliance, an international non-profit organization that enables connectivity of personal health devices. A survey was conducted of Continua members to quantify the time and cost savings. Case studies found that following Continua guidelines reduced integration time for a device manufacturer from 9 weeks to 3 weeks, saving $130,000, and for a system integrator reduced time from 12 weeks to 2 weeks for a project, saving $140,000. Overall, using Continua guidelines was found to save significant time and costs across organizations.
What are leadership The simple definizion is that leadership - islorileemcclatchie
What are leadership? The simple definizion is that leadership - is the art of motivating a group of people to act toward achieving a common goal. In a business setting it can mean directing workers and colleagues with a strategy to meet the company's needs.
This leadership definition captures the essentials of being able and prepared to inspire others. Effective leadership is based upon ideas (whether original or borrowed), but won't happen unless those ideas can be communicated to others in a way that engages them enough to act as the leader wants them to act.
Put even more simply, the leader is the inspiration for and director of the action. They are a person in the group that possesses the combination of personality and leadership skills to make others want to follow their direction.
<To develop a new medical device for China market >
< PMGT 699 – Applied Project Management >
Prepared By
< Soumitra G Shilotri >
<02/11/2020>
1.Executive Summary 3
2.Project Overview 5
2.1 Project Description 5
2.2 Problem Statement 5
2.3 Goals 5
2.4 Project Background 7
2.5 Product Objectives 7
2.6 Assumptions, Constraints and Dependencies 7
2.7 Project Deliverables 8
2.8 Schedule and Budget Summary 9
2.9 Evolution of the Plan 10
2.10 Definitions and Acronyms 10
3.Stakeholder Register 12
4.Schedule Component 14
5.Resource Plan with RACI 18
5.1Overview/Purpose 18
5.2 Resourcing Strategy & Assumption 18
5.3 Resourcing Development 18
6.Risk Management Plan 21
6.1 Review of Risk Management Plan 21
6.2 Risk Identification 21
7.Communications Plan 24
8. Procurement 28
9. Cost…………………………………………………………………………………………..30
10. Integrated Change Control 341.Executive Summary
1.1 Introduction
Johnson and Johnson (J&J) is an American multinational company that develops medical devices, pharmaceutical drugs and consumer products. J&J is one of the largest medical device companies in the world. There are various subsidiaries of J&J, however the medical device business of J&J includes 3 global franchises; mainly Ethicon (surgical), Bio-sense Webster (Cardiovascular & Speciality solutions) and Depuy Synthes (Orthopaedics). J&J has a presence in over 100 countries worldwide and the medical device companies manufactures and does R&D on various different kinds of surgical devices, implants that are used by doctors in laparoscopic surgeries.
Current project that I will be working on is named as Project RoadRunner by the project team. The project is to develop a new medical device implant for China market. The implant is a sterile product that is used by surgeons during bariatric surgeries. This implant is used alongside a vascular stapler and will improve the staple line integrity, force to fire and staple performance during surgery. This will be a big boost in the existing line of stapling implants by improving performance reliability and decrease market complaints. So far for earlier legacy devices, we were using 2-D st ...
Program Presentation Advance Program In Clinical Trial, Research & Data Man...biinoida
The document summarizes an advance program in clinical trial research and data management offered by the Bioinformatics Institute of India. The 6-month weekend program provides theoretical and practical training in clinical trial design, conduct, analysis and regulation. It includes classroom lectures, guest speakers and a clinical site visit. The program aims to prepare students for careers in the growing field of clinical research.
PreScouter Internet of Medical Things: Industry Roundtable WebinarPreScouter
PreScouter, a company that provides corporate innovation leaders with the data and insights on which to base product development and R&D planning decisions, invites you to learn about how competitors are using Internet of Things (IoT) to disrupt the healthcare and pharmaceutical industries through an exclusive PreScouter webinar.
In this IoT webinar, PreScouter partners with guest speakers: Alok Tayi, CEO of TetraScience and Neil Schappert, CEO of PilotFish to specifically address how Internet of Things will impact pharmaceutical and healthcare through a series of questions.
The full IoT report, which is approximately 130 pages, includes an introduction to IoT, findings and adaptations. Moving from a broad overview of IoT, the report takes an in-depth look at Smart Homes, Smart Healthcare, Smart Retail and Smart Manufacturing with infographics. Each section has an overview and an in-depth analsysis on several key players in the IoT space.
The IoT report covers Smart Healthcare innovators including Microsoft, Samsung, Oracle, GE, PilotFish and Chrono Therapeutics among others.
In the Smart Manufacturing space, adaptations from Schneider Electric, Honeywell, and Siemens are covered.
In the Smart Homes space, Intel, Smartrac, and IBM are some of the key players covered.
Two of the IoT report authors presented in an IoT Webinar - Internet of Medical Things: Industry Roundtable with two CEOs from companies spotlighted in the report, TetraScience and PilotFish.
IoT has a total potential economic impact of $3.9 tillion to $11.1 trillion a year by 2025.
We understand that our clients need to become abreast of current trends and quickly discover the competitive landscape and the market potential of disruptive technologies.
Don't miss out on this special PreScouter IoT report. Email: aelliott@prescouter.com.
Learn more about the commercial context of clinical trials, and how to leverage international networks to provide input into clinical trial designs that will generate value beyond regulatory approval, and provide supporting data to cause the adoption of medical devices.
This document summarizes the experience and qualifications of Greg Browne as a medical device R&D manager and design lead. He has over 15 years of experience in product development for consumer and medical devices. Some of his key qualifications include expertise in design management processes, usability research, agile development methodologies, and familiarity with FDA regulations for medical devices. He has experience leading cross-functional teams and new product development from concept through commercialization.
This document provides updates on several collaborative health IT projects in New Zealand, including:
1) The e-Labs project which aims to enable electronic ordering and sharing of lab test results between primary and secondary care.
2) The Consumer Health Portal proof of concept which created a personal health record for patients that integrated various online health tools and services.
3) The announcement of a new "Collaborate 2 Innovate" initiative seeking proposals for innovative collaborative health IT projects in New Zealand.
The objective of project is to improve end-users’ Healthcare experience through its IoT-based Healthcare services and to support business incubation scheme with better
regulatory support
For EAS 546: Engineering Entrepreneurship II at Penn, my team decided to prepare a business plan for DEKA Bionic Arm. This is the final presentation we gave at the end of the course
A smart enteral feeding system with integrated reflux monitoring and prevention. The system comprises of both proprietary hardware and software. A
feeding tube (LifeSafe Tube™) with embedded sensors collects data continuously. Proprietary algorithms analyze the collected data, weighing multiple risk factors such as patient position and physiological functions (ie: sneezing, coughing) to predict when reflux will occur. This information is used to automatically calibrate a feeding pump and optimize feeding rate in order to prevent reflux.
Anteo Diagnostics ASX Spotlight Presentation March 2014Matt Sanderson
Anteo Diagnostics is an Australian biotechnology company that develops proprietary surface coatings called Mix&Go for use in diagnostics and life sciences. In 2013, Anteo achieved solid commercial progress including partnership agreements that are enhancing the prospects of becoming cash flow positive in 2014. Anteo is now focused on advancing near-term opportunities to generate licensing fees and royalties from Mix&Go and expanding into the large market for bioseparations.
Apidays Singapore 2024 - Blending AI and IoT for Smarter Health by Matthew Ch...apidays
Blending AI and IoT for Smarter Health
Matthew Chua, Assistant Professor, Biomedical Informatives - National University of Singapore
Apidays Singapore 2024: Connecting Customers, Business and Technology (April 17 & 18, 2024)
------
Check out our conferences at https://www.apidays.global/
Do you want to sponsor or talk at one of our conferences?
https://apidays.typeform.com/to/ILJeAaV8
Learn more on APIscene, the global media made by the community for the community:
https://www.apiscene.io
Explore the API ecosystem with the API Landscape:
https://apilandscape.apiscene.io/
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Clinical Biometrics, Inc. Executive Overview
Description Clinical Biometrics is an organization dedicated to enabling predictive healthcare and disease prevention with the IoT. We are working on the IoT (Internet of Things) wireless, biomedical patient monitoring and vendor agnostic integration, pioneering programmable biosensors, integration products and services to monitor secure clinical data in real-time and over time, for inpatient and outpatient environments. Our model enables predictive and preventative healthcare delivery. We are developing vendor agnostic middleware that will allow the integration of the various vendor's sensors and protocols into a common platform with rich data analytics capabilities. This technology will impact our healthcare paradigms and usher us into the future of healthcare delivery including real-time predictive healthcare and disease prevention.
- Tim Crammer, CEO
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Whiteboard2Boardroom collaborates with more than 21 research institutions, hospitals and corporation to move technologies out of research labs into the marketplace.
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The document summarizes a proposed solution to improve the effectiveness of disposable medical gowns. Current disposable gowns do not meet FDA regulations as they gap and sag, exposing healthcare workers' clothing and risking contamination. The proposed solution extends the gown material up the neck to prevent gaps. This would make disposable gowns compliant with regulations while providing an inexpensive, simple solution. Further development requires demonstrating current gowns' ineffectiveness, such as with a fluorescent particle video test, and pursuing partnerships with manufacturers or the FDA to drive regulatory changes ensuring gown protection.
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Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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1. W2B Technology Snapshot Webinar Overview
Webinar Objectives
• Attract entrepreneurs to license technologies and start companies
• Attract corporations to license technologies as new product
opportunities
• Solicit input on the commercial viability of the technologies
presented
Agenda
Webinar schedule
Two technology opportunities
8-10 minute presentations
5-10 minute questions as needed
Send technology inquiries to Jim Baxendale at baxendalej@umkc.edu
3. MU COULTER BIOMEDICAL
ACCELERATOR
MIDWEST BIOMEDICAL
ACCELERATOR CONSORTIUM
“Translating academic biomedical innovations into products that
improve patient care and public health”
$1M+/year in funding, project management
and commercialization support for
MU innovators
$1M+/year in funding, project management
and commercialization support for
UM System and KU innovators
4. Jaya Ghosh, PhD
MU Coulter Program Director
MBArC Lead Program Manager
Phone: (573) 882-0522
Email: ghoshj@missouri.edu
7. What is the problem?
ARTHROFIBROSIS
Loss of Motion
Pain and Disability
Diminished Quality of Life
$$$$$
8. How does BioJoint Flex solve the problem?
• An affordable, easy to
use knee range of
motion device that
provides a gentle,
prolonged stretch for
people experiencing
motion loss
ARTHROFIBROSIS
9. What is the market use?
25% of US adults have knee
pain (60.5 million people)
>1 million major knee
surgeries/year
>75,000
patients per
year with
arthrofibrosis
following
surgery
Patient version
HCPCS code E1811 –
Medicare reimburses $149
Pro version
Market price ~$500
10% Entry Market Share over first 3-5 years
7,500 patient units
+
1,000 pro units
=
$1.1M/yr
10. What competition exists?
FEATURES: JAS Brace CPM Physical Therapy Surgery
Early Intervention X X X
Gentle X
Affordable ~$700 $100/wk $75-150/session $6,000-10,000
Clinic Use X X X
Home Use X X
Prolonged Stretch X
Track Record X X X
ARTHROFIBROSIS
Loss of Motion
Pain and Disability
Diminished Quality of Life
✓
✓
$149*
✓
✓
✓
✗
11. What is the status of the intellectual property?
• US nonprovisional patent application pending
– Application No. 16/180,783
– Publication No. US 2019/0133864
– “Knee Flexion Device and Associated Method of Use”
– Filing Date: November 5, 2018
• Evaluation revealed other devices that promote knee
mobility, but nothing with similar specifications
Patent/ Application # Patent/Application Title Status
Application: 16/180,783 Knee Flexion Device and
Associated Method of Use
Pending
12. What is the stage of development?
• Prototypes developed
and tested in initial
prospective randomized
clinical trial
• Complete data for 29
patients
– BioJoint Flex = 16
• 6F, 10M mean age 63 yrs
– Control = 13
• 10F, 3M mean age 64 yrs
13. Does it work?
• BETTER Flexion
• BETTER Function*
• BETTER Pain Relief*
• BETTER Patient Satisfaction
• Safe, Comfortable, Easy to Use
0
20
40
60
80
100
120
140
PreOP 6w 12w
BJF Standard PT
Knee Flexion
measured with goniometer
0
10
20
30
40
50
60
70
80
90
100
PreOP 6w 12w
BJF Standard PT
Knee Function
based on IKDC PROM
* = statistically significant difference (p<0.05)
Knee Pain
based on VAS PROM
0
1
2
3
4
5
6
7
8
9
10
PreOP 6w 12w
BJF Standard PT
0
1
2
3
4
5
6
7
8
9
10
BJF Standard PT
Patient Satisfaction
$$$$$$$$$$
14. What is needed for further development?
• Experienced Licensee with expertise in
orthopaedic device manufacturing,
sales and distribution
– Invest ~$1M for manufacturing, assembly,
and marketing of product for year 1
• Finalize Patient version
– $50 → $149
• Finalize Pro version
– Features: motorized, sensors,
microcontroller, digital display, blue tooth,
multi-use
– $100 → $500
• Regulatory Pathway
– 510K Exempt – Class 1 = safe & effective
• READY for commercialization
15. Jimi Cook, DVM, PhD, OTSC
Clinical Research & Development
Trent Guess, PhD
Engineering & Manufacturing
Cory Crecelius, PT
Clinical Implementation
Kylee Rucinski, MHA
Healthcare Financials
Sam Bish, PhD
Technology Advancement
The Mizzou BioJoint Flex Team