Medical device companies need to be adept at managing product changes to meet the increasing challenges of software-intensive, connected medical devices, including dealing with greater complexity, frequent changes, and cybersecurity issues.
This 10-minute lecture gives a step-by-step instruction on medical device definition. It covers the basic definition of a medical device, its key attributes, and intended purpose. A brief insight is provided into in vitro diagnostic medical devices. At the end of this lecture, the student will be able to differentiate a medical device from pharmaceutical and biological healthcare products. The student will also be able to decide whether a particular healthcare product comes under the definition of a medical device.
http://semoegy.com
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
The document discusses accelerating medical device development while improving compliance using lean and agile methods. It compares the traditional waterfall approach to a lean-agile approach through the story of two hypothetical product development teams. The lean-agile team prioritized learning and closing knowledge gaps early through testing, which allowed them to make more informed decisions later in development. The document provides examples of how agile software development practices can be adapted for medical device software while still meeting regulatory requirements.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
Currently worth a few million dollars, the emerging organs-on-chips market has the potential to become a multi-billion dollar market.
Organs-on-chips: the promise of solving one of the pharmaceutical industry’s major hurdles
Bringing a new drug to market is one of the longest and most costly paths any industry has to walk. Companies start with several thousands of compounds that may have positive effects against a disease or a human condition. More than twelve years and several billion dollars later, if they’re lucky they managed to get one of these compounds onto the market. All the others failed at one stage or another during the drug development process – and the later the failure, the more expensive it is. Current methods – cell culture in petri dishes and animal testing among others – are not predictive enough. Around 90% of drugs that have been validated on these models then fail during clinical trials because of toxicity or lack of efficacy. The pharmaceutical industry therefore needs more predictive tools to make drug candidates fail earlier and cheaper. Other industries where toxicity testing is a major concern, such as cosmetics, agro-food and consumer goods, also need such solutions, in particular because animal testing is now banned for these industries in certain geographical areas. Several options have been envisioned, the most promising of which is certainly organs-on-chips. These combinations of micro-technology and biology reconstitute the physiological and mechanical functions of human organs under the form of micro-engineered devices lined with living cells. Precisely controlled fluid flows combined with mechanical cues and tissue-tissue interfaces enable dynamic models, much more relevant than conventional static cell cultures. As a sign of confidence in this technology, significant funding has been allocated to organs-on-chips developers: DARPA and the NIH respectively awarded $140M and $76M over 5-year periods to support developments. In parallel, technology developers have raised more than $80M since 2012 with investors. In Yole Développement’s report, all the key elements to understand the organs-on-chips landscape are detailed.
For more information, please visit our website: https://www.i-micronews.com/reports.html
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Clinical Trial eConsent | Topic #2 of PharmaLedger's 2nd Open Webinar PharmaLedger
In this Clinical Trial eConsent Use Case presentation, you will find:
An introduction to Clinical Trial eConsent use case presented by : Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
The current flow of Clinical Trials and Informed Consent process
Pain points of the current Clinical Trials process
PharmaLedger’s Clinical Trial eConsent solution for the future state
Value added by PharmaLedger per actor involved
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Regulatory strategy for medical device start-upsRina Nir
The document discusses regulatory considerations for medical device startups. It notes that the regulatory environment will significantly impact business plans by influencing budgets, timelines, staffing needs and more. Startups must thoroughly assess their regulatory situation and strategy to navigate the complex approval processes in both the US and EU. Later slides provide more details on specific regulatory pathways, standards, and trends to consider for medical device development.
FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
This 10-minute lecture gives a step-by-step instruction on medical device definition. It covers the basic definition of a medical device, its key attributes, and intended purpose. A brief insight is provided into in vitro diagnostic medical devices. At the end of this lecture, the student will be able to differentiate a medical device from pharmaceutical and biological healthcare products. The student will also be able to decide whether a particular healthcare product comes under the definition of a medical device.
http://semoegy.com
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
The document discusses accelerating medical device development while improving compliance using lean and agile methods. It compares the traditional waterfall approach to a lean-agile approach through the story of two hypothetical product development teams. The lean-agile team prioritized learning and closing knowledge gaps early through testing, which allowed them to make more informed decisions later in development. The document provides examples of how agile software development practices can be adapted for medical device software while still meeting regulatory requirements.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
Currently worth a few million dollars, the emerging organs-on-chips market has the potential to become a multi-billion dollar market.
Organs-on-chips: the promise of solving one of the pharmaceutical industry’s major hurdles
Bringing a new drug to market is one of the longest and most costly paths any industry has to walk. Companies start with several thousands of compounds that may have positive effects against a disease or a human condition. More than twelve years and several billion dollars later, if they’re lucky they managed to get one of these compounds onto the market. All the others failed at one stage or another during the drug development process – and the later the failure, the more expensive it is. Current methods – cell culture in petri dishes and animal testing among others – are not predictive enough. Around 90% of drugs that have been validated on these models then fail during clinical trials because of toxicity or lack of efficacy. The pharmaceutical industry therefore needs more predictive tools to make drug candidates fail earlier and cheaper. Other industries where toxicity testing is a major concern, such as cosmetics, agro-food and consumer goods, also need such solutions, in particular because animal testing is now banned for these industries in certain geographical areas. Several options have been envisioned, the most promising of which is certainly organs-on-chips. These combinations of micro-technology and biology reconstitute the physiological and mechanical functions of human organs under the form of micro-engineered devices lined with living cells. Precisely controlled fluid flows combined with mechanical cues and tissue-tissue interfaces enable dynamic models, much more relevant than conventional static cell cultures. As a sign of confidence in this technology, significant funding has been allocated to organs-on-chips developers: DARPA and the NIH respectively awarded $140M and $76M over 5-year periods to support developments. In parallel, technology developers have raised more than $80M since 2012 with investors. In Yole Développement’s report, all the key elements to understand the organs-on-chips landscape are detailed.
For more information, please visit our website: https://www.i-micronews.com/reports.html
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Clinical Trial eConsent | Topic #2 of PharmaLedger's 2nd Open Webinar PharmaLedger
In this Clinical Trial eConsent Use Case presentation, you will find:
An introduction to Clinical Trial eConsent use case presented by : Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
The current flow of Clinical Trials and Informed Consent process
Pain points of the current Clinical Trials process
PharmaLedger’s Clinical Trial eConsent solution for the future state
Value added by PharmaLedger per actor involved
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Regulatory strategy for medical device start-upsRina Nir
The document discusses regulatory considerations for medical device startups. It notes that the regulatory environment will significantly impact business plans by influencing budgets, timelines, staffing needs and more. Startups must thoroughly assess their regulatory situation and strategy to navigate the complex approval processes in both the US and EU. Later slides provide more details on specific regulatory pathways, standards, and trends to consider for medical device development.
FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Emerging Trends In Medical Device ManufacturingEWI
To continue a trajectory of steady growth, the global medical device industry must adapt to the dynamic changes disrupting the healthcare landscape. An aging population, a push for more personalized treatment, and the increasing availability of healthcare are some of the factors driving new markets and an expanding consumer base. In addition, regulatory scrutiny and federal initiatives like the medical device excise tax have levied extra pressure on R&D budgets.
PharmaLedger’s Spotlight Session Presentations at DIA Europe 2021PharmaLedger
Download PharmaLedger’s Spotlight Session presentations from DIA Europe 2021.
In addition to our 3D Virtual Booth that took place all week long at DIA Europe 2021, PharmaLedger hosted two 60-minute Spotlight Sessions.
Spotlight Session #1: PharmaLedger – Demonstrating the Vision of Blockchain Enabled Healthcare
Tuesday, March 16th the sessions kicks off with an introduction of the PharmaLedger project, followed by a look into our Electronic Product Information (ePI) and Anti-Counterfeiting use cases, then concluding with a full demonstration of our first prototype of the PharmaLedger ePI app. Speakers include PharmaLedger Industry Lead Daniel Fritz (Novartis), and ePI use case co-leads Patrick Maher (Novartis) and Ken Thursby (MSD).
Spotlight Session #2: PharmaLedger – Data Privacy and the Vision of a Blockchain Enabled Healthcare
Friday, March 19th following a PharmaLedger introduction, our partners explore how data privacy and blockchain are being used to shape the project and our patient-centric solutions, and look into how PharmaLedger is reshaping the informed consent process for clinical trials with our eConsent use case. Speakers include PharmaLedger Regulatory, Legal & Data Privacy Framework Co-Lead Nenad Georgiev (KU Leuven), eConsent use case co-lead Hernando Giraldo (Boehringer Ingelheim), and Baldwin Mak (Boehringer Ingelheim).
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
www.imi.europa.eu
Disclaimer: Any information on this article solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
Taking The Pulse of Medtech innovation_Pitchbook, Dec, 2021Levi Shapiro
Report by Pitchbook (a Morningstar company), December, 2021- Taking the Pulse of Medtech Innovation. Medtech versus biotech: A capital investment comparison of the life sciences subsectors.
The red-hot life sciences industry has seen incredible growth in the last decade as the biomedical revolution of the early 21st century has gained traction. Key discoveries, ranging from the development of recombinant protein production to bioprosthetic implants to genome engineering, have propelled capital investment from VC investors to the tune of$20 billion annually for the past three years, with over $44 billion already deployed to life sciences companies in 2021 alone. Given large-cap multinational companies’ aversion to investing financial and human capital into high-risk early-stage research & development (R&D) projects, innovation within life sciences has fallen upon startups and venture-backed companies.
This white paper discusses trends in the medical device market and manufacturing in Asia. It notes that the medical device market is growing more slowly in Western countries but quickly in developing countries, especially Asia. Many large Western medical device companies are opening new manufacturing facilities and expanding existing ones in Asia to reduce costs and access growing Asian markets. The white paper provides an overview of the size and growth of major medical device markets globally and in Asia. It also summarizes manufacturing facilities and industry zones near Shanghai that are attractive for medical device production.
This feasibility analysis examines developing a nucleic acid detection probe for fungal infections. It discusses the unmet need for rapid and accurate diagnosis of fungal sepsis in immunocompromised patients. Currently, diagnosis can take 2-4 days via blood culture and has low sensitivity. The proposed invention is a DNA-based probe that can detect fungal infections in 4-10 hours with higher sensitivity. The analysis covers the intellectual property landscape, potential licensees in biotech and diagnostics, licensing terms, and financial projections. It estimates the US market size as $900 million annually and projects revenues of $198 million within 5 years of licensing. However, the single patent expires in 2017. The recommendation is to donate the intellectual property to research
A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st ...PharmaLedger
In this #1 Open Webinar | A trust-centric healthcare journey presentation, you will find:
An introduction to the PharmaLedger project presented by Lynn Wang (Johnson & Johnson)
Topic 1 | Clinical Supply Traceability presented by Francesco Spoto (Novartis) and Chad Sklodosky (Pfizer)
Topic 2 | Finished Goods Traceability presented by Dr Jan Wortmann (Bayer) and Bernhard Salb (Roche)
Topic 3 | ePI – Electronic Product Information presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Topic 4 | Anti-Counterfeiting presented by Daniel Fritz (Novartis) and Alberto Lòpez (Imprensa Nacional Casa da Moeda)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Theranos presented to investors with the goal of becoming the standard for improving drug therapies. Its initial market is phase IV clinical trials, using a product platform of cartridges, readers, and informatics services. Founded in 2003 with 50 employees, Theranos aims to generate $120-300M in revenue over 1.5 years through deals with pharmaceutical companies. The company's system allows for simultaneous quantitative measurement of drugs and biomarkers from small blood samples, returning results comparable to gold standards within 30 minutes. Theranos' value proposition is improving drug labels and safety by enabling real-time pharmacokinetic and pharmacodynamic monitoring during trials and treatment.
A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedge...PharmaLedger
In this presentation, you will find:
An introduction to the PharmaLedger project presented by Maria Eugenia (Xenia) Beltran | Project Coordinator / DRA and Use Case co-lead (Universidad Politécnica de Madrid)
Topic 1 | Clinical Trial eRecruitment | Despina Daliani (Onorach) and Ken Nessel (Pfizer)
Topic 2 | Clinical Trial eConsent | Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
Topic 3 | Health Data IoT Medical Device | Disa Lee Choun (UCB) and Francesca Rocchi (Bambino Gesù Children Hospital)
Topic 4 | Health Data Personalised Medicine | Beatriz Merino (Universidad Politécnica de Madrid) and Christos Kontogiorgis (Democritus University of Thrace)
You can also learn more about our #2 Open Webinar on Clinical Trials & Health Data by rewatching our video recording including the Q&A by clicking on the button below:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.
Bioexpert network have evalutionized of ArtGen Boris Maizel
We've created a method restoration of blood supply for the treatment of ischemia. We've launched a bio startup based in Rockville, MD. Founded in 2015, ArtGen is developing a novel non-viral gene therapy for treatment of vascular diseases. For the evaluation of the company, the experts have had access to the pitch deck of the Artgen and to the responses and comments that the company has been offering through the discussion forum.
These slides use concepts from my (Jeff Funk) course entitled Biz Models for Hi-Tech Products to analyze the business model for a real-time microbial detector from Instant Bio-Scan. This detector provides real time information on the existence of microbes in water using a laser- and photo-sensor-based system. Photo-sensors can identify microbes faster and with higher accuracies than can conventional systems that may take weeks before an analysis is done. Instant Bio-scan is targeting water treatment and pharmaceutical plants.
A complete scenario of Medical Device Industry Of USA and India as well as of some major players. The presentation also highlights the Rules and regulations with respect to the devices and also SWOT analysis of emerging markets
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
These slides use concepts from my (Jeff Funk) course on Business Models at National University of Singapore to analyze the business model for Theranos. Theranos provides diagnostic testing for consumers that is faster and cheaper than the existing system. Its tests are done in easy to access pharmacies (e.g., Walgreens) as opposed to hard-to reach doctors’ offices. The tests use small bio-electronic integrated circuits (ICs) instead of large scientific instruments. These ICs utilize micro-fluidic channels that require a pin-prick of blood instead of a vial of blood, which makes the tests more appealing and faster than the traditional tests. The slides describe the value proposition, method of value capture, customers, scope of activities, and method of strategic control for Theranos.
This document provides an overview of the challenges facing life science startups in therapeutics, diagnostics, medical devices, and digital health. It discusses the increasing costs and regulatory hurdles of drug and device development, including higher clinical trial standards and FDA scrutiny. This has led to declining venture capital investment in life sciences as startups face greater challenges in achieving approval and profitability. The author proposes testing a Lean LaunchPad approach to help life science startups commercialize research more efficiently and reverse negative industry trends.
New medical device regulation: implications for medical device manufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn More: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulation updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as knowledge resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
The document discusses trends in medical device manufacturing and regulation. It provides an overview of Georgia's Centers of Innovation which support industry collaborations. It also summarizes challenges with the FDA approval process, including lengthy times and high costs of clinical trials that have stalled innovation. Stakeholders are advocating for reforms that balance appropriate oversight with supporting new technologies to benefit patients.
SMi Group's Pre-filled Syringes East Coast 2019Dale Butler
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place April 8-10, 2019 in Boston. The conference will focus on the future of injectable drug delivery and feature speakers from pharmaceutical and device companies to discuss topics like regulations, connected devices, and patient-centricity. It will include presentations, panels, and workshops on developing combination products, human factors testing, digital health technologies, and more. Attendees can network and learn about the latest in pre-filled syringe development from industry experts.
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.
Emerging Trends In Medical Device ManufacturingEWI
To continue a trajectory of steady growth, the global medical device industry must adapt to the dynamic changes disrupting the healthcare landscape. An aging population, a push for more personalized treatment, and the increasing availability of healthcare are some of the factors driving new markets and an expanding consumer base. In addition, regulatory scrutiny and federal initiatives like the medical device excise tax have levied extra pressure on R&D budgets.
PharmaLedger’s Spotlight Session Presentations at DIA Europe 2021PharmaLedger
Download PharmaLedger’s Spotlight Session presentations from DIA Europe 2021.
In addition to our 3D Virtual Booth that took place all week long at DIA Europe 2021, PharmaLedger hosted two 60-minute Spotlight Sessions.
Spotlight Session #1: PharmaLedger – Demonstrating the Vision of Blockchain Enabled Healthcare
Tuesday, March 16th the sessions kicks off with an introduction of the PharmaLedger project, followed by a look into our Electronic Product Information (ePI) and Anti-Counterfeiting use cases, then concluding with a full demonstration of our first prototype of the PharmaLedger ePI app. Speakers include PharmaLedger Industry Lead Daniel Fritz (Novartis), and ePI use case co-leads Patrick Maher (Novartis) and Ken Thursby (MSD).
Spotlight Session #2: PharmaLedger – Data Privacy and the Vision of a Blockchain Enabled Healthcare
Friday, March 19th following a PharmaLedger introduction, our partners explore how data privacy and blockchain are being used to shape the project and our patient-centric solutions, and look into how PharmaLedger is reshaping the informed consent process for clinical trials with our eConsent use case. Speakers include PharmaLedger Regulatory, Legal & Data Privacy Framework Co-Lead Nenad Georgiev (KU Leuven), eConsent use case co-lead Hernando Giraldo (Boehringer Ingelheim), and Baldwin Mak (Boehringer Ingelheim).
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
www.imi.europa.eu
Disclaimer: Any information on this article solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
Taking The Pulse of Medtech innovation_Pitchbook, Dec, 2021Levi Shapiro
Report by Pitchbook (a Morningstar company), December, 2021- Taking the Pulse of Medtech Innovation. Medtech versus biotech: A capital investment comparison of the life sciences subsectors.
The red-hot life sciences industry has seen incredible growth in the last decade as the biomedical revolution of the early 21st century has gained traction. Key discoveries, ranging from the development of recombinant protein production to bioprosthetic implants to genome engineering, have propelled capital investment from VC investors to the tune of$20 billion annually for the past three years, with over $44 billion already deployed to life sciences companies in 2021 alone. Given large-cap multinational companies’ aversion to investing financial and human capital into high-risk early-stage research & development (R&D) projects, innovation within life sciences has fallen upon startups and venture-backed companies.
This white paper discusses trends in the medical device market and manufacturing in Asia. It notes that the medical device market is growing more slowly in Western countries but quickly in developing countries, especially Asia. Many large Western medical device companies are opening new manufacturing facilities and expanding existing ones in Asia to reduce costs and access growing Asian markets. The white paper provides an overview of the size and growth of major medical device markets globally and in Asia. It also summarizes manufacturing facilities and industry zones near Shanghai that are attractive for medical device production.
This feasibility analysis examines developing a nucleic acid detection probe for fungal infections. It discusses the unmet need for rapid and accurate diagnosis of fungal sepsis in immunocompromised patients. Currently, diagnosis can take 2-4 days via blood culture and has low sensitivity. The proposed invention is a DNA-based probe that can detect fungal infections in 4-10 hours with higher sensitivity. The analysis covers the intellectual property landscape, potential licensees in biotech and diagnostics, licensing terms, and financial projections. It estimates the US market size as $900 million annually and projects revenues of $198 million within 5 years of licensing. However, the single patent expires in 2017. The recommendation is to donate the intellectual property to research
A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st ...PharmaLedger
In this #1 Open Webinar | A trust-centric healthcare journey presentation, you will find:
An introduction to the PharmaLedger project presented by Lynn Wang (Johnson & Johnson)
Topic 1 | Clinical Supply Traceability presented by Francesco Spoto (Novartis) and Chad Sklodosky (Pfizer)
Topic 2 | Finished Goods Traceability presented by Dr Jan Wortmann (Bayer) and Bernhard Salb (Roche)
Topic 3 | ePI – Electronic Product Information presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Topic 4 | Anti-Counterfeiting presented by Daniel Fritz (Novartis) and Alberto Lòpez (Imprensa Nacional Casa da Moeda)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Theranos presented to investors with the goal of becoming the standard for improving drug therapies. Its initial market is phase IV clinical trials, using a product platform of cartridges, readers, and informatics services. Founded in 2003 with 50 employees, Theranos aims to generate $120-300M in revenue over 1.5 years through deals with pharmaceutical companies. The company's system allows for simultaneous quantitative measurement of drugs and biomarkers from small blood samples, returning results comparable to gold standards within 30 minutes. Theranos' value proposition is improving drug labels and safety by enabling real-time pharmacokinetic and pharmacodynamic monitoring during trials and treatment.
A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedge...PharmaLedger
In this presentation, you will find:
An introduction to the PharmaLedger project presented by Maria Eugenia (Xenia) Beltran | Project Coordinator / DRA and Use Case co-lead (Universidad Politécnica de Madrid)
Topic 1 | Clinical Trial eRecruitment | Despina Daliani (Onorach) and Ken Nessel (Pfizer)
Topic 2 | Clinical Trial eConsent | Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
Topic 3 | Health Data IoT Medical Device | Disa Lee Choun (UCB) and Francesca Rocchi (Bambino Gesù Children Hospital)
Topic 4 | Health Data Personalised Medicine | Beatriz Merino (Universidad Politécnica de Madrid) and Christos Kontogiorgis (Democritus University of Thrace)
You can also learn more about our #2 Open Webinar on Clinical Trials & Health Data by rewatching our video recording including the Q&A by clicking on the button below:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.
Bioexpert network have evalutionized of ArtGen Boris Maizel
We've created a method restoration of blood supply for the treatment of ischemia. We've launched a bio startup based in Rockville, MD. Founded in 2015, ArtGen is developing a novel non-viral gene therapy for treatment of vascular diseases. For the evaluation of the company, the experts have had access to the pitch deck of the Artgen and to the responses and comments that the company has been offering through the discussion forum.
These slides use concepts from my (Jeff Funk) course entitled Biz Models for Hi-Tech Products to analyze the business model for a real-time microbial detector from Instant Bio-Scan. This detector provides real time information on the existence of microbes in water using a laser- and photo-sensor-based system. Photo-sensors can identify microbes faster and with higher accuracies than can conventional systems that may take weeks before an analysis is done. Instant Bio-scan is targeting water treatment and pharmaceutical plants.
A complete scenario of Medical Device Industry Of USA and India as well as of some major players. The presentation also highlights the Rules and regulations with respect to the devices and also SWOT analysis of emerging markets
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
These slides use concepts from my (Jeff Funk) course on Business Models at National University of Singapore to analyze the business model for Theranos. Theranos provides diagnostic testing for consumers that is faster and cheaper than the existing system. Its tests are done in easy to access pharmacies (e.g., Walgreens) as opposed to hard-to reach doctors’ offices. The tests use small bio-electronic integrated circuits (ICs) instead of large scientific instruments. These ICs utilize micro-fluidic channels that require a pin-prick of blood instead of a vial of blood, which makes the tests more appealing and faster than the traditional tests. The slides describe the value proposition, method of value capture, customers, scope of activities, and method of strategic control for Theranos.
This document provides an overview of the challenges facing life science startups in therapeutics, diagnostics, medical devices, and digital health. It discusses the increasing costs and regulatory hurdles of drug and device development, including higher clinical trial standards and FDA scrutiny. This has led to declining venture capital investment in life sciences as startups face greater challenges in achieving approval and profitability. The author proposes testing a Lean LaunchPad approach to help life science startups commercialize research more efficiently and reverse negative industry trends.
New medical device regulation: implications for medical device manufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn More: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulation updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as knowledge resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
The document discusses trends in medical device manufacturing and regulation. It provides an overview of Georgia's Centers of Innovation which support industry collaborations. It also summarizes challenges with the FDA approval process, including lengthy times and high costs of clinical trials that have stalled innovation. Stakeholders are advocating for reforms that balance appropriate oversight with supporting new technologies to benefit patients.
SMi Group's Pre-filled Syringes East Coast 2019Dale Butler
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place April 8-10, 2019 in Boston. The conference will focus on the future of injectable drug delivery and feature speakers from pharmaceutical and device companies to discuss topics like regulations, connected devices, and patient-centricity. It will include presentations, panels, and workshops on developing combination products, human factors testing, digital health technologies, and more. Attendees can network and learn about the latest in pre-filled syringe development from industry experts.
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.
Building Consumer-Facing Health Devices and Apps and Doing it RightKent State University
Presentation to the Medical Capital Innovation Competition in Cleveland 4/23/18 including the regulatory pathway, importance of evidence and data integration.
Oxford AHSN Map My App Event 29th Jan 2014Anthony A Hill
The document outlines a 6 stage process for developing mobile health apps for the NHS. It discusses evaluating needs and requirements, designing prototypes, user testing, stakeholder reviews, medical device approvals if needed, and finally external deployment including options for commercialization. It provides background on the growing market for mHealth apps and considerations around ensuring patient safety, data privacy, and addressing a fragmented Android environment.
Building Consumer-Facing Health Devices and Apps and Doing it RightKent State University
John Sharp presented on building consumer-facing health devices and apps. He discussed key points like developing solutions that solve problems, understanding the market, prototyping and piloting before adopting and scaling, understanding the regulatory pathway, the importance of evidence, integrating data, and changing health behaviors. He also provided information on partnering with health systems, getting products to scale, involving patients in co-design, the FDA's digital health precertification program, developing digital evidence, and standards for data integration like FHIR and Continua Design Guidelines.
Shaping a Brighter Future: New Advancements in Healthcare Technology
Learning objective: Address the challenges of healthcare under Obamacare
Health IT is a major component of healthcare reform. The Obama Patient Protection and Affordable Care Act (PPACA) aims to reduce cost of health care and decrease the number of uninsured Americans. Advancement in Healthcare technology will be a critical player in improving healthcare outcomes and streamlining the delivery of health care. As we move forward, Health IT will continue to strive to meet the demands for existing and new drug channels, advancing drug discovery, and development, increased quality care, efficiency, and cost-effectiveness. This seminar will examine the role of PPCA in advancing healthcare technology to meet increasing healthcare needs and demands.
At the end of this seminar participants will be able to:
a. Identify challenges in healthcare delivery systems
b. Examine existing and new drug channels
c. Explore Systems Pharmacology Goals and Supply Chain integrity
d. Explore the Obama Patient Protection and Affordability Care Act and its impact on Healthcare technology
WHO Guideline on Quality Risk Management PostgradoMLCC
This document outlines a proposed guideline on quality risk management from the World Health Organization. It discusses applying risk management principles to both medicines regulatory authorities and pharmaceutical manufacturers. The goal is to help focus resources on risks to patients, encourage science-based decision making, and improve communication between organizations. The draft guideline is being circulated for comment before finalization.
Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...Yole Developpement
How will artificial organs revolutionize organ transplants and overcome shortages in the next 20 years?
FIVE OUT OF THE TEN LEADING CAUSES OF DEATH IN THE WORLD WILL BENEFIT FROM ARTIFICIAL ORGANS
Organ transplantation is often the only treatment for end-state organ failure, such as liver, kidney and heart failure. Tragically, most people on the waiting list die before they ever get an organ. Hence the dream of developing artificial organs made of electronic and mechanical parts has been around for decades. The first total artificial heart transplant was in the 1980s, yet since then few improvements have made these devices more efficient. Newcomers such as Carmat and Bivacor are aiming to change the paradigm from a single mechanical heart towards a smarter solution, with embedded sensors and intelligence.
The next wave of development came from the diabetes epidemic that affects every country, hitting more than 8% of the global population today. The artificial pancreas market will therefore experience a huge 49% compound annual growth rate (CAGR) over the next five years, to reach $1.3B in 2022. The next breakthrough to happen will come in 5-10 years, bringing artificial lungs and kidneys. The first commercially approved devices will be wearable systems such as the Wearable Artificial Kidney Foundation, Inc. (WAKFI) system.
More information on that report at http://www.i-micronews.com/reports.html
Building Consumer-Facing Health Devices and Apps and Doing it RightKent State University
For the HIMSS Delaware Valley Chapter. solve a problem; prototype, pilot, adopt and scale. FDA regulations, evidence, health behavior change, data integration
The document discusses using big data and remote patient monitoring to create a more personalized electronic health record (EHR) system. It proposes integrating data from sources like wearables, social media, medical devices and patient lifestyle directly into the EHR to improve health outcomes. This would allow healthcare providers to remotely monitor patients in a more convenient and cost-effective manner. The market for remote patient monitoring solutions is expected to grow significantly in coming years as its adoption increases.
SMi Group's 9th annual Pre-filled Syringes Europe 2017 Dale Butler
This document provides information on two half-day pre-conference workshops on January 17th, 2017 regarding pre-filled syringes in London, UK. Workshop A from 8:30-12:30 will explore how personalized medicine, enhanced patient experience, and improved outcomes will drive the development of digital therapy management ecosystems and how this will impact future parenteral drug delivery devices. Workshop B from 13:30-18:15 will examine regulatory challenges at the interface of medicines and medical devices. Both workshops aim to provide insights on these important topics for professionals in the pre-filled syringes industry.
This document discusses health challenges related to demographic changes and well-being under the Horizon 2020 program. It provides an overview of the Health challenge including priorities to promote active and healthy aging, a whole life approach, scaling up research, and reducing health inequalities. The document reviews funding rules and evaluation criteria for Horizon 2020. It also provides details on specific calls within the 2016-2017 work program related to personalized medicine, including calls on population cohorts, ICT solutions for aging, robotics, virtual coaching, and in-silico trials.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
AI-based Business Models in Healthcare: An Empirical Study of Clinical Decisi...ICDEcCnferenece
Marija Radic, Claudia Vienken, Laurin Nikschat, Thore Dietrich, Holger König, Lorenz Laderick and Dubravko Radic. AI-based Business Models in Healthcare: An Empirical Study of Clinical Decision Support Systems. (ICDEc 2022)
Sri Guru Hargobind Ji - Bandi Chor Guru.pdfBalvir Singh
Sri Guru Hargobind Ji (19 June 1595 - 3 March 1644) is revered as the Sixth Nanak.
• On 25 May 1606 Guru Arjan nominated his son Sri Hargobind Ji as his successor. Shortly
afterwards, Guru Arjan was arrested, tortured and killed by order of the Mogul Emperor
Jahangir.
• Guru Hargobind's succession ceremony took place on 24 June 1606. He was barely
eleven years old when he became 6th Guru.
• As ordered by Guru Arjan Dev Ji, he put on two swords, one indicated his spiritual
authority (PIRI) and the other, his temporal authority (MIRI). He thus for the first time
initiated military tradition in the Sikh faith to resist religious persecution, protect
people’s freedom and independence to practice religion by choice. He transformed
Sikhs to be Saints and Soldier.
• He had a long tenure as Guru, lasting 37 years, 9 months and 3 days
Impartiality as per ISO /IEC 17025:2017 StandardMuhammadJazib15
This document provides basic guidelines for imparitallity requirement of ISO 17025. It defines in detial how it is met and wiudhwdih jdhsjdhwudjwkdbjwkdddddddddddkkkkkkkkkkkkkkkkkkkkkkkwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwioiiiiiiiiiiiii uwwwwwwwwwwwwwwwwhe wiqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqq gbbbbbbbbbbbbb owdjjjjjjjjjjjjjjjjjjjj widhi owqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqq uwdhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhwqiiiiiiiiiiiiiiiiiiiiiiiiiiiiw0pooooojjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjj whhhhhhhhhhh wheeeeeeee wihieiiiiii wihe
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Prediction of Electrical Energy Efficiency Using Information on Consumer's Ac...PriyankaKilaniya
Energy efficiency has been important since the latter part of the last century. The main object of this survey is to determine the energy efficiency knowledge among consumers. Two separate districts in Bangladesh are selected to conduct the survey on households and showrooms about the energy and seller also. The survey uses the data to find some regression equations from which it is easy to predict energy efficiency knowledge. The data is analyzed and calculated based on five important criteria. The initial target was to find some factors that help predict a person's energy efficiency knowledge. From the survey, it is found that the energy efficiency awareness among the people of our country is very low. Relationships between household energy use behaviors are estimated using a unique dataset of about 40 households and 20 showrooms in Bangladesh's Chapainawabganj and Bagerhat districts. Knowledge of energy consumption and energy efficiency technology options is found to be associated with household use of energy conservation practices. Household characteristics also influence household energy use behavior. Younger household cohorts are more likely to adopt energy-efficient technologies and energy conservation practices and place primary importance on energy saving for environmental reasons. Education also influences attitudes toward energy conservation in Bangladesh. Low-education households indicate they primarily save electricity for the environment while high-education households indicate they are motivated by environmental concerns.
Open Channel Flow: fluid flow with a free surfaceIndrajeet sahu
Open Channel Flow: This topic focuses on fluid flow with a free surface, such as in rivers, canals, and drainage ditches. Key concepts include the classification of flow types (steady vs. unsteady, uniform vs. non-uniform), hydraulic radius, flow resistance, Manning's equation, critical flow conditions, and energy and momentum principles. It also covers flow measurement techniques, gradually varied flow analysis, and the design of open channels. Understanding these principles is vital for effective water resource management and engineering applications.
Digital Twins Computer Networking Paper Presentation.pptxaryanpankaj78
A Digital Twin in computer networking is a virtual representation of a physical network, used to simulate, analyze, and optimize network performance and reliability. It leverages real-time data to enhance network management, predict issues, and improve decision-making processes.
Digital Twins Computer Networking Paper Presentation.pptx
Embracing change mtf_a_joseph_mar-2019_ss
1. Embracing Change:
Modern Management of
Connected Medical Devices
Aaron Joseph
Principal Consultant - Sunstone Pilot, Inc.
sunstonepilot.com
Presented to MedTech Fron4ers – March 7, 2019
h@p://www.tripleringtech.com/category/medtechfronHers/
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 1
2. Aaron Joseph
Principal Consultant – Sunstone Pilot, Inc.
• 20+ years medical device development over a wide range of products:
• surgical roboHcs system, digital x-ray fluoroscopy system, drug inhaler devices, roboHc
catheter system, x-ray catheter for brachytherapy, laser eye surgery system, and heart-lung
bypass machine, mulHple IOT products
• >50 product development projects and >25 quality systems
• Assist clients with all aspects of design controls: risk management,
requirements management, V&V tesHng, refining design controls procedures,
and training R&D staff
• Implement requirements management tools to streamline DHF documentaHon
• Avid promoter of lean and agile methods for medical device development
• BSEE - Rice University and MS Bioengineering - University of Washington
2 Copyright 2019 Sunstone Pilot, Inc. 7-MAR-2019
4. New CapabiliFes à New Challenges
• More features à greater complexity, more
sobware components, more 3rd party sobware
• Connected à cybersecurity risks, privacy risks,
interoperability challenges
+ Greater regulatory scruHny!
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 4
5. Example Connected Medical Device
Firmware on
watch
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 5
• Wearable device + mobile app + cloud
• Heart monitor + analysis of other paHent data
• Distributed architecture with mulHple sobware plaiorms
Mobile app on
smart phone
Data analysis and storage on
cloud plaiorm
Browser or client app
on laptop
6. EscalaFng Cost of Change
Cost of Change
Product Launch
Product Development Timeline
Copyright 2019 Sunstone Pilot, Inc. 6 7-MAR-2019
Concept Pre-Produc4on Produc4on
?
Where is the design freeze?
How are changes handled aber design freeze?
Or aber product launch?
7. Design Controls and
Product Development
Developing products in a highly regulated environment
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 7
8. Design Controls
Establish and maintain procedures for…
1. Design and Development Planning – selng up for success
2. Design Input – what does the product need to do?
3. Design Output – what the product is
4. Design Verifica4on – does output conform to input?
5. Design Valida4on – does product meet user needs?
6. Design Review – are we on the right path?
7. Design Changes – improving product
8. Design Transfer – gelng new product into manufacturing
9. Design History File – how we ended up with the current product (also: shows
we did all of the above)
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 8
ß Involves all the other aspects of design controls
9. Product Development in Phases
3
Verifica4on
4
Pre-Produc4on
5
Produc4on
0
Concept
510k submission
Product Launch
GATE
GATE
1
Planning
2
Development
GATE
GATE
-Product
development
planning,
-Hazard Analysis,
-Requirements &
architecture
-Regulatory
strategy
Mfg
Process
valida4on
+
Launch
readiness
-HW & SW design,
-Detailed Risk Analysis,
-Prototyping
-Test method
development
-Mfg process development
-Design freeze
-Design verifica4on
-Mfg process
development
-Clinical tes4ng,
-Human factors
tes4ng
-Prepare
submission
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 9
DHF documents
10. Product Development Finished (?)
3
Verifica4on
4
Pre-Produc4on
5
Produc4on
0
Concept
Product Launch
1
Planning
2
Development
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 10
What does “Product Launch” really mean?
• product development team view = “All done!”
• company view = How can we lower mfg costs and increase sales?
• customer view = “just the baseline product that needs improvement”
à New set of challenges aber launch
11. Changes aLer Product Launch
Wait, I thought we were done!
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 11
12. Hardware vs. SoLware
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 12
What are typical changes
aber product launch?
Hardware-Only Device So[ware-Intensive Device
• Changes to packaging / labeling
• Changes to component suppliers
• Refinements to mfg process steps
(same)
• SW changes due to updated OS or 3rd party library
• SW changes to maintain interoperability
• SW changes to address security vulnerability
• Changes to GUI or other funcHons
• AddiHonal features
Ex: intravascular
catheter
VS
Not
planned
13. Product Design Changes
• How does a medical device company manage changes to a released
product?
• Changes can be internally driven (planned enhancements) or externally
driven (customer complaints, security issues, interoperability issues, etc.)
• Changes can be urgent or non-urgent
• Changes to product can be small or big
• What’s the best way to handle a wide variety of possible changes?
• Is the company even set up to handle changes?
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 13
14. Example Triage of Design Changes
Process scaled appropriately to different types of changes
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 14
Sobware Patch
Small?
Manage through rouHne
change process (ECO)
No
Yes
Big ?
No
SW
only?
Major Project: repeat all design controls
Yes
Change Needed*
Yes
3
Verifica4on
1
Planning
2
Development
4
Pre-Produc4on
Product Re-Release
Criteria to evaluate design changes (not exhausHve):
• New product feature?
• New hazards or risks?
• New regulatory filing?
• Large performance change?
• Major or minor change to requirements?
Minor Sobware Project
(SW design controls)
Minor Project (HW & SW):
repeat some design controls
No
No change to SW reqts
SW Release
*part of a larger change review process (i.e. involving a Change Review Board)
15. ImplemenFng Changes & UpdaFng DHF
• Problem: users repeatedly press wrong bu@on on watch
• SoluHon: change GUI on watch and GUI on phone (minor SW Project)
• New SW Project:
• Update DHF docs: SW Dev Plan, Risk analysis, SW reqts, SW design, SW test cases
• Revise sobware (in watch, in mobile app)
• Perform tesHng of modified sobware + regression tesHng
• Update DHF docs: SW reports, SW trace matrix, SW release docs
• Sobware release
• SW release candidate à SW release à product release
NOTE: Any change to the product SW is a new SW release, including small patches
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 15
Key Tools: task mgmt / defect tracking tool, requirements mgmt tool, test mgmt tool, SW configuraHon mgmt tool
16. Minimizing cost of design
changes
Corollary: prepare for change!
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 16
17. Minimize Cost of Design Changes
• Flexible development processes (scale to size and type of changes)
• Short review/approval cycles (days not weeks)
• Well-defined SW configuraHon and release process (“turn the crank”)
• Product designed for upgradeability (modular architecture, well-
defined interfaces, secure SW patching, etc.)
• Automated sobware tesHng
• Automated documentaHon (via requirements mgmt / ALM tool)
NOTE: These measures apply primarily to sobware changes (more difficult to minimize cost of
hardware changes)
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 17
18. Agile Cycles and Design Planning
Sprint Plan
Release Plan
Project Plan
• Design controls are organized around mulHple
cycles (layers)
• Project = one or more Releases
• Release = one or more Sprints
• Planning performed at all layers
• Regular updates to DHF documentaHon
18
SW Projects are controlled by a Sobware Development Plan:
• Defines all acHviHes and deliverables for project compleHon
• IdenHfies dependencies with other funcHons for product
release (Regulatory, Mfg, Clinical Training, Service, etc.)
• Enables team to scale to small or big SW projects
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc.
19. Managing SW Development by Project
19
R1 Release
SW Development Plan SW Maintenance
3 key acHviHes:
• SW verificaHon
• Document updates
• Design review
R1 candidate
S6 S7 S8
sprints
Working SW
from each sprint
S9 S10
R2 Release
R2 candidate
. . .
S13
R3 Release
R3 candidate
. . .
Commercial Release
V1.0 V1.1 V1.2
P1
P1 Release
P1 patch
V1.2.1
. . .
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc.
21. Monitoring (Product Surveillance)
• Customer complaint handling
• Incident response
• Bug fixes
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 21
What to look for?
22. Inputs to SoLware Defect Tracking – Post Release
7-MAR-2019 Copyright 2019 Sunstone Pilot, Inc. 22
Evaluate
SW Issue
Engineering Test
Clinical Test
Product Logs
Customer Feedback
Changes in SOUP
SQA
SW
change needed
now?
Keep issue for
next SW release
Evaluate SW
Change
• Safety impact?
• Regulatory impact?
• Fits within a maintenance patch?
Implement SW Change:
• Revise SW
• Test SW change + regression tests
• Other tests
• Update DHF/RMF
• Release SW
No
Yes
Changes to environment
(interoperability)
Cybersecurity Vulnerability
23. SoLware Patches
• Patches released in response to:
• Minor bug fixes
• Security issues
• OS / 3rd Party sobware upgrades
• Design new products for patching
• Secure, remote (over-the-air) sobware upgrades
• Consider designing 2 means of patching in case one
becomes vulnerable in the future
• Establish a cadence of SW patches to manage all
non-urgent changes
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24. Cybersecurity VulnerabiliFes Discovered Frequently in Medical Devices
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h@ps://mdviper.org/ics-cert-vulnerability-alerts-advisories/ (from MDISS website)
28. Managing Cost of Change
Cost of Change
Product Launch
Product Development Timeline
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Concept Pre-Produc4on Produc4on
Avoid inflaHng cost of change due to
inappropriate design control procedures
Set up processes and tools to:
(1) minimize cost of change* aber launch and
(2) get benefits before launch
*SW changes only
29. Slow Can Be Dangerous!
• The risks of responding slowly to a needed change (heart monitor):
• Unhappy customers ($)
• CommunicaHon failure—delayed diagnosis
• Malicious a@ack—incorrect data leading to incorrect prescripHon leading to
paHent harm
• For other devices, the risks can be even greater!
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30. Processes Prepared for Change
• Agile methods for product development
• Design iteraHons are expected during development (and aber product launch)
• Design controls are not forced to be sequenHal (don’t create a “waterfall” framework)
• MulHple iteraHons of risk management, design inputs, design outputs, V&V tesHng
• ConHnuum of product knowledge: development à sustaining
• Streamlined compliance
• Minimize delays in review, approval, and release
• Eliminate redundant records
• Centralized issue tracking (not compartmentalized)
• Test automaHon
• DocumentaHon automaHon
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31. Summary
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• Companies that are adept at managing product design changes:
• faster at product development
• be@er at post-market maintenance
• => longer product life!
• MulHple external factors can drive SW changes aber product launch
• Ensuring product safety and effecHveness:
• Old paradigm: prevenHng change
• New paradigm: responding to change
32. Suggested Online Resources
Background on managing highly iteraHve product development:
• h@ps://www.youtube.com/watch?v=502ILHjX9EE - Agile Product Ownership in a Nutshell – a short, animated descripHon of
scrum in operaHon by Henrik Kniberg
• h@ps://less.works/ - Large Scale Scrum (LeSS) framework for large scale projects
• h@p://www.scaledagileframework.com/ - a management system for large scale projects (SaFE)
• h@p://www.leanprimer.com/downloads/lean_primer.pdf - good overview of lean principles wri@en by two sobware
management consultants (Craig Larman and Bas Vodde) who include aspects of sobware agile methods as well.
Cybersecurity for connected medical devices:
• FDA Cybersecurity Guidances
• h@ps://www.fda.gov/medicaldevices/digitalhealth/ucm373213.htm
• h@ps://www.fda.gov/downloads/medicaldevice/deviceregulaHonandguidance/guidancedocuments/ucm482022.pdf
• Product Security Framework and security templates from the BD company website:
• h@p://www.bd.com/en-us/support/product-security-and-privacy
• NIST Cybersecurity Home Page with “Cybersecurity Framework”
• h@ps://www.nist.gov/topics/cybersecurity
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33. Q & A
Aaron Joseph
• Streamlined compliance for medical device development
• Assist clients with all aspects of design controls: risk management, requirements
management, V&V tesHng, refining procedures
• Contact me to schedule a Lunch & Learn or training session for your team:
• aaronanswers@gmail.com
• 408-529-2490
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