Join us in learning the newest trends and technical advances in the use of Polymeric Materials in Medical Applications; speakers are from premier institutions such as the world-class Ronald Reagan Medical Center at UCLA, ABBOTT Vascular, JOHNSON & JOHNSON-Cordis, BOSTON SCIENTIFIC, MEDTRONIC, REVA Medical, MiMEDX, BECKTON DICKINSON, ROCHE Diagnostics and more.
For Registration / Sponsorship / Details, please CLICK the link below:
http://www.MediPlastConference.com
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
EMR functionality for clinical research has long been dreamed about, but how close to reality is it actually? This presentation lays out some basic facts about the viability (or lack thereof) of using EMRs for Phase 1-3 clinical trials.
FDA STAMP Conference on CNS Shunts Agenda January 1999Stephen Dolle
Conference agenda for the 1999 STAMP Conference on CNS Shunts and anti siphon devices in Bethesda, MD, brought about by patient advocate Stephen Dolle and his efforts with a 1996 petition to FDA on anti siphon shunts. Dolle oddly was not invited to speak or be a panelist, or to have his new mHealth DiaCeph Test included in the conference. In the years since, CNS shunts have suffered significant medical device and design failures, most of which have not been reported to FDA, which Dolle attributes to the cover ups dating back to this conference. As of 2015, Dolle has undergone 12 shunt operations, with the majority of these caused by failing CNS shunts that were never reported to FDA. The more your know!
Patient Advocate Stephen Dolle's FDA Stamp Conference RecommendationsStephen Dolle
This is a paper of FDA STAMP Conference recommendations FDA patient advocate and CNS shunt user Stephen Dolle, which he wrote for this 1999 Conference in Bethesda, MD, a conference he was responsible for, yet was not invited to speak on panel, nor was his new solution oriented DiaCeph Test included in the conference. STAMP was held in part due to Dolle's 1996 FDA petition on anti siphon shunts, of which he was an affected user, and FDA upheld, but oddly withheld their Sept. 1998 ruling from the Federal Register. Dolle did everything he could possibly do to bring progress in CNS shunts, yet wasn't allowed.
You can read from his recommendations back in 1999 that he had a vision to bring progress in this area. Since 1999, CNS shunts have been plagued by widespread device failures, more notably programmable shunts.
CNS shunts users today face new risks from years of over use of CT scanning, which DiaCeph would have reduced. Some patients have had as many as 100 and 200.
I can be reached at contact[at]dollecommunications[dot]com and via my blog.
FDA's David L. Daly July 2002 Response and Denial to include CNS shunts in ne...Stephen Dolle
This is David L. Daly of the FDA official response and denial to my request to add CNS shunts to new 2002 FDA post market surveillance that would have likely prevented all of the failures with programmable and other CNS shunts in the years between 1999-2013. David Daly's negligence here ushered in a flood of failures with CNS shunts. I no longer have 949-642-4592 telephone number. Please reach me at contact[at]dollecommunications[dot]com
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
EMR functionality for clinical research has long been dreamed about, but how close to reality is it actually? This presentation lays out some basic facts about the viability (or lack thereof) of using EMRs for Phase 1-3 clinical trials.
FDA STAMP Conference on CNS Shunts Agenda January 1999Stephen Dolle
Conference agenda for the 1999 STAMP Conference on CNS Shunts and anti siphon devices in Bethesda, MD, brought about by patient advocate Stephen Dolle and his efforts with a 1996 petition to FDA on anti siphon shunts. Dolle oddly was not invited to speak or be a panelist, or to have his new mHealth DiaCeph Test included in the conference. In the years since, CNS shunts have suffered significant medical device and design failures, most of which have not been reported to FDA, which Dolle attributes to the cover ups dating back to this conference. As of 2015, Dolle has undergone 12 shunt operations, with the majority of these caused by failing CNS shunts that were never reported to FDA. The more your know!
Patient Advocate Stephen Dolle's FDA Stamp Conference RecommendationsStephen Dolle
This is a paper of FDA STAMP Conference recommendations FDA patient advocate and CNS shunt user Stephen Dolle, which he wrote for this 1999 Conference in Bethesda, MD, a conference he was responsible for, yet was not invited to speak on panel, nor was his new solution oriented DiaCeph Test included in the conference. STAMP was held in part due to Dolle's 1996 FDA petition on anti siphon shunts, of which he was an affected user, and FDA upheld, but oddly withheld their Sept. 1998 ruling from the Federal Register. Dolle did everything he could possibly do to bring progress in CNS shunts, yet wasn't allowed.
You can read from his recommendations back in 1999 that he had a vision to bring progress in this area. Since 1999, CNS shunts have been plagued by widespread device failures, more notably programmable shunts.
CNS shunts users today face new risks from years of over use of CT scanning, which DiaCeph would have reduced. Some patients have had as many as 100 and 200.
I can be reached at contact[at]dollecommunications[dot]com and via my blog.
FDA's David L. Daly July 2002 Response and Denial to include CNS shunts in ne...Stephen Dolle
This is David L. Daly of the FDA official response and denial to my request to add CNS shunts to new 2002 FDA post market surveillance that would have likely prevented all of the failures with programmable and other CNS shunts in the years between 1999-2013. David Daly's negligence here ushered in a flood of failures with CNS shunts. I no longer have 949-642-4592 telephone number. Please reach me at contact[at]dollecommunications[dot]com
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
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.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
Pharma Focus Asia, the leading Pharma Magazine in the industry, provides the latest issue 29 that discusses latest trends happening in the pharma industry. Explore our latest issue to enhance your knowledge. Check our Digital Magazine here: https://goo.gl/FHDDtt
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
10 Most Trusted Medical and Clinical Laboratories in 2022V3 1.pdfinsightscare
In the latest edition of Insights Care's 10 Most Trusted Medical and Clinical Laboratories in 2022, we walk you through the companies whose goals are aligned with the current market technology, trends and innovations, bringing in a wider range of opportunities in treatment catering to patients' needs.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Discover the innovative and creative projects that highlight my journey throu...
Medical Device-Polymers & Plastics
1. www.mediplastconference.com
The theme for this year’s 2-day conference on “Polymers & Plastics in Medical Applications” is to bring the
participants up to speed on the newest trends and technical advances in the field of Medical Devices as it
relates to Polymeric Materials.
The target audience is Medical Device producers, Molders of Sub-Assemblies, Plastic & Additive suppliers,
Equipment & Prototype Designers, Regulatory professionals, Sales, Marketing, and Business Development
leaders throughout the entire supply chain of the Health-Care industry. The conference has been structured to
provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the
value chain.
Conference Chairs
Dr. JaiPal Singh, CSO / VP-Research, Saint Joseph’s Translational Res., Institute, Atlanta, GA 30313
Dr. Daniel Bolton, Market Develop Mgr., Eastman Chemical, Kingsport, TN 37662
FEBRUARY 29 - MARCH 2, 2012
CAESAR’S PALACE
LAS VEGAS, NV, 89103, USA
2. CONFERENCE SCHEDULE
Optional Pre-Conference Course
9:00-12:00 Conference Schedule
High Growth Strategies for Medical Start ups: Creating the Next Blockbuster
Prof. Gary Lynn, Distinguished Service Professor Stevens Institute of Technology, USA
Named One-of-Ten Top Management Gurus in the World ………….Business 2.0 Magazine
Named One-of-Seven Leading Thinkers in Technology Innovation Management……IAMOT
Author of Blockbusters: Five Keys to Developing Great New Products
Over 60% of new technology ventures fail. There are five(5) critical practices that separate the high-growth companies
from the rest. You will learn these tested strategies that will help you develop new medical products more success-
fully, for less investment – and do it faster. Topics covered will include (i) identify your ideal customer (ii) articulate
your customer value proposition - clearly and succinctly (iii) size your market - accurately and believably (iv) identify
and secure channel partners (v) create an accurate growth schedule, (vi) value your company, and (vii) raise external
funding faster and easier.
2:00-5:00 Regulatory Considerations for Selecting Materials for Medical Devices
Dr. Linda Braddon, President, Secure BioMed Evaluations, USA
All too often in the design of a new medical device, regulatory considerations do not come to the forefront until
after the device is designed. By performing a regulatory impact review of your material choices very early in
the design process, a new medical device company can expedite their time to market and reduce the regulatory
burden. By performing simple activities early in the process, such as identification of FDA friendly materials,
manufacturers can reduce the burden of proving safety of their medical devices and decrease the time to prod-
uct launch. An overview of materials selection in the light of regulatory approval, will be presented.
7:30-8:15 Registration and Continental Breakfast
8:15-8:30 Welcome and Opening Remarks
8:30-9:15 Keynote Address
Plastics in Medical Technology: Highlights, Challenges & Opportunities
Prof. Aman Mahajan, M.D., Ph.D., FAHA
Chief of Cardiothoracic Anesthesiology
Director- Interventional Cardiology Operations
Director - PeriOperative Echocardiraphy
Ronald Reagan UCLA Medical Center, Los Angeles, CA 90095, USA
Polymeric Materials represent one of the greatest innovations in science & biotechnology that have led
to advancement in almost every field of medicine. This keynote presentation will discuss the parallel
growth in plastics and medical technology and how several landmark technological advances in
different fields of medicine were made possible by use of plastics. Topics will include how innovations
in the field of plastics have contributed to the advancement of surgical equipment and techniques, criti-
cal care and life support hardware, and radiologic evaluation with the advent of MRI and how changes
in these fields have shaped the current practice of medicine. Presentation will also address how the
evolution of plastic technology in and out of the hospital have lead to decreasing rates of infection and
medication-related error. Furthermore, challenges & opportunities for medical devices of the future will
be mentioned.
3. 9:15-9:30 Coffee break
Session I: Polymers in CARDIOVASCULAR Devices
Polymeric Materials in Medical Devices: Challenges & Opportunities
Dr. Patricia Davis-Lemessy, Manager-Polymers, Cordis-a Johnson & Johnson Company, USA
Assessment of Polymer Coatings for Drug Eluting Stents
Dr. Barbara Huibregtse, Director-Preclinical Sciences, Boston Scientific, USA
The Importance of Polymer Biocompatibility for Long-Term DES Outcomes and Safety
Dr. Josiah (Cy) Wilcox, Chief Scientific Officer, Medtronic Cardiovascular, USA
Novel BioResorbable Polymer based Drug Eluting Scaffolds
Dr. Joanzy Zeltinger, VP-Scientific Affairs, Reva Medical, USA
Role of BioResorbable Polymeric Scaffold in Vascular Systems
Dr. Syed Hossainy, Director-Innovation Incubator & Volwiler Fellow, Abbott Vascular, USA
Self-Expanding BioResorbable Scaffolds for Peripheral Artery Disease
Dr. Maria Palasis, Exe VP & Chief Technology Officer, Arsenal Vascular, USA
New Approaches to Define Biological Response of Biopolymers and Drugs used in Vascular Stents
Dr. JaiPal Singh, Chief Scientific Officer, Saint Joseph’s Trans Res. Institute, USA
Innovative Plastic for Cardiovascular & Renel Devices
Dr. Brock Thomas, Sr. Appl. Development, Eastman Chemical, USA
Gopal Saraiya, Global Segment Leader-Med Devices, Eastman Chemical, USA
Session II: Polymers in ORTHOPAEDIC Devices
High Strength Collagen Polymers for Orthopaedic Applications:
Creating Biomimetic Tendons
Dr. Thomas Koob, Chief Sci. Officer & Exe VP, MiMedx Group, USA
Biomaterial Innovation Takes Shape: Drug Delivery Device Forming Possibilities
Utilizing Extrusion Technologies
Anthony Listro, Managing Director-Delivery Science, Foster Corp, USA
High Performance Biocompatible Implantable Plastics
Michael Wallick, Technical Support Manager, Invibio, UK
Failure Modes in Polymers for Orthopaedic Applications:
Material Requirements/Design Constraints
Dawn Lissy, President & CEO, Empirical Testing Corp., USA
4. Session III: Advances in MATERIALS & COATINGS
Controlling Polymer Surface Properties for Tailored Biological Interactions
Dr. Theresa Hermel-Davidock, Manager-R&D, Beckton Dickinson, USA
Diagnostic Devices: Addressing Chemical Resistance of Plastics in Clinical
Environments
Matt Sauers, Principal R&D Engineer, Roche, Diagnostics Operations, USA
Novel Approaches to Address Chemical Resistance & Toughness:
Advances in Thermoplastic Alloys & Design
Dr. Steve Blazey, Technical Director, Diamond Network Polymers, USA
AntiMicrobial Acrylic: A New Medical Polymer Compound for Medical Device
Applications
Dr. Zhen Zhu, R&D Manager, Evonik Cyro, USA
AntiMicrobial Solutions for Next Generation Medical Devices
Troy Mohr, VP-Business Develop, BioMerics, USA
Alternative to PVC Plasticizer DEHP in Medical Applications: Eastman 168™
Dr. Mark Holt, Manager-Plasticizers Market Develop, Eastman Chemical, USA
Session IV: Advances in MANUFACTURING: Devices & Materials
State-of-the-Art Additions to Molding Machines for Medical Applications
Dr. Juergen Giesow, Regional Manager, Arburg, USA
Process Monitoring & Control for Medical Molders
Shane Vandekerkhof, Business Develop Mgr, RJG Inc., USA
Medical Devices & Packaging: Pushing the Boundaries of Conventional Thermoforming
Andy D’Esposito, Tek Packaging, USA
Session V: REGULATORY Requirements for Medical Polymers
FDA Medical Device Approval Process: An Overview
Dr. Linda Braddon, Secure BioMed Evaluations, USA