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Harvard i-lab | Understanding Medical Device Development
 
01:26:42
The healthcare industry is a hot bed of innovation. A convergence of new technologies, connectivity, big data and analytic models are creating a multitude of opportunities to improve health outcomes and reinvent platforms for device and service businesses. Working in a regulated industry requires special considerations that can prove challenging for the uninitiated. From concept generation to launch, this session, led by Aidan Petrie, Chief Innovation Officer of Ximedica, will provide an overview of six essential components of successful product development specific to the development of medical devices and healthcare products. We will start with a discussion around the regulatory considerations that drive many of the activities surrounding each of the development phases and then cover step-by-step each phase of development including an overview of funding milestones and potential sources. Part how-to, part know-how the aim of this short workshop is to equip anyone who is currently trying to bring a product to market or may do in the future with a high level view from experts in the field. Ximedica is the largest product developer the country that is focused solely on the medical space. Our clients range from Fortune 30, VC's, university incubators and everything in between.
Medical Device Product Development: the process is more than design controls
 
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Product development is a complex process, which requires integration of business and technology to deliver a successful product. Medical devices must also follow the requirements of design controls, which are based on engineering best practices for product development. We often see companies using the required elements of design controls as their product development process, at the risk of ignoring the business elements needed for a successful product. Learn more...
Views: 1261 Strategy2Market
How Are Medical Devices Developed? The Engineering Process at SpineFrontier Inc.
 
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Are you a surgeon interested in working on product development with us? Visit http://www.spinefrontier.com/ to learn more about us and contact us to schedule a VIP Tour at our Greater Boston area facilities.
Views: 937 SpineFrontier
Medical Device Design with SolidWorks 3D CAD
 
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Successful medical products—from drug delivery systems to diagnostic equipment and surgical devices—advance patient care. Manufacturers of these products must create innovative approaches while working in a stringent regulatory environment. See how SolidWorks® product development solutions help designers in the medical field reduce design cycle time and costs, while still focusing on quality and reliability to increase patient safety and reduce liability. Learn more: http://www.solidworks.com/sw/industries/medical-devices-products-manufacturing.htm
Views: 22917 SOLIDWORKS
Project Management for Medical Device Development
 
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Project Management Seminar Series Erin McKenna, MBA December 10, 2014
Human Factors & Medical Product Design in 2017
 
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With new technologies come new user experience (UX) trends that blur the boundaries between consumer and medical product design. Bill Horan, Bresslergroup's Creative Director, Interaction Design, and Conall Dempsey, Director of User Research, talk about technology-driven UX trends that characterize how these two product categories, once far apart, are moving toward each other. The pair also present best practices for digital-physical and UX solutions in healthcare environments as well as key issues in the FDA's finalized guidance for medical device developers. For more about medical device design, visit http://www.bresslergroup.com/expertise/medical-product-design/ Check out our work! http://www.bresslergroup.com/work/
Views: 591 Bresslergroup
Design Controls - Requirements for Medical Device Developers
 
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The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" – "fast cycle" product development. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/LJLB/
Project management for product development of medical devices - Course information
 
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Course information to help you decide if this medical device project management course is the right one for you. Check out the link below to request the course program and more information. http://gantus.com/product/project-management-product-development-medical-devices/
Views: 69 Peter Sebelius
InnoGermany GmbH - Medical Product Development and Prototyping
 
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in-house product development and prototyping with focus on the medical field. InnoGermany GmbH provides talents, ideas and innovation in product development plus engineering abilities across all areas needed to come up with innovative medical products. Service includes industrial design and CAD, mechanical engineering, mechatronics, electronics, programming, optics, production and science, marketing and consulting.
Views: 179 InnoGermany GmbH
Lean and Agile in Medical Device Product Development
 
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Some medical device companies feel that lean and agile techniques cannot be used because of design controls. However, the regulations don’t prevent the use of those techniques during product development. This webinar discusses these issues in more detail.
Views: 503 Strategy2Market
Smart Manufacturing™ Streamlining Medical Product Development
 
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Download this eBook to learn: http://bit.ly/2GyVdA1 PolyOne and GW Plastics have put some guidelines together based on our extensive healthcare product development knowledge. •Best practices for streamlining the three major phases of developing a new or next-generation medical device — concept & design, tooling & pre-production, manufacturing & supply chain •Ways to get the most from your material supplier and manufacturing team •Why early involvement is critical to a better process
Views: 392 PolyOne
Product Development for Medical Technologies - Neo Tech Talks
 
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Speaker: Rahul Rajeev, Engineer, Neo Innovation (@rhlrjv) Produced by Engineers.SG Help us caption & translate this video! http://amara.org/v/WCef/
Views: 59 Engineers.SG
Microfluidics—A Powerful Technology for Diagnostic and Medical Product Development
 
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Microfluidics is an enabling technology which allows the development of highly integrated diagnostic or medical devices. We will present several examples of such devices which include steps like sample preparation, amplification and detection on--chip. Applications include the detection of viral and bacterial infections, low abundant tumor cells and biomarkers. Low-cost industrial fabrication methods for such devices will be discussed. Speaker: Holger Becker, Chief Scientific Officer, mircrofluidic ChipShop GmbH
Views: 3071 QMedicalDevice
Engineering Medical Devices at MIT
 
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Mechanical engineering students from MIT work with clinicians from Boston-area hospitals to design cheaper, safer, and more efficient medical devices.
Medical Device Development: Quality Assurance and Testing
 
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For more information visit https://intland.com/medical-device-development/ Watch this webinar recording to learn more about the quality assurance and testing processes used in the development of medical devices. In such a highly regulated safety-critical industry, software quality, reliability and safety are vital. That's exactly why risk management, QA and testing, as well as the documentation of these are all regulated in various industry standards (ISO 14971, IEC 62304, and a variety of FDA regulations). This webinar lets you learn more about compliance with these standards, as well as QA and testing processes of medical device software with codeBeamer.
Views: 3390 Intland Software
Kaleidoscope Design and Innovation Medical Product Development Capabilities
 
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Healthcare and medical procedure and device development today is about much more than a single physician using a single instrument on a single patient. To meet shorter deadlines, lower costs and reduce risks, medical product and process innovation must account for the entire ecosystem. That's where we can help. We offer in-house clinical expertise, corporate experience, Healthcare ecosystem understanding, regulatory guidance and an on-site laboratory.
Views: 69 Margee Moore
Medical Device Product Development Kensey Nash
 
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http://www.kenseynash.com/research-and-development/product-development - Kensey Nash offers product development services for regenerative medicine and medical device quality and regulatory authorities system for customers to meet their requirements.
Views: 60 vicente cast
The Lifecycle of Medical Devices from Idea to Market
 
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Course Description: Overview of the different steps of a typical medical device lifecycle from idea to market. This course provides a roadmap of the different steps involved in bringing a device to market and how to ensure continuous improvement of a product. Learn more at: http://www.wmdo.org//course-detail.aspx?id=87
Views: 1892 WMDO
Succeeding with outsourced medical product development: Here are the secrets
 
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Three pros behind outsourced medical product development – Karten Design's Stuart Karten, Acessa Health's Kim Bridges Rodriguez and Minnetronix's Jim Reed – share their secrets at DeviceTalks West, December 2017 in Orange County, Calif.
Views: 39 MassDevice
The 5 Personas of Product Management and How to Hire Them by Jason Shen
 
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Product managers are one of the toughest roles to define and hire for, in part because depending on the company and the project, they perform a wide variety of activities. It can be helpful to think of the role as five characters — the Explorer, the Analyst, the Planner, the Advocate, and the Sherpa. Access Productized Conference 2018 talks on standard resolution on youtube or buy the FullHD 1080p version on vimeo: https://vimeo.com/ondemand/productized17/
Views: 7487 PRODUCTIZED
Industrial, Mechanical and medical product design - engineering
 
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How to achieve good design and engineering. Warwick Design Consultants - Industrial Mechanical Product Design Please click the link - http://www.warwickdesign.com Our product development consultants bring you fresh thinking and flash feasibility to quickly focus on ideas which have value and are highly likely to succeed. We get to grips with the complexities of your business and work co-operatively to formulate new product needs and capture them in a succinct brief and strategy. Our technical design and development skills enable us to build ideas which are practical and reliable for you. Warwick Design provides companies by combining research, innovation, design, development and industrialisation into a flow of new and profitable products. Laboratory and workshop testing refine the concept until we have demonstrable confidence in the product. Toleranced drawings are created from our CAD files which we can deliver to you as a part of the production data package. If preferred, we continue liaising into production stages to ensure a smooth transition. reating devices which are simple to use, reliable and robust to enhance patient safety and compliance. We provide customers with twenty years of device development experience from delivery experimentation to entire devices like Ellipta for GlaxoSmithKline. We are very familiar with the drug delivery landscape, requirements and restrictions in new, combination and generic devices. Thank you for looking
Idea to IDE: A Medical Device in the Making
 
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Most medical device inventions start out as a single great idea, but how does that idea become a marketed medical device? This video provides a brief overview of how a medical device, which can range from a contact lens to a knee implant to an MRI machine, begins with an idea and ends with its submission to FDA. The video highlights aspects of the Investigational Device Exemption (or IDE) process, and provides general information on medical device clinical trials. The audience is device manufacturers and health care professionals. Presenter: Chrissy Cochran, PhD Toxicologist, FDA [vpmedicaldevices]
Views: 24328 USFoodandDrugAdmin
Synectic Medical Product Development - Who We Are
 
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Synectic® Medical Product Development is a full-service product development company focusing on design, research, development, and manufacturing. Our focus is on medical device design and manufacturing, though our specialties also include industrial design, production design, mechanical design, electrical engineering, intellectual property, pre-clinical testing, and manufacturing. We tailor our designs for clinical relevance, manufacturability, ergonomics, and cost efficiency.
MIDI is Expert in Medical Product Development Innovation
 
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MIDI is an award winning strategic turnkey, FDA and ISO compliant product development consulting firm with over 40 years experience servicing domestic and international clientele representing medical, life sciences, and home healthcare markets. Our multi-disciplined, talented group achieves innovative results within rapid time lines under stringent regulatory constraints. MIDI's dedicated teams of research, design and engineering professionals offer a unique combination of talent and experience, consisting of key personnel working together with a record of outstanding achievement in developing Class I, II and III products. Our prime goal is total satisfaction for the clients we serve. We consider our clients true partners.
Views: 186 MIDImedical
Worrell® - Contact Us For Complete Medical Product Development Under One Roof
 
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Recently, Worrell debuted a special short film at the Body Computing Conference at USC. The film features a novel approach to healthcare stakeholder engagement and a conceptual patient centric technology, holding the possibility of transforming the delivery of healthcare. www.Worrell.com
Views: 15584 Worrell Design
SolidWorks 2014: Product Design
 
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Whether you develop high tech, consumer, or medical products—or even injection mold tooling—SolidWorks software solutions help you manage and improve every aspect of your end-to-end product development process. Learn more: http://www.solidworks.com/launch/overview.htm?SCID=sm_yt_launch14_productdesign_092013&pmid=3450
Views: 21425 SOLIDWORKS
Synectic Medical Product Development MD&M East 2018 Raffle Winner
 
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Synectic Medical Product Development's Mac McMurray Announces This Year's MD&M East Raffle Winner
Device Product Development Engineer [Medical Device Recruiter]
 
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http://www.johnstonsearch.com/blog Hello and good day! In this J-VLOG (Job Video Blog) Brian, your Medical Device Recruiter discusses hot new Medical Device Engineering opportunity! Title: Product Development Engineer Location: Irvine, CA Salary: DOE Keys: You want to use your Mechanical Engineering degree! You thrive in solving problems at component level. You enjoy FDA Medical Device industry. You have created a product from concept to deliverable. It would be nice to see vascular/cardiac surgery accomplishments. You actually enjoy highly regulated jobs (FDA, QSR, etc.) Is this you, then I would LOVE to here from you! (brian AT johnstonsearch DOT com) medical device recruiter, medical device headhunter, medical device staffing, medical device jobs, medical device agency Until we connect, you refer friend, or request confidential chat, enJOY your day! To you Medical Device success, Your Medical Device Headhunter, Brian- http://youtu.be/JrTpyKsDhog
DeviceLab - Medical Product Development and Medical Device Design
 
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DeviceLab is a contract medical device design and product development firm. Expertise includes medical user interface (UI) design, custom medical cart development, medical device, industrial design, hospital equipment and lab instrument development. Contact DeviceLab to take your product from concept to market.
Views: 1231 DeviceLab
Agile and Medical Device Development
 
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Lean-Agile principles and more specifically, the Scaled Agile Framework, can be used to greatly improve the medical device development process. From meeting regulatory requirements like providing complete traceability in hardware and software development to improving the speed and reliability of which updates are tested and released, the benefits of adopting these best practices are well documented. In order to achieve this however, organizations must take the first step in truly understanding what this organization-wide “transformative” mindset requires. Join the Continuous Engineering Experts’ Bryan Smith as he welcomes Dr. Harry Koehnemann – SAFe Fellow and SPCT – from Scaled Agile, Inc. to the show, as they discuss how medical device companies can leverage new techniques in agile development to reduce costs, increase productivity and accelerate innovation throughout their organizations. 0:01:50 – What is Agile and how is this different than the Scaled Agile Framework (SAFe)? 0:02:54 – Do you have to be a really large organization to get the benefits of SAFe…or can you be a smaller org.? What’s the sweet spot? 0:04:10 – How massive can the Scaled Agile Framework go? Are we talking a few hundred or even a few thousand engineers here? 0:05:16 – Can you define the terms “Alignment” and “Value Streams” for our audience? What do they mean? 0:09:20 – Can you give us a little background information about the Scaled Agile Framework and how it got integrated with systems engineering? 0:12:20 – How does SAFe deal with documentation (requirements, design, etc.) and testing? 0:14:36 – Let’s talk about a medical device company for example, how can SAFe specifically benefit them with regards to compliance requirements? 0:15:28 – What is the definition of “done” in this scenario? 0:17:36 – What’s the first real step leadership must take in order to get started in an organization-wide “lean-agile transformation”? 0:22:45 – Can you tell us what an Agile Release Train is and how this would apply to the medical device development process? 0:25:15 – You have an upcoming “Executive Briefing” webcast on February 13th that goes a little deeper into how the medical device development process can benefit greatly by adopting SAFe. Can you give us a little preview? Want to learn more? Join us on Tuesday, February 13th at 1pm Eastern for a free live webinar and get your questions answered: How to Revolutionize the Medical Device Development Process in 2018 and Beyond. http://bit.ly/321_MedDeviceBriefing
Views: 5937 321 Gang
Non-Medical Product Development & Regulation
 
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Cannabis Science and Policy Summit 2016 The potential variety of cannabis products is dazzling, while possible changes in the burgeoning recreational cannabis market presents new challenges for both regulators and suppliers of cannabis. One-size-fits-all application of medical cannabis regulations to the recreational market could result in under-regulation, with respect to advertising and high THC product. Both industry participants and regulators face complicated decisions—how can they address them? What are the likely future trends in product development? Is very-high-THC product, and especially product that is high in THC and low in CBD, a health risk? If so, what can or should be done about it? How much is or could be known about the importance of molecules other than THC and CBD? What is the right policy toward testing and labeling for those compounds? Should some products remain available only with medical recommendation? Moderator: Sandy Mullins, Senior Policy Advisor, Washington State Governor’s Office Speakers: Alex Cooley, Co-Founder, Solstice Andrew Freedman, Director of Marijuana Coordination, State of Colorado Rick Garza, Director, Washington State Liquor and Cannabis Board Brendan Kennedy, Chief Executive Officer, Privateer Holdings
Views: 48 Botec Analysis
Managing Requirements in Medical Product Development – Sunrise Labs
 
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Jim Turner, Sunrise Labs' Program Manager/Software Engineering Group Leader, discusses Managing Requirements: A Systems Approach to medical device requirements for efficient and compliant design and development at BIOMEDevice 2015. Sunrise Labs outlines a Systems based framework to Requirements Management, which provides the rigor required for medical product development with the appropriate level of documentation and testing. This framework has been created based on over 20+ years of medical device development experience, and provides a method to tailor your requirements to risk and level of classification. Requirements Management is core to FDA design controls. Defining, planning, implementing, testing and tracing requirements efficiently and effectively have enormous benefits for the initial development, maintenance, and life cycle of a medical device.
Views: 200 Sunrise Labs, Inc.
Medical Product Development Experts
 
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Insight works with medical companies all over the world and over the last 22 years we have developed 270 healthcare programs. That means we have conducted 20,000 hours of contextual research and have vast experience in virtually every corner of the hospital and every clinical specialty. This gives us the knowledge and the arsenal to attack even the most complex of projects. Watch this video as it details our areas of expertise and our medical product development experience.
Views: 996 insightpd4660
Medical Device Design
 
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Views: 1891 WB Engineering
New Product Development
 
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A brief, simple animation that explains the new product development process at Neotech. Our cast of characters will walk you through the steps so you know what to expect when you approach Neotech with your medical device invention.
Views: 11169 neotechprod
Medical Devices and Diagnostics: Product Launch
 
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Tony Wicks, Senior Vice President of Business Development, Client Management and Analytics of Premier Source shares considerations and best practices for device and diagnostic manufacturers to increase the chance of a successful launch.
Views: 808 ABSGknowledgedriven
MSc Medical Product Design – Mark Golab
 
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Mark tells us about his life as a postgraduate student studying MSc Medical Product Design in the School of Architecture, Design and the Built Environment at NTU. For more information, order your 2016 Nottingham Trent University Postgraduate Prospectus today http://www.ntu.ac.uk/prospectus To find out more visit us at one of our postgraduate events in 2016. Book your place at http://www.ntu.ac.uk/pgevents
Examining Medical Product Development in the Wake of the Ebola Epidemic
 
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More here: http://1.usa.gov/1qJc3gr
Views: 366 energyandcommerce
Medical Device PLM   Design Control
 
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Learn why PLM is important for Medical Device companies and how Minerva's Medical Device PLM solution can help. This video focus on Design Control
Views: 809 MinervaPLM
350 Million Reasons to Disrupt the Medical Device Industry | Craig Robertson | TEDxGlasgow
 
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The medical device industry is overshadowed by huge companies which both stifle innovation and drain available resources. In the field of retinal imaging, there are just a handful of companies with revenues in the hundreds of millions of dollars but they make large and expensive devices that are inappropriate for the developing world. Dr Craig Robertson and his company, Epipole, make smart intelligent devices that address specific illnesses using robust, high quality but relatively inexpensive hardware and very intelligent cloud-based storage and computing. In his talk, Craig will look at what disruption means in the medical device industry. He’ll explore how we can make devices that fulfil the needs of the many, not the few, and make them at a price that allows for ethical trading. Dr. Craig Robertson is the founder of Epipole Ltd, a company which develops intellectual property in the domain of image, data and signal processing. His current project is a medical device which is particularly tuned to the detection of retinopathy. Craig’s background is in invention, mathematical problem solving and algorithm development. He invented 3D data acquisition systems, holds patents in the fields of optics, software and medical devices and has been a programmer for over 30 years. Craig has produced over thirty peer-reviewed papers, co-authored three books and produced many technical reports on subjects ranging from automated diagnosis to evolutionary optimisation and Open Source business integration. This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at http://ted.com/tedx
Views: 7176 TEDx Talks
MEDICA-TradeFair.com: Product Development - The Long Road to the Medical Device
 
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Often, years pass from the first idea to the finished medical product, as medical devices are only allowed to be released onto the market and can be implanted into humans after sufficient research and a sometimes tedious search for the right cooperation with different disciplines, as well strict control on the part of the legislator. We spoke to Professor Feldhusen at RWTH Aachen about his experiences in this exciting field of research and development.
Views: 203 MEDICATradeFair
Porticos: Product Design and Product Development Engineering Services
 
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Porticos is a product design and product development engineering consulting firm. What makes us unique is our incredible team of talented engineers who have worked on product development projects in consumer electronics, heavy industrial, military, and medical. This video shows a bit about what it's like to partner with Porticos on a product design project.
Views: 253 Porticos
Medical Device Human Factors-Catching up to the FDA
 
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User Centric is now a part of GfK! Read more about GfK's medical device UX research and design solutions. (http://www.gfk.com/solutions/ux/health/Pages/Medical-device-UX-research-and-design.aspx) The release of the FDA's draft guidance document (Applying Human Factors and Usability Engineering to Optimize Medical Device Design) has caused many medical device manufacturers to realize that adjustments to their human factors research process are necessary. Understanding how product development processes and lifecycles can be shaped to meet human factors engineering standards while minimizing the impact to overall time and cost of product development is a critical success factor for these organizations. For example, identification of representative user groups, risk analyses (FMEA), and human factors validation research may have existed previously as independent activities, but according to sound research design and FDA guidance these activities are necessarily interdependent. Medical device manufacturers are struggling to make this adjustment in the middle of product development cycles that may have been underway for several years, as well as for future development cycles. Join Korey Johnson, VP, User Experience, GfK, in this webinar to learn how to get answers to the questions you should be asking during exploratory research and how to use those answers to ensure safe and effective use of your medical device for your intended user population. You will leave this session with some practical ideas on changes that can be made to your product development process. In this 60-minute webinar, Korey will provide insights and tactics to: -Identify potential user groups. -Understand the difference between unique groups and variation within a group. -Eliminate major usability issues early in the design process. -Incorporate users into risk analyses. -Choose the right tasks for a human factors validation study. -Understand potential outcomes by way of generalized real-world examples.
Views: 4003 User Centric
Medical device development medical device design & manufacturing
 
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http://www.fairwaymed.com Medical device developer, designer & manufacturer. Twenty years FDA experience. Pioneer venture commercialization-capital raising.
Views: 1464 fairway57

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