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Packaging & Sterilization
Amcor Launches Enhanced Heat Seal Coating Technology
New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.Amcor 08.23.21
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How to Become ISO 13485 Certified
Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.Emily Drinks, Digital Content Consultant with WebFX 08.05.21
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ILC Dover, an Affiliate of New Mountain Capital, Acquires Flexan
The combined company will serve a broader client base situated in both medical device and biopharmaceutical end markets.New Mountain Capital 07.26.21
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3D/Additive Manufacturing | Molding
Metal Injection Molding and Metal 3D Printing Examination
Both MIM and metal AM serve as alternative options to machining for medtech manufacturers requiring metal components.Mark Crawford, Contributing Writer 07.22.21
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MDIC Partners With Booz Allen on Device Cybersecurity
Companies will identify best practices in cybersecurity benchmarking that can be replicated by manufacturers to ensure patient safety and security.Business Wire 07.19.21
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Tubing & Extrusion
Thousands of Stock Components for Medtech—MPO Videobites
Jeff Cushner of Qosina speaks with MPO's Sean Fenske about how his company fulfills medical device component needs rapidly.
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TÜV SÜD North America Gains FDA Accreditation for Device Testing
TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.Business Wire 06.29.21
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Top 483s of 2020—Mike on Medtech
Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.Sean Fenske, Editor-in-Chief 06.08.21
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Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing
he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.Michael Barbella, Managing Editor 06.04.21
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Digital Health
Empowering Value-Based Care Through Interoperability
EHR interoperability and medical device connectivity enable healthcare providers to meet the shift toward value-based care and reimbursement.Josh Hetler, Executive Vice President, Business Intelligence, DataLink 05.13.21
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Materials
The Plastics Problem—Infection Control vs. Medical Equipment
Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21
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Digital Health
What Could Medical Device Hacking’s Future Look Like?
MPO's Sean Fenske and Alan Grau of Sectigo discuss potential hacking strategies for future instances of gaining access to medical technology.Sean Fenske, Editor-in-Chief
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Software & IT
Realizing the Value of Today’s Connected Worker—A Medtech Makers Q&A
Connected workers gain an advantage while in the workplace as they can maintain oversight of the systems and projects they are tied to at any moment.
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Electronics
Mastering Motion for Robotic Surgical Systems—A Medtech Makers Q&A
maxon's Peter van Beek provides insights on critical factors and considerations of motion control for robotic surgical systems.
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Digital Health
Thinklabs' Digital Stethoscope for Digital Health
MPO's Sean Fenske speaks with Clive Smith of Thinklabs about his digital stethoscope and how it was used during the pandemic.Sean Fenske, Editor-in-Chief 04.13.21
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Contract Manufacturing | R&D & Design
Moving from Concept to Design—MPO Videobites
Mike Schultz of Spectrum Plastics Group speaks with MPO’s Sean Fenske about the Launch Pad Engineering Service the firm offers for medical device manufacturers.Sean Fenske, Editor-in-Chief
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Molding | Surgical
Optimizing MIM in Medical Device Manufacturing
Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.Steve Santoro, Executive Vice President, MICRO 04.01.21
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Testing
The Evolution of Chemical Characterization for Medical Devices
Evaluation of biological safety of devices is experiencing some of the most significant changes in history.Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
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Materials
Outward Appearance: Reviewing Surface Treatment Options
Surface modifications and coatings imbue medical devices with a slew of valuable properties.Sam Brusco , Associate Editor 04.01.21
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Contract Manufacturing | Molding
Molding Validation Optimization—A Medtech Makers Q&A
PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.
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Four Ways Remote Freelance Experts Can Help Medtech
Changes in the regulatory landscape and working-from-home scenarios reduce the degree of change when working with remote consultants.Ramya Sriram, Digital Content Manager, Kolabtree 03.15.21
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An Overview of the ASCA Pilot Program
The FDA published a three-part final guidance on the voluntary program.David Jensen, Staff Writer, MasterControl 03.11.21
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Update on FDA's STeP Designation—Mike on Medtech
Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.Sean Fenske, Editor-in-Chief 02.26.21
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FDA Appoints its First Cybersecurity Director
University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.Michael Barbella, Managing Editor 02.17.21
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4 Trends Driving Medical Manufacturing in 2021
Manufacturers across the sector had to manage disruptions last year, but economists say recovery may begin soon.Emily Newton, Editor-in-Chief, Revolutionized 02.16.21
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The 8 Major Types of PPE Supply Chain Fraud
Medical device manufacturers need to be aware of what’s happening within the space if they are making protection equipment themselves.Richie M. Hecker, Managing Director, TS Health Supplies Division, Traction & Scale LLC 02.10.21
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Cybersecurity Measures are Crucial as COVID-19 Drives Adoption of Remote Access Devices
Cybercriminals are taking advantage of the health crisis to breach hospitals and healthcare systems.Michael Barbella, Managing Editor 02.10.21
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Digital Health
Evolving Trends in the Medical and Orthopedic Devices Industry
There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.Jacqueline Trovato, Healthcare/Legal Writer 02.09.21
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Contract Manufacturing
Use Vertical Integration to Increase Productivity, Drive Innovation
The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21
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Molding
Material Science for Micromolding—A Medtech Makers Q&A
Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.
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CMS Expedites Breakthrough Device Access; Industry Applauds
New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’MPO Staff 01.13.21
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Communicating with the FDA—Mike on Medtech
Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.Sean Fenske, Editor-in-Chief 12.15.20
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Digital Health
Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20
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Materials
Setting the Standard: Protective Nanocoatings for Today's Medtech
Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20
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Surgical
Galen Robotics' Robotic Surgery Subscription Concept
MPO's Sean Fenske speaks with Bruce Lichorowic of Galen Robotics about the firm’s unique subscription plan for its robotic surgery system.Sean Fenske, Editor-in-Chief 12.01.20
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Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market
Medtronic is the leading player in the region, according to market data.GlobalData 11.24.20
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Machine Solutions Acquires Beahm Designs
Expands its catalog of catheter manufacturing equipment and broadens its engineering resources.Machine Solutions Inc. 11.20.20
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Former Abbott Executive Joins Centricity Vision Board
New member has more than four decades of business and ophthalmology industry experience.Business Wire 11.11.20
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R&D & Design
Collaborating with Full-Service Design and Development Providers—A Medtech Makers Q&A
Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.
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Chronic Disease
Pharmaceutical Focus: A Look at Combination Products
Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.Mark Crawford, Contributing Writer 11.04.20
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3D/Additive Manufacturing
The Printed World: Additive Manufacturing in Medtech
Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.Sam Brusco, Associate Editor 11.04.20
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Cardiovascular
The Heart of the Matter: Trends in Cardiology
Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.Maria Shepherd, President and Founder, Medi-Vantage 11.04.20
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Advanced Technology for Staking and Swaging Medical Plastics
It reliably assembles heat- and vibration-sensitive components, and works with a wide range of plastic materials.Priyank Kishor, Global Product Manager—PulseStaking, Branson at Emerson 11.04.20
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Quality Assurance When Supply Chain Disruptions Arise
From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
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3D/Additive Manufacturing
Additive Manufacturing: Debinding Fluids Must-Haves
As the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing is gaining widespread acceptance.Venesia Hurtubise, Technical Chemist, MicroCare Medical 11.04.20
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My 2020 Holiday Wish List
There are many lessons to be learned from actions taken during the pandemic. Are there positives that can actually be taken from this mess?Sean Fenske, Editor-in-Chief 11.04.20
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Molding
A Primer on the Benefits of Metal Injection Molding
High volume, high performance, complex surgical instrument parts are achievable at an affordable cost with the fabrication process.Steve Santoro, EVP, MICRO 10.13.20
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Electronics
Capacitor Considerations for Medical Applications
Careful selection of even the smallest electronic components can make a significant difference in a device’s capabilities.Rich Bestafka, Key Account Manager—Medical, Knowles Precision Devices 10.12.20
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Contract Manufacturing
Expediting Time to Market—A Medtech Makers Q&A
Donatelle’s Mike Kaiser and Todd Owens provide insights on speeding up development to get products out to market more quickly.
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Testing
