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• Software & IT
  

  5 Ways Manufacturers Can Improve IoMT Device Security

  Manufacturers cannot make development and security mistakes with IoMT devices.

  Online Exclusives Emily Newton, Editor-in-Chief, Revolutionized 03.23.21
  

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  The Many Hats of an Integrated Contract Manufacturer

  and How Each One Fortifies Your Medical Device Supply Chain

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  Speed & Scalability: The Advantages of Outsourcing to a Vertically Integrated Contract Manufacturer

  If there is one thing that is predictable in today’s medical device market, it is lack of predictability.

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  Driving Market Advantage: Six Critical Contract Manufacturer Skillsets

  Optimizing the outsourcing equation involves far more than simply finding a company to manufacture products in an area with low cost wages.

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• The Many Hats of an Integrated Contract Manufacturer

  Here are the five hats your fully-integrated CM should wear.

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  Perspectives on Post-Pandemic: For Manufacturers, Flexibility Is Key

  MICRO’s Steve Santoro comments on how medtech suppliers need to be nimble and solution-oriented for customers to ensure success.

  Online Exclusives Steve Santoro, Executive Vice President, MICRO 02.03.21
  

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• Diagnostics
  

  Rapid Antigen Tests Manufacturer Acquires BIOLAB

  Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.

  Innova Medical Group Inc. 01.14.21
  

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• Diagnostics
  

  Manufacturer of Rapid Antigen Tests Acquires BIOLAB

  BIOLAB acquisition will create jobs and increase Innova's U.S. COVID-19 testing capability.

  PR Newswire 12.18.20
  

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  Rapid Product Development: Four Areas to Audit When Selecting a Contract Manufacturer

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  Manufacturer Develops New Ventilator Sensor

  The sensor took only 14 weeks from concept, through validation, to manufacture and delivery.

  Hummingbird Sensing Technology 12.07.20
  

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  Survey: Medical Device Repair Professionals Fix Equipment Manufacturers Cannot Remedy

  Finding underscores FDA's conclusion that manufacturer technicians provide 'high quality, safe, effective servicing' of medical devices.

  U.S. PIRG 11.18.20
  

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• Contract Manufacturing | Electronics
  

  Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

  But many companies are hesitant to start new development projects while the coronavirus is still rampant.

  Online Exclusives Michael Barbella, Managing Editor 10.05.20
  

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  Six Reimbursement Tips For Medtech Manufacturers

  Product development and regulatory pathway are important, but if no one is paying for your product, how will it succeed?

  Online Exclusives Katherine Rundell, Technical Writer, Academic Writing Services 09.29.20
  

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  Manufacturer’s Version of Rice Ventilator Gains EUA

  Stewart & Stevenson Apollo ABVM receives EUA during COVID-19 pandemic as bridge for patients in need

  Mike Williams, Rice University 08.05.20
  

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• Diagnostics
  

  5 Trends Shaping Medical Imaging Manufacturers Need to Know

  New life-supporting imaging equipment designs must incorporate modern patient, physician, and technician demands.

  Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 06.17.20
  

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• Contract Manufacturing
  

  Shopping Smart: What to Look for in a Contract Manufacturer

  A contract manufacturing organization can help shoulder the workload of bringing a new device to market.

  Claudio Hanna and Jennifer Ponti, Web Industries Inc. 06.04.20
  

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• Contract Manufacturing
  

  Reshoring Checklist for Manufacturers—the Math Works!

  Reshoring manufacturing back to the USA isn't just a trend due to COVID. Look at the math to see why reshoring adds up.

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  Medtech’s Battle on Multiple Fronts Against COVID-19

  From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.

  Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20
  

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• Surgical
  

  FDA Update on Essure Postmarket Activities

  All unused Essure devices of which Bayer is aware have been returned to the company.

  U.S. Food and Drug Administration 04.27.20
  

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  Sporting Goods Brand Now Making Millions Of Face Masks

  Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.

  StringKing 04.27.20
  

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  Hasbro, Cartamundi Partner to Produce Personal Protective Equipment

  Companies to donate 50,000 face shields per week to local hospitals in Massachusetts and Rhode Island.

  Business Wire 04.27.20
  

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  Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts

  Tests will aid in responsible back-to-work assessment, according to manufacturer.

  Ortho Clinical Diagnostics 04.27.20
  

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• Materials
  

  Plastics and Medtech: Annual Industry Survey Results

  Medical device manufacturers prefer domestic plastics manufacturing and many use thermoforming on a project.

  Online Exclusives Jason Middleton, Vice President of Sales & Development, Ray Products 04.24.20
  

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  Kurin Receives FDA 510k Clearance for Its Push-Button Needle

  Company's technology automatically and passively sidelines potential contaminants during blood culture collection.

  Business Wire 04.24.20
  

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  Endonovo Therapeutics Introduces Support of SofPulse With New Patient Brace

  The brace allows site-specific application and promotes ease of use for patients and medical professionals when using the SofPulse device.

  Globe Newswire 04.23.20
  

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  Diversified Plastics Increases Capacity of Acceleration Station to Meet Manufacturing Demand

  The Station’s engineering and production teams work closely with customers to save time and money by optimizing parts for digital manufacturing.

  Diversified Plastics Inc. 04.23.20
  

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• Molding
  

  Mack Molding, Health System Partner to Develop Face Mask Alternative

  Within two weeks, the team fabricated an attachment to a snorkeling scuba mask.

  Mack Molding 04.22.20
  

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  FDA Further Eases Burden on N95 Manufacturers

  Nevertheless, demand for face masks continues to outstrip supply.

  GlobalData 04.21.20
  

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  MPE Launches an Emergency Medical Cart to Meet Critical Ventilator Need

  Company went from napkin sketch to market-ready product in only 10 days.

  PR Newswire 04.20.20
  

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• Contract Manufacturing | Diagnostics
  

  Medtech Matters: AdvaMed's Scott Whitaker on Medtech's COVID-19 Response

  MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.

  Sean Fenske, Editor-in-Chief 04.17.20
  

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• Surgical | Testing
  

  Medical Robots: Assessing Safety and Performance in a Growing Field

  Be aware of potential hazards robots may present and testing options to address them.

  Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
  

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• Diagnostics
  

  Sense Biodetection Accelerates Instrument-Free COVID-19 Diagnostic Test

  Scale-up with Phillips-Medisize is underway to ensure timely delivery and distribution.

  Sense Biodetection Limited 04.17.20
  

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• Molding
  

  Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding

  MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.

  Vaupell Midwest 04.16.20
  

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  Is Singapore a Good Option for Your Medical Product Development Strategy?

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  Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

  The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

  Tolomatic 04.13.20
  

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  Mike on Medtech: COVID-19, Part 2

  Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.

  Sean Fenske, Editor-in-Chief 04.08.20
  

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  ZVerse Working to Produce 20 Million Face Shields

  Small digital manufacturing company pivots to support COVID-19 response.

  Globe Newswire 04.08.20
  

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  Pentax Medical to Pay $43 Million Over Misbranded Endoscopes

  Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.

  U.S. Department of Justice 04.08.20
  

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• Software & IT
  

  Seeking Software Partners During a Crisis

  The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.

  Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20
  

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• Surgical
  

  Olympus' Non-Surgical BPH Device Wins FDA De Novo

  The iTind flexible three-strut nitinol device can be placed during an in-office procedure.

  Olympus 04.06.20
  

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  MIT Begins Mass Manufacture of Disposable Face Shields

  A team from MIT has designed disposable face shields that can be mass-produced.

  Videos Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology

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  Tru-Form Plastics Develops Face Shield for COVID-19 Fight

  Southern California manufacturer producing over 100,000 protective face shields per week with investment plans for greater production capacity.

  Tru-Form Plastics 04.06.20
  

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  Polyzen Helps to Address Shortage of PPE

  Commits to assist manufacturers, hospitals, and other healthcare facilities in getting the supplies they need.

  Polyzen 04.03.20
  

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  Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic

  A reminder of what manufacturers should keep in mind during this turbulent time.

  Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20
  

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• Diagnostics
  

  Sense Accelerates Instrument-Free Molecular Diagnostic Test for COVID-19

  Pioneering new class of diagnostic product will transform fight against pandemic.

  Phillips-Medisize 04.02.20
  

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• Diagnostics
  

  Haemonetics Acquires enicor to Expand Advanced Viscoelastic Testing

  Haemonetics gains ClotPro, a new generation whole blood coagulation testing system.

  PR Newswire 04.02.20
  

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• Diagnostics
  

  PCR Biosystems Works to Ensure Availability of COVID-19 Test Reagents

  Company has the capacity to manufacture enough reagent daily for 4 million reactions, which is sufficient for millions of diagnostic tests.

  PCR Biosystems 04.02.20
  

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  Mike on Medtech: COVID-19, Part 1

  Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.

  Sean Fenske, Editor-in-Chief 04.01.20
  

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  The Challenge and Opportunity in Corporate Environmental Sustainability Efforts

  One company shares its experiences and outcomes with ongoing efforts toward a focus on environmental stewardship.

  Neil Peterson, Alisha Jerauld, CPA and Matt Wold, Merit Medical Systems Inc. 04.01.20
  

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  A Manufacturer’s Secret Weapon: R&D Tax Credits

  For small and medium-sized medical device manufacturers, qualifying for the tax credits could result in an unexpected windfall.

  Chris Lake, President, R&D Tax Credit Consultant 04.01.20
  

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