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Outcome-based Pricing Initiatives in the Healthcare Industry

July 11, 2019 By MassDevice Leave a Comment

By Joe Miles – Global Vice President, Life Sciences (SAP Industries) and Bob Steller – Industry Principle, Life Sciences (Vistex) A distorted reimbursement model has driven healthcare costs ever higher, and elevated healthcare spend to the top budget item for many governments across the globe. But several major industry players have begun to experiment with […]

Filed Under: Sponsored Content Tagged With: Vistex

Clinical Study Cleanup: How to Get Your Study Back on Track

July 1, 2019 By MassDevice Leave a Comment

By Kelly Jasko, Lead Clinical Research Associate Every year, the U.S. Food and Drug Administration (FDA) releases metrics detailing the outcomes of the Bioresearch Monitoring (BIMO) inspections done at facilities conducting clinical research within the previous year. Of the 104 Sponsor/Monitor/Contract Research Organization (CRO) inspections done in fiscal year 2017, 36 percent were found to […]

Filed Under: Sponsored Content Tagged With: IMARC

Silicone Materials for Long-term Medical Implants: Innovate for the Future

June 4, 2019 By MassDevice Leave a Comment

By Feifei Lin, Ph.D., Business Development Manager, Healthcare, Elkem Silicones USA Corp. With the growth of the aging population, the number of age-related diseases has increased. Every year millions of patients sustained or improved their lives through surgical procedures involving implanted devices. Medical implants such as orthopedics, pacemakers, cardiovascular stents, defibrillators, neural prosthetics or combinational […]

Filed Under: Sponsored Content Tagged With: elkemsilicones

Delivering Quality – The ISO 13485 Certification

June 3, 2019 By MassDevice Leave a Comment

By Charlie Sears, Quality Manager, Goddard Inc. The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold in the U.S. and worldwide. The ISO 13485 standard specifies requirements for a quality management system (QMS) for an organization […]

Filed Under: Sponsored Content Tagged With: Goddard

Devices Roar Into The Next Decade

June 3, 2019 By MassDevice Leave a Comment

Medical device investments skyrocketed in 2018, and these trends are continuing into 2019. The activity now will influence healthcare for the next decade. This year, the medical device and diagnostic industry saw record-breaking increases in the investment scene. As noted by Silicon Valley Bank’s (SVB) analysis, Trends in Healthcare Investments and Exits 2019, investing in […]

Filed Under: Sponsored Content Tagged With: medicaldevices, Medidata Solutions

Life in the Fast Lane: 3 Lean Tools to Speed Products to Market

May 2, 2019 By MassDevice Leave a Comment

By Don Welling, Sr. Director of Technical Solutions, Viant The average driver can change a tire in about 20 minutes. A NASCAR pit crew can change all four tires in less than 20 seconds, thanks to the right tools and processes. Of all the tools used in NASCAR racing, the air wrench has saved the […]

Filed Under: Sponsored Content Tagged With: viant

The need for new business models under MDR/IVDR

April 17, 2019 By MassDevice Leave a Comment

In less than 12 months, the world’s second largest market for medical technologies is going to be turned upside down. The new medical devices regulation (MDR) and in vitro diagnostic device regulation (IVDR) — which set forth more stringent safety and data requirements for devices distributed in the EU — will go into effect in […]

Filed Under: Sponsored Content Tagged With: ICON plc

5 Guidelines for Writing a Useful Clinical Monitoring Report

January 31, 2019 By MassDevice Leave a Comment

Taking Your Report from Good to Great By Brandy Chittester, Chief of Clinical Operations A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight […]

Filed Under: Sponsored Content Tagged With: IMARC

Design for Manufacturing Breakthroughs

January 14, 2019 By MassDevice Leave a Comment

Producing Innovative Micro Medical Devices By Lindsay Mann, Director of Sales & Marketing How to Overcome Roadblocks When Producing a Micro Medical Breakthrough When trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the […]

Filed Under: Sponsored Content Tagged With: MTD Micro Molding

Global Excellence in Delivery Device Testing

December 31, 2018 By MassDevice Leave a Comment

Introduction There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can […]

Filed Under: Sponsored Content Tagged With: Medical Engineering Technologies

The Promises (and Problems) of Real World Data

November 26, 2018 By MassDevice Leave a Comment

By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, […]

Filed Under: Sponsored Content Tagged With: Medidata Solutions

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