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MedTech Intelligence

Volume 13 Issue No. 13


MedtronicMedtronic Gets FDA Approval for the First
Non-Surgical Valve for Patients with
Congenital Heart Disease

By MedTech Intelligence Staff

The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.


drishti - From cGMP to cEMP: Why settle for "good" when you can be "Exraordinary?"

Featured Articles


Crucial Metrics for Medical Device Manufacturers:
Cost-to-Serve (Part 2)

By Shawn LaRocco, ServiceMax

Understanding the cost to service by product and by subcomponent will help you identify which service events are the most impactful to the bottom-line financials of the business.


COVID-19 Pushes Technology to Facilitate Hybrid Patient Care

By Erik Vanderlip, M.D., ZOOM+Care

Increased access to care is a vital part of the vision to innovate the delivery of healthcare.


How to create scalable connectivity ecosystems for in-hospital medical equipmentHow to create scalable connectivity ecosystems for in-hospital medical equipment

Sponsored By S3 Connected Health

Connectivity is now a must when designing or redesigning in-hospital medical equipment.

Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment.

Download now!


Marc Dufresne, Evidence PartnersHow Literature Review Automation Improves CER and
PER Program Management

By Marc Dufresne, Evidence Partners

Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.


How Hospitals and Health Systems Can Accelerate Innovation

By Kristian A. Werling, McDermott Will & Emery

Among the many lessons from the COVID-19 pandemic, it’s clear that the future of healthcare belongs to those who can harness science and technology—sometimes rapidly—to improve population health through more efficient and accessible care.


Quantum Computing Makes Inroads in Life Sciences

By Eric M. Luyer, Axendia, Inc.

Quantum computing has spurred the development of new breakthroughs in life sciences from using machine learning methods to diagnose illnesses sooner to identifying materials to make more efficient devices.

Siemens - Modern and integrated manufacturing execution systems in medical devices


EU IVDR - Process, Data, Reporting & PlanningEU IVDR - Process, Data, Reporting & Planning

March 30 - April 27, 2021

The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels.

Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market.

March 30, 2021: EU IVDR Introduction (On-Demand Recording)

April 6, 2021: Quality Processes and Documentation

April 13, 2021: Clinical Evidence & Surveillance

April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling

April 27, 2021: Strategy and Planning

Details & Registration

MedTech Library

The Business Value of Cybersecurity in MedTechThe Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

Download now!

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