Featured

Conducting Remote GxP Audits: Three Keys to Success

While remote audits have always been an option, the pandemic forced quality units to take a fresh look at how to use them effectively.
Online Exclusives Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting Inc. 05.07.21
Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.
Sam Brusco, Associate Editor 05.06.21
Chronic Disease

BD to Spin Off Diabetes Care Biz

Transaction is expected to be completed in the first half of 2022.
Sam Brusco, Associate Editor 05.06.21
R&D & Design

Overview of the Medical Device Design History File, Technical File, and Design Dossier

The FDA requires manufacturers to follow design control principles to ensure that specified design requirements are met.
Online Exclusives David Butcher, Staff Writer, MasterControl 05.06.21
Digital Health

Connect America to Buy Philips' Aging and Caregiving Biz

Combined business will service expanded customer base of Personal Emergency Response System.
Sam Brusco, Associate Editor 05.05.21
Software & IT

Digitization Streamlined Quality and Production: A Case Study

Recognizing that managing a paper-based quality system was no longer practical, the company took steps to modernize with digital solutions.
Online Exclusives David Butcher, Staff Writer, MasterControl 05.05.21
Diagnostics

COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

MPO's Sean Fenske speaks with Chris Hagen of Beckman Coulter about the company’s response to the need for COVID diagnostics and the rapid ramp-up of production.
Sean Fenske, Editor-in-Chief 05.04.21
Embedding Risk-Based Thinking into Quality Efforts

Controlling risk is an important requirement for companies developing regulated products.
Online Exclusives David Jensen, Staff Writer, Master Control 05.04.21
Spectrum Plastics Group Acquires Laser Light Technologies

Advances the group’s offerings as a full-service partner for medical devices, life sciences, and other applications.
Charles Sternberg, Assistant Editor 05.03.21
Video & Analytics: Differentiators in a Compliance-Adherent Crowd

Instead of checking the box with minimal investment in compliance, the firm that elevates its manufacturing practices beyond cGMP will gain more market share.
Prasad Akella, Founder/CEO, Drishti 05.03.21
R&D & Design

Medical Device Design for Smaller and Smarter Medtech

Developers of medtech are asked to reduce the size of devices, and fortunately, can take advantage of newer tools that better enable them to do just that.
Mark Crawford, Contributing Writer 05.03.21
Respiratory Equipment's Pandemic Spotlight

Ventilator and critical component manufacturers supercharge production to meet COVID-19’s demand for respiratory aids.
Sam Brusco, Associate Editor 05.03.21
Contract Manufacturing

Medtech's 2021 Full Service Outsourcing Roundtable

Outsourcing service providers share lessons learned and how they were able to tackle the COVID-19 challenges to fulfill the needs of their OEM customers.
Sean Fenske, Editor-in-Chief 05.03.21
Defying the Laws of (Mask) Supply and Demand

Cases of N95 respirators are piled high outside the headquarters of Prestige Ameritech.
Michael Barbella, Managing Editor 05.03.21
Fertility Treatments—A Patient Self-Pay Paradise

According to the National Conference of State Legislatures, the average IVF cycle costs between $12,000 and $17,000 (not including medication).
Maria Shepherd, President and Founder, Medi-Vantage 05.03.21
Paying it Forward: How Mentorship Pushes Us to Success

The right people can build us up, push us to excel, and persevere when we think we can’t go on.
Dawn A. Lissy, Founder & President, Empirical 05.03.21
A Lifetime in Medtech: MassMEDIC’s Brian Johnson Offers a Snapshot of the Industry

Johnson shares his thoughts on a number of pandemic-related topics, from lessons learned to the need for changes in the supply chain.
Sean Fenske, Editor-in-Chief 05.03.21
Surgical

High-Quality Materials and Precision Engineering in Robotic Medical Technology

The XACT ACE Robotic System is designed to be able to deliver an instrument to a target within 1.7-mm average accuracy on the first insertion.
Chen Levin, CEO, XACT Robotics 05.03.21
A Paradigm Shift—Third-Party Immersive Execution

A reputable firm will provide a thorough and unbiased review of all portions of your business and supply fractional leadership where you may have gaps.
Kevin Haines, Partner, Factor 7 Medical 05.03.21
Ensuring Regulatory Compliance for Medical Device Manufacturing

EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices.
Tim McGinnis, Vice President, Medical Quality and Regulatory Affairs, Sanmina 05.03.21