Manufacturing: Page 2

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Medtech needs to be solutions-oriented, not product-driven

What can medtech do to differentiate when differentiation is hard to prove with products alone?

By Rohan Agni • Oct. 23, 2018

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Living on a slope: Agile commercial strategies for IDN success

Why adopting an agile commercial strategy in medtech is like 'living on a slope.'

By Bret Caldwell, Principal, ZS • Sept. 25, 2018

FDA says Florence unlikely to cause critical device shortages

The agency is closely monitoring 10 sites that make critically important devices and biological products.

By Nick Paul Taylor • Sept. 20, 2018

Cook resolves FDA warning letter that slammed quality processes

The close-out letter follows four years of work to improve quality management.

By Nick Paul Taylor • Sept. 12, 2018

Becton Dickinson sells bioprocessing business to Thermo Fisher

Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.

By Susan Kelly • Sept. 10, 2018

How TraceLink will use $93M in new funds to showcase the benefits of serialization

The data network plans to expand into a life sciences software suite to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.

By Edwin Lopez • Aug. 23, 2018

FDA extends EpiPen expiration date to ease shortages

Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

By Suzanne Elvidge • Aug. 22, 2018

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The end of the "Features War": The changing definition of value in Medtech

In today’s evolving hospital environment, features simply are not enough: Products must create indisputable value.

By Brian Chapman • Aug. 21, 2018

With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season

Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.

By Nick Paul Taylor • UPDATED: Aug. 15, 2018 at 11:47 a.m.

Baxter boosts 2018 outlook but IV bag supply still under pressure

"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO ​José Almeida told investors.

By David Lim • July 26, 2018

Deep Dive

Pharma and AI? Let's try augmented intelligence first

Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.

By Lisa LaMotta • July 23, 2018

Industry seeks clarity on latest FDA Pre-Cert working model

A software coalition questioned the agency's statutory authority to run a pilot test in 2019.

By David Lim • July 19, 2018

Cannabis-based drugs and devices: A winning combo?

Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.

By Barbara Boughton • July 17, 2018

Biogen looking to expand into medtech: report

The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes. 

By Lisa LaMotta • July 16, 2018

US imposes 25% tax on $836M in Chinese medtech imports

The extent of the tariffs represent a minor victory for the medtech industry, which lobbied to bring the value of products covered by the levy down from nearly $3 billion.

By Nick Paul Taylor • July 10, 2018

GE to spin off healthcare unit in latest restructuring

Moody's and investors applauded the move, which comes amid a reboot of the health division.

By Meg Bryant • June 27, 2018

UPS seeks to disrupt implantable medical device supply chain

But without device manufacturer buy-in, uptake of the effort appears to be slow.

By David Lim • June 05, 2018

Hospitals facing IV solution shortages after Hurricane Maria

The FDA has granted one of the largest manufacturers of IV solutions permission to import IV bags from its facilities in other countries.

By David Lim • Nov. 16, 2017