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Manufacturing Execution

Product development roles and responsibilities in medical device manufacturing
September 11, 2015
Product development roles and responsibilities in medical device manufacturing

How to Create Effective Relationships with Your Development Partner

By Art Rousmaniere

As medical device companies move technology concepts into the commercialization stage, collaborating with outside partners is crucial.

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September 2, 2015

Account for Quality Across Product Design

By Maria Fontanazza

Much of this involves communicating with your customer, and doing it often.

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Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers
September 1, 2015
Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers

Why the Hybrid Cloud is Practical for Medical Device Manufacturers

By Mika Javanainen

Cloud-based information management platforms improve collaboration without sacrificing compliance.

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June 30, 2015

Gain More Control over Your Supply Chain

By Maria Fontanazza

Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.

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Dan Baril, CEO, Baril Corp.
June 29, 2015
Dan Baril, CEO, Baril Corp.

Three Prototyping and Pilot Production Strategies to Cut Weeks from Product Launches

By Dan Baril

Assessing the Manufacturing Readiness Level of your new product can help identify risks and opportunities to cut time to market.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
June 23, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Establishments Must Calibrate and Maintain their Equipment, Who Knew?

By Dr. Christopher Joseph Devine

Production and operations managers—make sure your preventative maintenance procedures are up to snuff.

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April 15, 2015

Healthcare Executives Say Supply Chain Effectiveness Is Critical to Compete

Product differentiation is important, but failing to nurture supply chain partnerships is a mistake that companies still make.

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December 11, 2014

Managing Pain Points in the Healthcare Supply Chain

Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
September 3, 2014
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Buyers Beware!

By Dr. Christopher Joseph Devine

What happens when the contract manufacturer a  device establishment selects for manufacturing support runs afoul of FDA?

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August 6, 2014

Executives Offer Prospects for Med-Tech Business Model

By Daniel R. Matlis

In order to compete globally, companies must be proactive in their business plans and anticipate the challenges they may face, concur three med-tech executives.

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Columns

August 10, 2026

Taking Lean Manufacturing to the Next Level

By Matt Stekier

The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

December 4, 2025

The Hidden Complexities of Medical Needle Design

By Kelly Peterson

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

September 26, 2025

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

By MedTech Intelligence Staff, Rene Zoelfl
Product Lifecycle Management

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

January 21, 2025

Public Health Impact of Medical Device Supply Chain Vulnerabilities

By Michelle Tarver, M.D., Ph.D.

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

January 10, 2025

AAMI Updates Materials Compatibility Guidance for EO, Other Modalities

AAMI Logo

In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives.

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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