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Manufacturing Execution

Dr. Christopher Joseph Devine, President, Devine Guidance International
October 28, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Number 13 Proves Unlucky for California Establishment

By Dr. Christopher Joseph Devine

Perhaps the organizational soul searching should begin after receiving one Form 483.

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Finger prick lab tests, Theranos
October 28, 2015
Finger prick lab tests, Theranos

FDA Says Theranos Device Uncleared, Finds Host of Problems

By Maria Fontanazza

Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.

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John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015
October 14, 2015
John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015

2015 MedTech Highlights: Low Industry Growth, VC Declines, M&A Impressive

By MedTech Intelligence Staff

Ernst & Young’s Pulse of the Industry report is out, and once again, it’s not all gloom and doom.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 7, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Gasoline in the Stockroom, Burning Down the House!

By Dr. Christopher Joseph Devine

Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.

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Cloud based solutions in the medical device industry
September 23, 2015
Cloud based solutions in the medical device industry

Weighing the Risks and Benefits of the Cloud

By Maria Fontanazza

Device manufacturers are concerned about data availability and security, as well as risk to their brand.

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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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Columns

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.

December 13, 2024

Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

Overcoming 21 CFR compliance challenges - stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.

September 12, 2024

APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare

By Erica Freeze
MDIC Annual Public Forum

The MDIC Annual Public Forum 2024 kicked off this week with experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA. Topics included the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem and how can we leverage emerging technologies to bring innovative and safer solutions to patients.

August 24, 2024

MEDICA & COMPAMED 2024: Adapted Hall Layout for Even Better Integration of Trade Fair and Ancillary Program

MEDICA 2024 and COMPAMED 2024 trade fairs in Düsseldorf, Germany attract more than 6,000 exhibitors from about 70 countries. These events are globally unique information and business platforms for the entire value chain of medical technology systems and products - including development and manufacturing. MEDICA and COMPAMED will take place from November 11 – 14, 2024.

April 19, 2024

Ask the Expert: Harnessing the Potential of Digital Quality – Transforming Manufacturing Outcomes for Long-Term Success

By MTI Marketing Staff
Garth Conrad

Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.

April 8, 2024

Utilizing CSF to Manage Cyber Risks

By MedTech Intelligence Staff
Dave Bailey

Dave Bailey, VP of Consulting Services at Clearwater Security, highlights the need for top-down support in managing healthcare-related cyber risks and how the new NIST Cybersecurity Framework can help enhance cybersecurity in healthcare and MedTech organizations.

  • Digital Health
  • MedTech Economics
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