User-centered design

Challenging the Assumption of ā€œThe Fewer Steps the Betterā€

By Charlotte Lux, Ed Geiselhart

…be further developed. Usability testing in simulated use Formative usability testing, the third research step, typically evaluates a single design direction. Here, testing validates hypotheses and confirm that users are…

…be further developed. Usability testing in simulated use Formative usability testing, the third research step, typically evaluates a single design direction. Here, testing validates hypotheses and confirm that users are…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA and DOJ Working Together: No If, Ands, or Butts: Part Deux

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. North Carolina man…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. North Carolina man…

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Ameing for Asia

Tissue Bank Market in Asia: 2016 Status

By Ames Gross

…success selling their products in Asia, with limited competition from domestic tissue banks. Examples include: Geistlich. A Swiss company that specializes in the production and sales of animal-based biomaterials for

…success selling their products in Asia, with limited competition from domestic tissue banks. Examples include: Geistlich. A Swiss company that specializes in the production and sales of animal-based biomaterials for

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Medical device recall

Cook Medical Recalls Wire Guides Due to Potential Glass in Hydrophilic Coating

By MedTech Intelligence Staff

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

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Product Development, Human factors engineering

HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency

By Allison Strochlic, Michael Wiklund

…this model most often call upon external HFE consultants when they (1) need to conduct usability testing (a multi-week effort including test planning, execution, and reporting), and (2) seek an…

…this model most often call upon external HFE consultants when they (1) need to conduct usability testing (a multi-week effort including test planning, execution, and reporting), and (2) seek an…

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Barcode, UDI

Preparing for UDI in Europe

By Steve Cottrell, Madris Tomes

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

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Dollar, money

Controlling Costs an Issue in Product Development

By MedTech Intelligence Staff

REGISTER HERE for the free webinar, Accelerating MedTech Product Development | Monday, September 12, 2016 | 1 pm – 2:30 pm ET Medical devices undergo many changes, with improvements being…

REGISTER HERE for the free webinar, Accelerating MedTech Product Development | Monday, September 12, 2016 | 1 pm – 2:30 pm ET Medical devices undergo many changes, with improvements being…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Protect Your Investments!

By Dr. Christopher Joseph Devine

for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements…

for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements…

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Mosquito, zika

Rocheā€™s Zika PCR Test Wins FDA Emergency Use Authorization

By MedTech Intelligence Staff

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

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Intuitive Surgical, robotic assisted surgery

The Transformation of Robotics in Asia

By Ames Gross

…more precision and accuracy, as well as simultaneously monitor MRI readings and data from other devices. In 2015, Japanese researchers revealed EMARO, an air-powered endoscopic robot that gives surgeons hands-free

…more precision and accuracy, as well as simultaneously monitor MRI readings and data from other devices. In 2015, Japanese researchers revealed EMARO, an air-powered endoscopic robot that gives surgeons hands-free

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