1. Medtech Insight
  2. >>Business
  3. >>Strategy

FDA Tackles 3-D Printing Considerations In Draft Guidance

A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.

FDA has published a draft leapfrog guidance on 3-D printing that draws from a 2014 agency workshop on the topic. The guidance outlines key issues manufacturers should think about when designing products made with 3-D printers, including the materials used to make those devices and considerations when planning devices specific to individual patients.

Additive manufacturing, or 3-D printing, employs computer models to build three-dimensional objects by printing layers of materials – including plastics and polymers, metals, powders and liquids – on top of each other

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Strategy

Roche To Localize CGM Manufacturing in US with $550M Indiana Site Investment

 
• By Shubham Singh

Roche’s Indianapolis site currently produces 5.2 billion Accu-Chek test strips annually and supports distribution to 53 countries. The new CGM line will add to an already diversified operational footprint, which includes R&D, laboratories, manufacturing, and IT services.

‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 
• By Natasha Barrow

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

GE HealthCare Warns Of $500M Tariff Hit In 2025, Eyes Recovery in 2026

 
• By Shubham Singh

GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.

More from Business

GE HealthCare Warns Of $500M Tariff Hit In 2025, Eyes Recovery in 2026

 
• By Shubham Singh

GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.