September 25, 2018
As the fall season is upon us, so is the ramp up of another Additive Manufacturing conference season. The UL AM team has been busy across the globe presenting on safety in AM. Before wrapping up the 2018 conferences at TCT UK this month and FormNext in November, the team took a moment to summarize and share some highlights from recent events.
3D Printing of Medical Devices: Meeting Regulatory Requirements, Singapore, August 21
Organized by UL ASEAN and the Singapore Manufacturing Federation (SMF), the workshop hosted participants from medical device companies, research organizations, regulatory bodies, and hospitals. The session included a focus on 3D printing and the compliance requirement for medical device software per IEC 62304. Dr. Khalid Rafi, UL AM Lead Development Engineer, presented on:
- Fundamentals of 3D printing
- 3D printing applications
- Advantages and Challenges of using 3D printing for medical devices
- Overview of regulatory landscape for 3D printed medical devices
- 3D printing workflow and related impact on device quality
- Demonstration of FDA guidance document for Additive Manufacturing using a case study
The workshop provided basic understanding on the use of additive manufacturing for medical devices and clarity on the applicable standards and regulations with respect to additively manufactured medical devices. The demonstration of FDA guidance document on technical considerations for additive manufactured medical devices gave the participants an insight on what factors they should look for when they produce a medical device using AM and to seek approval from FDA.
2018 Taiwan International 3D Printing Exhibition, Taiwan, August 29 – September 1
UL participated in the Additive Manufacturing Association of Taiwan (AMAT) seminar on August 30 which included the promotion of new technologies and general market trends. Core topics focused on safety and security with UL covering facility safety, volatile organic compounds (VOCs) and particle emissions, and plastic part production.
Seminar highlights included:
- From the exhibition, there was a clear increase in regional product availability with AM metal machines showing stable growth. The sole Taiwanese manufacture of AM metal printers, Tongtai, had a strong presence and many of the major equipment manufacturers were present either through their own promotion or through distributors. These included Renishaw, Shining3D, 3D System, EOS, SLM, GE Additive and HP. Promotion from local metal powder manufacturers Chiayi Steel and Circle Powder was also prominent.
- The growth of photopolymer SLA or DLP was greater than plastic FDM compared to the prior year. Young Optics and XYZ continue to lead the FDM space among the local brands. The market is pushing for large format FDM in industrial manufacturing and small nozzle with high resolution for the connector
International Manufacturing Technology Show (IMTS), Chicago, September 10 – 15
The UL AM team was busy walking the exhibit floor at the premier manufacturing technology show and attending the co-located Additive Manufacturing Conference (AMC). UL’s Paul Bates, AM Lead Development Engineer, and Bob Starasinich, Senior Field Evaluation Engineer, contributed to this year’s AMC agenda covering AM facility and equipment risks and hazards and relevant standards.
Across the exhibit, many major AM equipment manufacturers announced new metal equipment. Show highlights included:
- EOS launched the M300-4
- HP unveiled its Metal Jet
- Velo3D announced its support-free metal Sapphire system
- 3D Systems in partnership with GF Machining promoted the DMP 500
Optomec and Mazak announced new hybrid technologies combining both subtractive and additive technology.
Another key theme was the automation and digitization of manufacturing in the next industrial revolution. AM is being promoted as one part of the manufacturing value chain and there is a strong focus on advancing software simulation and enabling automation to demonstrate the industrialization potential of AM and other advanced technologies. The integration of AM in manufacturing was also demonstrated by the increase in AM technology across the traditional machining and manufacturing exhibit floors.