PF Blog

Update: FDA Releases Draft Guidance for Additive Manufacturing of Medical Devices

By: Barbara Kanegsberg 25. May 2016
3D printer at work

3D printer at work

 

Readers of Products Finishing will benefit from reviewing and commenting on the new FDA draft guidance document about additive manufacturing for medical devices. Not concerned about medical devices? Not even thinking about AM? Read the document anyway, because the wave of (AM) impacts not only medical devices but also automotive, aerospace products and consumer products.

 

 The document, “FDA’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing,” (1) includes items from a 2015 FDA workshop on AM for medical devices. The document contains a range of aspects of design, printing, and processing. Our area of specialization is critical cleaning and surface quality; and as invited participants to the workshop at FDA headquarters we addressed challenges with cleaning AM devices. As indicated in Section VI(E), of the draft guidance, cleaning processes can be more difficult in AM devices than with those produced by traditional (non-additive) means.

 

The benefits of AM may result in cleaning challenges. The layer-by-layer process of AM allows complex internal support structures and tortuous internal channels; the result can be a product with desirable features.  In addition, products are becoming more complex, including instances where, in post-printing operations, AM is combined with traditional manufacturing processes. This means that particles (including residue of powder from the printing process) and/or metalworking fluids can become entrapped. Manufacturers have to design and demonstrate effective cleaning processes.

 

To assure that the FDA considers comments before it begins work on the final version of the guidance, they request that comments be submitted by August 8, 2016. (2)

 

 

1. “Technical Considerations for Additive Manufactured Devices, Draft Guidance for Industry and Food and Drug Administration Staff”

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

 

2. Federal Register announcement: https://www.federalregister.gov/articles/2016/05/10/2016-10924/technical-considerations-for-additive-manufactured-devices-draft-guidance-for-industry-and-food-and

 


Plating Shop Owner Richard Taylor Going Strong at 100

24. May 2016
Bob Mueller expresses his best wishes to Dick Taylor on Tuesday during his 100th birthday celebration at Taylor Metal Products. Photo by Jason J. Molye of the Mansfield News Journal and used with permission.

Bob Mueller expresses his best wishes to Dick Taylor on Tuesday during his 100th birthday celebration at Taylor Metal Products. Photo by Jason J. Molye of the Mansfield News Journal and used with permission.

 

Taylor Metal Products owner Richard Taylor recently celebrated a milestone with his 100th birthday on April 25. The Mansfield, Ohio, shop was started by Taylor's father, and features zinc coatings with chromate top coatings, as well as bright chrome decorative finishes are available.

 

A wonderful story in the Mansfield News Journal by Linda Martz highlights Taylor's birthday celebration.

 

You can read the story HERE.


Col-Met Opens New Manufacturing Facility

20. May 2016

 

 

Col-Met celebrated the opening of its new manufacturing facility in Rockwall, Texas, in April with a festive open house.

 

The company’s distribution partners, suppliers, industry partners, local city officials and employees were invited to celebrate and view the new 150,000-square-foot facility. With nearly 300 people in attendance, Col-Met kicked off the event with with live music, a Texas barbeque and plant tours to share its product capabilities and the launch of new innovations.

 

The tours went through Col-Met’s history, the engineering products department, drafting, innovations and into the plant to get a full understanding of the company's manufacturing process, from sheet metal and fabrication to the coating process and superior accessories integrated into the products.

 

 

In January 2015, Col-Met broke ground on the 150,000-square-foot facility that would expand their capabilities and allow them to achieve an aggressive growth strategy for the long term. In November, they moved into the new building that includes expanded office space, state-of-the-art manufacturing space, and a training room designed for enhanced distributor training.

 

 

 

Following the plant tours, popular band Emerald City kicked off the celebration while attendees enjoyed a Texas barbeque dinner. With great food, drinks and even raffle drawings, the remainder of the evening was spent networking and listening to outstanding music.

 

In conjunction with the open house, Col-Met hosted distributor training courses in its new training room with nearly 50 attendees. The courses are designed to provide a first-class educational opportunity to learn all facets of finishing operations, as well as provide extensive knowledge on Col-Met product lines regarding engineering, design, safety, user friendliness and ongoing support after the sale.

 

 

“What an event,” says Steve Houston, Col-Met’s chief marketing officer. “It was better than expected. Twenty years ago our founder and CEO, Eric Jones, had a dream and today we celebrate that dream in a 150,000-square-foot, state-of-the-art manufacturing facility that put us in a position to support our aggressive growth plans.”

 

For more information, please visit colmetsb.com

 

 


New England NASF Chapter Hosts Suppliers Night

18. May 2016

 

More than 30 years ago, the New England Chapter of the National Association of Metal Finishers (NAMF) conceived a plan to recognize the efforts and support of the Metal Finisher Supplier community by setting aside a special evening in their monthly meeting schedule as Supplier Appreciation Night.

 

At that time NAMF membership was strictly limited to Metal Finishing job shop owners and managers. Suppliers were not allowed membership, so this was indeed an extraordinary event.

 

Many things have changed over the years. As the metal finishing community became smaller the need for strength in numbers became more apparent and Suppliers are now a significant part of the membership makeup of the New England Chapter, presently operating under the umbrella of the National Association for Surface Finishing (NASF).

 

While many things changed, the founding principle of this event has remained constant throughout the years, the desire to recognize the support of the Metal Finishers Suppliers to the success of the operation of Metal Finishing Job and Captive shops. To this end what started as a social dinner event with a neutral/ non-technical speaker, and then evolved with the addition of a mini trade show, has remained a main stay premier event on the New England Chapter calendar.

 

This year’s Supplier Appreciation Night was held on April 21 at the Holiday Inn in Marlborough, Massachusetts. It encompassed all of the founding principles of the original Suppliers Nights with speakers, twenty plus supplier table top exhibits, door prizes, scholarship raffle prizes and the presentation of seven scholarships to college age children of employees of member companies presented by Chapter President Robert Messore. The attendants were also given an update by our National Board Member, Chris Capalbo, on the benefits of the local board’s decision to sign the NASF Chapter Affiliates Agreement, a presentation of the new Chapter Logo and a look at the future New England Chapter web site being developed by NASF staff.

 

All 100 plus attendees commented on the well orchestrated evening this event has been over the years and are already looking forward to next year’s Supplier Appreciation Night.


General Magnaplate Closes California Plant After 36 Years

16. May 2016
Candida Aversenti, CEO of General Magnaplate

Candida Aversenti, CEO of General Magnaplate

 

General Magnaplate is closing its Ventura, California, facility after 36 years and will serve customers from its Texas and New Jersey operations.

 

Candida Aversenti, CEO of General Magnaplate and daughter of founder Charles Covino, said there are two reasons for the facility closure: difficult business conditions created by the state of California, and the settlement of a potential lawsuit threatened by the Santa Barbara-based Environmental Defense Center (EDC), which claimed that General Magnaplate had violated the Clean Water Act, which the company denies.

 

“The simple fact is that the state of California does not provide a business friendly environment,” Aversenti said. “Increases in workers compensation costs and government regulations — combined with predatory citizens groups and law firms that make their living entirely by preying on small businesses — have left us with no other choice but to shut down our California facility. This is in stark contrast to our New Jersey and Texas facilities, which are flourishing in small business-friendly environments created by the respective local governments and environmental agencies.”

 

The EDC claimed that General Magnaplate was discharging polluted storm water into the Santa Clara River, which General Magnaplate President Edmund Aversenti flatly denied.

 

“General Magnaplate is not in violation of the Clean Water Act and ongoing investigations suggest that the alleged polluted storm water runoff from our facility actually came on to our property from neighboring properties exempt from CWA compliance,” he said. “We have agreed to settle with the EDC for purely economic reasons. This is particularly upsetting given that we have a strong Storm Water Pollution Prevention Plan in place at the California facility, and have contracted consultants to insure that we are in compliance.”




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