Marking Medical Devices, UDI Compliance, and Dealing with Difficult to Mark Materials

Marking Medical Devices, UDI Compliance and Dealing with Difficult to Mark Materials

The Challenge for Medical Device Manufacturers

According to the U.S. Department of Commerce, there are more than 6,500 medical device companies in the U.S. with a total market size of $148 billion.   The most active sub-category in the industry is surgical and examination instruments (based on value of export shipments), which includes products ranging from scalpels to intricate catheters.  Combined with strict regulations and proposed new rules (Unique Device Identification system) by the U.S. Food and Drug Administration and the European Union, the opportunities are enormous for Telesis.  Telesis is well positioned to offer a wide variety of reliable and innovative solutions to often difficult and challenging marking tasks.

Many medical devices, especially those found in a surgical environment, are made of stainless steel. Our EVC and Fiber Lasers are ideal for marking on stainless. For maximum flexibility and robustness, our FQ Series (now known as FQDS indicating Dual Sensor for the shutter mechanism, a key advancement in laser safety) is the preferred choice and available in many different wattages.

The Telesis Solution – Fiber Laser Marking

The FQ fiber laser series is a versatile product robust enough for heavy industrial etching and delicate enough for annealed marks.  Typical for medical applications are annealed marks which does no damage to the surface or the material and maintains the corrosion resistant nature of the medical instruments.  This form of non-invasive processing is crucial in the prevention of bacterial accumulation. Whether it’s banded titanium needles or high-grade stainless steel scalpels, this laser can mark them with precision, consistency and reliability. Our Vari-Z technology allows for 3D and 3 Axis control of the beam to maintain perfect resolution and consistency over curved surfaces without mechanical rotation.

Referencing the photos below, we see an annealed mark of a serial number, an annealed mark with precision measurement graduations, and a light etching of a serial number on curved surface with virtually no inconsistencies in text shape or quality despite a variation in surface Z plane.

 

While stainless Steel is a common material in surgical instruments, we also find a products with plastic molded details. Plastics can be difficult to mark and while fiber lasers have some capabilities for marking plastic, traditionally, CO2 lasers have been used to create “melt marks” in different plastics. Of ocurse, this does change the surface quality of the material, which can lead to less effective sterilization, as well as limiting contrast and thus readability.

The Telesis Solution – Green Laser EV4G

Coupled with the appropriate F-Theta lens, the EV4G laser with its 532nm wavelength can create high contrast marks with absolutely no damage to the polycarbonate or ABS plastic housing assembly of catheters (shown on the right).  Whether in-focus or off-focus, the green laser can create color change in the material that achieves the annealed effect without damaging the surface. Click here for more info on Telesis Green Lasers

The photo below shows a high contrast mark on Polycarbonate with a cycle time of 10 seconds

Another challenging material group would be Silicone and PVC. And while traditional lasers create a mark through heat imparted on the material, in some cases a “cold mark” may be preferred. In addition, when marking a part with graduated measuring positions, spot size resolution and control is paramount to a quality product.

The Telesis Solution – UV  Laser Marker

The Telesis UVC laser, with the combination of short wavelength (355nm) and excellent M2 value, produces a small spot size, which makes it an ideal choice for creating delicate marks on sensitive materials.  For example, the UV laser reacts well with silicone or PVC to create fine graduated markings that denote depth of insertion on the catheter tubes below.  Since the laser beam only creates color change on the surface, the material is not damaged and is free from bacteria contamination.  Thus, this laser allows a safe and reliable process for medical device manufacturers. The photo on the left depicts very small characters (2.5 X 1.5 mm) and were marked in 1.4 seconds; the graduations on the left were marking is 2.1 seconds.

Unique Device Identification (UDI) Regulation

As with any safety-centric product, traceability has become a requirement in order to maintain high quality and track any problems from the field. In the medical device market, UDI (Unique Device Indentification, has been adopted by the FDA and the EU. While it is impossible to delve into all the details around this regulation, we can offer a few key insights, as it related to marking:

  • UDI offers benefits on identification, traceability, reduction of errors, prevention of counterfeits, management of recalls, and more.
  • UDI is a system that includes a unique device identifier in human- and machine readable- form.
  • Proposed UDI regulations between the FDA and the EU are very similar as they wish to bring uniformity and consistency to global manufacturers, users and other partners.
  • The system will be phased in over several years.
  • Telesis lasers markers can apply GS1 compliant standard and 2D barcodes. See below for a typical example.

Telesis offers a diverse lineup of marking systems to satisfy UDI marking requirements on a wide variety of materials.  Customers can count on our years of experience to provide dependable and complete marking solutions.

Let’s have some fun! Grab your smartphone and open your QR code reader, and click some of the codes below for additional information:

Telesis Laser Marking Website:

FDA UDI webpage:

Production Components Website:

Telesis Landing Page on Production Components website:

For more information on Telesis, see their page on this website:
http://www.production-components.com/manufacturers%20list/telesis/
or call us at 203 881 3103 or email at mail@production-components.com

Sources:
www.fda.gov
www.selectusa.gov
http://www.ghx.com
https://ec.europa.eu
Department of Commerce – International Trade Administration: 2016 Top Market Report Medical Devices

R&I Grippers Now Available On Our E-commerce Web-Store

Having added another premier manufacturer, R&I Manufacturing, to our line, we are pleased to announce we now have grippers available for sale on our website.

R&I Manufacturing sells the very best in angular and parallel grippers, as well as air shuttles, slides and escapement devices, to name a few. See their catalog at http://www.rimfg.com/catalog.htm, then enter the part number in the search box in the top right corner of our home page at www.production-components.com.  Or you call us at 203 881 3013, or email us at sales@production-components.com.

Press Release – Production Components and Jack Breen Associates Merge

July 2, 2018, Wallingford, CT – It is with great pleasure that we announce that Production Components Inc of Wallingford, CT and Jack Breen Associates of Clinton, CT have merged and are now in a position to serve our common customer base and principals even better. Both companies have a rich history in representing premier product lines dedicated to assembly, part marking, test and automation processes.

The newly merged company will operate as Production Components, Inc., and will be headquartered in Wallingford, CT, with satellite offices in New Hampshire and Rhode Island. Jack Breen, owner of Jack Breen Associates, will continue to support his existing New England customer base. In addition to the merging of principals, the expanded company will be providing coverage for several key principals in the Eastern PA, Metro NY, NJ, MD, and DE areas.

“Jack and I have crossed paths many times over the past 30 years, but more recently we realized that our current product lines were more complimentary and synergistic than they were competitive”, says Scott White, President of Production Components. He continued, “It became clear that there would be numerous benefits to our principals, our customers, and our respective teams, by joining forces”.

The expanded company will include 5 field sales reps, as well as inside sales and marketing. Both Jack and Scott will continue to call on their long-time customer base. “We discovered very quickly that we had a lot of commonality in our customer lists”, says Breen. “And we knew many of the same key customers within each other’s database, further reinforcing that the merger would ultimately serve our customers and principals well”.

The response from their respective principals has been overwhelmingly positive, with an added energy and excitement in anticipation of the future. “The support of our key principals was very important to a successful transition”, says White. “In fact, my largest principal – Telesis Marking Technology – had some great insight and suggestions based on their previous experience with other agency successions”, added Breen. Additional guidance from MANA, whose resources included guidelines for transitions, mergers, and other manufacturer’s rep specific concerns, made the drafting of an agreement easy and protective of both parties.

Dukane presents “Particulate-Free Welding Technologies” Lunch & Learn at NPE2018

If you’re planning on attending The Plastics Show in Orlando, FL (register for the show here), don’t miss our partner Dukane’s Lunch & Learn presentation –
“Particulate-Free Welding Technologies”
on May 9th at 1PM.  See the details below or sign up here.

Register today!

 

Are you are looking for a robust plastic welding process that delivers particulate free and cosmetically appealing welds?

Our technical experts are presenting
“Particulate-Free Welding Technologies”
at
NPE 2018 Expert Super Session.

When: May 9th from 1:00 p.m. – 2:00 p.m
Where: W203A, West Building, Orange County Convention Center, Orlando, Florida.

Join us to learn about the benefits of incorporating these technologies in your welding process & enjoy complimentary lunch.

Click on the button below to register!!!

 

Apprenticeships – One Of The Solutions For The Workforce Shortage Problem In U.S. Manufacturing?

Production Components is a representative and distributor for some of the top assembly equipment in the manufacturing sector.  Working with our principals and partners, we develop solutions for our customers that are robust, reliable, and affordable. We strive to add value to our principals and our customers, and help them to become more productive, more competitive, and more profitable.  Today we are debuting the first in a series of blogs regarding the challenges that face manufacturing companies today and some possible solutions. Our hope is to spark dialogue and share ideas about how best to solve these issues. Much of the content was inspired by and sourced from a recent story featured on NPR’s Marketplace program, but with additional insight specific to our market, focus and experience. Please share and contribute your thoughts.

Apprenticeship programs – One Of The Answers For The Shortage In The U.S. Workforce In Manufacturing?

The United States needs to create more manufacturing jobs: Nobody disputes this. The loss of manufacturing jobs is a problem here in the U.S. where factory workers are aging and manufacturers are worried there won’t be enough young people with the technical skills to do their jobs in the future.  The worker shortage is a national problem. Estimates are that U.S. manufacturers will need to fill more than 3.5 million jobs over the next decade.

Germany, which continues to maintain manufacturing at nearly a quarter of its economy (about twice the share as the US manufacturing has in our economy), doesn’t have the same worker shortage problem. Why is that?

A key element is Germany’s apprenticeship training program.  Every year, about half a million young Germans enter the workforce through their apprenticeship programs. This gives manufacturing in Germany a continuous stream of highly qualified workers, maintaining its well-deserved reputation for manufacturing top-quality goods.

The effectiveness of Germany’s Apprenticeship programs in preserving Germany’s manufacturing standing in the world has not gone unnoticed in political circles here the U.S.  Felix Rauner, a professor at the University of Bremen and one of the world’s leading authorities on apprenticeships and vocational education says, “Every president of the United States [in] the last 30 years, after becoming elected, said, ‘Oh, we should implement the apprenticeship system’,”

Rauner says the U.S. approach to education in the trades hasn’t been effective because it’s often not connected to specific jobs at real companies.  One of the reasons for this is the difficulty in getting American companies to buy into the apprenticeship programs because of the up-front cost of training.  Ludger Deitmer, also of the U of Bremen, is international research coordinator at the Institute of Technology and Education at the University, says that the low cost of apprentice labor reduces a company’s net training cost a little over $10,000,  The real pay-off, he adds, is that after three years they have a highly-skilled worker trained specifically for what that company does.

Starting in 2011, the German American Chamber of Commerce helped set up German-style apprenticeship programs in ten states: Georgia, Illinois, Wisconsin, Michigan, Indiana, Virginia, North Carolina, South Carolina, Alabama and Tennessee. Here’s how the programs are going in two of those states.

Georgia

The state of Georgia, through a program called Georgia Consortium for Advanced Technical Training (CATT) starts high school students in a three-year program when they’re 15. The program matches the student with a nearby technical college and a factory where they learn technical skills on the actual plant floor.

Companies train and mentor high school students, but also commit to $25,000 to fund student salaries. There are 20 manufacturers that are part of the program.

Kenny Adkins with the Technical College System of Georgia says,  “There was a great need for not only this occupational training, but we also know that if these students graduate high school and go off to find themselves, then it takes them about 10 years to come back to the technical college system and look at the skilled trades as a viable career option,”

Georgia’s Lt. Gov. Cagle says the state of Georgia’s goal is to offer this kind of opportunity to every high school student by 2020. “This is a great win-win, for not only the student but obviously for industry,” said Cagle.

South Carolina

South Carolina started a program called Apprenticeship Carolina.  Unique about South Carolina’s program is that they have taken the apprenticeship beyond what is typical – the trades and manufacturing –  and implemented the program to other fields like nursing, pharmacy and IT.

Brad Neese, the program’s director, says, “When we started the program we only had 90 companies that had apprenticeship programs,  we’ve hit 670… we only had 777 apprentices in 2007. And we’ve now serviced nearly 11,000 apprentices. So it’s been a phenomenal growth.”

What’s the South Carolina’s secret of success? Firstly, they give a state tax credit for companies  – $1,000 per year per apprentice for four years.  The biggest factor though, is German companies like BMW and Bosch, which have plants in the state and brought with them the German system of apprenticeships.

At United Tool and Mold in Easley, S.C. , which repairs and re-engineers molds, the company has a successful apprenticeship program.  When asked why the program, United Tool and Mold manager Jeromy Arnett responds,  “Because every day, your workforce gets older. We’ve been walking around here for 20 minutes, and our workforce aged 20 minutes. We can’t go back and get the time from the employees that are growing older.”

The company followed the German model starting apprentices off early. They start after their junior year in high school, combining classwork with on-the-job training. “We didn’t go over and take verbatim what their model is, but a lot of how we set up our apprenticeship is based on that German model,” Arnett says.

Graduates of the company’s apprenticeship program make around $16 an hour and can earn up to $24 as they gain more experience.

“These folks in here are making a living so they can buy a house for their family, they put food on the table, they take that family vacation,” Arnett says. “They get the car that they want. Take care of their kids. To me, that’s middle class.”

So Why Aren’t There More Apprenticeship Programs In The U.S.?

“Apprenticeships are win-win,” says Former U.S. Labor Secretary Thomas Perez. “Apprenticeships are opportunities for young people to punch their ticket to the middle class and for employers to get that critical pipeline of skilled labor.”

One would think, given all the positives to be gained from apprenticeships, implementing the programs country-wide would be a no-brainer. Instead, in the last 15 years the number of apprentices in the U.S. has gone down from almost 500,000 to less than 300,000.

But people involved in apprenticeships have noticed the following: the stigma associated with a young person not going to college after high school.  In many cases, there is the belief that  a child going into the trades after high school, instead of college, is somehow a failure on both the child and parent’s parts.  This is not the case in many parts of Europe, where a student early on in high school is steered toward his or her vocation based on their strengths and aptitude. Europe understands that not everybody wants to be a CEO or sit behind a desk.  In Germany there’s still lots of prestige attached when someone, trained through apprenticeship, achieves master status.

“It’s a stigma that we’re trying to get over, especially in our schools,” Arnett says. “Just because they don’t have a sheet of paper hanging on the wall saying they went to school for four years doesn’t mean that they’re any less important to our country and the economy of our country than anyone else.”

Perez says apprenticeships can be a boon for the U.S. economy. But some of the toughest People to convince  are parents. “When you talk to people in the manufacturing context and you say, ‘Hey, your son or daughter should be an apprentice manufacturer,’ too many parents look at me and say, ‘Tom, my kid’s going to college.’ “.  Perez adds that apprentices can always get their degrees while they work — and employers will often help defray that cost.

Dave Zabrosky, North American Sales and Marketing Manager for SCHMIDT Technology Corporation (www.schmidtpresses.com; www.production-components.com/schmidt ) elaborates, “I began the college route, as most high school graduates have been and still are pushed to do now, and found, at significant personal and financial expense, it wasn’t a guaranteed springboard to success.  I was fortunate to find an apprenticeship program with a local tool and die company for machining and earn my journeyman papers while making a good wage.  The push for a college degree reflects many parent’s mindsets towards status instead of success or a vocation appropriate to their children’s aptitudes.  The skilled trades have been portrayed as a lower form of work, erroneously considered lower paying, dirty and unstable and as a result, we have lost generations of our skilled labor force.  This has left us, as a country, without the ability to manufacture for ourselves and with a job pool that is a vacuous glut of highly educated, unexperienced graduates that can’t find a job in the flooded markets that remain.”

Zabrosky points out that he progressed from journeyman machinist to head of all sales and marketing for a company in less than 12 years, and that he has multiple journeymen colleagues who have risen to such positions as regional sales managers, general managers of a company and company owners.  Zabrosky adds, “I tell kids all the time to consider the apprenticeship route. You get paid as you are working towards your journeyman’s papers, which is essentially a degree with experience, versus being in massive debt and unemployed with a piece of college letterhead in one hand while you knock on doors with the other.”

What’s Next?  What Do You Think?

So while Apprenticeships may not be a cure-all for the shortage in the manufacturing workforce, it could be one avenue to explore to help solve the problem.  It certainly seems to be working for Germany and looks to have real potential in the two states highlighted in this article.  Is there a way to start de-stigmatizing the fact that a student might want to build things instead of going to college?  Can the U.S. change its attitude regarding jobs in the trades vs. “white-collar” jobs?  Are there enough companies willing to take the risk and try something new like apprenticeships?  Are there better ways to build up the manufacturing work-force?  These are some of the questions we face as we look to the future in manufacturing.

As the U.S. explores new ways to remedy a lack of skilled labor with apprenticeships and specialty programs, we at Production Components believe that the proper machinery, tools and technology are essential in bridging the worker shortage gap.  Without the right tools and technology, no amount of manpower is going to drive the renaissance of manufacturing in this country. And in this time of increasing globalization, with emerging markets that promise amazing growth opportunity, and significant competition from those markets and other developed countries, we must be able to compete and be profitable with our manufacturing.

We invite you to talk to us about how the technology and machinery we represent can help create the kind of sustainability you and your company will need to get to stay competitive and profitable. And how harnessing today’s disruptive technologies can help your business attract the people you will need to grow and prosper over the next decade. If you have a comment or an opinion on this topic, go ahead and let us know by submitting your comments by clicking on “Leave a reply” at the top of this post.  We would love to hear from you.

Sources:

www.marketplace.org
npr.org