The LaserTower Compact 2D marking and engraving system is for medical device marking and glass barcode requirements mandated by the U.S. Food and Drug Administration (FDA). Systems can include Fonon’s autofocus laser height sensor for reading on transparent and solid surfaces. The system is an industrial-grade machine requiring little to no maintenance.
Designed to operate under continuous shock, vibration, and dust conditions, the system is plug-and-play, requires no consumables, and has a mean time between failure rating of >50,000 hours. Marks created by the machine are permanent, legible, non-removable, and optimized for medical device barcoding requirments as mandated by the FDA.
All marks are easily readable with a mobile scaner on highly reflective metals, including stainless steel and aluminum. Each machine is a production-ready system available with either a fiber or CO2 laser in a variety of wattage options and focal lenses, all optimized for medical device marking and engraving.
When designing a medical product, specific challenges occur during the design process and prototyping stages. Because of the nature of the device, keep these considerations in mind throughout the process, including ease of use and compliance with Food and Drug Administration (FDA) regulations.
Sterilization
Sterilization is crucial for parts of devices that come into contact with a patient. The standard thermometer offers a simple solution: a box containing disposable plastic covers for the thermometer needle. However, not all medical devices have or can have a sterilization feature.
It’s necessary to determine what needs cleaned – camera, tubes, the entire device – when designing the product. There are several questions to consider based on the need of the device, available materials, and sterilization methods:
Is this easy to dismantle to sterilize?
Can a single part be removed and replaced after each use?
During sterilization, are the internal components protected?
Is there a design flaw that prohibits part sterilization?
Devices used daily require quick and easy cleaning. If the device is too difficult, too expensive, or too time-consuming to clean, buyers will look for alternatives.
Portability
Portable devices are necessary when providing care after disaster strikes or offering basic medical care for those in developing countries. As demand increases for portable devices, designers and manufacturers must fit big capabilities in smaller packages.
Integration
Medical devices need to be designed with synchronization in mind. Capabilities include cyber-secure connection for transferring medical information or imaging to hospital networks or companion devices such as tablets. Also, consider how easy it is to integrate the device with existing technology: can the user implement it, or does it require special knowledge?
This presents a secondary issue since technology changes at an exponential rate. Several laws can predict changes. In 2013, MIT researchers found that of these laws, Moore’s law and Wright’s law were the best predictors. Moore’s law states improvement will double every two years, but the rate is dependent on the technology; Wright’s law states that progress increases with experience.
Keeping these laws in mind, designers should anticipate changes in technology that can render the device useless or momentarily limit its capabilities.
Usability
A device is only as capable as its user. The device may be the most high-tech, highly rated product on the market, but if it’s difficult to use, it’s useless. One way to ensure that the device is usable is to have product testing and feedback sessions so designers can see the device in action. What did users deem difficult, and what visual cues indicated a struggle in using the device?
Usability issues can range from product design to misunderstanding software navigation, and changes may be necessary. With all the changes to increase usability, there may still be human error issues that occur, especially with new, never-before-seen technology.
FDA regulations
The biggest challenge is meeting the FDA Center for Devices and Radiological Health regulations, which include:
Establishment registration
Medical device listing
Premarket notification/approval 510(k)
Investigational device exemption
Quality system regulation
Labeling requirements
Medical device reporting
Establishment registration – Any facility that produces and/or distributes medical devices must register with the FDA annually. Additionally, the manufacturer/facility must list the devices created and the devices’ uses.
Medical device listing – Facilities are required to list their devices with the FDA, including manufacturers, re-manufacturers, specification developers, re-packagers, and re-labelers.
Premarket notification /approval 510(k) – Devices requiring a 510(k) require FDA authorization prior to commercial distribution. If the device is high risk, it will need preapproval before going on the market, and if a device requires premarket approval, designs must show clinical data that supports device claims.
Investigational device exemption (IDE) – To secure FDA approval, an IDE is required for the device’s use in a clinical study. If the device poses significant risk, both the FDA and an institutional review board (IRB) must give approval. If the device does not pose significant risk, only the IRB must give approval.
Quality system regulation – The FDA inspects all facilities and aspects of the process to create the devices, including designing, manufacturing, and packaging methods.
Labeling – The device must bear appropriate labels and include companion literature that provides descriptive and informational information about the device.
Medical device reporting – Under the requirements of the FDA’s medical device reporting, all issues with medical devices must be reported, including any malfunctions, serious injury, or death resulting from device use.
Failure to meet these regulations means rejection of the device until in full compliance, so keeping these topics in mind while designing a medical device.
Companies in the Midwest and Northeast can attend Discover More With Mazak technology and education events.
The first will be at Mazak’s Midwest Technology Center in Schaumburg, Illinois, April 19-21, 2016, from 9 a.m. to 6 p.m. The technology and education event will explore how today’s advanced metalworking technologies and data-driven production strategies contribute to productivity gains and improved quality management. https://goo.gl/0moqmK
From models with simple milling and turning capabilities to advanced manufacturing cell solutions, real-world part cutting demonstrations will occur on 25 of Mazak’s tools, many of which will feature the latest ancillary equipment from its Value Inspired Partners.
Mazak application engineers will also be available during the demonstrations to discuss how to solve production challenges. Attendees are encouraged to bring their toughest projects for help in developing optimized machining strategies.
The second event will be at Mazak’s Northeast Technology Center in Windsor Locks, Connecticut, May 3-4, 2016, from 9 a.m. to 6 p.m. This event will feature the largest presentation of Mazak CNC machine tools in the region, as well as other innovations for enhancing productivity and versatility on the shop floor. A special day for students will be held on Thursday, May 5. https://goo.gl/P0TqWG
Several Value Inspired Partners will also be on hand to discuss how tooling, fixturing, CAD/CAM, and other peripheral equipment can create total manufacturing solutions. Those attending the event will see Mazak’s Smooth Technology, a process-performance platform that combines the company’s Mazatrol Smooth CNCs with advanced machine design and engineering resources to create ease of use and productivity. www.mazakusa.com
Holt named president of the Americas at Sandvik Coromant
Effective Jan. 1, 2016, Sean Holt was appointed president of the Americas market area. An experienced executive in the manufacturing industry, Holt was a key member of the Americas management team as the vice president of engineering and is now part of the global sales management team reporting to Eduardo Martin, global vice president of sales, whom he succeeds as the head of the Americas organization.
“Sean brings in-depth knowledge to all facets of our industry,” Martin says. “From business development and sales to engineering and R&D, I believe that his experience and skillset will be significant in delivering high-value solutions to our customers.”
“Sandvik Coromant is in a good place with a strong market position and we will continue to build on that. Drawing inspiration from the talented people throughout the company and our network of partners, we will focus on our customers’ needs and ensure that we consistently exceed their expectations,” Holt states. www.sandvik.coromant.com
H&I Mfg. acquired by Spectronics
Bohemia, New York-based H&I Mfg. Inc. has been acquired by Spectronics Corp. H&I became a new division of Spectronics, and its machinery and personnel were moved into the parent company’s 100,000ft2 manufacturing facility in Westbury, New York. Kristian Immoor, the former president and owner of H&I, is now the advanced manufacturing foreman of the new division.
H&I’s machinery, plus the planned acquisition of additional machinery, will boost Spectronics’ R&D efforts while streamlining the output, quality, and dependability of existing products. With Spectronics’ ISO 9001:2008 quality management certification and AS9100 aerospace certification, which H&I did not have, the company will further develop services. www.spectroline.com;www.himanufacturing.com
Encouraging news for manufacturing
Despite market volatility, economic indications from the Credit Managers’ Index (CMI) from the National Association of Credit Management (NACM) are pointing in a positive direction.
A combined reading of 53.5 for January 2016, up from December’s 52.8, “puts the numbers back to what they were in October of last year,” according to NACM Economist Chris Kuehl, Ph.D.
“In general, the CMI report [for manufacturing] is more upbeat than the case in the recent past,” Kuehl says. However, regarding a two-point drop in the rejections of credit applications, “there are companies that are in trouble right now and seek someone to throw them a lifeline by offering credit when that would likely be a bad idea.”
The combined CMI score for manufacturing has improved from 51.6 to 52.5, higher than at any time since last October. The data for the favorable factors showed a jump from 54.1 to 56.2, comparative to levels of last October. The combined index for the unfavorable factors remained unchanged, just as the overall CMI unfavorable index. The reading has remained at 49.9. www.nacm.org
Gosiger, Schütte partner
In an arrangement that supports the sales efforts of Schütte USA, Gosiger High Volume now offers the Schütte line of multi-spindle machines, including 6- and 8-spindle models.
According to Gosiger High Volume President, Mark Walker, “As we continue to support the Euroturn with service and parts, we are excited to offer the innovative quality products of Schütte as a way for our customers to upgrade to the latest technology. These products, along with BTB rotary transfer machines and iFP vacuum solvent parts washing systems, enable us to recommend the most appropriate technology to our customers.” www.gosiger.com; www.schutteusa.com
rConnect Central Communications platform
Officials from GF Machining Solutions have introduced rConnect, a central communications platform for the company’s milling, EDM, and laser texturing machines. Advancing the Industry 4.0 vision of the smart factory of the future, the first phase of rConnect is Live Remote Assistance (LRA), allowing customer-authorized remote assistance by connecting machines to GF Machining Solutions’ local diagnostics center and plants in real time.
Through LRA, unexpected machine downtime is minimized, and downtime is reduced when an issue does occur. LRA allows a manufacturer to interact directly with GF Machining Solutions via audio, video, chat, whiteboard, file transfer, screen sharing, and system access.
rConnect and LRA are powered by an instant virtual private network that allows highly secure access to the machine and is certified with TÜViT Trusted Product Certificate. rConnect and LRA result from GF Machining Solutions Industry 4.0 partnerships with European research institutes. www.gfms.com/us
Delcam’s PartMaker hosts user group tour
A series of user group meetings will be hosted around the country to launch PartMaker 2016. Each event will focus on the more than 50 new features and enhancements.
PartMaker product specialists will be on hand to answer any technical questions. They will also discuss the future of PartMaker’s development efforts and listen to delegates’ input to incorporate into future versions.
It’s a presidential election year, so combing through headlines to find any positive news is challenging. Both sides of the aisle are trying their best to spin the news in their favor. You have Republicans saying the economy is in turmoil, pointing fingers at the current administration. Democrats are walking a tight rope, promoting the positives that have occurred in the last 7+ years while acknowledging there’s room for change, improvements, or a slightly “different” approach. Then again, there’s always room for improvement somewhere, in something.
As I looked into the strength of the medical device manufacturing industry, this, too, was overshadowed by doom and gloom, and glory for only a select few. Headlines claim that manufacturing is struggling, cutting-tool consumption is down, and machine tools sales are off. Then, on the “other side of the aisle” headlines scream how the aerospace and automotive manufacture sectors continue to grow at some of the strongest paces since pre-Great Recession levels. This is true, since our sister publications, Aerospace Manufacturing and Design and Today’s Motor Vehicles, continue to report on the strength of these sectors. The medical device sector is strong, and all indications are that it’s staying that way. While some parts of manufacturing struggle, with just a little digging through headlines, I could find a lot of good news about the medical device sector. It’s not struggling.
Each year medical device regulatory consultant firm Emergo produces a Global Medical Device Industry Outlook. This year’s report notes that, “while economic conditions in Europe, Brazil, Japan, and China remain uncertain, the medical device sector showed resilience in 2015, with firms generally optimistic about their prospects for 2016. In terms of economic and regulatory conditions, 2015 was no cakewalk in terms of performance for medical device firms, but more than 80% of the respondents are expecting improved outlooks in 2016, both for themselves and the industry as a whole.”
Additional key takeaways from Emergo’s study:
North American firms were more optimistic about their prospects for 2016 than European and Asian counterparts – highlighting the strength of the U.S. economy
7% of survey respondents reported sales decreases, down from 19% in 2014
72% indicated that North America had average-to-high growth potential for medical device sales for the next 5 years, only overshadowed by 80% of respondents saying they felt Asia had growth potential
Manufacturing still faces challenges. One is the need for educating and developing the next generation of skilled workers – a key reason AMT – The Association For Manufacturing has partnered with us in the #WhyMFG campaign (www.WhyMFG.com). Another is reducing healthcare costs, which is putting pressure on delivering products at lower price points or innovating products that allow better patient outcomes.
The medical device industry must continue to innovate – all industries must if they want to grow and thrive. So, there’s no better time to take a close look at your manufacturing operations, equipment, and processes; determine where you need to upgrade, improve, or change; and then chart your course for growth now and well into the future. What are your plans to innovate and thrive?~ Elizabeth
