Dimensional metrology hardware and software for medical parts can be combined to create different types of systems with widely different costs. The systems vary in complexity, ranging from easy-to-learn manual optical comparators to fully programmable, multi-sensor CNC systems.

Higher-end products tend to be electro-mechanical metrology systems that combine optics with precision mechanical motion, linear encoders, and digital image and data processing. These systems include optical comparators, vision (or video) metrology systems, and digital comparators – a vision metrology system that functions like an optical comparator but uses a DXF digital overlay instead of traditional overlays.

Depending on the application requirements, each metrology solution has its advantages. Quality control (QC) demands for medical parts are extremely high and warrant a close look at the most advanced metrology solutions.

Forgoing go/no-go

Medical parts inspection demands are increasing with tighter accuracies, traceability, and 100% inspection. Many manufacturers have been accustomed to using go/no-go methods of gaging, such as the use of overlays in optical measuring or functional fit gages. However, with overlays, operator subjectivity is a significant factor. There are fine nuances to contend with, such as:

• On-screen placement
• Imprecise or worn Mylars
• Magnification
• Fatigue
• Data accuracy
• Complex part shapes
• Lack of detailed, variable data

Such issues force an inspector into the realm of judgment, which varies operator-to-operator.

Functional fit gages also present challenges. The gage-development process is usually lengthy and expensive, with limited flexibility when parts change. And again, no variable data is attainable in the inspection process.

Neither overlays nor functional fit gages provide opportunities for a comprehensive audit trail and traceability process, which is paramount in medical manufacturing.

Repeatability, reproducibility

Any inspection program should attain maximum gage repeatability and reproducibility (GR&R) and, in the process, provide comprehensive data for statistical process control (SPC) and traceability.

Reliable GR&R is possible with non-contact video, multi-sensor systems, and advanced software. Display readout and software measuring technology, such as Metlogix M3, provides full qualitative/quantitative profile analysis functions where an inspector compares a part profile against a nominal CAD model, obtaining a graphic representation of any deviation from the CAD file.

The system automatically finds and tracks the edge, continuously comparing it to a 2D profile, and superimposes the edge to a CAD model. In this scenario, an operator automatically collects tremendous amounts of data that are archived and documented with date, time, lot number, and job number, to remove operator error from the equation. Not only can 100% inspection be realized, but inspection speed and throughput can increase with automated system measurement routines and, depending on the application, palletized multi-part fixture inspection tables.

Selection tips

To achieve the best outcome, consider the following when consulting with an expert in this field.

1. Measurement complexity: A 2D optical comparator may suffice for simple measurements and visual comparison, but more complex medical parts may require a multi-sensor metrology system with coordinate measuring machine (CMM) style touch-probe capability.
2. Measurement throughput: A manual system may be an option for prototypes, occasional, and short run measurements by the QC department, but an automatic-CNC system is more economical if complete production runs are to be verified.
3. Tolerance requirements: A vision metrology system with a granite base may be required for meeting crucial tolerances for manufacturing medical parts. Tight tolerance may also indicate the need for higher-magnification optics.
4. Part size, weight: A benchtop optical comparator or video metrology system may be appropriate for small parts, while a larger, floor-standing system can be helpful for large and heavy parts.
5. Environment harshness: Most optical comparators are designed for typical machining environments, but varying temperatures, vibration, dust, and airborne contaminants can be present and need to be taken into consideration.
6. Man-made interface: Various interface options are available for optical comparators and video-based measurement systems including digital readouts, touch-screen PC solutions, and rack-mounted computers with monitors/software.
7. Software features: Capabilities can range from a simple 2-axis readout to 3D multi-sensor capability with a rich set of measurement software tools, CNC control, statistical packages, DXF CAD file import and export, touch-screen operation with Windows Operating Systems, and network connectivity.

The L.S. Starrett Co. – Metrology Div.
www.starrett.com
IMTS 2018 Booth #135532

About the author: Mark G. Arenal is the general manager at Starrett Kinemetric Engineering Inc. in Laguna Hills, California, a subsidiary of the L.S. Starrett Co. headquartered in Athol, Massachusetts. He can be reached at 949.348.1213 or marenal@starrett.com

According to a recent report, the 3D printing industry grew more than 20% last year – surpassing $7 billion total value. No other industry has had a bigger hand in the expansion of 3D printing than medical.

From introducing much-needed customization to cutting costs, 3D printing has the opportunity to bring several benefits to medical professionals and patients across the world.

Making things personal

Prior to the emergence of 3D printing, consumers received implants – knees, hips – that adhered to set standards. While such devices help patients lead better lives, there’s room for improvement since one size simply doesn’t fit all. To better meet patients’ needs, doctors and physicians are trading in mass-produced implants for those designed and manufactured with specific measurements in mind; this is where customization makes all the difference.

A study from Arthroplast Today found patients with customized knee implants experience fewer problems than those who have standard implants:

• 5% of customized implant patients need to visit a rehabilitation center
• 15% of standard implant patients need rehabilitation

As 3D printing technology continues to improve, patients will gain greater post-surgery success as surgeons will choose a 3D-printed implant that’s an exact match, removing much of the discomfort accompanying implants while delivering greater freedom of movement.

Bringing down costs

Nearly all manufacturing professionals expect to see an increase in medical applications for 3D printing. In addition to patient customization, 3D printing has the potential to minimize costs. The manufacturing costs for creating customized and standard knee replacements are nearly the same, but patients with customized knee implants save an average of $913 in medical bills.

For patients from war-torn countries, lower costs can be lifesaving. Each year, 26,000 people fall victim to landmines that are often left behind long after a conflict has subsided. Plenty of time and money is dedicated toward providing relief to those physically impacted, and among the most effective solutions is 3D printing.

By paving the way for low-cost prosthetics, 3D printing has helped disabled patients regain mobility.

Whether it’s a limb or brace, there’s no limit to how 3D printing can aid those in need. And, as 3D printing technology progresses, customized prosthetics will be produced at a fraction of the cost of standard medical devices.

Picking up the pace

With 3D printing, medical professionals may have the opportunity to take action sooner rather than later, especially in emergencies when there is no more than a few minutes to assess the situation.

Last fall, engineers at MIT created a desktop 3D printer that’s 10x faster than existing printers. This uptick in speed – hours not days for an implant – promises to go a long way toward saving lives. Too often patients lose time traveling to care sites better equipped to handle a specific emergency, especially in remote areas. 3D printing can help deliver advanced capabilities to more hospitals and medical centers.

Anatomical models that are produced through 3D printing can also enhance surgeon education and preparation. Doctors can use the models to closely study fracture patterns or generate new surgical strategies. The added insight paves the way for better care, shortening operation times, reducing patient trauma, and treating more patients.

As 3D printing technology continues to push the boundaries of what modern medicine can accomplish, manufacturers have just scratched the surface of what’s possible. Medical device and equipment manufacturers need to take advantage of the benefits 3D printing brings to the table. Manufacturers that embrace 3D printing technology stand to deliver the customization, cost savings, and speed today’s medical professionals require.

Kuka Robotics
www.kuka.com
IMTS 2018 Booth #236200

About the Author: Joe Gemma is the chief regional officer at Kuka Robotics. His primary role is to oversee strategy and sales growth in North America, encouraging collaboration across teams and enhancing the customer experience. At Kuka Robotics since 2014, Gemma previously worked as the CEO at Staubli Corp. and executive vice president of sales and marketing at ATS. He holds a degree in business management from Rhode Island College. For more information contact Kuka at 800.459.6691 or kukaInfo@kukarobotics.com.

Situated amongst tall pines in the picturesque area between Minneapolis and St. Cloud, Minnesota, one wouldn’t suspect Big Lake to be a hotbed of medical device manufacturing creativity and world-renowned excellence. But it is, and recently its capacity has nearly doubled in size and scope.

Expansion

LISI MEDICAL Big Lake’s 55,000ft² expansion, almost doubles the size of the building from 66,000ft² to 121,000ft². The culture of the parent company, LISI, is evident in its green policies.

Orench joined the Big Lake facility on April 1, 2011 – he has been through three ownership changes, “But I believe that LISI has bought Big Lake for the long-term.” LISI has already made a large commitment to the company, investing millions of dollars in expansion and improvement.

“Initially it de-cluttered this part of the facility,” Orench says, “We had 46,000ft² of production, and it was filled to about a 99% capacity.”

Construction was conceived with an environmental goal of zero net ground addition/extraction. Crews extracted 3 million square yards of dirt, but none left the site, and none was brought in.

After the April 2017 ground breaking LISI MEDICAL Big Lake was able to quickly take partial occupancy in December, and they started moving machines into position.

Hydromat row

As additional capacity was required for some specialty components, the lineup of Hydromat and Icon Technologies machines had expanded, leaving LISI MEDICAL Big Lake with a floor space problem. Now, in a prominent place on the new floor, Orench has moved machines and created his Hydromat Row, a lineup of all his Hydromat transfer and Icon mill/turn machines.

When Orench joined the Big Lake facility, he saw Hydromat and Icon machining in action for the first time and became enamored with the production possibilities. At that time, they were in the process of buying their second Hydromat advanced technology (AT) pallet transfer machine, and later they would purchase a third. The AT 10-115 features 10 machining positions and a 10-position pallet-transfer design. This arrangement provides strength and flexibility in a turnkey machining system.

The machines from Icon Technologies, a Division of Hydromat Inc. located in St. Louis, Missouri, are multiple-station, offering the rigidity to handle all components and all material types within its work envelope. The creation of Icon Technologies 2008, and the subsequent development of the Icon 6-150 was a perfect fit for LISI MEDICAL’s needs. Described by Hydromat as a mill/turn productivity center, it is a 4-machining position design with horizontal and vertical spindles at each station, and a tool changer for each spindle. The table uses a 6-position pallet transfer design with a load/unload station and another station for gaging or inverting the part for 6-sided machining. The Icon 8-150 is a 6-machining position, 8-pallet version for additonal capacity. The Icon machines specialize in precision metal cutting, LISI MEDICAL now has a number of 6-150s and 8-150s running production.

The Icon 6-150s and 8-150s in production at LISI MEDICAL have the precision machining capability for various workpieces and many styles of medical components.

“Including the robots within the Icon Technologies machines, we have more than 30 robots in this facility,” Orench says. He has some robots that unload multiple Swiss machines, removing parts and running them through the secondary processes.

Improved performance

Since joining the LISI Group, LISI MEDICAL Big Lake has embraced their LISI Excellence Achievement Program (LEAP). It’s essentially the Japanese lean system adapted to fit LISI’s specific needs. Also, they employ the single-minute exchange of dies (SMED) program to reduce setup time and increase machine uptime.

“We take it very seriously, we are looking for ways of reducing time,” Orench says. “This creates a better production situation that translates to excellent on-time deliveries and greater customer satisfaction.” They also work under 5S standards and the Workstation Standardization programs. Workstation standards are verified daily. There are 8 standards (Safety, Skills Matrix, 5S, Maintenance, Process Control, Product Control (Quality), Non-conformance Management, and Logistics) for how each workstation should look. “It’s about standardization, sticking to it, and making sure everyone follows it. A place for everything, everything in its place.”

LISI MEDCIAL Big Lake is a 24/7 facility running 4 shifts; two shifts during the normal work week, and two weekend shifts. The weekend a three-day schedule, Friday morning until Monday for a total of 36 hours. The expansion of the facility is also creating new job openings.

Shaping new talent

The LISI Apprentice Program helps the company develop young talent to become highly trained, well paid technicians who can start their careers without college debt. The program, which includes tuition reimbursement, brings in local high school students as youth apprentices. Later, they become interns who work 20 to 25 hours a week while attending technical college. They learn the business from the ground up, beginning in the shipping & receiving area, then they move to quality, materials, mills, Swiss, and lasers for a total of 42 months in the program. During this time, they are assigned a mentor, a LISI veteran who they can go to with any question at any time.

Keith Johnson is held up as an exceptional example. He joined the Big Lake facility 26 years ago and now a senior manufacturing engineer who started as a machinist when he was 20 years old. He knows the jobs inside and out. He now deals with the large projects when LISI MEDICAL must bring in new equipment and new technologies.

Product-focused

Specialties at the Big Lake plant include MIS Advanced Surgical Instruments (scissors, grips, blades, or staplers for example), Spine implants (pedicle screws, rods, connectors, or interbody cages for spine fusion), and Trauma/Extremity implants (plates and screws).

To stay competitive in a marketplace that has ever increasing pricing pressure they look to their workforce for creative thinking, automation to cut overhead, and the use of multi-station machining technologies like the Hydromat Rotary Transfer and Icon Mill/Turn machines to speed production and eliminate secondary operations.

Hydromat Inc. 
www.hydromat.com
IMTS 2018 Booth #338348

LISI MEDICAL Big Lake
www.lisi-medical.com

Medical & pharmaceutical original equipment manufacturers (OEMs) must ensure products surpass minimal requirements, offering quality and assurance against cross contamination and the risk of medical environments.

Aside from low contamination levels, successful medical sealing must also demonstrate mechanical performance and chemical resistance. Finding sealing suppliers that can meet those standards is critical.

Whether a medical application requires diaphragms, O-rings, gaskets, lip seals, or custom parts, the right sealing solution expert will help OEMs identify the key elements to consider in medical seals.

Elastomers

Medical sealing must demonstrate resistance to harmful and toxic chemicals – withstanding process media, potent active pharmaceutical ingredients (APIs), and aggressive cleaning regimes.

Depending on the medical application, certain qualities may be required of a seal’s elastomer, so it’s important to choose a sealing manufacturer with a variety of available materials.

To ensure chemical resistance, OEMs must also certify that their medical sealing is manufactured from the highest performing elastomers and the highest qualities.

Novotema engineers use specially-developed elastomer materials manufactured by sister company, Precision Polymer Engineering, with properties suitable for medical sealing applications:

Perlast – Perfluoroelastomers for sealing applications requiring chemical resistance, high temperature performance
Detectaseal – Metal detectable elastomers for containment, contamination control

Quality assurance

International standards assure quality in a component’s material. When selecting sealing components look for:

• Food & Drug Administration (FDA) approval
• United States Pharmacopeia (USP) Class VI approval

In addition to material compliance, look for partners that maintain full batch traceability throughout the entire manufacturing process with the availability of BS EN ISO 10204 certification.

Cleanroom manufacturing

For low contamination levels in medical sealing, OEMs should opt for sealing solutions that offer a wide range of services and engineering capabilities. Perhaps the most significant for medical applications – cleanroom manufacturing – allows manufactures to closely examine products to ensure that each component leaves the facility without compromising quality standards, including contamination levels.

It is imperative that a manufacturer and supplier of sealing solutions demonstrate compliance with appropriate governing standards set by the International Standards Organization (ISO).