Details of any medical device’s manufacturing processes must be completely traceable so manufacturers can monitor product quality, make timely updates, and quickly recall defective items. Traceability extends from the original equipment manufacturer (OEM) to suppliers of individual components.

Should defects occur, cradle-to-grave tracking makes it possible to pinpoint exactly where changes in product quality initiated.

Medical device manufacturers face U.S. Food and Drug Administration (FDA) inspections and regulatory mandates as well as ISO requirements and risk management pressures. Quality shortcomings in an artificial joint or pacemaker can have lifelong or life-ending consequences, so tracing an error or omission to a single process is critical. Recently, some medical implant recalls have been tracked to failures of individual electronic components or to process errors such as inadequate part cleaning.

The right data

Manufacturers can collect information almost instantly at multiple steps in a process, however such advances can generate massive amounts of data, and knowing exactly which are useful is a challenge. For OEMs, the key is determining which data are critical, translating them into useful information, and sharing appropriate information with suppliers.

Traditionally, supplier manufacturing engineers and quality assurance personnel decided which dimensions to inspect, how frequently to make inspections, and how to tabulate results. However, suppliers’ decisions don’t always match customer priorities.

An OEM can avoid data collection and reporting inconsistencies by presenting suppliers with a consistent set of standards, requiring the same information for inspection and reporting. Information should include drawings with part dimensions and establish a standard identification system for inspecting the characteristics of a part and recording the results. Manufacturers can achieve standardized identification of part requirements by annotating drawings with numbered callouts or balloons that point out individual part features. Balloon numbers correspond with numbers on a dimensional data form that lists dimensions, tolerances, and other requirements. Every supplier producing a certain part can use the same drawing balloon information to make the part, inspect it, and report results. Multiple suppliers can make the same part, delivering manufacturing and inspection data to the OEM in an identical format.

Quality information

Automatically extracting geometric dimension and tolerancing (GD&T) information from the source part drawing eliminates interpretation and laborious manual tasks. Scanning the 2D drawing or PDF once for each part, via automatic ballooning and other quality requirements, assures dimensions are defined and numbered the same way on all suppliers’ drawings. A single source for dimensional information makes inspection results easily identifiable and able to be compiled for trend analysis showing dimensions in relation to specifications.

The OEM’s inspection plan can include instructions about inspection frequency – pointing out which part dimensions require 100% inspection and those that need less frequent inspection. Inspection information includes standardized serial numbers that are stored and recalled from a central database and can be searched and recovered quickly. Standardizing part feature identification and inspection plans can also help generate easily comparable supplier quotes.

Quality information management software gets all medical device manufacturing process contributors on the same page for part dimensions, tolerances, and data reporting – maximizing process efficiency. An automated, integrated approach to data management practically eliminates data-based errors and provides consistent product quality that protects the ultimate customer: the patient for whom the medical device can be a life-preserving resource.

High QA Inc.
https://www.highqa.com

Rehabilitation patients could walk or run using the same therapeutic exoskeleton, thanks to design advancements and a sophisticated algorithm that detects the patient’s gait.

Researchers at Harvard’s Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS) and the University of Nebraska Omaha have developed the lightweight exosuit made of textile components worn at the waist and thighs and a mobile actuation system attached to the lower back.

“Our study demonstrates that it’s possible to have a portable wearable robot assist more than just a single activity, helping to pave the way for these systems to become ubiquitous in our lives,” says Conor Walsh, Ph.D., who led the study.

The hip exosuit was developed as part of the Defense Advanced Research Projects Agency (DARPA)’s former Warrior Web program and is the culmination of years of the team’s research and optimization of the soft exosuit technology.

The team’s most recent hip-assisting exosuit is simpler and lighter, and assists the wearer via a cable actuation system. The actuation cables apply a tensile force between the waist belt and thigh wraps to generate an external extension torque at the hip joint that works in concert with the gluteal muscles. The device weighs 5kg with more than 90% of its weight located close to the body’s center of mass.

A major challenge facing the team was that the exosuit needed to distinguish between walking and running gaits and change its actuation profiles accordingly to provide the right amount of assistance at the right time in the gait cycle.

Biomechanists often compare walking to the motions of an inverted pendulum and running to the motions of a spring-mass system. When walking, the body’s center of mass moves upward after heel-strike, then reaches maximum height at the middle of the stance phase to descend toward the end of the stance phase. While running, the movement of the center of mass is opposite. It descends toward a minimum height at the middle of the stance phase and then moves upward toward push-off.

In ongoing work, the team is focused on optimizing all aspects of the technology, including further reducing weight, individualizing assistance, and improving ease of use.

Harvard Wyss Institute for Biologically Inspired Engineering
https://wyss.harvard.edu

John A. Paulson School of Engineering and Applied Sciences (SEAS)
https://www.seas.harvard.edu

University of Nebraska Omaha
https://www.unomaha.edu

How can smaller shops, mold-makers, and toolmakers begin their march toward digitalization? First – become informed by reading trade magazines. They demonstrate much of the emerging technology, often with real-world examples of shop floors that are actually implementing it. Dedicate one person at your shop to learn about digitalization – someone in your organization with an open mind who will become knowledgeable about what digitalization means for your operation.

It’s all about connectivity, gathering data, and analyzing that data to develop a smart action plan. You also need to make yourself comfortable with the buzzwords and acronyms – overall equipment effectiveness (OEE), Big Data, Industry 4.0, mean time between failure (MTBF) – so you can sense which direction to head.

Most shops have been gathering data and logging it in a production-schedule format, so digitalization and a focus on data is not entirely new.

The second step is to find a partner – someone to guide you from initial evaluation to implementation. Be sure it’s someone who knows your industry, because that will reduce startup time. It’s critical that this person or advising group knows your process flow and has the trust of your entire organization.

Siemens’ Mindsphere group offers many solution partners. A good partner may be someone already advising you on your CNC machines. They can visit Siemens to learn about digitalization, and then they’ll go to your shop with a proposed solution.

Next, find someone within your shop to be your digitalization consultant. Don’t think about all your equipment at the beginning, start with one or two machines where you want to get data and begin tracking. Talk to all machine operators and get them onboard so they know what is happening. Place a large display in the middle of the shop where everybody can see the data you’re capturing and ask why it’s red or green. Let everyone have access to the entire process, so they buy into it. Get their reactions, and they may come up with questions about why key data aren’t showing on the screen.

Talk daily about the data. People will ask questions and have different opinions on what data are being tracked, why a certain value isn’t shown, or why cycle times are varying on the same part on the same machine. Their input and collaboration will lead to the first return on your investment.

So, inform yourself, get a strong partner, ask actively for highly visible data, and dedicate one person inside your organization who drives the entire process.

The old Chinese proverb says the journey of 1,000 miles begins with a single step. Take it.

Siemens Industry Inc. Digital Industries – Motion Control Machine Tool Systems
www.usa.siemens.com/cnc

About the author: Ramona Schindler, general manager machine tool systems for Siemens Switzerland and can be reached at ramona.schindler@siemens.com.

Europe’s medical device market has grown quickly, representing more than $22 billion in revenue. From 2003 to 2013, France went from 144 ISO13485-certified manufacturers to more than 1,000. The medical devices made today involve machining increasingly complex, high value-added parts, driving manufacturers to evolve rapidly to improve their production capabilities and maintain their competitive edge.

In the city of Pessac, near Bordeaux, France, Rescoll Mfg. managers have seized the opportunity for rapid medical sector growth using Esprit CAM software from DP Technology Corp.

Move to CAM

From its founding in 2012, manufacturers turned to Rescoll Mfg. for increasingly complex projects. While most included simple turning, more required machining complex parts, 5-axis milling and surface finishing operations, making part programming increasingly difficult. By 2014, managers decided to invest in computer-aided manufacturing (CAM) software.

“Our wish was to integrate a CAM solution adaptable to our entire range of Swiss and 3- and 5-axis machines. We knew Esprit’s potential and the distributor UsInConcept reinforced our choice,” explains Fabien Guillaume, methods manager at Rescoll Mfg.

Rise in productivity

As programmers began Esprit training, Guillaume says, they realized that the software offered flexibility when programming parts.

Rescoll’s programmers then set to work on various 5-axis parts, optimizing full use of CNC machines and rapidly increasing productivity. The Methods department created a library of standard machining processes using Esprit to automate, facilitate, and improve CNC program generation. Process archiving and automatic shape recognition helped cutting tool managers fully use the software’s functions for intelligent machining.

With production in the shop on the rise, Rescoll Mfg. faced a new challenge: programming a cervical plate with complex 3D surfaces that required 5-axis machining on a milling lathe. Using Esprit CAM, the team machined the part on a 5-axis Mazak lathe in just one operation, meeting all of the customer’s expectations.

Capturing evolving markets

For Rescoll Mfg., integrating Esprit CAM software solved many machining difficulties related to tight tolerance intervals, less-sophisticated machines, and refractory materials.

“We had problems completing a grooving operation on a 3-axis machine, and Esprit allowed us to simply program the machine using trochoidal cutting movements, which solved all our problems,” says Frédéric Combarnous, head of Rescoll Mfg.

The growing experience of Rescoll’s programmers also made it possible to diversify the typology of its parts and extend their use through improved quality. Simulation features integrated within Esprit enabled programmers to visualize everything – from machine environment, to part machining, to interferences.

“Esprit is a very reliable tool that allows you to anticipate errors and optimize the set-up times on the machine,” Guillaume says.

After using Esprit CAM for a few months, Rescoll Mfg. dramatically reduced its programming time and enhanced its production capabilities.

“With Esprit, we can optimize toolpaths, test manufacturing processes, and reduce programming and cycle times,” Combarnous summarizes.

Rescoll Mfg. had faced a choice between producing basic parts or growing its production capabilities to capture evolving markets. It chose the latter.

Using Esprit CAM software, programmers at Rescoll Mfg. can respond rapidly to customer requests and successfully meet any machining challenge from the medical and aeronautics markets.

Looking ahead, Rescoll Mfg. plans to acquire new 5-axis machines to produce even more complex parts, increasing its presence in Europe with Esprit CAM at the heart of its manufacturing process.

DP Technology Corp.
http://www.espritcam.com

Mazak Corp.
https://www.mazakusa.com

Rescoll Mfg.
https://www.rescoll-medical.com/ manufacturing