With robotics’ use growing in North America, exhibitors at the upcoming Industrial Automation North America 2016, co-located at IMTS from Sept. 12-17 at McCormick Place in Chicago, hope to inform visitors on topics such as collaborative learning, core isolation, and setting standards.

According to the Robotics Industries Association (RIA), robotics orders grew 14% in 2015 as North American companies placed orders valued at around $1.8 billion. By 2018, there will be 1.3 million industrial robots operating in factories around the world, according to the International Federation of Robotics (IFR). Rapid advancements in robotics continue to drive interest, as today’s robots are lightweight, highly flexible, and easy to implement. They can weld, assemble, handle materials, and package food – lowering costs and offering opportunities for manufacturers of all sizes.

Top robotics trends

More sophisticated technology has enabled smarter robots that can collaboratively learn and sense what is going on around them.

“Collaborative robots are going strong and you will see a larger role in force sensing and control,” says Steve Somes, president of Force Robots. “Responding to external forces not only makes robots safer for collaboration, it also enables more tasks like assembly, grinding, and deburring.”

According to Will Sobel, CEO of System Insights, “Automation needs to move from tech-based to intent-based, meaning we communicate tasks and the robot and machines figure out how to make them happen. Robots simply need to perform dynamic path planning with vision and sensors instead of static instructions.”

Core isolation, or core splitting in multi-core CPUs, has also been made possible through advancements in PC-based control software. According to Matt Prellwitz, drive technology application specialist at Beckhoff Automation, this means that the machine controller can serve double duty as the robot controller.

“All machine and robot functionality can run independently of the OS, which helps elevate performance and pushes kinematic applications to an exciting new level,” Prellwitz says.

Ensuring safe movement

Standards are critical to robot success, enabling movements between locations and allowing one or more robots to interact with the same set of equipment.

“Through the open standards available, PC-based control enables greater integration of robots into enterprise systems and cloud-based services for Industrial Internet of Things (IIoT) and Industry 4.0 style concepts,” Prellwitz says. “Technology like mobile device integration can also be used so plant specialists can receive push notifications and scale HMI for the machine and robot to any piece of glass, from smartphones to tablets. It can even lead to highly advanced manufacturing and assembly methodologies, such as object-oriented manufacturing.”

Benefits and limitations

By using robotic advancements to manage mundane tasks, manufacturers gain the benefit of motivating employees with more interesting responsibilities.

“We can better utilize the talent we have when robots handle the more mundane work,” Sobel says. “When we increase productivity through robots without impacting the workforce, we can move to a more efficient and larger manufacturing base.”

Robots do have limitations – due to their mechanics; conventional robots have difficulty with fine resolution force control. Employee safety should always remain a concern, and Somes recommends that manufacturers stay mindful of possible additional protections needed for humans with any automation.

Industrial Automation North America

www.industrialtechnology.events

Post-market surveillance has often been pushed aside by medical device manufacturers. However, regulatory bodies globally are starting to implement more rigorous requirements for post-market surveillance, so medical device manufacturers must start taking action to remain compliant. Regulatory bodies are shifting emphasis onto proactive approaches rather than relying on reactive systems, such as complaints monitoring. All of this is compounded by the imminent publication of the new medical device regulation (MDR).

Stricter regulations are being implemented to minimize impact on patient and user safety by making sure that any issue with a medical device is acknowledged as soon as possible. Manufacturers must understand and correctly implement the requirements for post-market surveillance in the geographies they are looking to distribute.

In order to help manufacturers meet new compliance regulations, the national competent authorities (NCAs) have been working toward ensuring that the requirements for post-market surveillance, as defined within the medical device directives, are more clearly defined and specified, leaving no room for misinterpretation and subsequently any surprises during the next regulatory body audit or review.

Post-market surveillance interpretations

Understanding and correctly implementing requirements has never been more critical for manufacturers wishing to introduce or maintain distribution of their devices within markets that have requirements for post-market surveillance, such as Europe and the United States. Unfortunately, there is a lot of room for misinterpretation within the new guidelines.

The MDD 93/42/EEC, Annex II, for example, stipulates manufacturers institute and keeps a systematic procedure up-to-date to review experience gained from devices post-production. This is to be treated as an addition to the provisions in Annex X, which require manufacturers to implement appropriate means to apply necessary corrective action and notify authorities.

Post-market surveillance requirements should be in direct relation to risks associated with the device based on its intended use, such as the product or technology being new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products and technology. Providing incident reports to NCAs is mandatory when a serious deterioration in health is caused by a medical device. However, concluding what is a serious deterioration in health can be difficult.

For example, the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK competent authority, considers the prolongation of surgery what requires additional anaesthetic to be administered as a serious injury, a benchmark of an extra 30 minutes being a trigger point. However, not all competent authorities are aligned, and it can be argued that no two surgeries are the same, and that a difference of 30 minutes cannot be considered significant.

As well as implementing stricter procedures and reporting, MEDDEV 2.12-1, Vigilance Guidance Document, Revision 5, was updated to include that all manufacturers have efficient systems for proactive scrutiny of trends in complaints and incidents. Manufacturers should provide trend reports to their NCAs whenever there is a significant increase in incidents that are normally excluded from individual reporting.

Post-market clinical follow up studies

MEDDEV 2.12-2, concerning post-market clinical studies, was created with the intention to provide guidance on when and how to conduct post-market clinical follow-up (PMCF) studies. This document emphasises the importance of post-market surveillance when trying to identify and investigate enduring risks associated with medical devices already on the market.

Factors influencing the need for PMCF can be:

• Innovation
• Significant changes to device or usage
• Risk factors
• Type of procedure
• Population
• Safety
• Post-market surveillance findings
• Emergence of new informationon safety or performance and CE marking

However, bear in mind that a PMCF might not always be required, usually because the medium- to long-term safety and clinical performance of devices is already established because data already exists from previous use of the device or where other post-market surveillance activities have provided enough data to prove that risks have been addressed. Manufacturers are still obliged to provide detailed justification as to why the PMCF was not performed.

Risks and benefits of post-market surveillance

Manufacturers who are not taking their post market surveillance seriously can receive large financial fines or face seizure of products, imposition of special compliance contracts, and jail terms for responsible executives.

Implementing an ongoing post-market surveillance investigation lets manufacturers quickly identify any needed improvements. Other benefits include lower complaint costs due to fewer incidents, and greater customer loyalty and engagement.

To meet compliance standards, manufacturers must implement processes to ensure they are compliant with the most up-to-date requirements for distributing in each region. This is extremely time-consuming; manufacturers who find themselves without the time or the resources to stay on top of international requirements should think about recruiting external help as needed.

Post-market surveillance should be viewed by manufacturers as the opportunity to ensure the early detection of device issues and protecting patient/user safety so that only devices proved to be as safe as possible remain on the market. In addition, early detection helps improve design and processes, which ultimately will drive manufacturers to produce better performing devices. This will not only increase the manufacturer’s overall sales, but it will boost the company’s reputation.

The challenge for manufacturers is to meet compliance standards in all countries in which they distribute devices and to provide evidence that they are keeping compliant. Manufacturers should make sure that they have proactive processes in place to identify current post-market surveillance requirements for all countries and ensure they keep up to date with changes. Some manufacturers will choose to implement procedures that detail requirements for each country, while others will adopt the highest requirements across the board for all countries. For manufacturers to solely rely on the notification of revision of applicable external documents leaves them open to periods of non-compliance and forces the business to implement very costly last-minute solutions to meet all compliance standards.

Maetrics

www.maetrics.com

About the author: Parminder Kalle is the senior solutions delivery manager at Maetrics and can be reached at +44.78.8740.6673 or pkalle@maetrics.com.

Medical device industry

Value of total exports based on North American Industry Classification System (NAICS)

29% Surgical & medical instruments

Includes anesthesia apparatus, orthopedic instruments, optical diagnostic apparatus, blood transfusion devices, syringes, hypodermic needles, catheters

22% Surgical appliances & supplies

Includes artificial joints and limbs, stents, orthopedic appliances, surgical dressings, disposable surgical drapes, hydrotherapy appliances, surgical kits, rubber medical and surgical gloves, wheelchairs

14% Electro-medical & electro-therapeutic apparatus

Includes pacemakers, patient-monitoring systems, MRI machines, diagnostics imaging equipment, ultrasonic scanning devices

17% In-vitro diagnostic substances

Includes chemical, biological, or radioactive substances

8% Irradiation apparatus

Includes X-ray devices, diagnostics imaging equipment, computed tomography equipment

6% Ophthalmic goods

Includes eyeglass frames, lenses, related optical and magnification products

3% Dental equipment & supplies

Includes dental hand instruments, drills, sterilizers, dental chairs, plaster, amalgams, cements

The U.S. leads

• World productionof medical devices
• Global consumptionof medical devices
• Medical devicemarket with a value of $140+ billion;
• 45% of the global market

43 billion with 1.5% annual growth

2015 total value of U.S. industry product shipments under medical NAICS categories

Source: 2016 ITA Medical Devices Top Markets Report

Glebar has opened a parts distribution facility in Dublin, Ireland, providing 24-hour turnaround for critical machine components in Europe. This is the company’s third rapid-response parts distribution outlet in addition to one in Tokyo, Japan, and its headquarters facility in Ramsey, New Jersey. Glebar will be opening another distribution facility in Costa Rica to service its many medical customers in Central and South America.

“Approximately 35% of our overall revenue, on average, is international,” says Adam Cook, Glebar CEO. www.glebar.com, IMTS 2016 Booth #N-7317

Rollomatic, Haas donate machines to Delta College

Delta College, Midland, Michigan, hosted the 14th annual Great Lakes Regional Haas Technical Educators Council Conference (HTEC) in conjunction with a ceremonial ribbon-cutting opening the school’s state-of-the-art CNC Machine Tool Lab in late April. Features of the upgraded facility include $1.2 million in new equipment as well as four CNC machines valued at $1 million entrusted to the school by Rollomatic Inc. and Haas Automation Inc.

Terry Morse, CNC program coordinator and associate professor at Delta, thanked the approximately 130 in attendance, along with the various companies that have supported the new CNC lab by presenting company representatives with custom-machined plaques. Those acknowledged for their support were Fred Schultz and Patrick Lynch of Haas Automation; Mark Handcock of Tru Tech Systems Inc.; and Eric Schwarzenbach of Rollomatic.

Joining Schwarzenbach, president of Rollomatic, at the event was Ambassador André Schaller, Consul General of the Consulate General of Switzerland in New York. At the Delta College Haas Technical Educator’s Conference, each took time to speak about the need to support training to develop a skilled workforce.

According to Morse, Delta College is the first college in the U.S. to enter into an entrustment program with Swiss-based Rollomatic and the first to begin training in multi-axis CNC grinding. www.rollomaticusa.com, IMTS 2016 Booth #N-7200 & N-7214; www.haascnc.com, IMTS 2016 Booth #S-8100; www.trutechsystems.com, IMTS 2016 Booth #N-7337

Medical market overview

Medical sensors market worth $15 billion by 2022

The medical sensors market is estimated to grow at a compound annual growth rate (CAGR) of 8.5% between 2016 and 2022, reaching $15 billion by 2022. The rapid growth is due to the increasing incidences of cancer, acute myocardial infarction, and diabetes mellitus, as well as the increasing number of postoperative rehabilitation patients across the globe. Electrocardiogram (ECG) sensors accounted for the largest market share in 2015, and are expected to grow at a high CAGR between 2016 and 2022. Asia-Pacific is expected to grow at the highest CAGR, due to the increasing population with respiratory diseases and the aging population. It is expected to be the fastest-growing region in terms of technological advancement, healthcare, and marketing. www.marketsandmarkets.com

Ophthalmic device global market to reach $22.1 billion

The global market for ophthalmic devices reached $16.8 billion in 2013 and nearly $17.7 billion in 2014, and is forecast to grow at CAGR of 4.6% to reach $22.1 billion in 2019. The market in the U.S. is projected to grow to $7.6 billion in 2019 and the market in the Asia-Pacific region is expected to grow to $6.4 billion by 2019 during the same forecast period. www.researchandmarkets.com

Medical power supply devices market to $1.6 billion globally

Proliferation of diagnostic equipment and systems, coupled with rising incidences of chronic diseases, is expected to drive the global adoption of medical power supply devices to $1.6 billion by 2022 with a CAGR of 4.5%. Power supply devices, also known as electric power converters, are electronic devices that convert one form of electrical energy into another and supply electrical energy to an electric load. They are used in a range of medical applications such as MRI, X-ray, CT and PET scanners, patient monitors, blood analyzers, DNA equipment, dental equipment, and robotic surgical devices. www.persistencemarketresearch.com

CNC Software is Mazak’s newest VIP

Mazak has certified CNC Software Inc. as the newest member of its Value Inspired Partners (VIP) technology program.

Mazak’s VIP program brings together producers of complementary technologies to create more innovative products and turnkey processes. Collaborating on R&D and integration efforts, the VIP program fosters a high level of cooperation and technological integration that moves beyond individual pieces of equipment. The program also fuels development of comprehensive training solutions for manufacturers.

CNC Software brings to Mazak customers programming solutions for milling, turning, wire EDM, router programming, plasma cutting, and lasers, along with 3D design and drafting. www.mazakusa.com, IMTS 2016 Booth #S-8300; www.mastercam.com, IMTS 2016 Booth #E-3340

US high-tech polymeric development, production

Raumedic’s new U.S. headquarters in Mills River, North Carolina, is a high-tech center for the development and production of customized and efficient polymeric products for the North American market. During the first stage of expansion, customized tubing, molded parts, and systems will be produced in the 13,000ft² of cleanroom space.

Raumedic AG is a development partner and manufacturer of tubing, molded parts, catheters, and components for the medical and pharmaceutical industry. The company processes medical-grade thermoplastic polymers and silicones at four production sites in Germany and the U.S., and develops and produces high-precision pressure measurement systems with microchip technology for the indication areas of neuromonitoring, urology, and traumatology. www.raumedic.com

Jerry Rex appointed COO at Methods Machine Tools

Officials at Methods Machine Tools Inc. have appointed Jerry Rex as the company’s new chief operating officer. Rex, a manufacturing industry veteran with more than 25 years of management experience, complements Methods’ strategic plans for future growth.

Bryon Deysher, president and CEO at Methods says, “Jerry brings an energetic, passionate approach to leadership and shares the vision for Methods’ future. He is an excellent communicator, motivator, and team builder who will have assignments that will touch every level of the organization.” www.methodsmachine.com, IMTS 2016 Booth #S-9119

Kyocera expanding industrial ceramic operations

Kyocera Industrial Ceramics Corp. broke ground on a $10 million expansion of its manufacturing operations in Vancouver, Washington. Planned for completion this year, the construction will expand Kyocera’s existing facility to 58,000ft², and could create up to 30 new jobs during the next few years.

Conceived as a research and development center for advanced ceramic materials, the facility now serves as a specialty custom-order manufacturer of high-added-value engineered ceramic components. www.americas.kyocera.com

MarSolutions Engineered Metrology Team established

In response to increased demand for custom gaging solutions for dimensional metrology, Mahr Federal has established the MarSolutions Engineered Metrology Team, within its Engineered Products Division to augment custom gage development with customers. Operating from facilities worldwide, the team will help customers analyze the gaging requirements of their application, then design and build a customized gaging solution.

“Manufacturers often spend endless time searching catalogs and web pages without finding just the right gage for their job,” says Paul Mailloux, MarSolutions product manager. “We can help manufacturers determine how, when, and why to do their gaging.” www.mahr.com, IMTS 2016 Booth #E-5614