Page 35 - MetalForming January/February 2022

these core competencies:
• Hone your ability to quickly uncov-
er inefficient manufacturing processes and improve them, identifying and eliminating those persistent, recurring production hiccups.
• Structure your management team and the production floor to successfully take on new business.
• Maintain industry-leading com- munication and responsiveness with customers.
• Track and automate Identify those quality metrics that matter most to your customers and track them regu- larly, responding to any metrics that require attention.
Finally, new regulations loom. According to a recent issue of Medical Products Outsourcing magazine:
“The medical-device manufacturing industry—like most others—is recovering from one of the most challenging years in recent memory. Manufacturers across the sector had to manage disruptions to demand, an unstable supply chain, and new workplace safety practices.
“On May 21, 2021, the new EU Med- ical Device Regulation (MDR) went into effect,” the article continues. “The MDR, the successor to the 1994 EU Medical Device Directive (MDD), has been interpreted by many manufac- turers as more stringent than the FDA’s current regulatory standards. For man- ufacturers whose devices have existing MDD certifications, not much will change. They’ll still have until 2024 to prepare devices for new MDR certifi- cations. Manufacturers seeking to launch new products in the EU, how- ever, may face new challenges while seeking CE marks for those devices.”
And this, according to a MedTech Dive article:
“( While) FDA warning letters to medical-device manufacturers plum- meted by nearly 90 percent between 2015 and 2019, experts say such letters (were) set to rebound in 2021... We’re going to see more inspections, more warning letters, and we may see more enforcement actions."
The article also quotes Foley & Lard- ner LLP partner and health-services
Custom medical-product manufacturer MPE Inc., Milwaukee, WI, has developed expertise in product design, engineering and design for manufacturing, in addition to sheet metal fabrication and assembly. Its move to forward scheduling, cellular manufac- turing and kitting of fabricated parts has contributed to reducing lead times by more than
50 percent.
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expert Kyle Faget, who expects the FDA to continue its push to harmonize its Quality System Regulation with ISO 13485, to reduce confusion and lessen the burden for medical-device manu- facturers. As a result, it is expected that device makers will need to modernize their risk-management practices and align their quality systems more closely with ISO 13485.
Aerospace
“Trends in commercial air travel and customer order activity are in much better shape than earlier post-COVID expectations, which is a positive sign for the industry,” reads Deloitte’s 2022 aerospace and defense industry out- look. “Global distribution of COVID vaccines is helping to clear a path toward normalization of air travel, though the current surge in Delta-vari- ant infections in certain regions will likely keep demand for travel subdued into early 2022.”
The International Air Transport Association, the industry's main trade body, Reuters reports, predicted that net losses at airlines would total $11.6 billion in 2022, an improvement from an estimated $51.8-billion loss in 2021. Like revenues, industry jobs also took a beating during the pandemic’s height, with job losses totaling 87,000 through
the third quarter of 2021, according to 2021 Facts and Figures: U.S. Aerospace & Defense, an analysis developed by the Aerospace Industries Association (AIA) with the support of IHS Markit.
As of September 30, Boeing and Air- bus in 2021 delivered 241 and 424 air- craft, compared to 98 and 341 in the first nine months of 2020, according to Defense & Security Monitor in a December 2021 report. Notably, according to PwC, Boeing experienced order declines in both 2019 and 2020, the first negative rate for the plane builder in at least three decades.
“For the full year 2020,” reads the report, reflecting the impact of COVID- 19, “Boeing delivered 157 aircraft, com- pared to 380 and 806 in 2019 and 2018, respectively. In 2020, Airbus delivered 566 aircraft and won the deliveries crown for the second year in a row. Due to COVID-19, deliveries were down from 863 and 800 in 2019 and 2018, respectively. Airbus is expected to retain the deliveries crown for years to come due to the company’s comfortable backlog lead over its American rival.”
The 2021 Commercial Market Out- look from Boeing reflects that the glob- al market is recovering. Key findings from the outlook, which covers overall industry demand and production:
• Long term, market fundamentals and resilience drive demand through