The road to advanced manufacturing starts with collaboration, and collaboration starts here. Let’s dive into how advanced manufacturing can improve the industry.

Advanced manufacturing is not a specific destination that all medical device companies need to reach. Instead, it’s a journey of incorporating tools and concepts that promote manufacturing maturity, which enables companies to successfully react to industry challenges while enabling process efficiency and flexibility.
In this webinar, industry experts from the Medical Device Innovation Consortium (MDIC) and the U.S. Food and Drug Administration (FDA) discuss with Siemens Digital Industries Software how to successfully implement existing technologies that are critical to advanced manufacturing.

You will learn:

• How technology, such as the digital twin, enables advanced manufacturing
• How to optimize the flow of information across digital threads
• What FDA’s role is in advancing the medical device industry
• How MDIC’s industry collaboration and Siemens’ solutions play a role in advanced manufacturing
• How companies move forward to develop the right strategy and technology partner

Registration for the Dec. 7, 2021 11AM ET webinar is open and free, sign up today!

MITRE and the Medical Device Innovation Consortium (MDIC) announced the release of their co-authored “Playbook for Threat Modeling Medical Devices,” providing insights to organizations developing or evolving an approach to creating threat models in a systematic and consistent way. The playbook is available for download from MDIC and MITRE.

For several years, the U.S. Food and Drug Administration (FDA) has recognized the value of threat modeling as an approach to strengthen the cybersecurity and safety of medical devices. To increase knowledge and understanding of threat modeling throughout the medical device ecosystem, FDA engaged with MDIC and MITRE to conduct a series of threat modeling bootcamps for medical device manufacturers in 2020 and 2021 and to subsequently develop a playbook based on the learnings from those convenings.

“We are excited about working with MDIC and MITRE on cybersecurity threat modeling to ultimately help medical device manufacturers strengthen their cybersecurity efforts,” said Dr. Suzanne Schwartz, director of the Office of Strategic Partnerships & Technology Innovation at the FDA’s Center for Devices and Radiological Health. “The threat modeling bootcamps and the first-of-its-kind playbook apply scientific methods of threat modeling, leading to safer, more resilient medical devices that improve patient lives.”

The goal of the bootcamps was to scale existing threat modeling training to the medical device ecosystem via a “train-the-trainer” approach, creating ambassadors for threat modeling in their respective organizations.

“MDIC recognizes that every company has unique challenges when it comes to safety and security of the devices, but it is evident that the cybersecurity is a shared responsibility of a wide range stakeholders including the patient community, and we need more and more collaborative efforts to increase awareness and scale best practices in this area,” said Pamela Goldberg, MDIC President and CEO.

In addition to leveraging learnings from the bootcamps, MITRE and MDIC interviewed cybersecurity experts from medical device manufacturers to distill current practices and strategies for implementing threat modeling into the medical device development lifecycle.

“MITRE is proud to once again support the FDA’s strong commitment to medical device cybersecurity and patient safety,” said Kim Warren, vice president, director, Health FFRDC, MITRE. “As a co-author of the Playbook for Threat Modeling Medical Devices we applied our decades of cybersecurity expertise helping other organizations prepare to defend attacks on their infrastructure. As medical devices increasingly connect to the internet, all private and public stakeholders must continue to prioritize device cybersecurity for patient safety.”

This new playbook builds upon MITRE’s continuing efforts to help safeguard medical devices, and the patients that rely on them, from bad actors. In October of 2020 MITRE published a rubric for applying the Common Vulnerability Scoring System (CVSS) to medical devices, earning qualification by the FDA as a Medical Device Development Tool (MDDT). MITRE partnered with the FDA in October of 2018 to create the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which outlined a framework for health delivery organizations (HDOs) and other stakeholders to plan for and respond to cybersecurity incidents around medical devices, ensure effectiveness of devices, and protect patient safety.

July 2021 U.S. cutting tool consumption totaled $162.3 million, according to the U.S. Cutting Tool Institute (USCTI) and AMT – The Association For Manufacturing Technology. This total, as reported by companies participating in the Cutting Tool Market Report collaboration, was down 5.7% from June's $172.1 million and up 25.5% when compared with the $129.4 million reported for July 2020. With a year-to-date total of $1.1 billion, 2021 is up 4.6% when compared to July 2020.

According to Brad Lawton, chairman of AMT’s Cutting Tool Product Group, “The cutting tool industry continues to show year-over-year positive growth for 2021 from the low of the pandemic year. However, the last few months have slowed for many reasons and have produced an up-and-down performance because of disruptions to the normal business conditions. Supply chain shortages, labor shortages, inflation, weather disruptions, and of course, the continuing COVID effects have all played a part in the roller-coaster ride, but in the end, the manufacturing industry shows the demand for growth, and the cutting tool industry is poised to respond.”

Chris Kaiser, executive advisor of Big Kaiser, comments, “July’s cutting tool report slipped to the negative compared to the previous month, probably due to supply chain disruptions and summer vacations. On the positive side, the 12-month average follows durable goods, which is increasing slowly and may get to pre-pandemic levels by the end of Q1 2022. If cutting tool consumption follows the machinery order trend, which it normally does with a two to five-month lag time, we should see better numbers by year-end and a good start to 2022.”

August 2021 U.S. cutting tool consumption totaled $163.5 million, according to the U.S. Cutting Tool Institute (USCTI) and AMT – The Association For Manufacturing Technology. This total, as reported by companies participating in the Cutting Tool Market Report collaboration, was up 0.7% from July's $162.3 million and up 27.4% when compared with the $128.3 million reported for August 2020. With a year-to-date total of $1.3 billion, 2021 is up 7% when compared to the same time period in 2020.

These numbers and all data in this report are based on the totals reported by the companies participating in the CTMR program. The totals here represent the majority of the U.S. market for cutting tools.

Bret Tayne, president of USCTI, notes, “Although year-over-year growth in the cutting tool sector for April through August has been robust, we remain well below 2019 levels. Our growth path remains uneven, and steadier improvement is frustrated by policy and other factors. That said, colleagues, supply chain partners, and end-user customers that I have spoken to recently seem to be universally confident in the near term.”

Pat McGibbon, chief knowledge officer of AMT, comments, “We think the outlook for cutting tools is bright. Cutting tool shipments' year-over-year moving average has been 24% over the past four months, and machine tool orders are up 48% year-to-date from 2020 levels. We see the severe difference in growth rates between consumables and equipment as a reflection of the challenge downstream customers are having in securing materials and parts to machines. It is just a matter of time before these bottlenecks break loose.”

The Cutting Tool Market Report is jointly compiled by AMT and USCTI, two trade associations representing the development, production, and distribution of cutting tool technology and products. It provides a monthly statement on U.S. manufacturers’ consumption of the primary consumable in the manufacturing process – the cutting tool. Analysis of cutting tool consumption is a leading indicator of both upturns and downturns in U.S. manufacturing activity, as it is a true measure of actual production levels.

BIG KAISER Precision Tooling Inc. will change its name to BIG DAISHOWA Inc., effective January 1, 2022.

“BIG DAISHOWA is a global leader of tooling systems, and we have been a member of the BIG DAISHOWA group of companies for many years,” says Jack Burley, President & COO. “The name change is a natural evolution in this relationship. Being known as BIG DAISHOWA in North America will strengthen our corporate presence on a global scale.

“Our customers won’t notice any change in our business day-to-day,” Burley says. “They will receive the same superior products, personal support and performance guarantee we’ve been delivering for more than 30 years.”

The name change will not impact operations, product lines, staff, distribution, or licensing agreements in North America. The company will continue to offer the same high-precision tool holders, cutting and boring tools, workholding, tool measurement systems and accessories manufactured in Japan, Europe, and the United States.