Every day, regulatory, clinical, quality, and marketing teams at diagnostics manufacturers must refer to the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). To make this process easier, a new, freely available IVDR filtering tool is being offered to the market by RQM+, the world's leading medical device and diagnostics focused regulatory and quality consulting firm. The tool has organized the IVDR by key themes and allows users to navigate the legislation using the subject areas most likely to be relevant to their day-to-day work.

Even though the MDR deadline was delayed to May 2021, the impending deadlines for the IVDR have not yet changed, so diagnostics companies remain under considerable time pressure to achieve compliance with the new Regulation to keep their products available on the EU marketplaces. Failure to comply on time could result in CE mark certification being withdrawn. Therefore, any ways to make regulatory preparation more efficient will benefit the whole diagnostics industry to participate effectively in EU markets.

RQM+ is hosting a dedicated webinar on July 27, 2021, offering “The Urgency of IVDR: Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance.” The IVDR date of application is less than a year away and yet Notified Bodies are currently predicting certification timelines of at least 7-12 months. For expert guidance on achieving IVDR compliance in a timely manner, register to attend here! https://resources.rqmplus.com/ivdr-webinar-july-2021

Legislation is drafted to define legal responsibilities, rather than to provide optimum ‘searchability’ for Regulatory, Clinical, and Quality Assurance professionals. RQM+ has drawn on its wide-ranging and in-depth expertise to overlay IVDR with thematic metadata which categorizes each section by fundamental compliance themes. Using this tool, regulatory, clinical, and quality teams can save considerable amounts of administrative time and concentrate their precious expert effort on professional workflows.

Providing this tool free, for the general benefit of the diagnostics industry, is the initiative of Nancy Morrison, RQM+ Executive Director, Regulatory & Quality Consulting Services. She notes, “There’s nothing more frustrating than to have to spend time searching through legislation to gather the key sections (or even sentences!) for each phase of regulatory compliance. That’s something I’ve even been told by regulators and notified bodies! Many colleagues across the sector have already been using our IVDR search tool, and we look forward to adding its MDR equivalent soon. In this way, our initiative can become even more worthwhile.”

The RQM+ IVDR Search Tool is available to download here. 

Sandvik has signed an agreement to acquire U.S.-based DWFritz Automation Inc., a leading global provider of precision metrology, inspection, and assembly solutions for advanced manufacturing. DWFritz Automation designs, builds, and supports engineer-to-order, high-speed, non-contact metrology solutions and automation systems. Established in 1973, the company is a trusted partner of many Fortune 500 customers – with more than 2,000 systems installed worldwide.

“This is in line with our strategic focus to grow organically and through acquisitions in the advanced manufacturing space, with special focus on industrial software, industrial metrology and additive manufacturing solutions,” says Stefan Widing, president and CEO of Sandvik.

With DWFritz Automation, Sandvik would expand its current metrology offering and take a leading position in in-line metrology, including a broader position in high-speed, high-volume, non-contact inspection and assembly automation.

“By acquiring DWFritz Automation, we will be able to expand our metrology and automation offering further. This will not only strengthen our position, but will also enable us to offer full metrology solutions to our customers – which will reduce cost and improve quality significantly in their broader value chain. I look forward to welcoming the DWFritz team to Sandvik,” says Kim Hansen, president of the metrology division in Sandvik Manufacturing Solutions.
The privately held company, DWFritz Automation is headquartered in Wilsonville, Oregon, with offices in China and France. In 2020, the company had about 560 employees.

Mike Fritz, CEO of DWFritz Automation says: “We are truly excited with the opportunity to become part of the Sandvik family. Since our founding, we have continuously advanced the interests of our customers by being innovative and investing in new technology to help accomplish their critical missions. This synergy will allow us to add even more value to customers and partners, in addition to expanding our footprint across key markets through Sandvik’s global presence. This agreement is a game-changer in the world of metrology and automation and we are thrilled to be part of it.”

Over the years, DWFritz Automation has developed complex precision automation and metrology systems for some of the world’s most well-known brands across many verticals. Several products constitute the company’s product portfolio – including the ZeroTouch product family, which is based on a unique and patented, high-speed, non-contact metrology platform architecture with micrometer precision.

Through this acquisition, DWFritz Automation will become part of the Metrology Division, within business area segment Sandvik Manufacturing Solutions. The transaction is expected to close during the second half of 2021, subject to customary regulatory approvals.

Two metrology companies are already part of the Metrology Division in Sandvik: Metrologic Group and ATT Metrology Services. Metrologic Group designs and sells 3D measurement software solutions, electronic devices and related services to blue chip customers, where accuracy ranges from a few micrometers to sub-millimeters. With more than 40 years of experience, the company has also developed robotized solutions, combining robot programming and metrology in one single software. ATT Metrology Services is a provider of advanced on-site precision measurement services, using state of the art metrology equipment and software – and has more than 30 years of experience.

 

Cambrio acquisition

Sandvik has signed an agreement with Battery Ventures to acquire US-based Cambrio, a leading company with an end-to-end portfolio in CAD/CAM software for manufacturing industries like automotive, transportation, energy, medical and aerospace. Cambrio will be reported in the Design & Planning Automation division within Sandvik Manufacturing and Machining Solutions.

“This is in line with our strategic focus to grow organically and through acquisitions in the advanced manufacturing space, with special focus on industrial software close to component manufacturing, industrial metrology, and additive manufacturing solutions. Cambrio will enable a broadened customer offering, covering more of the total manufacturing value chain,” Widing says.

Sandvik’s strategic ambition is to provide customers with software solutions enabling automation of the full component manufacturing value chain – from design and planning to preparation, production, and verification. Computer aided manufacturing (CAM) plays a vital role in the digital manufacturing process, creating an offer of automated solutions from design to machining.

By acquiring Cambrio, Sandvik will establish an important position in the CAM market that includes both toolmaking and general-purpose machining. This will complement the existing customer offering in Sandvik Manufacturing Solutions.

Cambrio’s product portfolio includes GibbsCAM for production milling, turning, and mill-turn operations, Cimatron for mold and die, as well as SigmaNEST for sheet metal fabrication.

“With the addition of Cambrio’s product offering, we will be able to help our customers to further increase productivity in the broader value chain. We share the same desire to automate workflows and make our customers more efficient and sustainable. I look forward to welcoming the Cambrio team to Sandvik,” says Mathias Johansson, president of the Design & Planning Automation Division in Sandvik Manufacturing Solutions.

Cambrio is headquartered in Ohio and has 375 employees. In 2020, the company had revenues of about SEK 628 million (68 million USD) with an EBIT margin slightly dilutive to Sandvik Manufacturing and Machining Solutions. Impact on Sandvik’s earnings per share will initially be neutral. The parties have agreed not to disclose the purchase price.

The transaction is expected to close in the second half of 2021 and is subject to customary regulatory approvals.

 

Fanar acquisition

Sandvik has signed an agreement to acquire the Polish company Fabryka Narzędzi FANAR S.A. (Fanar), a manufacturer of round tools. The company will be reported in Seco, a division within the business area Sandvik Manufacturing and Machining Solutions.

“We continue to execute on our growth strategy and this acquisition is an additional step to strenghten our  round tools offering” Widing says.

The acquisition enhances Seco’s product offering in taps and solid threading applications and improves the presence in Poland and the growing market for round tools.

“I am very pleased that we have reached an agreement to acquire Fanar, it will enhance our presence in the important Polish market and strengthen our exposure to our focused segments” says Nadine Crauwels, president of business area segment Sandvik Machining Solutions.

Fanar was established in 1966, is headquartered outside Warsaw and has 230 employees. In 2020, Fanar had revenues of about SEK 175 million. Impact on Sandvik’s earnings per share will be limited. The parties have agreed not to disclose the purchase price.

The transaction is expected to close during the fourth quarter of 2021 and is subject to relevant regulatory approvals.

Join us July 29 for an encore panel reviving the discussion about collaborative automation, spanning from basics to burgeoning trends. In this one-hour session, these industry experts will chat about the economy and how it’s affecting the manufacturing job market, market recovery and outlook for 2022. The panel will get into specifics on cobots themselves – the latest in UR-compatible kits and components, highlighting some of the latest applications like automated screwdriving and plasma cutting. They’ll talk pros and cons of do-it-yourself cobot integration and when it makes sense to do; how the recently increased payload on the most popular UR collaborative robot opens up more opportunities, along with benefits of pairing a cobot with a mobile robot. Just like their May discussion, this one is sure to be a lively discussion, chock-full of automation news and information you can use. Sign up today!

The promise of shop-floor connectivity and Industry 4.0 is to drive more informed decisions, gain real-time visibility into production, and optimize processes. As a result, manufacturers can achieve efficient and flexible production and are better equipped to make predictions and adjust to changing operation conditions.
Harnessing these capabilities to become fully digital, however, requires a roadmap. During this panel discussion, industry experts will discuss the latest trends and capabilities in digital technologies, how to leverage collected data, and share strategies to achieve digital transformation goals.

Topics will include:
• First steps to building your smart factory
• Adopting new technology and connecting existing equipment
• Gaining real-time visibility into production, machines, and equipment
• Leveraging and managing collected data
• The latest industry 4.0/IIoT approaches to boost operations and opportunities
• Tools to help achieve fully automated production