The FDA’s New Approach to Digital Health

In Digital Transformation, medical device, technology by Cressida MurrayLeave a Comment

Recognizing that their traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the more rapid and iterative design, development, and validation phases used for software products, the FDA has created a new Digital Health Innovation Action Plan. One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. This pilot program, which began on September 1, 2017, is a voluntary program that will enable the FDA to develop a tailored approach toward regulating digital health technologies by looking first at the software developer and/or digital health technology developer, rather than the product. The purpose of this is to streamline the regulatory process for companies with a history of developing and testing quality products. Once pre-certified, that developer would be empowered to make software iterations and changes as needed. The nine participants that have been selected for the Software Pre-Cert Pilot Program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. According to the FDA, these participants were chosen as they “represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.”  

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E-commerce Puts Increased Pressure on CPG Supply Chains

In Digital Transformation, supply chain by Cressida Murray2 Comments

A new report authored by The Boston Consulting Group (BCG) and commissioned by the Grocery Manufacturers Association (GMA) shows that online shopping, new digital technologies, and increasing channel fragmentation are intensifying the pressures on US consumer packaged goods (CPG) supply chains. The report, How CPG Supply Chains are Preparing for Seismic Change, is based on the findings of an in-depth benchmarking study of more than 30 leading CPG companies.

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Additive Manufacturing in the Aerospace Industry

In 3D printing, additive manufacturing, aerospace, Digital Transformation, manufacturing, technology by Cressida MurrayLeave a Comment

“With 3D printing, the old rules of how we design things are out the window,” said Terry Woychowski, VP, NA Test Operations at LINK in his talk on “The Brilliant Machine Age” at the American Automotive Summit. “You can now create a component exactly how you want it, without excess material.” The result is lighter, more cost-effective parts. The opportunities this presents are endless. We have previously covered additive manufacturing in the automotive industry, but the aerospace industry is another place we are seeing the effects of this new technology today. Despite the tremendous opportunities additive manufacturing presents, it is still a time-consuming process, and therefore best suited for high-end components used in low-volume products, such as aircraft. According to a recent study by ABI Research, due to the sheer size of the American aerospace industry and its defense budget, the U.S. aerospace and defense industries will drive much of the growth in additive manufacturing over the next ten years, producing additive manufactured parts and products with a value of US$17.8 billion in 2026.

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Additive Manufacturing in the Automotive Industry: Insights from Ford & BMW

In 3D printing, additive manufacturing, Digital Transformation, emerging technology, innovation, manufacturing by Cressida Murray1 Comment

In 2014, Local Motors printed the first 3D printed car from an ABS carbon-fiber blend. They call it The Strati. John Fleming, Former EVP, Manufacturing and Labor Affairs at Ford Motor Co., showed this video of The Strati during his presentation at the American Automotive Summit. He explained, “I showed this video not because I think Ford or anybody else is soon going to be 3D printing whole cars, I don’t see that. But I do see additive manufacturing as one of the technologies that is going to be one of the most critical in the future because it has the opportunity to do things that we’ve never been able to do before – to design components and manufacture them like we’ve never been able to before – and I do think it will disrupt the business, and this is happening already.”

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Industry 4.0 Realized: How BMW is approaching digital transformation

In 3D printing, additive manufacturing, automation, automotive, design, Digital Transformation, emerging technology, Industry 4.0, innovation, manufacturing by Cressida MurrayLeave a Comment

The promise of Industry 4.0 is being realized in the automotive industry, and BMW is at the forefront of the evolution of automated production. At last year’s American Manufacturing Summit, Dirk Hilgenberg, VP, Assembly at BMW shared with us how BMW is incorporating Industry 4.0 concepts to innovate at each stage of the production process, from design to post-market.

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The Digital Tipping Point: Achieving Superior Insight & Agility

In aerospace, Digital Transformation, supply chain by Cressida MurrayLeave a Comment

In his session “The Digital Tipping Point” at the American Aerospace & Defense Summit in 2016, Matthew Cordner, Director, Global ERP and Business Intelligence at Textron Inc., told the audience that, “For many companies in mature markets, excellent product performance is no longer a differentiator, it merely earns you the right to compete.” What differentiates a company, he argues, is their ability to provide superior insight and agility. Cordner provided Netflix and Dell as examples. Though these companies did not sell especially superior products to what was already on the market, it was innovation in their supply chains that allowed them to be successful. Netflix, which began by delivering rental DVD’s to customers, improved on the Blockbuster model by selling the same product but getting it to customers faster and more conveniently. They were able to collect tremendous amounts of data that allowed them to not only to go digital and recommend content to viewers but also produce that content and capture more value from their products.

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Enabling the Digital Thread: Is your Organization Ready?

In automation, Digital Transformation, Industry 4.0, Smart Factory, Uncategorized by Cressida MurrayLeave a Comment

The digital thread refers to the communication framework that allows a connected data flow and integrated view of the asset’s data throughout its lifecycle across traditionally siloed functional perspectives. It is the digital thread that connects product design, supply chain, production, and maintenance services and allows for a truly smart factory, delivering “the right information to the right place at the right time.” Is your enterprise prepared for the smart factory evolution?

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iBASEt: Following the Digital Thread Into the Future

In automation, capacity management, Continuous Improvement, Design Thinking, Digital Transformation, Industry 4.0, innovation, Internet of Things, IoT by Harshini SrikanthanLeave a Comment

What is the digital thread? The digital thread links systems used to execute and track design, engineering, manufacturing and MRO (maintenance, repair, and overhaul), establishing a seamless flow of information from product conception to delivery and beyond. The concept of the digital thread was spearheaded by the military aircraft industry, from its desire to improve the performance of future programs by applying lessons learned. Why is it important? With the emergence of the Industrial Internet of Things, smart manufacturing, and automation, it is integral to create a communication framework that connects data flow from initial design to development. “The digital thread brings customers, vendors, and suppliers close, tying them into holistic feedback and evaluation loops. To learn more about the Digital Thread, read Tom Hennessey’s (Vice President of Marketing at iBASEt) article on Following the Digital Thread Into the Future.

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How Does Technology fit with your Lean Initiative?

In Continuous Improvement, culture, Digital Transformation, Lean Implementation, manufacturer, manufacturing, Plant Optimization by Harshini SrikanthanLeave a Comment

With rapid innovation and the proliferation of data, technology promises improvements in nearly every area of manufacturing. The implications for increased efficiency are tremendous, but our experts warn that technology will not solve all your lean problems. At our 2016 American Manufacturing Summit, we spoke to some lean leaders about how you should think of technology within the framework of your lean initiative. The consensus is that while technology can be a great complement to your lean initiatives, providing you with insights you wouldn’t otherwise have, it cannot entirely replace the human aspects of lean. Learn what they had to say on this topic. 

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