01Jul/19
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The Augmented Workforce – Taking Human Capabilities to New Heights

PTC 2019 LiveWorx Event Brief

By: Eric M. Luyer, Industry Research Analyst

The theme at PTC LiveWorx this year was: “The Augmented Workforce – Taking Human Capabilities to New Heights.”  Approximately 13,000 people, attending in person as well as live streaming, took part in the annual industry conference held in Boston, MA, in early June.

In today’s digital enterprise, the objective of PTC is not only unlocking new levels of productivity, insight and efficiency with automated processes and emerging technologies, but also to use these tools to “augment” the workforce.   PTC is predominantly positioning emerging technologies such as Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR) and 3D Printing.  When added to the existing capabilities of Computer Aided Design (CAD), Product Lifecycle Management (PLM) and the Internet of Things (IoT), AR will become more complementary to workers’ creativity and labor satisfaction.  It is PTC’s premise that things that make us all uniquely human – intuition, creativity, decision making – will be more powerful and useful than ever, if we optimize the use of these emerging technologies.

Digital Transformation

The emphasis of LiveWorx was helping industries with their Digital Transformation strategy and approach.  PTC sees AR as an ideal tool for training.  Workers benefit by getting a 3D- understanding of production processes and the challenges in a production environment (where the shortage of skills is often a challenge – yet shorter lead-times are expected.)

PTC AR PhotoImplementing an “Augmented Workforce” as part of the digital transformation process requires new strategies, a strategic roadmap and bold experimentation – as well as a culture ready to embrace change.

The use of AR makes a workforce more complete, rather than being replaced by it – where workers and machines unite to make and manage what’s next.  In her keynote address, Maria Wilson DDA, of Howden Group noted, “Augmented reality extends the value of our IoT data, and it changes our customers’ experience of owning and operating equipment.”

The Digital Thread

Jim Heppelmann, CEO of PTC, emphasized the importance of having the technology and the tools available to have full insight of what’s happening in the product lifecycle:  from design – engineering – manufacturing & supply chain – customer operations – customer services to Corporate/CXO.  In his keynote, Heppelmann explained the capabilities of the current PTC offerings for manufacturers:  from complex configuration management to high performance computing, including how CAD + PLM + IoT + AI follow and support the concept of the Digital Thread.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

According to Heppelmann, “A digital thread means the information that was originally created for one purpose – say an engineering prototype – gets reused for many different processes.  The digital thread weaves its way across the value chain. ” The digital thread is in fact a framework which connects the data flows to provide a holistic view of all data of (all) assets and the processes linked to these during the lifecycle of the product. All information including protocols, security and standards are visible and transparent.

The concept of the digital thread describes the traceability of the data that supports the digital twin(s) back to requirements (i.e., design phase), parts and controls that can make up the physical asset(s) or the entire production process.

Life-Sciences and The Future of Medical Innovation

The Life Science industry is in a state of transition at many levels, with new market entrants (e.g. Google and Amazon) and a wave of mergers and acquisitions shaking up the competitive landscape.  Now more than ever, medical innovators face an increasing need for technology solutions to support the transition to connected healthcare, personalized and precision medicine, and improved patient outcomes as a service — all while ensuring compliance with regulatory requirements.

PTC’s portfolio and expertise aims to help medical device manufacturers gain a competitive advantage in a complex, fast paced and highly regulated marketplace. With targeted focus on quality in the design phase, combining Additive Manufacturing (3D printing) capabilities (specifically AR and VR in support of quality for design, services and training) PTC is offering its Life Science clients well-thought-out, and high-performing technology solutions that can grow with the increasing complexity of quality and regulatory requirements.

Life Science innovators face transformative opportunities and challenges. The health-care value chain is becoming more collaborative, outcome-based and metrics-driven. Precision medicine, additive manufacturing, and connected medical products are rapidly expanding the art of the possible. For medical innovators and the healthcare communities they serve, the future is bright in the eyes of PTC’s solutions development group.

Cybersecurity

In this new digital world, cyber safety and security must become everyone’s responsibility, and work must be done to address the challenges and threats around safety and security. “Sophisticated software and hyper-connectivity are fuelling innovation at an unprecedented pace,” said Joshua Corman, SVP and Chief Security Officer, of PTC. “Those conditions can potentially introduce new classes of accidents and adversaries,” added Corman.   PTC has subsequently initiated a Coordinated Vulnerability Disclosure (CVD) Program that supports the reporting and remediation of security vulnerabilities that could potentially affect the environments in which PTC products operate, including industrial and safety-critical industries.

Announcements: Featured Partnerships

At LiveWorx 2019, strategic partnerships were on display.  First, Rockwell Automation.  This partnership is expected to accelerate growth for both companies and enable them to be the partner of choice for customers who want to transform their physical operations with digital technology. “Leveraging Rockwell Automation’s industry-leading industrial control and software technology, strong brand, and domain expertise with PTC’s award-winning technology, enables industrial enterprises to capitalize on the promise of the Industrial IoT. I am incredibly excited about this partnership and the opportunity it provides to fuel our future success,” said Jim Heppelmann, CEO of PTC.

Secondly, PTC’s partnership with Microsoft.  On June 10th, PTC announced that it has expanded its strategic alliance with Microsoft by delivering its industry-leading PLM solution Windchill on Microsoft Azure. Optimizing Windchill with Azure is yet another milestone in the growing alliance between the two companies since the initial announcement in 2018. PTC and Microsoft have closely collaborated on integrating Azure IoT with PTC’s IIoT solution platform, which has allowed customers to create innovative products and improve operations with IoT connectivity, rich contextualization, business systems orchestration, and breakthrough user engagement via mixed reality.

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In conclusion, LiveWorx 2019 was an interesting and forward-thinking conference this year…especially for organizations that are either starting or are already on their journey of digitally transforming their key business processes.

Download a PDF of this Event Brief.

 

28Jun/19
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Artificial Intelligence Can Make Pharmaceutical Companies More Competitive

Quartic.AI Briefing Note

By: Eric M. Luyer, Industry Research Analyst

Axendia was recently briefed by the senior executive team of Quartic.ai, based in San Jose, CA, US.   Quartic.ai was founded in 2017 by veterans in process automation, manufacturing, and reliability in conjunction with data scientists to optimize the practical use of information through Artificial Intelligence (AI) deployment.  The company had been recognized last year as the fastest growing technology leader in industrial AI by CIO Review Magazine.

The mission of Quartic.ai is to enable subject matter experts (SME) to help solve manufacturing problems by using AI. “We look at this as becoming another tool in their tool-belt of problem-solving. What we’re building enables the SMEs to build their solutions with AI”, said Rajiv Anand the CEO of Quartic.ai.

According to Rajiv Anand, their vision and mandate is not to grow their business through providing services, but by providing the technology. Their technology is a complete “smart industry platform” to support process- and pharma manufacturing industries via digital transformation using the concepts of the Industrial Internet of Things (IIoT) and AI. Continue reading

26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence to accelerate product innovation supporting rapid introduction of life-saving technology for patients “Digital evidence” is already being used at FDA to predict clinical outcomes, inform clinical trial design, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on July 10 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital and real world evidence  
  • Modeling and Simulation to support improved quality and patient outcomes 
  • Examples of Digital Evidence currently in use at FDA 
  • The Review of the Futureharnessing the power digital and real world evidence through digital transformation 

Meet Your Trusted Sources

Tina and Dan for CC

Over 200 FDA employees are part of the Agency’s Modeling and Simulation working group. Find out what they are working on and more.  

Register to view this webinar on-demand.

register

13Jun/19
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7 Reasons Life-Science Companies are Implementing eQMS in the Modern Cloud

ComplianceQuest Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Prashanth Rajendran, CEO, and Nikki Willett, Chief Strategy Officer, at ComplianceQuest.  The company sees multiple drivers for an up-tick in the adoption of eQMS in the Life Sciences industry, especially on a modern cloud platform:

  • Electronic Quality Management System (eQMS) as a necessity for emerging growth companies
  • Digital transformation (Quality 4.0)
  • Collaborative global regulatory bodies requiring consistent control
  • The services society demanding more managed applications
  • The power of a single platform to meet multiple business needs
  • The role of quality in merger and acquisition activities
  • Operational efficiencies are driving the top line and profitability

Historically, QMS had been targeted at managing quality/compliance documents. The transition that Axendia has noticed in the marketplace is that while companies still require documentation to support quality processes, what is more important is the underlying data that is housed in those documents. Emerging growth companies typically will focus on the product and getting the product approved…and eQMS was not always at the top of the minds of executives.  However, we’re seeing quite a bit of a change in that emerging growth companies are seeing that going electronic as early as possible is a value and an efficiency gain for them, said Willett.

Register to receive the entire Briefing Note in your inbox.

06Jun/19
ispe cover

The Surge of CAR-T Products Drives Medicare to Evaluate Coverage

An Excerpt from ISPE’s iSpeak Blog

By: Sandra K. Rodriguez, Market Analyst

“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years, reflecting significant scientific advancement and the clinical promise of these new innovations.” stated Scott Gottlieb M.D., 23rd Commissioner of Food and Drug Administration in a January 2019 press release.

One such new therapy is Chimeric Antigen Receptor T-Cell (CAR-T) Therapy. “The new immunotherapy treatment CAR-T represents a paradigm change in cancer therapy. For the first time, cancer treatment can be directed specifically to the cancer cells, sparing most of the normal cells, and resulting in very high remission rates in patients who have otherwise failed all other available treatment. Many patients who would have otherwise succumbed to their disease, are alive and well today, as a result of the CAR-T treatment” commented Mounzer Agha, MD, UPMC, Hillman Cancer Center.

The Centers for Medicare & Medicaid Services (CMS) recently proposed to cover this new form of cancer therapy as there is no national Medicare policy. This lapse allows Medicare Administrative Contractors (MAC) to determine whether and how much to pay. The proposed determination would require Medicare to cover the therapy nationwide which would improve access and promote better patient outcomes.

Continue Reading the Full Article

In related news, Novartis announced the world’s most expensive drug – with a price tag of over $2 Million for a one-time treatment.  See the press release.