RQM+ announced an investment by Linden Capital Partners (Linden), a Chicago-based healthcare private equity firm. Headquartered in Monroeville, Pennsylvania, a suburb of Pittsburgh, RQM+ is the largest international provider of regulatory, quality and compliance consulting services dedicated to medical device and in-vitro diagnostics manufacturers.

Maria Fagan, CEO of RQM+, states, “We are extremely proud of the business we have built at RQM+ and excited to partner with Linden to accelerate our growth and expand the breadth of services we can provide to our customers. We chose the Linden team as our partner for the next phase of our growth due to their exclusive focus on healthcare investing and shared vision for RQM+.”

Richard Thomas, incoming board member of RQM+ and industry veteran, says, “We commend Maria Fagan, Lisa Casavant and the entire management team at RQM+ on building an extraordinary business providing superior quality and services that are essential to helping their clients navigate a dynamic and increasing complex regulatory landscape. As manufacturers accelerate product and technology innovation to meet future healthcare needs, RQM+ is uniquely positioned to support the industry with an expanding suite of end-to-end capabilities and approaches to strategic partnership.”

Michael Farah, a partner at Linden and incoming board member of RQM+, adds, “Our investment in RQM+ is a direct result of our dedicated and longstanding outsourced medical device services sector effort, and we are excited to partner with an organization with such a strong market reputation in a highly fragmented industry. We look forward to supporting the entire RQM+ team as they seek to grow both organically and through acquisitions.” 

Members of the RQM+ leadership team have long-tenured careers rooted in medical device product development. This powerhouse team has led the company’s growth to:

• Over 400 employees and multiple offices across the U.S. and Europe,
• Remarkably high customer and employee retention rates,
• A one-of-a-kind caring and empowering culture that attracts the industry’s best talent, and
• The strongest reputation for client satisfaction in the industry, as confirmed by net promoter score client surveys to the world’s largest multinational medical device and IVD manufacturers.

In assessing partners, Fagan also says, “The RQM+ leadership team sought out a partner that was both focused on healthcare and supportive of our continued, intense focus on our core values. Maintaining an incredible culture for employees and delivering innovative solutions to our clients to ensure medical devices reach the patients who need them is what RQM+ is all about. We found Linden to be perfectly aligned to these same core values.”

June 2021 U.S. cutting tool consumption totaled $172.1 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 7.1% from May's $160.7 million and up 20.5% when compared with the $142.9 million reported for June 2020. With a year-to-date total of $974.7 million, 2021 is up 1.8% when compared to June 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.

According to Bret Tayne, president of USCTI, “The cutting tool market resumed its upward march in June. The 12-month moving average improvement is in a healthy range. The cutting tool market continues to experience short-term volatility from a variety of factors, but the overall trend remains positive. Our companies are planning for continued growth as projected by our market economists.”

Eli Lustgarten, president of ESL Consultants, comments, “The U.S. economy has fully recovered from its short recession and is entering second half of 2021 in boom conditions. U.S. manufacturing is a key driver with the ISM index (59.5) at very high levels. We expect that the recovery of cutting tool demand should continue through the remainder of 2021 and well into next year. The pandemic is under better control, as the U.S. has learned to live with it; the Delta variant may not have a big impact in the U.S. unless more drastic restrictions are implemented. There is likely to be a larger impact abroad (especially Asia) reflecting the weaker vaccination status.”

Wind River, a global leader in delivering software for intelligent systems, has issued new research, “13 Characteristics of an Intelligent Systems Future,” which examines the technology characteristics roadmap for a mission-critical intelligent systems world. The study predicts that success depends on properly timing the implementation of 13 key intelligent system characteristics that support a rapidly evolving intelligent systems machine economy.

An intelligent systems future
By 2030, $7 trillion of the U.S. economy will be driven by the machine economy, in which systems and business models increasingly engage in unlocking the power of data and new technology platforms. Intelligent systems are helping to drive the machine economy and more fully realize IoT. Further fueling this future is the growth of 5G, AI, automation, and cloud native technologies, as well as an increasing intersection of IoT and the edge. This potent combination has opened up new possibilities for far edge applications such as robotics, drones, telemedicine, and autonomous vehicles. Realizing this promise requires a new approach to building systems that can compute, sense, learn, and adjust in near-latency-free real time on the edge. Executives across the automotive, energy and utilities, medical, telecommunications, industrial manufacturing, and aerospace and defense sectors share a common belief that this future is going to require a new blueprint.

The report surveyed technology executives across various mission-critical industries and revealed the 13 requirements of the intelligent systems world for which industry leaders must prepare. The research found that 80% of these technology leaders desire intelligent systems success within the next five years.

Success in this machine economy will be dictated by the technology approaches and capabilities that are built now. 62% of technology leaders are putting into place strategies to move to an intelligent systems future, and 16% are already committed, investing, and performing strongly. It’s estimated that this 16% could realize at least four times higher ROI than their peers who are equally committed but not organized for success in the same way. Additionally, those who are succeeding have prioritized overcoming challenges posed by skill shortages and ongoing cyberthreats, which were two of the most commonly cited barriers in the study.

“In a growing machine economy driven by intelligent systems, humans and machines are on a path to a future where data will exponentially increase the volume, type, and quality of work that is possible, across all industries. These new use cases will demand more complex computing workloads, data, and analytics, and often that must happen in real time,” said Michael Gale, chief marketing officer at Wind River. “Wind River is at the forefront of helping companies address the complexities surrounding the secure development, deployment, operations, and servicing of mission-critical intelligent systems for the next generation.”

Blueprints leverage 13 key intelligent systems characteristics
The research surfaced 13 key characteristics that are critical markers for successful intelligent systems. It also highlighted the importance of investing the right elements at the right time, or “blueprinting.” In the case of building intelligent systems, three concepts are key: prepare the right infrastructure first, next work on foundational needs, and then address longer-term capabilities.

The 13 key characteristics are:

• Ability to simulate and emulate in near real time
• Automated learning and machine learning functionalities
• Digital feedback loops that influence product development
• Action based on sensory data and algorithms
• Customized device experience in the cloud
• True compute on the far edge
• Adapting tasks based on reprogramming via cloud
• Ability to predict stresses and failures
• Detection and resolution of events
• Total automation
• Near-real-time, seamless connections across multiple ecosystems
• Real-time collaborative workflow platform
• Experimenting as a learning system

The study also indicates that just four of the 13 characteristics create the most possible impact: true compute on the edge, a common workflow platform, AL/ML capabilities, and ecosystems of real-time applications. These characteristics are core needs on which longer-term success is dependent. Without these, it would not be possible to build all the remaining characteristics and achieve success.

Insights by industry
The report also highlights key findings by vertical industry, providing a blueprint that isolates the key characteristics most critical to that market and pinpoints when to invest in them. Input was sourced from companies in the aerospace and defense, automotive, energy and utilities, industrial, medical, and telecommunications markets. Leaders in these markets shared their perspectives in the following areas:

• Key components for mission-critical success in intelligent systems
• Barriers and drivers in the adoption of intelligent systems
• Factors that would accelerate the adoption of intelligent systems in each sector
• The importance of each intelligent systems characteristic as it pertains to investments
• The importance of 5G, AL, ML, and cybersecurity in their decision-making
• What the future of embedded devices and solutions looks like in an intelligent systems world
• Where digital feedback loops are most crucial for success
• Which key metrics define success
• Where intelligent systems could have extensive value in addressing wider societal issues

The extreme demands of an intelligent systems future present new complexities and challenges. Drawing from its proven expertise across the intelligent systems landscape, Wind River can help companies at any stage of the journey. Wind River Studio is a cloud native platform for the development, deployment, operations, and servicing of mission-critical intelligent systems from devices to cloud. It enables dramatic improvements in productivity, agility, and time-to-market, with seamless technology integration that includes far edge cloud compute, data analytics, security, 5G, and AI/ML.

Full research findings, including in-depth vertical industry insights and technology investment blueprints, are available at here.

Squirting a jet of water through a drop of liquid may sound like idle fun, but if done precisely, and understood thoroughly, the splashy exercise could help scientists identify ways to inject fluids such as vaccines through skin without using needles.

That’s the motivation behind a new study by engineers at MIT and the University of Twente in the Netherlands. The study involves firing small jets of water through many kinds of droplets, hundreds of times over, using high-speed cameras to capture each watery impact. The team’s videos are reminiscent of the famous strobe-light photographs of a bullet piercing an apple, pioneered by MIT’s Harold “Doc” Edgerton.

Edgerton’s images captured sequential images of a bullet being shot through an apple, in explosive detail. The MIT team’s new videos, of a water jet fired through a droplet, reveal surprisingly similar impact dynamics. As the droplets in their experiments are transparent, the researchers were also able to track what happens inside a droplet as a jet is fired through.

Based on their experiments, the researchers developed a model that predicts how a fluid jet will impact a droplet of a certain viscosity and elasticity. As human skin is also a viscoelastic material, they say the model may be tuned to predict how fluids could be delivered through the skin without the use of needles.

“We want to explore how needle-free injection can be done in a way that minimizes damage to the skin,” says David Fernandez Rivas, a research affiliate at MIT and professor at the University of Twente. “With these experiments, we are getting all this knowledge, to inform how we can create jets with the right velocity and shape to inject into skin.”

Rivas and his collaborators, including Ian Hunter, the George N. Hatsopoulos Professor in Thermodynamics at MIT, have published their results in the journal Soft Matter. 

Penetrating pores
Current needle-free injection systems use various means to propel a drug at high speed through the skin’s natural pores. For instance, MIT spinout Portal Instruments, which has sprung from Hunter’s group, centers on a design that uses an electromagnetic actuator to eject thin streams of medicine through a nozzle at speeds high enough to penetrate through skin and into the underlying muscle.

Hunter is collaborating with Rivas on a separate needle-free injection system to deliver smaller volumes into shallower layers of the skin, similar to the depths at which tattoos are inked.

“This regime poses different challenges but also gives opportunities for personalized medicine,” says Rivas, who says medicines such as insulin and certain vaccines can be effective when delivered in smaller doses to the skin’s superficial layers.

Rivas’ design uses a low-power laser to heat up a microfluidic chip filled with fluid. Similar to boiling a kettle of water, the laser creates a bubble in the fluid that pushes the liquid through the chip and out through a nozzle, at high speeds.

Rivas has previously used transparent gelatin as a stand-in for skin, to identify speeds and volumes of fluid the system might effectively deliver. But he quickly realized that the rubbery material is difficult to precisely reproduce.

“Even in the same lab and following the same recipes, you can have variations in your recipe, so that if you try to find the critical stress or velocity your jet must have to get through skin, sometimes you have values one or two magnitudes apart,” Rivas says. 

Beyond the bullet
The team decided to study in detail a simpler injection scenario: a jet of water, fired into a suspended droplet of water. The properties of water are better known and can be more carefully calibrated compared to gelatin.

In the new study, the team set up a laser-based microfluidic system and fired off thin jets of water at a single water droplet, or “pendant,” hanging from a vertical syringe. They varied the viscosity of each pendant by adding certain additives to make it as thin as water, or thick like honey. They then recorded each experiment with high-speed cameras.

Playing the videos back at 50,000 frames per second, the researchers were able to measure the speed and size of the liquid jet that punctured and sometimes pierced straight through the pendant. The experiments revealed interesting phenomena, such as instances when a jet was dragged back into a pendant, due to the pendant’s viscoelasticity. At times, the jet also generated air bubbles as it pierced the pendant.

“Understanding these phenomena is important because if we are injecting into skin in this way, we want to avoid, say, bringing air bubbles into the body,” Rivas says.

The researchers looked to develop a model to predict the phenomena they were seeing in the lab. They took inspiration from Edgerton’s bullet-pierced apples, which appeared similar, at least outwardly, to the team’s jet-pierced droplets.

They started with a straightforward equation to describe the energetics of a bullet fired through an apple, adapting the equation to a fluid-based scenario, for instance by incorporating the effect of surface tension, which has no effect in a solid like an apple but is the main force that can keep a fluid from breaking apart. They worked under the assumption that, like a bullet, the fired jet would maintain a cylindrical shape. They found this simple model roughly approximated the dynamics they observed in their experiments.

But the videos clearly showed that the jet’s shape, as it penetrated a pendant, was more complex than a simple cylinder. So, the researchers developed a second model, based on a known equation by physicist Lord Rayleigh, that describes how the shape of a cavity changes as it moves through a liquid. They modified the equation to apply to a liquid jet moving through a liquid droplet, and found that this second model produced a more accurate representation of what they observed.

“This new method of generating high-velocity microdroplets is very important to the future of needle-free drug delivery,” Hunter says. “An understanding of how these very fast-moving microdroplets interact with stationary liquids of different viscosities is an essential first step to modeling their interaction with a wide range of tissue types.”

The team plans to carry out more experiments, using pendants with properties even more like those of skin. The results from these experiments could help fine-tune the  models to narrow in on the optimal conditions for injecting drugs, or even inking tattoos, without using needles.

This research was supported in part by the European Research Council under the European Union Horizon 2020 Research and Innovation Programme.