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Globus Layoffs Resurface Integration Concerns

Globus is eliminating 157 positions across the former NuVasive headquarters campus.

By Amanda Pedersen

Globus Medical and NuVasive caused quite the stir last year by merging in a market that remembers all too clearly the integration ghosts that have haunted spine deals in the past.

Now, five months after Globus and NuVasive completed the $3 billion all-stock deal, reports of layoffs at NuVasive's former headquarters campus in San Diego, CA have resurfaced those integration concerns.

According to a Jan. 3 notice filed with the state of California, the company is eliminating 157 positions across the campus including administrative, sales, legal, marketing, quality, and engineering jobs, effective March 5.

Earlier this month, Globus announced preliminary fourth-quarter revenue of $615.5 million (beating analyst expectations of $602.5 million) and full-year 2023 revenue of $1.567 billion (beating analyst expectations of 1.554 billion).

The Audubon, PA-based company also forecasted 2024 revenue to fall between $2.45 billion and $2.47 billion, which was below analyst expectations.

"Overall, we think results do not dissuade concerns that the integration still poses some risk in 1H24, but as [Globus] distances itself from the merger closure, we think they can begin to overcome these fears with solid results as they posted for 4Q23," Ryan Zimmerman, a medtech analyst at BTIG, wrote in a January 10 report.

VeraVue Single-Use Flexible Cystoscope Gets Limited Market Release

Distributed by Boston Scientific, the cystoscope is intended to help clinicians diagnose and treat urinary tract conditions.

By Katie Hobbins

Boston Scientific recently announced the limited market release of VeraVue Single-Use Flexible Cystoscope, which received FDA 510(k) clearance in October 2023. Developed and manufactured by Medimaging Integrated Solutions and marketed and exclusively sold by Boston Sci through a distribution agreement, the scope is intended to help clinicians diagnose and treat urinary tract conditions, providing visualization of the lining of the bladder and urethra while displaying images to perform various diagnostic procedures.

Unlike reusable scopes, VersaVue helps optimize schedule and workflow by eliminating the time associated with reprocessing, repair, and maintenance, according to the company, and may help reduce patient wait times associated with a lack of available reusable options. Additionally, the cystoscope come in sterilized packaging for every patient, removing the risk of infection caused by possible cross-contamination of reusable scopes.

The system is designed to be lightweight and compact for easy transportation across clinical settings and includes the 14” VersaVue Tablet to display images and video.

“The VersaVue Single-Use Flexible Cystoscope was developed as an alternative to reusable flexible cystoscopes,” Ron Morton, MD, chief medical officer, Urology, at Boston Scientific, told MD+DI. “By utilizing a unique sterile packaged cystoscope for each patient, practices can eliminate the risk of infection due to cross-contamination associated with reusable scopes. Moreover, opposed to relying on the availability of reprocessed scopes being able to open a new scope for each case may also help improve the outpatient clinic experience by eliminating wait times and or cancellations due to lack of reusable scope availability.”

Currently, the cystoscope is only commercially available in the US.

Getting to the Heart of What the Medical Battery Market Needs

Wyon's Marcel Inauen discusses the challenges of miniaturizing power sources and how to overcome the hurdles.

By Omar Ford

As wearable or implantable medical devices become ever smaller, of course so do their power sources. And these can be tricky to design.

“The power source must be cleverly adapted to meet the dimensions of the devices while ensuring highest performance and consistent quality standards,” said Marcel Inauen, CTO of Wyon Company.

Inauen will be presenting a Medical Battery Conference at MD&M West in February, where he will discuss the challenges manufacturers might face in miniaturizing power sources, and how to approach them using innovative thinking, sometimes borrowing from other industries, rather than the traditional techniques.

MD+DI recently asked Inauen for his take on some of these challenges and what attendees can expect to learn at the conference. ?What are some of the challenges that arise when developing power sources for ever smaller devices??Can you provide some background on this issue??

Inauen: The smaller the devices get, the smaller the battery must be, while the performance must remain at a comparable level to larger cells. But physics count, and thus energy density shrinks while getting smaller due to the influence of wall thickness, internal electrical connections, and the overhang of the anode to cathode. Also, when you reduce the height of a cell, the well-known jelly roll approach of a cell design does not work anymore.

In some cases, also, standard form factors, such as cylindrical, are a limiting factor. Freedom in shape would allow better use of volume or even allow a more ergonomic design of the device. Furthermore, manufacturing of micro parts is a real challenge in precision, which is a must to have a stable production process and reliable quality of the product.?

When you adapt a power source for a miniature device, is it just a matter of “shrinking” the size of the power source or are there other considerations??

Inauen: With the challenges discussed before, yes, the goal is to shrink the size of the cell. Wyon is pushing the limits of feasibility and is reducing the wall thickness, space for internal connections, and overhang. We also use a stacking approach to reduce cell height to even below 2mm. With the stacking cell technology, we are able to build arbitrary-shaped cells that are not bound to a standard form factor.

We use sources for machine parts from the watch industry, who have experience in manufacturing parts aiming for the highest precision. And we develop machines and manufacturing processes by ourselves to get the precision and reliability needed.

Additionally, our unique plastic housing technology offers several advantages, including lower eddy current losses, corrosion resistance, reduced weight, or mounting options to further reduce overall device size.

Could you share an example of how you approached adapting a power source to fit a smaller device??

Inauen: Without disclosing names or project details, I can tell you the following: For a device that needed to be as small as possible with a magnet in the center, we built a cell around the magnet, meaning the cell became C-shaped.

Who should attend your upcoming session at IME West???

Inauen: All kinds of medical device manufacturers or engineering companies designing next-generation small body-worn or even implanted devices who are challenged by miniaturization. I believe it is worth seeing the options Wyon may offer as a solution provider with 25 years of experience in within the complex medical device market.

What do you hope your attendees will take away from your session???

Inauen: When starting a new device project, people often only think about the standard solutions available, but thinking outside the box would open up new possibilities. Knowing that such solutions are possible helps to set the process in motion. I hope that I can convey this accordingly.

Inauen will present “Solving the Needs of the Demanding Medical Battery Market,” on Tuesday, February 6, from 11:00 to 11:25 a.m., in Hall E, Booth #268.

For more information, including how to register for the Medical Batteries Conference at MD&M West, visit?www.imengineeringwest.com.

Doubling Down on Innovation with a Digital Twin

A digital twin can play an essential role in designing a device that aligns with current standards and regulations while anticipating future market needs.

By Joe Darrah

Approximately half of new technologies fail to reach the market, and the actual number is probably higher, according to Leyla Mirmomen, founder and CEO of Optimuos, a client-based engineering company headquartered in Los Angeles.

From insufficient integration of customer needs into a specific technology and regulatory complications to prolonged and intricate development processes, most market failures stem from roadblocks that are inherent to conventional approaches. Traditional development methods tend to worsen the odds of launch because they delay communication of customer feedback and market insights. An alternative method exists, says Mirmomen, that can help developers to improve their chances of accelerating time to market and achieving a timely product launch.

The trick is "commencing an exhaustive study of customer requirements in tandem with the initiation of the development and primary design phases," said Mirmomen. "This early-stage exploration facilitates a comprehensive understanding of engineering challenges, cost implications, and regulatory constraints. Armed with this knowledge, early design iterations can be implemented, reducing the need for substantial investments. This strategic approach significantly improves the likelihood of formulating a technology solution that aligns with market demands and identifies potential failure points from the outset, enabling a shift toward more viable alternatives."

Key to achieving development goals for new technologies is the utilization of what’s known as a "digital twin" — a virtual version of a real device that’s generated through a blend of data and physics. Falling within the realm of artificial intelligence (AI), digital twins can reportedly serve as a valuable component to enhance decision-making by providing a system’s virtual representation. Mirmomen and her colleague Pirouz Kavehpour, a professor of engineering at UCLA, will present an educational session on digital twins at the upcoming Medical Design & Manufacturing (MD&M) West event in Anaheim, CA, running from Feb. 6 to 8. During the session, scheduled for 11:15 a.m. on Feb. 6, Mirmomen and Kavehpour will discuss the sequential steps required for constructing a digital twin while exploring various applications and its potential as an AI-driven predictive tool.

Driven by data

Validating the potential of new technologies using a digital twin melds data-driven insights and core physical principles to craft predictive models that serve as agile virtual systems, says Mirmomen. "In the current landscape, data play a pivotal role across diverse applications, encompassing a broad spectrum of processes under the umbrella term 'data driven,'" she said. "Our organization strategically employs data-driven insights in two primary capacities: We leverage data to develop highly accurate and cost-effective simulations of systems, and we utilize data to construct various scenarios, subjecting the digitally engineered system to these scenarios to iteratively enhance system behavior and functionality." These methodologies produce multi-layered benefits, including alignment of technologies with targeted objectives and precise predictions of system behavior, Mirmomen said. "From the initial stages of concept development, it's imperative to be conscious of the standards and regulations with which the device must be in compliance," she continued. "Having this data at the outset allows us to identify potential technical challenges and streamline the regulatory path. For instance, designing a device using off-the-shelf parts that already comply with standards expedites the regulatory process."

Contrary to conventional methods, where product design is the first issue of focus while regulatory considerations follow post-prototype testing, digital twinning advocates for integrating regulatory steps earlier in the concept-development phase. "In today's dynamic market, while meeting all the necessary standards is crucial, the most significant element, alongside compliance, is the ability to swiftly enter the market with a reasonable investment," Mirmomen said. "Leveraging technology is key to designing a device that not only aligns with required standards and regulations, but also anticipates future market needs. It's essential to capture and implement customer feedback rapidly, ensuring a competitive edge and responsiveness to evolving market demands."??

Going beyond AI?

While AI tools require algorithms to make decisions based on the events they are trained for, a digital twin provides a virtual representation of the system it is trained for and can serve as a more valuable component to enhancing decision-making, says Mirmomen.?

"The integration of a digital twin into AI decision-making processes can significantly decrease the initial dependency on a massive amount of data," she said. "The virtual representation offered by the digital twin enables more accurate decision-making without relying solely on extensive datasets. Moreover, the digital twin exhibits a unique capability to interface seamlessly with the physical device. Through constant learning and iterative improvements, it attains the proficiency to mimic the exact behavior of the system in real time. This transformative capability positions the digital twin as an invaluable asset, not only in predicting system behavior, but also in actively adapting and evolving alongside the real-world counterpart." At the same time, the use of digital twins aligns seamlessly with AI to ensure smarter, precise solutions and bridges the gap between ideas and reality for agile development, meticulous validation, and streamlined progress, according to Mirmomen.

Comprehensive collaboration

As technology continues to advance, there’s evidence of a "fifth industrial revolution." With this as a backdrop, there is a discernible trend across diverse industries, including medtech companies, toward the integration of digitization and related technologies within their research, development, and engineering frameworks, says Mirmomen.

"In the swiftly progressing era of digitization, where technological advancements are pervasive, product development emerges as a sector ripe for substantial digital transformation. I firmly believe that understanding market needs and knowing your customers, along with the regulatory and standards landscape, should shape the primary design of the device. This awareness should extend through development and prototype testing until the device is ready to launch. This approach ensures compliance, user-friendliness, and cost-effectiveness."

At Optimuos, companies are engaged across various project stages spanning from initial concept development to the optimization of fully functional devices already in the market. Serving as an extended research and development arm for clients, Mirmomen and her team adopt a collaborative approach throughout the development journey to concurrently constructing the virtual system while actively contributing to the product’s design, testing, and prototyping processes.

"We optimize the utilization of available resources, ensuring a synchronized and efficient development process," said Mirmomen. "This collaborative method not only facilitates the timely achievement of goals, but also promotes cost-effectiveness by leveraging existing resources effectively."

De-risking technology through simulation

Another crucial element to leveraging the benefits of digital twins is the "in silico,” or virtual, trial that aligns with the FDA-recognized use of simulation in the regulatory process. This approach de-risks technologies through simulation — by mimicking the physical system virtually and significantly reducing the size of clinical trials, thereby impacting both the cost and time associated with the regulatory process. "The digital twin plays a pivotal role in this concept by providing a virtual representation that behaves like the physical counterpart," said Mirmomen. "This enables our team to run diverse scenarios, integrate patient data, and record outputs, facilitating continuous improvement of the device while capturing valuable insights."

Mirmomen believes the use of a digital twin can become the core to any decision-making for future AI tools, simplifying and enhancing their accuracy. "The paramount aspect of digital twinning lies in its capability to ensure simulations accurately capture the fundamental physics of the device," she said. "Leveraging advanced methods for refining and implementing data, the digital representation of the system closely mirrors the authentic functionality of the device. This integration not only elevates the efficiency of product preparation for production, but also plays a pivotal role in pushing the frontiers of innovation within the medtech industry."

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