Ambu USA | A Revolution in Healthcare Arena | Steven Block

Steven Block

President

Today’s healthcare arena faces numerous challenges, including patient safety, workflow, efficiency, cost-effectiveness, worker safety, and COVID-19. Reducing/eliminating the risk of cross-contamination and infection is an obvious challenge that single-use endoscopy tackles, but healthcare leaders have to answer other strategic and operational questions with subtle interpretations embedded therein, such as:

  • How do healthcare organizations expand services and capacity without additional capital investment when the pandemic has caused a backlog in elective procedures?
  • How do physicians, supply chain, and finance leaders obtain the full picture of all the cost drivers associated with reusable endoscopes?
  • How much exposure to financial risk is inherent to reusable endoscopes when considering that most of the costs associated with reusables are largely fixed: depreciating capital investments, reprocessing equipment and operations, and repair and service contracts?
  • And should an outbreak occur related to endoscope contamination, how significant is the potential impact not just financially but on institutional reputation?

Ambu was founded over 85 years ago with a mission to make a difference in patients’ lives and change the world for the better. This legacy extends to the responsibility the company feels to seek sustainable paths for its business.

Ambu currently provides single-use endoscope families in bronchoscopy, rhinolaryngoscopy, cystoscopy, and duodenoscopy, and its single-use gastroscope was recently granted FDA clearance. Their innovative platform also forgoes the traditional video endoscopy tower size and expense in favor of its aView and aBox all-in-one video displays.

By combining the multiple single-use endoscopes with versatile displays, hospitals can invest in a platform that is a fraction of the expense required for video towers and is far more compact and portable.

Single-use flexible endoscopes are sterile and patient-ready out of the package — enabling improved safety by eliminating the risk of patient cross-contamination and improved clinical workflows by eliminating endoscope cleaning and reprocessing.

The productivity boosts for healthcare providers are a byproduct of a flexible endoscopy system that is always ready when needed, without the traditional large-scale capital and repair budgets required for reusable endoscopes. This strategy works because it eliminates, where possible, time- and resource-intensive processes. Using single-use scopes instead of reusables can facilitate higher volumes while at the same time reducing repair and reprocessing costs. Another benefit of single-use endoscopy is capital efficiency, as single-use turns endoscopy into a variable cost that is directly linked to procedure volumes. Reusable, on the other hand, has a fixed cost structure regardless of procedure volumes.

Central to Ambu’s flexible endoscopy platform is its high-definition video monitor and the way it serves as an endoscopy hub. The company introduced the aView 2 Advance to power the bronchoscope, rhinolaryngoscope, and cystoscope lines and enable clinicians and hospitals to use the same high-performance, all-in-one, touchscreen unit across various departments and sites.

Unlike traditional video endoscopy towers — known for stacking multiple peripherals and being hard to transport — the aView series is highly portable, can be set up on an IV pole, can operate on battery life, and can fit into most clinical locations with little effort, thanks to its compact size. Ambu wants to empower healthcare organizations to expand endoscopy procedures across various settings, especially at the bedside or in cramped operating rooms.

The aBox 2, meanwhile, is Ambu’s next-generation displaying and processing unit with a built-in touchscreen and will debut with its new single-use gastroscope. The aBox 2 is designed to be at the center of the single-use endoscopy ecosystem of the future, with a full HD image, advanced image processing, and increased processing power compared with existing monitor technology.

That, combined with a new camera sensor in some of their high-performance single-use endoscopes that is four times more powerful, will set a new benchmark in terms of image performance — enabling doctors to see vasculature more clearly, which is important in many kinds of routine diagnostic procedures. The touchscreen display, meanwhile, has been described by doctors as intuitive, comparable to high-end tablet computers.

Industry-Leading Technology

The company’s industry-leading technology represents a new approach to the longstanding challenge of expanding endoscopy procedures while ensuring devices are safe, affordable, and accessible.

Ambu was founded in Copenhagen in 1937 by German engineer Holger Hesse, and in 1956 they gained notice for their self-inflating resuscitator. Developed by Hesse and anesthesiologist Henning Ruben, the Ambu ventilation bag would mark a major milestone in emergency medical equipment and hospital care and define the product category. Indeed, the bag would become synonymous with Ambu much the way tissue paper is synonymous with Kleenex.

The company’s track record of innovation in the medical device industry includes its ability to rapidly accelerate the introduction of new technologies with shorter product life cycles. This is important because reusable scopes typically have very long product life cycles, leading to slower adoption of new technologies. The high capital invested in reusable scopes demands depreciation before replacing the product. Technology and design constraints exist, as the endoscope must withstand high-level disinfection or sterilization.

Ambu, by contrast, can leverage a single-use innovation cycle and deliver solutions with short development and product life cycles (two to three years). This approach requires minimal capital depreciation and rapidly adopts new technologies and design improvements.

Research & Innovation

Pairing innovation with high-scale, low-cost manufacturing is Ambu’s mission. They are developing their fifth-generation bronchoscope and adding innovations and improvements to every new iteration. New market entrants, meanwhile, are not as advanced in product design.

Ambu is doing this in part by taking advantage of the rapid technological advancements in image sensors, materials, artificial intelligence, and image enhancement. Their short product life cycles are unique; as soon as a product has been launched, they have already started developing the next generation in most cases.

Ambu received a Global New Product Innovation Award in March 2021 from Frost & Sullivan for these and other reasons. This international consulting firm honors companies it deems to be at the innovation and growth forefront of their respective industries. “Frost & Sullivan feels that Ambu distinctly stands out in the market with its R&D and manufacturing engines, outperforming competitors with its focus on innovation and high-scale, low-cost manufacturing.”

In April 2021, Ambu won not one but two Red Dot product design awards for the company’s cystoscope and duodenoscope. The Ambu aScope Duodeno also was honored in the “Innovative Products” category. Red Dot’s international jury comprises 50 specialists from a wide variety of business sectors and is one of the most recognized design awards in the industry.

And in March 2022, Ambu was named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2022. The list honored businesses making the biggest impact on their industries and culture and thriving in today’s ever-changing world and included companies such as Microsoft, SpaceX, and GlaxoSmithKline.

Strengthen its Global Position

The positive impacts of Ambu’s innovations in single-use endoscopy are seen every day as hospitals eliminate the risk of cross-contamination by transitioning from endoscopes that need to be adhered to a complex cleaning process in between uses to a scope that can be used once and discarded.

The transition to the single-use endoscopy market continues to accelerate. And over the last several months, the FDA released an updated safety communication recommending that healthcare providers consider using single-use bronchoscopes when there is increased risk of spreading infection and when treating COVID-19 patients.

That’s increasing the cost of using reusable bronchoscopy, and at the same time, clearly encouraging healthcare systems to consider single-use bronchoscopy for certain patient profiles.

Then, more recently, a new, highly anticipated update to standards for reprocessing reusable endoscopic medical devices was released and it classifies flexible endoscopes — including duodenoscopes, bronchoscopes, ureteroscopes, cystoscopes, and others — as “high-risk,” necessitating sterilization rather than high-level disinfection to rid the scopes of contaminants that could harm patients.

Client Testaments

Memorial Health System, which operates hospitals in Marietta, Ohio and health facilities across southeastern Ohio and northwestern West Virginia, became the first hospital system in the U.S. to convert to Ambu’s aScope Duodeno for ERCP procedures.

Duodenoscopes are used for visual examinations of the duodenum and play a key role in diagnosing and treating conditions such as gallstones, pancreatitis, tumors or cancer in the bile ducts or the pancreas. More than 500,000 ERCP procedures are performed annually in the U.S.

Hospital-acquired infections are rare but are linked to flexible endoscopes more than any other medical device, and some experts believe the numbers are underreported due to poor surveillance and tracking. Studies have connected “superbug” outbreaks to flexible duodenoscopes, heightening scrutiny not only of cumbersome reprocessing measures undertaken to clean endoscopes but also their design attributes, which makes cleaning them inherently difficult.

Dr. Juan Tejada, a gastroenterologist and advanced endoscopist with Memorial Health, told news outlets the transition to single-use duodenoscopes was “a win for both physicians and patients” by marrying innovative design with a mission to advance patient safety.

Meantime, the radiation oncology department at the University of Florida College of Medicine, UF Health, made the switch to single-use by bringing in the Ambu aScope 4 RhinoLaryngo to help diagnose and treat head and neck cancer, which is the sixth most common form of cancer worldwide.

“The COVID-19 pandemic has forced us all to take a look at how we balance careful infection control with fiscal and environmental responsibility,” said Dr. Kathryn Hitchcock, a physician and University of Florida assistant professor. “These new scopes help us achieve all three goals by providing an affordable single-use solution coupled with a clear plan for keeping these materials out of landfills. Once we saw the excellent clarity of the images provided by these devices, we knew they were the answer.”

Towards the Future

It is pertinent to mention that Ambu’s product development infrastructure is global, with innovation centers in Denmark, Germany, and Malaysia focused on rapid high-tech innovation. Over two years starting in 2020, Ambu has more than doubled their engineer headcount and today count 400 in-house engineers with expertise in electronics, optics, software, artificial intelligence, and clinical research, among other areas.

They are generating proprietary technology around modular camera and sensor platforms, image processing capabilities, ergonomics, and maneuverability. One result of these efforts: Ambu filed more patents from 2020-2022 than in the previous decade combined.

All of this investment is geared to Ambu’s aggressive product launch schedule. That includes their recent entry into the GI market with the launch of its upgraded aScope Duodeno and single-use gastroscope system, recently cleared by the FDA and targeting a market of more than 20 million

" It is pertinent to mention that Ambu’s product development infrastructure is global, with innovation centers in Denmark, Germany, and Malaysia focused on rapid high-tech innovation "

Steven Block

President