The COVID-19 pandemic has shined a spotlight on ventilators, but not many know much about what they do or how they work. A ventilator pumps air—typically with extra oxygen—into airways when patients aren’t able to breathe adequately on their own. When lung function is severely impaired, patients may need a ventilator. It’s also used to support breathing during surgery.

Also known as life-support machines, ventilators won’t cure an illness. But they can keep patients alive while fighting an infection such as COVID-19 or as their body heals from injury. A ventilator is usually used in a hospital’s intensive care unit (ICU), but those needing it for longer may be in a different area of the hospital, at a rehabilitation facility, or even at home.

When the immune system can’t fight off an infection like COVID-19, it can travel to the lungs and cause potentially fatal acute respiratory distress syndrome (ARDS). In ARDS, the lungs’ alveoli fill with fluid, diminishing their ability to provide vital organs with enough oxygen.

Instances of ARDS brought on by severe COVID-19 infections created enormous demand for critical care ventilators to keep patients breathing. Firms making these devices were challenged to ramp up production to levels that were previously thought impossible.

For example, according to Bothell, Wash.-based Ventec Life Systems, its VOCSN Multi-Function Ventilator is the first and only multi-function ventilator that integrates five separate devices: a ventilator, oxygen concentrator, cough assist, suction, and nebulizer into one unified respiratory system. Cleared by the FDA in April 2017, it’s 70 percent lighter than existing machines, has a nine-hour on-board battery, and has a user-friendly touchscreen interface. It’s designed to work in hospital, institutional, transport, and home environments. The portable, critical care ventilator provides invasive, noninvasive, and mouthpiece ventilation.

“The flexibility, capability, and supply of VOCSN V+Pro makes it the primary critical care ventilator in the U.S. Strategic National Stockpile,” said Mark SooHoo, VP of marketing and communications at Ventec. “At its core, VOCSN is a critical care ventilator, one of the few portable ventilators to achieve the rigorous critical care standard for safety and accuracy. VOCSN delivers a comprehensive set of modes and settings, which provide clinicians with a flexible tool to meet evolving respiratory needs.”

Ventec began a partnership with General Motors (GM) last March to build VOCSN critical care ventilators. Tooling and manufacturing capacity at GM’s facility was augmented so the companies could ramp up to a manufacturing capacity of over 10,000 critical care ventilators per month with infrastructure and capability to scale further.

“After partnering with GM in March 2020, we established a new production facility in Kokomo, Ind., and created the fastest, largest increase in critical care ventilator production in history,” said SooHoo. “Together, the team completed a $489 million contract to supply 30,000 VOCSN V+Pro Emergency critical care ventilators to support healthcare professionals on the front lines against COVID-19. At its peak, the partnership produced 80x Ventec’s previous monthly production, producing one ventilator every seven minutes. The contract was completed on time and on budget.”

Global medical device maker Philips’ Trilogy Evo home ventilator and Trilogy EV300 critical care ventilator help clinicians maintain effective respiratory care across changing conditions and care environments. According to the company, Trilogy Evo is the only portable life support ventilator designed for consistent, transitional therapy and monitoring as conditions change. It features proprietary Care Orchestrator patient management software. The connected system, according to Philips, reduced unscheduled visit frequency by 13 percent, and scheduled visits by 22 percent during the first 30 days of therapy.

The Philips Respironics E30 and V60 ventilators have been valuable tools to treat COVID-19 patients requiring respiratory support.

“At the initial pandemic impact’s height, we quickly scaled E30 emergency use ventilator production, keeping healthcare worker and COVID-19 patient needs in mind while complying with medical device quality standards. Philips received EUA for the device in April 2020,” said Pamela Hall, sleep category leader at Philips Sleep and Respiratory Care. “In addition, we quickly took steps to upgrade our V60 hospital ventilator to offer new advancements to meet evolving needs. The V60 Plus, with high flow therapy cannula, is a modification to the existing FDA cleared V60 ventilator. Philips V60 Plus was previously only available outside the U.S., and had been pending 510(k) approval when the pandemic hit. We received EUA for the V60 Plus so U.S. care providers could flexibly and efficiently address a wide variety of respiratory needs. The device can provide noninvasive ventilation, invasive mechanical ventilation, and high flow therapy, along with circuitry consistency for quick transitions between treatment types, helping reduce delays in transitions between modalities.”

According to San Diego-based ResMed, the firm is a top five global ventilator producer, top two in bi-level devices delivering non-invasive ventilation. Their devices are fit for home and hospital, and cloud-connectable so clinicians can remotely monitor their patients. The company’s portfolio of ventilators include the Astral and Stellar devices for both invasive and non-invasive ventilation, and the bi-level AirCurve 10 ST-A and Lumis, which can treat respiratory insufficiencies of COVID-19 patients or various chronic respiratory disorders.

“In the first few weeks of the pandemic, we quickly and safely shifted our manufacturing and distribution teams (whom we call our “ResMed Heroes”) worldwide to maximize the number of ventilators we could send to patients in need,” said Jim Hollingshead, president of ResMed’s sleep and respiratory care business. “We set a goal to triple the number we typically produce. We surpassed that, producing a record 150,000 ventilators in the first six months of 2020—3.5 times more than that same period the year before. We have fulfilled governments’ and health systems’ needs. Due to these efforts and others across the industry, ventilator demands have lessened of late, though we continue to actively engage with key contacts in highly impacted countries to spot and meet new demands where they arise.”

“Our employees displayed flexibility and resourcefulness as production of acute care equipment and solutions significantly increased—including our critical care ventilators and accessories,” said Hall. “We were able to continue to quadruple our critical care ventilator output and continue to distribute them globally, using a fair and ethical approach to meet surging demands.”

Oceanside, Calif.-based Emergent Respiratory’s PortO2Vent Oxygen Delivery System is a gas-powered device that delivers non-invasive constant positive airway pressure (CPAP) to spontaneously breathing patients who are awake and can maintain a patent airway. It delivers CPAP at operator adjustable levels throughout breathing, independent of the patient’s inspiratory flow requirements. According to the company, PortO2Vent reduces intubation rate in CHF patients between 50-80 percent, reduces the length of hospital stay, reduces nosocomial infection rate, and improves outcomes.

“Sometimes, the only option that will work is intubation because the patient isn’t able to breathe for themselves,” said Chris Oleksy, CEO of the company. “When they can, for many years PortO2Vent has been known as the gold standard for minimally invasive breathing support—three of the top five U.S. teaching hospitals utilize our product. Our therapy is a fraction of the cost of full ventilation, minimally invasive, and patient testimonies praise the relief they feel when our therapy is deployed. We’re thrilled we were able to relieve the discomfort and anxiety experienced from COVID-19.”

Strain on the Supply Chain
With the explosive demand for ventilators, those supplying critical ventilator components also felt the squeeze. In addition to the sudden skyrocketing demand, component suppliers faced sourcing and logistical challenges brought on by the pandemic’s restrictions.

“Having responsive suppliers was mission critical; supplies were strained globally and much ingenuity was needed,” commented Oleksy. “More frequent communications were required among many other changes but for the most part, doing more and quicker while maintaining the same level of quality level became all ventilator suppliers’ mantra. Further, many of the same parts are utilized across different organizations’ ventilators. The ‘small guy’ like us had difficulty securing some items when the goliaths (General Motors’ or Ford’s prioritization by the U.S. government) were consuming needed parts.”

“The biggest challenge to face the ventilator supply chain was the combination of multiple forms of supply chain disruptions from a singular event—which spanned nearly an entire year and still persists,” added Ryan Oleksy, president of Emergent Respiratory. “Obvious, universally agreed complexities surrounded the ability to quickly source parts from heavily affected areas in Asia, coupled with lockdowns that crippled factories’ ability to get their shipments out—even if they were able to keep operations running. The inability to ship timely, uncertainty of restrictions coming, and common parts being utilized by the ventilation OEM landscape led to a ‘multiplier’ to the disruption—the result of governments around the world rapidly trying to procure ventilators.”

Given how critical the parts were, suppliers used whatever methods they could to ramp production.

“We started working overtime and added weekend shifts as needed to supply the surge in volumes,” said Steve Bello, VP of business development at St. Petersburg, Fla.-based Halkey-Roberts, which supplied valves to the ventilator market. “We had to work with our suppliers to ramp up and sustain the supply of components used in our valves. We implemented some lean manufacturing techniques to streamline the assembly and testing of these critical components, and also realized our supply chain’s importance and partnering with them to solve problems.”

To get more info about the ventilator supply chain and steps firms took to meet the demand, MPO spoke with:

Joe Alcamo, technical director, and Eric Wilson, director of sales and marketing, at KNF Neuberger Inc., which supplies compressor pumps that deliver pressure controlled by the ventilator.

Christian Fritz, director of sales—motion control and electronics at maxon group, which provides high-performance motors used in sub-assemblies like blowers and compressors for ventilator applications.

Craig Stiffler, GM at Parker Precision Fluidics, which offers nine precision solenoid valves (proportional and on/off), and three miniature diaphragm pumps for ventilators.

Brusco: What operational adjustments were needed to respond to the sudden, increased demand for ventilator components?

Alcamo: We quickly reconfigured the receiving and production areas to handle a 10-fold throughput increase, which required optimization of the flow of incoming materials, rethinking of quality control protocols, revamping of how components and subassemblies progressed across the assembly line, and a packaging and shipping method overhaul.

We decided at the beginning to quarantine all incoming shipments for five days, putting an extra constraint on material flow. As further guidance was received, we reduced this to one day then eliminated the practice. We notified all affected vendors our volume would be increasing 10-fold so they could start planning, and collaborated with some vendors to retool for certain critical components to increase mold and machining capacity for greater quantity per run.

We worked with vendors to streamline incoming materials to reach the production line with minimal time and touches. We purchased returnable containers to reduce time needed to pack and unpack, reducing space needed for unpacking and dealing with packing materials. When material protection was still needed, the vendor reworked the packaging to minimize and make it more user-friendly. The large plastic bins were delivered directly to production lines, then returned to vendors for the next shipments. This eliminated sorting and putting materials into and out of inventory areas. Every elimination of a “touch” was an increase in efficiency. However, staging product at the production lines required more space, which had to be considered when the production area was reconfigured.

To further streamline receiving, we worked with our qualified vendors to perform more inspections at their sites before shipment. Usually, inspections are conducted on a percentage of received parts. But if a vendor produces multiple shipments worth of product in a single batch, then it is more efficient to inspect at the batch level then at the shipment level. This required us to place more trust in our qualified vendors, but the foundation of that trust was in place prior to the pandemic and based on long-term partnerships.

Before the pandemic, we investigated, developed, and qualified more domestic machine shops for sourced-out work to further reduce dependence on global sources, particularly Europe. If we hadn’t completed this work just prior to the pandemic, we would have been in a more challenging position.

We use a Kanban system, but with consistent, high-volume production, it was adjusted to further streamline inventory. Floor space was at a premium, so we couldn’t pull in weeks of inventory as with a traditional safety stock method. We had vendors shift to shipping consistent amounts per week, more in line with a just-in-time process supported by Kanban.

We made several adjustments to increase efficiency and out-the-door speed for post-production shipping. Traditionally we boxed each pump manually with foam-in-place packaging created per piece. We quickly transitioned to automation, making the foam-in-place packaging in bulk with an insert tool. We also reduced box and packaging size to increase the number of pumps per pallet, reducing the amount of floor and truck space needed per shipment.

Fritz: We’ve been collaborating with ventilator manufacturers for many years. We had established communication channels and regular forecast conversations; the global pandemic situation threw a wrench into this approach. At first, the manufacturing industry came to a halt, impacting global supply of all types of raw materials and components. Logistics channels were interrupted, and every company had to adjust operations to ensure employee safety.

There was also a sudden increase in demand for critical medical supplies (including ventilators) from established manufacturers and large manufacturing organizations from different supporting industries who were trying to help.

Four things had to be established very quickly: Appropriate qualification and prioritization of requests; a proactive outreach to the customers in need; engaging everyone in global supply chain to get access to the required raw material; and addressing potential manufacturing bottlenecks. We quickly implemented a global cross-functional team of representatives from all departments from sales to manufacturing, procurement, and logistics. This team exclusively focused on requests from customers delivering critical medical equipment. To ensure we could swiftly address all the needed activities, process changes, or investments, the leadership team was closely involved.

Stiffler: We formed a leadership team to organize our response and actions. We organized ourselves around safety, supply chain, management of change, personnel, customers, information technology, and quality. This team met twice a week to share and get status updates on actions and gaps. In this forum, a visual management technique in a war room setting ensured all actions were understood and transparent with clear ownership and due dates. We established helpful principles early on, including prioritization tasks and jobs, investment needs, and preempting response to supplier actions.

This structure, cadence, and process enabled us to complete the largest and fastest ramp in output we have ever experienced. From March to August, we increased capacity by as much as five times for the highest demand product families. We added 15 new manufacturing lines—including automated cells, increased operations to four-shift rotations over seven days and increased our production team by 400 percent to achieve unprecedented capacity expansion.

We were therefore able to ship products to 38 locations across the globe from Spain to China to Brazil and the U.S. Each ventilator design utilizes a unique component set, but we estimate having shipped sufficient components to build about 500,000 ventilators from March through October.

Brusco: What lessons were learned during the pandemic that you will apply to current/future operations?

Alcamo: Responding to the pandemic’s extreme requirements necessitated rethinking every aspect of how we do business: production and logistics, QC, sourcing, material flow and inventory, personnel, safety—even financing and risk assessment. With consistent high-volume production flow, you can more proactively test and demonstrate Lean manufacturing and other techniques and tools (Kanban, Value Stream Map, Continuous Flow, 5S) to optimize production. Consistent high-production facilitates training, education, demonstration, proving out techniques, tracking, and measuring. We can apply these lessons to other high-volume and some medium-volume products we produce.

A deeper demonstrated understanding of how much to order, the number of touches and time to move it into and around our facility, and consciousness of space and location. We had to make a lot of material flow adjustments, so now we can apply these learnings more broadly. The more vendors and the vendor locations, the more there is to coordinate when the supply chain is stressed. This experience has reinforced the benefits of consolidation and second-qualified sources.

Fritz: The number one factor to avoid component shortages is open communication between all internal and external stakeholders. Exposing your supply chain to the demand on hand is not enough. To allow swift reaction when demands change, keep them in the loop on upside potential and discuss possible scenarios in advance. Assessment and analysis of the different scenarios should be performed by a cross functional team including engineering resources to ensure the devices are designed with a robust supply chain in mind. Evaluate strategies like leveraging off-the-shelf components that share a wider customer base, perhaps from different industries. But even with the best planning, swift action is required if a crisis arises.

Stiffler: We took aggressive measures as quickly as we could. When we learned of our first confirmed COVID-19 case, we shut the plant down and a qualified third party did a full cleaning. Our rapid response helped assure nervous team members their safety was held in the highest priority. Frequent and transparent communication to team members was key, within the bounds of maintaining individual team members’ privacy. As we gained more experience and confidence physical distancing, hygiene, and PPE measures were working, team members could be less nervous.

To respond quickly to demand, we created a twice-weekly leadership cadence wherein each major discipline of such a response was owned, actioned, and reported on by the leadership team. Examples include safety, management of change, customer prioritization, personnel, and so on. Visual management techniques in a war room type setting helped us see where we were making progress. Each leader formed sub-teams and attacked each problem within the discipline, where interdependencies were identified and prioritized. Many of our team members learned the importance of our cadence’s frequency, visual management techniques, and escalation of issues to be solved. It wasn’t perfect, but we continued to the manufacture of over 500,000 ventilators and emerged a stronger, more capable organization.

Wilson: We already using video conferencing daily to communicate and collaborate with global colleagues and customers—we were well positioned to transition fully to virtual meetings. It’s now common to virtually meet a customer with attendees from multiple customer and KNF locations. We can demonstrate a pump, share performance and testing data, whiteboard system configurations, or show how to perform pump maintenance. The advantages of virtual collaboration will bring a blend of virtual and personal cooperation. 

Breathe Freely and Sleep Easy Continuous positive airway pressure therapy (CPAP) uses a machine to help a person with obstructive sleep apnea (OSA) breathe more easily when sleeping. A CPAP machine increases air pressure in the throat so the airway doesn’t collapse when inhaling. It’s used every night when sleeping. A CPAP machine will have one of the following: a mask that covers the nose and mouth; a mask that covers only the nose (called nasal CPAP or NCPAP, this is the most common type of mask), or prongs that fit into the nose. CPAP is the most effective nonsurgical treatment for OSA, and the first treatment choice for adults. To gain more insight on recent CPAP developments and efforts to make wearing them more comfortable, MPO spoke with Philips’ Pamela Hall and ResMed’s Jim Hollingshead. Brusco: What recent CPAP innovations has your company developed? Hall: Launched in July 2020, Philips Mask Selector became the first and only clinically validated, 3D facial scanning solution that helps fit nine of 10 patients with the right mask. Mask Selector personalizes selection and fitting for PAP therapy with a proprietary algorithm and advanced 3D scanning technology to recommend mask options tailored to individual needs, helping improve satisfaction and compliance with PAP therapy through personalized care. This algorithm offers a novel solution in the shift toward healthcare digitization, helping improve business efficiencies by reducing fitting time and mask waste costs. In response to COVID-19, we also introduced a 2D mobile version for home use. The 2D version allows self-scan for remote sizing and shares standard mask recommendations with medical equipment providers to review and fulfill. Last December, we also introduced DreamWear Silicone Pillows to the award-winning DreamWear system of masks. Designed for a variety of facial types using Philips 3D-scanning technology, the all-silicone, minimally invasive nasal pillows conform to various nostril shapes and sizes to provide additional comfort to sleep in any position and move freely during the night. CPAP users often cite discomfort, nostril irritation, and limited range of motion during sleep as reasons for abandoning CPAP therapy. The DreamWear Silicone Pillows address adherence challenges with a customized fit and freedom of movement, reducing trips back to the doctor for refits. We are personalizing care pathways with our Patient Adherence Management Service (PAMS) and DreamMapper patient engagement app. We believe in supporting patients in every aspect of their journey so they can live better lives through better sleep, and helping clinicians streamline care to increase capacity to care for more patients. This is where solutions like Philips Care Orchestrator cloud-based patient management tool—including options like Adherence Profiler—and Home Delivery and Remote Setup come in to play. Hollingshead: On top of making devices smaller, quieter, and more comfortable, our digital health solutions aim to significantly improve a patient’s experience and health outcomes, plus the efficiency of the doctor, the clinician, and the HME caring for that patient. During this pandemic, we’ve debuted ResMed MaskSelector, a digital tool for HMEs to make remote patient mask selection and sizing easier and more effective. We also developed HelloSleep, a free app for patients just diagnosed with sleep apnea, that helps clinicians successfully transition patients onto PAP treatment. Every year, we invest 7-8 percent of our revenue into R&D, which helps us develop solutions that help improve patient experience and adherence, and providers’ interactions with patients. Brusco: How are you responding to patients’ needs for less cumbersome CPAP solutions? Hall: We utilize customer feedback to create data-driven solutions to ease pain points for patients and providers. We have collected and continue to leverage more than 4.7 billion nights of sleep therapy data to help drive our R&D process. Many innovations, such as our DreamWear system of masks, DreamStation, and DreamStation Go solutions personalize obstructive sleep apnea care by minimizing the footprint and volume of sleep therapy. Hollingshead: Our two latest masks reinforce our commitment to making CPAP less cumbersome: AirFit F30i—the first tube-up full face CPAP mask, making it easier to sleep in any position; and AirTouch N20—our softest nasal CPAP mask that uses memory foam. The comfort features of these masks fit well into our mask portfolios. Additionally, with our AirMini CPAP device, we offer a smaller, smart sleep apnea device for compact, portable therapy.