Medical Device Product Development for Critical Care Ultrasound Training with Blue Phantom

COVID-19 is the biggest health crisis of our time. So far, it’s been responsible for hundreds of thousands of deaths, with the number of infections continuing to rise. Finding a way to stem the tide is the top priority for the medical community, and critical care ultrasound training is a vital part of that. Technicians are seeing a surge in demand for these skills, though training programs are limited. That is where the Blue Phantom COVID 19 Ultrasound Lung Simulator comes in.

Blue Phantom’s Jay Kahlon quickly spearheaded a medical device product development project to create a detailed simulator explicitly focused on the illness. Through this unique design, he was able to help many healthcare workers better detect lung issues created from COVID-19 and treat them faster.

Blue Phantom Case Study: Improving Critical Care Ultrasound Training

Medical training is continuously evolving as we learn more about the human body and discover new issues to treat. COVID-19 created an additional need for advanced training, which Jay Hanlon of Blue Phantom recognized when he found an issue with coronavirus testing and care.

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The Problem

While CT scans are considered the gold standard for monitoring COVID-19 progression in the lungs, they’re just not practical in a pandemic. Every single CT of a COVID-19 patient requires two hours of follow up sanitation time, making the machine unavailable for others. When dealing with an urgent setting, this timeframe could result in massive backups.

The alternative is the point of care ultrasound. These systems are easier to clean and move around. They can even be done on smartphones! Unfortunately, they’re not as detailed as CT scans, which represents a challenge for clinicians. Coronavirus patients present sonographic artifacts that can be a challenge to identify by new users.

This issue can only be solved with training, though training options specific to COVID-19 cases were limited. Jay Kahlon realized this hole in the market and quickly developed a tool to help medical professionals better diagnose COVID-19 cases via ultrasound.

The Solution

The development of the Live Lung Ultrasound Training Model was unique because of how imperative it was to get a working model out quickly. This wasn’t merely a matter of beating out the competition – it was about saving lives. The device had to be available fast to provide training for those on the front lines of the pandemic. Through intelligent planning and thorough design, PRL was able to make his concept a reality in under a month.

March 17 – Jay has his first brainstorming session with PRL, which includes going over materials, market needs, and specific requirements. Possible production methods that would represent the highest quality product in the shortest period are thoroughly vetted, and a plan created.
March 18 – PRL moves forward with 75 different experiments designed to simulate artifacts in COVID-19 patients, to include representations of thickening B-lines or “rocket tails” and consolidation of lesions or pneumonia. Those experiments lead to the creation of molds for the model.
March 27 – The first visual prototype is developed, evaluated, and updated.
April 1 – The first functioning unit is delivered, and Jay demonstrates it to doctors in the US, UK, and Australia. Interest is immediate, with one of the most prominent doctors in the US reporting, “this is amazing how close it images like a real patient.”

The Results

Since the delivery of the first unit on April 1, twenty-three additional units were shipped and distribution arrangements made. Through this, Blue Phantom expanded the knowledge needed for ultrasound testing of COVID-19 patients quickly and effectively.

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Tools for Rapid Medical Device Product Development

One thing Jay came to the table with that gave him a distinct advantage was his extensive experience working in medical product development. As he’d created similar models in the past, he was able to fully understand what needed to go into the one designed for COVID-19. That allowed him to move quickly into the prototyping phase, where he was able to take advantage of several high-speed processes including:

Rapid prototyping: Using 3D printing, CNC machining, and mold making and casting is an excellent option for speeding the development of a prototype. These quick prototypes allow creators to test and refine their designs over and over again until they have the perfect product.

Rapid tooling: Rapid tooling uses many of the same processes as rapid prototyping, but in this case, the creator develops the tools they need for manufacturing in a fraction of the time when compared to traditional methods.

Contract manufacturing: Usually, it would take months or even years to source all the machinery needed to establish a manufacturing process. Aside from that, the creator would also have to hire skilled labor to operate these machines. Contract manufacturing allows a creator to leverage someone else’s manufacturing floor and their labor to create their products on a mass scale. This is especially important in medical product manufacturing, as the products require highly exacting specifications.

When time is of the essence, rapid prototyping and tooling can help creators develop their products quickly, while contract manufacturing speeds it to market. In the development of the Live Lung Ultrasound Training Model, such processes were imperative to ensure the device could get in the hands of those who needed it quickly. Moreover, security and discretion during the manufacturing process were necessary, as this was a proprietary project. By working with an experienced partner, Jay Kahlon was able to expedite medical device product development and provide a tool necessary to respond to a worldwide pandemic.

Optimize Your Medical Device Product Development

Pacific Research Laboratories provides medical device product development and manufacturing for creators in the industry who want to respond to real-world problems rapidly. Visit our contact page or call (206) 408-7603 for more information.