Medical Device Manufacturing

LeMaitre Vascular

Protecting Vulnerable Transplant Tissue from Temperature Excursion Threats

How Sonicu temperature monitoring supports life-saving tissue transplants 

Kris Demczyszyn helps people live longer and healthier lives in ways that were unimaginable decades ago. 

He’s in charge of storing and protecting donated tissues bound for transplant to patients in dire need. 

He’s a hero to vulnerable patients for whom the transplanted tissues represent a second lease on life. 

But he’s faced several obstacles in delivering this remarkable service. 

Losing his organization’s tissues to temperature excursion is no longer among those obstacles thanks to his recent investment in a remote, wireless temperature monitoring system from Sonicu. 

His firm, Massachusettes-based LeMaitre, turned to Sonicu when they sought a trusted and reliable technology provider that could deliver cryogenic temperature monitoring at various sites across the country, all accessible in a single dashboard. 

“This is mission critical to how we serve our clients and how the hospitals and doctors maintain trust in us to deliver these delicate services,” he said. 

“Having a product like Sonicu that we trust and the support team behind it is one less item I have to think about every day.” 

He’s one of thousands who rely on Sonicu’s simple and affordable cryo and ultra-low temperature monitoring to support their critical work, including some of the most respected public and private university research departments, as well as scores of private labs on the vanguard of biomedical research. 

The Initial Challenge: Beyond the Cryo Freezer 

Lemaitre needed reliable monitoring for tissue preservation, given the high storage requirements: a minimum of -100°C for up to five years. 

“The reliability and trustworthiness of the monitoring solution had to be well established and verifiable,” he said. 

Initially, they tried different brands of cryogenic freezers that included an organic monitoring solution and realized that compatibility and service accessibility were crucial. 

They sought a monitoring solution that didn’t rely on hospital infrastructure, which led them to Sonicu. 

“We wanted to be confident that we could scale a solution across different sites that would not be limited by different IT infrastructure or challenges at different locations,” he said. 

“This may sound straightforward, but it was a challenge to find a solution that could meet that important criteria.”

The Sonicu system was able to be installed anywhere we have our cryo freezers with confidence that local IT would not be an obstacle.” 

Sonicu offers a diverse slate of connectivity options for every monitoring application, from the conventional Wi-Fi and cellular options to a more unique and ultimately scalable solution known as SoniLink, which leverages the LoRaWAN network to communicate between sensors and a central hub over long distances with low power consumption.

The Tissue Industry: Essential and Growing to Serve More Patients 

Donated tissues play a crucial role in healthcare by providing life-enhancing or life-saving treatments to patients. 

A few examples of tissue donation in the healthcare industry include:

Orthopedic and Sports Medicine

• Bone Grafts
• Tendon and Ligament Repairs

Burn Treatment

• Skin Grafts

Ophthalmology

• Corneal Transplants

Cardiovascular Procedures

• Heart Valves
• Blood Vessels

Reconstructive Surgeries

• Soft Tissue Repair

Dental and Oral Surgeries

• Bone Grafts for Dental Implants

Research and Medical Training

The benefits to patients are significant, often extending life and healthspan, including: 

• Improved Quality of Life 
• Reduced Mortality Risk
• Accelerated Recovery

By utilizing donated tissues, healthcare providers significantly enhance their ability to treat complex conditions and improve patient outcomes.

Sonicu's Advantage: Integrated Hardware and Software 

Sonicu stood out because it combined hardware and software into a single unit, eliminating the need for multiple subscriptions and reducing equipment costs and technical issues. 

“We found systems in Canada that required an external relationship with a communicating hub that involved a whole separate data subscription,” he explained. 

“That’s just one more subscription to manage and another item to track, so it was a major benefit to have Sonicu be able to bundle the entire system.” 

Sonicu’s integrated system allowed Lemaitre to monitor storage units remotely without involving hospital systems. 

As he learned about the software and communications options, Demczyszyn was convinced Sonicu was the ideal wireless temperature monitoring solution for his sensitive cryogenic freezers storing life-extending tissues. 

“Having the flexibility of different communication systems was another important characteristic for us when selecting Sonicu,” he said. “The software was easy to use, and the connectivity was not going to be an issue, these were highly valuable features for our team.”

Compliance and Reporting 

For Lemaitre, Sonicu wasn’t just about monitoring for asset protection with tailored alerts — it was about ensuring compliance. 

The system provided accurate temperature data that hospitals could incorporate into their logs, reducing risk and liability for Lemaitre. 

Sonicu has developed a deep understanding of the compliance requirements across virtually every regulatory body enforcing temperature and environmental standards in healthcare and life science, translating that knowledge into automated reports for organizations like Lemaitre. 

Whether its highly specific requirements for 21 CFR Part 11 for life science organizations, that include personnel traceability or more conventional temperature logs for a school cafeteria to share with the county board of health, Sonicu helps thousands of compliance professionals streamline what was once a tedious and error-fraught process. 

“Protecting valuable assets such as cryogenically stored tissue is mission critical to many of our clients. Sonicu has a battle-hardened, industry-leading alerting system tailored to clients like Lematire. This combined with our automated compliance software, helps our customers prevent loss, save significant staff time, and reduce the stress associated with annual regulatory audits,” said Joe Mundell, Chief Revenue Officer at Sonicu.

“When you combine both of these features with the time saved by staff not logging temps or compiling reports, Sonicu delivers tremendous value with an enduring return on investment.”

On-the-Go Monitoring and Quick Response 

Demczysyn frequently uses the Sonicu mobile app, allowing him and his sales reps to showcase real-time data to hospitals. 

This visibility reassures hospitals, showing the level of care Lemaitre places on maintaining the integrity of donated tissue. 

“The mobile app is so simple and pulls it all together so nicely,” he said. 

“I love knowing that critical information is on my phone and I can respond with so much real-time knowledge should we have a temperature excursion.” 

The SoniCloud mobile app is far more than just a portal to a client’s monitoring system. It also features an intuitive installation wizard as well as diagnostic and network testing capabilities that make it an invaluable facet of a client’s monitoring system.

Scaling the Solution: With Reliable Customer Support 

Lemaitre has recently doubled their client base in a short time span by providing a reliable and straightforward storage solution. 

He now oversees a growing network across North America and plans to expand even further. 

He said Sonicu’s quick shipping and reliable performance provide him and his larger team confidence that they can effectively scale their freezer infrastructure 

Demczysyn said the support staff has helped him quickly and professionally when they’ve encountered the occasional technical hiccup. 

“You learn not to take reliable customer support for granted,” he said. “That’s been impressive and affirms our decision to go with Sonicu.” 

Mundell said Sonicu’s continued investment in a highly skilled support team has been crucial in maintaining strong customer loyalty and satisfaction.

“We’ve built a team of technical experts here in Indiana who are available every day to train, support, and serve our growing customer base. We know that the value of our solution extends beyond the sensors and software,” he said.

“Our customers rely on being able to reach a real person quickly and providing free, unlimited training for their teams is a key part of that support. This investment in people and data infrastructure helps keep clients like LeMaitre confident in their monitoring systems.”

About LeMaitre

The company began when George D. LeMaitre, MD, a vascular surgeon, wasn’t satisfied with the options that were available to him. He sought to develop a better way to treat lower extremity arterial disease in his patients. 

Working with an engineer, he designed a valvulotome that could be used to cut valves in peripheral veins without the burdensome requirement of direct vision.

Pleased with the performance of his valvulotome, Dr. LeMaitre founded the company in 1983 to serve more surgeons. Today LeMaitre sells directly to hospitals in 29 countries and through distributors in more than 65 countries.