Tobra Medical

Bone Dust Collector

Challenge

Allow surgeons to easily and aseptically capture a clean, quality sample of patients’ bone particulate for allograft.

Approach

At the time of this project, there were only a few similar products on the market. We knew there was a better way for surgeons to capture cleaner and higher-quality samples. Taking into account the inadequacies of current bone dust collection products, we created the Tobra Medical Bone Basket. It is a sterile, single use device that reduces the amount or potential need for costly bone substitutes. The crucial component of this device is the basket itself, which we constructed out of a unique mesh specifically designed and tested to capture bone dust. The basket is removable and can be inverted, maximizing the amount of sample that can be collected and easily removed from the basket. The Bone Basket is easy to set up and connects to flexible tubing for in-line connection so that samples can be collected without interrupting the continuous flow of blood and irrigation fluids. Working with Tobra founders, we took this from a simple concept all the way through to full development with a full detailed design, tool building, and ongoing in-house manufacturing.

Outcome

A small and compact surgical device for in-line collection of bone dust that is easy to set up and assists surgeons in maximizing the collection of autologous bone. The Bone Basket also provides cost savings by reducing the amount of costly bone substitutes, biologics and allografts needed.

Yukon Medical

Safe Preparation and Delivery of Injectable Medications

Challenge

Protect healthcare workers from cytotoxic exposure as they prepare and deliver hazardous drugs while minimizing workflow disruptions.

Approach

We began by interviewing thought leaders (nurses, pharmacists, pharmacy technicians) in the safe handling of hazardous drug space to understand user needs and points of possible drug exposure. These insights from the healthcare practitioners led us to design and develop the Arisure Closed System Transfer Device – a drug access and delivery system with unique advantages. Features of this system include locking vial adapters that won’t accidentally detach and a completely dry, needle-free connection. The Arisure system meshes seamlessly with nursing and pharmacy workflow due to its simple, intuitive design.

Outcome

A complete system that allows clinicians to safely access, transfer and administer drugs while minimizing exposure to toxic chemotherapy agents. This system was nominated as a finalist for the Medical Design Excellence Awards in 2019.

Anutra Medical

Buffered Anesthetic Delivery System

Challenge

Anutra’s founders presented us with a challenge to develop a system that would efficiently and aseptically allow lidocaine to be buffered at point of use. The goal of this system was to speed up the onset of anesthesia and improve patient experience by reducing the pain of injection.

Approach

The key to the success of this delivery system is its ability to utilize off the shelf drugs in their existing primary packaging. This not only increased efficiency when preparing a buffered lidocaine mixture, but it also greatly simplified the original concept of this system, reducing timeline and cost. We designed and developed three products that work together as a system: The Anutra Dispenser, which allows dentists to measure out a precise dose of buffered anesthetic, The Anutra Cassette, designed to precisely mix lidocaine with epinephrine and sodium bicarbonate to effectively buffer local anesthetics, and The Anutra Syringe, offering multiple dose delivery and providing haptic feedback to tell the user how much volume has been delivered.

Outcome

A full buffered anesthetic delivery system that utilizes off the shelf multidose containers to aseptically and efficiently to allow a dentist to prepare a mixture of buffered lidocaine.

Medical Technologies of Georgia

Closed System Urinary Catheters

Challenge

Faced with global competition due to their original flagship product coming off-patent, Medical Technologies of Georgia (MTG) wanted to develop a novel product to address deficiencies that current intermittent urinary catheter products had. They set out to make self-catheterization of the bladder possible for anyone, including tetraplegic users with very limited hand dexterity.

Approach

Self-catheterization is difficult. Our first step was to identify which factors we could change to make this process easier, and then design and develop a device system that could meet these criteria. We also recognized that the urinary catheter market is cost-sensitive, and so we formulated concepts, prototyped various versions, and selected those that worked best while remaining inexpensive to implement. Some of the biggest challenges we sought to address with catheterization products were retraction of the catheter tube during insertion, difficulty gripping the small tube inside of the drainage bag, and the discrete use and disposal of the product. Addressing these issues led to the creation of several key product features: the MTG EZ-Advancer, the MTG EZ-Gripper, and the MTG Mini-Pak. The patented EZ-Advancer valve secures the catheter tube after each forward advancement, preventing the tube from retracting during insertion. The EZ-Gripper is a patented gripper handle outside of the bag that allows for easy tube advancement. Finally, each of these features were included and provided in sterile packaging that was half the size of the previous product for some models.

Outcome

Created the MTG EZ-Gripper and MTG EZ-Advancer to provide individuals with an easier and more discrete means to self-catheterize, even if they have limited hand dexterity.

Ophthalmic Drug Delivery System

Challenge

Create an ophthalmic drug delivery device that allows patients to self-administer eye drops while keeping the head upright.

Approach

Many patients, especially elderly patients, have a hard time administering eye drops correctly for a number of reasons. This patient population often has limited hand dexterity and limited head tilt.  In collaboration with a major NC University eye research center, we sought to solve this problem. This led to the creation of the upright eye dropper dispenser. A bottle container is placed upside down into the device and a mechanism pierces the bottle, pulling medication into a small chamber. A closed system with hydrophobic filtration prevents any bacteria from entering. Pulling the trigger releases pressure, squirting out a stream of medication into the eye. The device measures proper dosage, with one pre-measured dose being released per “click” and reduces the chance of tip contamination.

Outcome

An upright eye dropper dispenser that has the ability to assist patients with eye drop placement, improving the experience with drop instillation and increasing compliance.

Myocardial Solutions

Phantom Heart Pump

Challenge

Absolutely no ferromagnetic materials can be present in the MRI field. We needed to design and develop a custom, automated phantom heart pump for MRI application utilizing alternative materials without metal to be used in the MRI suite. The pump also had to be easy to use and integrate seamlessly with MyoStrain, the diagnostic software developed by Myocardial Solutions.

Approach

Some of our best engineers with varying areas of expertise teamed up to tackle this electromechanical challenge. Not being able to use ferromagnetic materials meant that we could not use off-the-shelf pistons or actuators, as those contain metal.  We elected to use silicone as our primary material to create a functioning phantom heart with a 100% polymer-based pump and a remote pneumatic system for driving the pump.  The pump compresses a block of silicone to very precise measurements to mimic a patient’s heartbeat with varying strain. The automated phantom heart outputs an EKG signal to trigger the ultrasound echocardiogram and MRI Scanner, allowing the MyoStrain software to validate the specific MRI pulse sequence.

Outcome

A dynamic phantom heart for MRI use that is fully automated, free of ferromagnetic materials and has a programmable heart rate of between 60 and 100 beats per minute. The Myocardial Solutions Phantom is compatible with MyoStrain software, a rapid non-invasive cardiac function test without breath hold or contrast.

Salter Labs

Capnography Mask

Challenge

Frustrated with current capnography techniques, anesthesiologist JW Beard, MD knew there had to be a better way to monitor CO2 output while oxygenating a patient. He approached Gilero with the idea to design an oxygen mask with a port to monitor CO2.

Approach

The initial mask we designed was exactly what the customer asked for: an oxygen mask with PVC Luers molded into it. Before settling on a mask made up of one large molded PVC piece, Gilero engineers brainstormed other solutions and decided to try adding a Luer to a standard O2 mask. Our engineers prototyped a mask that looked and functioned like a standard O2 mask with the addition of two ports on either side. This idea evolved into the final multipiece design with two twist lock Luers bonded into an oxygen mask that could be hooked up to monitors for capnography. Luers on both sides of the mask provided two points of access so that monitor tubing could be connected on whichever side was more comfortable for the patient. Aside from designing and developing the product, our team had to complete a great deal of testing in order to demonstrate the efficacy of this device to monitor CO2 levels. We built a breathing simulator that simulated human breath by CO2 expiration, supplying us with a normal CO2 profile that we control and test. We were able to prove through our testing that the device’s ability to measure CO2 and deliver O2 was equivalent to current methods on the market while being easier to use. We also executed ISO 594-2 Luer testing, force testing, clip retention testing, accelerated aging and real time aging.

Outcome

The CapnoVue M1, a capnography face mask that incorporates CO2 sampling ports into an oxygen delivery mask and can be used on adult, pediatric and infant patients. Dr. Beard’s company, Monitor Mask, was ultimately acquired by Salter Labs.

Cypris Medical

Minimally Invasive Surgical Suturing Device

Challenge

When Cypris Medical first approached us, the initial design and development for their minimally invasive surgical suturing tool was almost complete. The product design had a few problem areas that needed to be resolved in order to finish the design and development and get this device ready for market. The small size made it difficult to create a reliable suture mechanism that could perform all the necessary functions. The biggest concerns our team needed to address were device jamming, inadequate tissue capture and needle compatibility.

Approach

Our team of engineers worked to improve the design and functionality of this device in a few key areas. The internal suture mechanism was redesigned to be smaller, more reliable, reproducible and cost effective. Externally, we redesigned the wand portion of the device to make it more functional. The original wand design contained a slot at its distal end to capture and hold tissue. This slot design made it difficult for a patient’s tissue to adequately fill the space prior to passing a needle through. Our design engineers reconstructed the end of the wand with a more open design so that the tool could grab onto a larger amount of tissue and have a more secure hold.  This enhanced design provides a more ergonomic shape for the tissue to sit in, making it easier to use and leading to higher rates of success than with the original slot design. Our team also developed a small, custom needle to address compatibility issues and minimize trauma at the surgical site.  In addition to the design and development work, we supported Cypris throughout the regulatory process by generating DHFs, assisting with quality documentation and executing a regulatory assessment.  We also manufactured products for clinical builds and generated prototypes for tradeshows. Throughout our work on this project, design for manufacturability was kept top-of-mind to ensure a seamless transition to manufacturing.

Outcome

Gilero’s design and development process improved the form and function of this device, leading to the Xact surgical suturing device that is on the market today. Xact is a hand-held device used to approximate and pass suture through soft tissue.

Otsuka Pharmaceutical

Topical Applicator for Antiseptic

Challenge

Design and develop a novel, easy-to-use topical applicator for antiseptic. It was a requirement that the antiseptic container could be filled aseptically, and glass could not be used as a container material.

Approach

Otsuka Pharmaceutical wanted to launch the first topical applicator in Japan for the antiseptic they had developed. In the Japanese market, a product such as this could not have a glass container. Not only was our team tasked with sourcing an alternative container material, but we also had to ensure the container we chose could be aseptically filled.  Our team developed a foam that would have specific delivery characteristics while being fully compatible with the antiseptic. This foam performance allows the antiseptic to come out as a foam onto a foam applicator which is then rubbed onto the skin. The device we created was able to be actuated with one step, came in a glass-free container and withstood the low threshold for ethylene oxide and ethylene glycol residuals. In addition to designing and developing this device, we also built tooling and validated processes for the manufacturing and assembly of these devices. Towards the end of this project, we helped the Otsuka team navigate the international patent landscape and successfully transferred this device and technology to Japan.

Outcome

The first topical applicator for antiseptic use that could be aseptically filled and came in a glass-free container.