Gilero’s response to COVID-19: Now Providing Face Shields
Gilero works with some of the most trusted brands in the world to create innovative medical & drug delivery device solutions. Below is a small sampling of our work. Whether we are developing a single-use prefilled syringe, multiuse inhaler, or complex electromechanical pump system, our team is able to accelerate project timelines from concept to commercialization. If you don’t see what you are looking for, please contact us to learn more about the types of devices we work on.
Gilero was approached by an interventional radiologist with an idea to create a sterile skin anesthetic spray that could reduce the pain associated with needle procedures. A number of skin anesthetic sprays were already on the market, but none had achieved sterility of both the container and the liquid inside. Gilero was tasked with designing and developing a sterile, single patient use vapocoolant spray.
The design and development of this device started from a simple concept. Gilero engineers developed this concept with consideration of both technical and end-user requirements in mind. Since this device had applications for pediatrics, we wanted to find a way to make the product look more visually appealing than the average medical device. After several early prototype iterations to address functionality and aesthetics, a polar bear canister design was selected. There were a few challenges with the device that the product development team had to address, the most complex of which was sterilization. The vapocoolant fluid is housed inside of a metal canister, which meant that Gilero engineers needed to figure out if common medical device sterilization methods would be powerful enough to penetrate through the can and sterilize the fluid. This took a lot of trial and error with several different sterilizers, and we had to develop a custom test method to prove whether or not the sterilization was effective. Gilero executed other types of testing for the product as well, including developing a safe and ethical test method to measure temperature on synthetic human skin. Gilero designed product labeling and packaging, authored regulatory submissions, completed a design verification and validation (DV&V) build, and successfully transferred the design to manufacturing. The product, nüm, is now being manufactured by Gilero in our Pittsboro, NC facility.
Gilero successfully took this idea from a simple concept all the way through commercialization. Nüm works instantly to numb the skin, resulting in a reduction of pain associated with needlesticks, and the polar bear design is a welcome distraction for younger patients. Nüm is the only sterile, single patient use topical skin anesthetic on the market today.
Protect healthcare workers from cytotoxic exposure as they prepare and deliver hazardous drugs while minimizing workflow disruptions.
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.
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.
Allow surgeons to easily and aseptically capture a clean, quality sample of patients’ bone particulate for allograft.
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.
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.
Pulmonary Arterial Hypertension (PAH) is a rare, life threatening disease that has no known cure and few treatment options. Historically, physicians have had a difficult time diagnosing and treating PAH patients, and they’ve struggled with finding reliable tools for characterizing the extent of disease. As part of their work to provide tools and resources to help physicians manage PAH in patients, biotech company United Therapeutics created paper worksheets for physicians to facilitate the PAH risk assessment process. While these worksheets have proved to be an invaluable tool, there are drawbacks, including the need for physicians to carry a physical copy of the worksheet with them, and reliance of physicians to do math on the spot. Gilero was asked to help United Therapeutics turn these paper worksheets into online automated calculator tools that physicians could easily access and use.
A few constraints dictated the boundaries of our development.
1. Calculator web pages needed to integrate with the corporate website. This required us to collaborate with the client’s website vendor to ensure a seamless user interface and consistent user experience, as well as the client’s IT department for hosting and deployment logistics.
2. There must be a consistent look and feel between the electronic calculators and the paper worksheets so that physician experiences would be the same no matter which tool they used. This included mirroring existing design elements, placement of selection options, and rules for generating results.
3. Physicians needed to be able to access and use these calculator webpages on a desktop, tablet, or mobile device, without creating a true mobile app. This required two webpages to be developed for each calculator where the device selects the appropriate page to load.
4. To protect patient privacy, no data or results from the calculators could be stored. Once the calculation was complete, the data had to be cleared.
5. Physicians needed the ability to print results in a format that resembled the paper worksheet.
To meet these needs, the Gilero team deployed a reactive design methodology enabling each calculator to fit on a variety of devices and screen aspect ratios. We used a combination of HTML, CSS, and JavaScript to build and implement these calculators. JavaScript was used to create a novel PDF print function, allowing calculator results to be saved or printed in a format that resembles the original paper worksheets.
In just a few short months, Gilero’s team of software and product development engineers turned the paper-based calculation worksheets into electronic versions, delivering four web-based PAH risk calculators that are accessible from the PAHI health care provider website. Each calculator represents one of four different methodologies for calculating risk status in patients with PAH – REVEAL 2.0, REVEAL Lite 2, ESC/ERS Guidelines, and Non-Invasive French in two form factors – one optimized for a computer and one for a mobile device. A physician can simply click to select the calculator of interest and is immediately presented with a user-friendly interface for selecting the parameter values associated with patient test results. The tool does the math in real time, and when the physician is done entering the data, the risk status is presented. The electronic worksheet can then be printed or saved as a PDF and added to the patient’s medical record.
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.
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.
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.
Vascugenix first approached us in the beginning of the COVID-19 pandemic with their nearly completed Speed-Torque device, a medical device used to improve guidewire manipulation in interventional cardiovascular procedures. Vascugenix had several single-cavity tools which they had used to create prototypes, but little else to scale up manufacturing. They were looking to finalize development and get Speed-Torque released in the market, and came to Gilero for their regulatory, testing, and manufacturing needs. This project was further complicated by the broken supply chain across globe and difficulty bringing new products to market during the global pandemic.
Despite all of the obstacles caused by the pandemic, Gilero’s quality and engineering teams worked to push this device through all sterilization, biocompatibility, and mechanical testing needed to gain FDA regulatory clearance. In parallel, we took the initial single cavity tools that Vascugenix had used for prototypes and designed higher cavity tools in order to scale up production. Using these tools, we mass produced the Speed-Torque device at our injection molding facility in Shenzhen, China. Following approval from the FDA, Gilero successfully transferred this design to manufacturing. Vascugenix chose to move forward with Gilero as their manufacturing partner as well, and we are now manufacturing the Speed-Torque device utilizing our high cavitation mold tooling capabilities.
In a relatively short period of time, Gilero helped Vascugenix to finalize development and commercialize the Speed-Torque, getting it released in the US market despite the constraints of the pandemic.
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.
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.
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.
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.
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.
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.
After arterial access procedures, consistent pressure must be applied to the access site in order to stop bleeding. Existing products on the market restricted blood flow to the area, successfully creating hemostasis, but did not allow the artery to continue flowing.
Working closely with the founder of Forge Medical, an interventional radiologist, our objective was to design a device that would apply hands-free, constant pressure to stop bleeding at an arterial access site. It was also important that the device let clinicians maintain visibility of the puncture site to monitor bleeding. To apply pressure, we designed a plunger mechanism with ratchet arms. When the plunger is pushed down, it applies pressure to the area below. The ratchet arms keep the plunger in place as constant pressure is applied. Adhesive pads and a foam band were added on either side of the compression component so that the device would stick securely on a patient’s skin. Clear plastic materials were selected for most of the device components to increase visibility. A clinician can check on the puncture site by adjusting the ratchet arms to release pressure and can easily resume applying pressure by pushing the plunger mechanism down again, all while the device remains securely attached to the patient. This design also allowed the artery to continue flowing, preventing numbness in the hand as radial pressure is applied. The device is easy to release so that a patient can go home with the device in place and remove it later. In addition to product design, Gilero provided regulatory consulting, helped to build the Design History File and produced the first round of devices using prototype injection mold tools.
Gilero designed & developed VasoStat, a hemostasis device that applies consistent pressure to stop bleeding after arterial access and is less costly and less complex than competitor devices on the market.
Create an ophthalmic drug delivery device that allows patients to self-administer eye drops while keeping the head upright.
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.
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.
Medication dosing errors are not uncommon in neonatal and early pediatric patients. Current methods for measuring drug volume within a syringe are susceptible to both human and equipment error. When administering very small amounts of a drug, as is common for neonatal and pediatric patients, it becomes increasingly difficult to get an accurate measurement. Dr. Eckel of Assure Technologies wanted to create a solution that would provide a more accurate and precise measurement of drug volume and improve patient safety by reducing medication errors.
Gilero was tasked with developing a syringe accessory that could use standard syringes and measure the exchange of drug volume in and out of the syringe. Before starting concept development, we researched the workflow of pharmacists and clinicians when preparing or administering a medication. Understanding current workflows and benchmarking similarities helped us to determine how a connected syringe accessory might fit into a hospital or pharmacy setting and be adopted by users. We then researched possible technologies based on cost, form factor, power consumption and scalability. Based on that research, our engineers chose the most appropriate technology to develop engineering models, electrical engineering documentation, firmware, and then a prototype. Our team was able to design, develop and build prototypes to demonstrate the capabilities of this connected medical device. Product development is in progress.
Precynge, as the device is called, can precisely measure small volumes of a drug without relying upon gravimetric or manual measurement. The final iteration of Precynge will be handheld and rechargeable with an easy-to-read display and many other connected features that will streamline workflows and reduce medication errors.
Faced with a global shortage of PPE due to COVID-19, Gilero recognized an opportunity to use our medical device design expertise and manufacturing capacity to help combat these shortages.
Gilero engineers quickly got to work designing several different PPE options. Ultimately, working with a tight turnaround time, we decided to focus on the design & development of a face shield that could be manufactured locally at our Pittsboro, NC facility. With the use of face shields and other PPE increasing, we knew our design had to meet more needs than traditional face shields on the market. We designed a contoured shield to provide full face and ear coverage and with enough space between the shield and the face for masks and eyewear, including N95 masks and surgical loupes, to be worn underneath. Materials were selected with comfort and durability in mind so that the face shield could withstand all-day use. Rapid prototyping capabilities allowed us to test and modify the design until it was just right. By designing & developing in-house, we were able to streamline the process and ensure that the face shield was designed for manufacturability. Once the design was finalized, Gilero kicked off tooling immediately, building molds for the face shield frame and dies for tubing, foam and shield. We then partnered with a local injection molder to produce the molded face shield components and shields. Resources at our Pittsboro manufacturing facility were reallocated to focus on assembling, packaging and shipping high volumes of face shields. From concept to commercialization, this entire process took us less than six weeks.
Gilero designed, developed and manufactured a face shield that provides full face and ear protection from liquid splashes and sprays. Two months after initial concept development, Gilero face shields were being produced at a rate of 80,000 parts per week.
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.
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.
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.
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.
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.
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.
Create an added layer of protection for healthcare workers to reduce the risk of infectious aerosol exposure. Due to increased demand for safety solutions brought on by the COVID-19 pandemic, this device needed to be designed as quickly as possible and developed in a way that would allow it to be mass produced.
The initial design for the device, created by SCONE Medical Solutions with clinical support from Mayo Clinic, involved a polycarbonate, reusable box that would have to be sanitized in between each use. The Self-Contained Negative Pressure Environment (SCONE) device utilized existing hospital suction lines and HEPA filtration to create a small capacity self-contained negative pressure environment. Gilero was tasked with simplifying this design for manufacturability while keeping the technology intact. We were able to redesign the SCONE device to be disposable, affordable, and easy to use. The redesigned device can now be deployed quickly and easily in healthcare settings when triaging potentially infectious patients, during aerosol generating procedures, and while transporting a patient throughout the facility. In addition to completing the design and development of this device, Gilero assisted with patent applications, provided prototypes, sourced materials, and successfully transferred the design to manufacturing. After taking this device from concept to commercialization in just four months, Gilero began assembling, packaging and shipping the SCONE devices from our U.S. manufacturing facility.
An “active” barrier protection device that helps control the risk of infectious disease transmission in healthcare facilities.
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.
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.
The first topical applicator for antiseptic use that could be aseptically filled and came in a glass-free container.
