Medical

The hardware centered at the core of Paradigm️’s platform is Prism™, an array of image sensors, 3D scanning equipment, and video cameras held by a robotic arm positioned above the sterile field in an operating room. The robotic arm extends from a medical cart containing the computer, driver, power,

and interface components powering Proprio’s Adaptive Registration. An integrated workstation table and display provide pre-operative and intraoperative utility, while standalone monitors assist surgeons with critical 3D imagery mapped in real-time to the patient’s anatomy.

The Proprio Paradigm system exemplifies a vision for improving people’s lives through better medical technology. It belongs in a surgical ecosystem designed for the best assistance to surgeons, OR staff,

and hospitals. With Proprio’s proprietary technology and their team of trailblazers, we’re excited to see a future of continued innovation.

Seno Medical enlisted Tactile to help with the industrial design and mechanical engineering of their next-generation medical device, Imagio®, which uses their Opto-Acoustic imaging to diagnose breast cancer and in many cases, without a biopsy.

Like many of our clients, Seno Medical has a fully operational engineering department. However, we offer engineering specialty skills that complement any organization interested in bringing new products to life.

Imagio® is a complex medical cart weighing over 400 pounds. Tactile built an articulating armature that’s capable of holding the weight of the user-interface console, positioning the display and user-controls close to the bedside as well as capable of moving the whole cart when locked into position. We explored many options and finalized on a four-bar linkage design with gas-assist for raising the user interface

console. Additionally, low-friction slew bearings were used to allow for two points of rotation both at the cart interface and at the console interface. The armature is locked into position when inactive and electromechanical silinoids are utilized for unlocking the armature in short intervals to move the arm into the desired position.

A simple and intuitive foot-activated locking mechanism was built for the two front wheels of the cart. This is complicated by the position and wheels out away from the cart. We designed a mechanism,

which mounts to a flat plate for rigidity and takes up very little space while also making the foot-activated lock serviceable in the field.

Due to Imagio®’s size, the unit needed to be reliable and easily serviceable on-location by trained technicians. We developed a drawer system for the most frequently serviced internal components. The service technician can remove a few discrete screws on the device along with three body panels, offering direct access to cabling and any diagnostic connections. The compact drawer system allows all the components to be tightly packaged during use

but easily exposed during service. The drawer holds the weight of the heavy components during service and within their cord length so technicians don’t have the burden of lifting heavy loads, balancing components on small surfaces, or disconnecting circuits. This limits the drop risk for components, allowing for quicker re-assembly and permits diagnostic testing with the device in a partially assembled state.

The final deliverable was a functional POC prototype of the entire system, engineering validation unit, design files, and engineering specifications for many of the custom components of the system. We provided design and engineering specification documents that equip Seno Medical engineering to

bring the device to market. We take pride in being able to work alongside companies at any design stage they’re in to support their efforts toward definition, development, and realization of a new product.

ASSURE WCD needs to be comfortable enough for patients to wear, around-the-clock, for 1-3 months. The design team constructed a garment using breathable, lightweight fabric designed to move as the patient moves. The electrocardiogram (ECG) sensors are cushioned and embedded to maximize

comfort and signal quality. From the beginning, the design team set out to solve the challenge of a wearable defibrillator in a mobile environment (walking, exercising, driving, etc.) to reduce false alarms and improve arrhythmia detection accuracy.

Many elements of the ASSURE WCD system design are intended to dramatically reduce the noise caused by motion artifacts. The SensorFit™ Garments are designed with cushioned, integrated sensors to keep the sensors snug against the skin. The sensor surfaces consist of high-quality silver, an exceptional conductor for electrical signals; they are “resistive” electrodes–smaller, thinner sensors with improved ECG quality. The ECG cables are custom-designed

with double-shielding specifically to reduce noise. Quad Channel Processing™ utilizes four channels of high-quality ECG to determine the patient’s heart rate and rhythm. The ASSURE Detection Algorithm includes an ECG filtering technique called Adaptive Patient Intelligence™, a proprietary technology that adapts to the patient’s heart rhythm to filter out artifacts caused by patient motion.

The ASSURE WCD system is an FDA-approved medical device used to continuously monitor patient heart rhythms that can provide automatic detection and defibrillation for ventricular arrhythmias. It uses integrated sensors, a cardiac rhythm monitor, and an automated external defibrillator, delivering a defibrillation shock to restore the heart’s normal rhythm when needed. Additionally, the ASSURE WCD system interfaces with a mobile patient application

and remote patient data platform for clinician review. The ASSURE WCD system monitors the patient’s heart rate for dangerous heart rhythms. If the system automatically detects a fast, ineffective heartbeat (ventricular fibrillation), or if the system detects the heart’s lower chambers (ventricles) are beating too quickly (ventricular tachycardia), a shock is automatically delivered to restore normal heart rhythm.

The ASSURE WCD system assures patients will be protected during their recovery after a cardiac event through improved comfort, reduced false alarms, and constant connection to their healthcare team. The ASSURE WCD is available in two different garment

styles in multiple sizes, ensuring a comfortable fit for most patients. To learn more about the ASSURE Wearable Cardioverter Defibrillator system, visit Kestra Medical.

By minimizing buttons and knobs, Tactile focused on the main goal: to improve sleep without the disruption of multiple and confusing controls. A simple and intuitive dead-front display clearly communicates information only when activating the knob, avoiding a constant glowing display that could disrupt sleep.

An optional GentleWake™ setting stops the device from cooling a half hour before wake-up time, enabling a gradual entry into the morning.

Universal Design Language

With Thermage as the introductory product for Solta’s UDL, Tactile addressed the following design challenges:

After conducting extensive medical cart/console research and concept development to understand the competitive landscape and users’ needs, the design team worked with Solta’s engineers for

production feasibility and refinement. Thermage FLX’s modernized and timeless design features became a precedent for Solta’s future products.

Designing medical devices has become more than an interest for us—it’s a passion. Tactile’s main challenge was to redesign the original Ekosonic Endovascular system to minimize the overall product footprint while adding functionality to treat two pulmonary arteries simultaneously. The team minimized the control unit complexity from an ID and UX perspective to streamline the overall set-up procedure and help monitor the treatment.

Currently the only FDA-approved device to treat PE on the market, the EKOS Control Unit 4.0 allows physicians to easily monitor and independently manage two EKOS devices simultaneously, simplifying bilateral PE treatment. The EKOS Control Unit 4.0 provides the power to the EKOS System’s ultrasonic core device that uses acoustic pulses to efficiently and safely dissolve blood clots and restore blood flow in patients with PE.

Reducing
Anxiety

Along with designing the control unit, Tactile developed an intuitive, highly visible user interface that reduces alarm fatigue and brings critical information to the forefront. Several iterations of the interface design proved to be pivotal in understanding how doctors and technicians interact with the interface and the patient’s response to the graphics and visuals.

EKOS wanted to streamline the EKOS Control Unit 4.0 packaging to improve efficiency when identifying the products on shelves. Tactile designed the infusion catheter/ultrasonic core packaging and the console box package.

The newly designed packaging simplifies shelf display for quick, intuitive identification of each product component.

Quality is the hallmark of a great professional tool. From the very beginning, we’re determined to ensure quality is built into the design. Our process is to collaborate early on with manufacturing, applying

the appropriate level of engineering scrutiny at every stage of the design. With fewer changes late in the development process, our clients are able to maintain the design intent while shortening the time to market.

Engineering exploration determines whether a concept is achievable or not. This isn’t optional in our work, it’s our development process. Great products don’t just look great, they feel great. The smooth joint

or a graceful hinge is the small (yet so satisfying) pleasure of our work. We take pride in the craftsmanship that comes from rigorous ME ideation, prototyping, and iteration.

In order to update the way the device is used, we needed to understand the changing landscape of who uses it and the variety of patients. We met with a consulting doctor and reviewed actual use-case scenarios for the technicians who would use the device every day. Through observational research and interviews, we came away with a list of questions and set to work on the solutions. We made significant changes, such as updating the screen from a push button/soft key interface to a touchscreen. Environmental factors always play a big role in the design and use of a device.

The varied ways technicians used the scanner informed the simplicity of the UI and focus of the image on the bladder. Throughout the process, Verathon conducted user testing. During the refinement phase, we incorporated actual use-case responses into the final design. The feedback we received led to improvements in the cart tray layout, the ergonomics of the scanner, and the hierarchy of information on the screen.

On the Road to
Development

The functionality of the Cold Chain vessel will undergo further evolution in the lab, and in the field, before it ultimately fulfills its mission to effectively deliver lifesaving vaccines to those who need them most. Tactile is proud to have contributed to the development of this important innovation.