At Force Detectors, we offer innovative engineering solutions to address unmet clinical needs in the healthcare and medical device industry. Our engineers will rapidly design, develop, fabricate, and test your device or system to ensure that it meets the requirements and specifications of the intended market and clinical need. Moreover, we do so with strict adherence to any applicable regulatory bodies involved.
Check out how we've implemented these strategies in the examples below.
As intrasaccular aneurysm devices (devices which fill aneurysms, as shown in Figure 1) have evolved with the development of new technologies to improve aneurysm treatment, test method procedures must also be simultaneously developed to test the safety and efficacy of these new medical devices. Recently, technological advances have allowed more complex intrasaccular devices to be produced. One such device uses a three-dimensional, self-expandable mesh to provide a scaffold that conforms to the shape of the aneurysm, promotes intrasaccular thrombosis, and lowers the risk of aneurysm rupture. Since current treatments use more rigidly shaped devices to treat aneurysms, current test method procedures are unsuitable for assessing the functional safety and regulatory compliance of these 3D devices. To overcome this dimensional limitation, we proposed a repeatable and reproducible test method protocol and fixture design that is capable of adapting to the structural variability of the device, evaluating device performance under simulated physiological conditions, and identifying any potential design flaws.
Our test method was designed to accurately characterize the different forces that an intrasaccular device may experience or exert in the neurovascular system during deployment. As a part of this process, we have designed a test fixture that provides a stable, reliable, and robust system for housing the intrasaccular device and measuring the parameters of interest, including force, pressure, and deformation. The primary components of the fixture, as shown in Figure 2 consisted of a custom pressure syringe, custom aneurysm model, digital pressure gauge, and rotating hemostatic valve, which, when assembled, will be installed within a glove box to maintain stable pressure within the system. The syringe in the initial set up creates a vacuum and the pressure gauge measures changes in pressure due to device deployment. Once the intrasaccular device is deployed into the aneurysm model, the readings from the pressure gauge are recorded and used to compute the forces exerted on and by the device during deployment. The process is then repeated across multiple trials before analyzing the results and determining their compliance with FDA regulations.
Our current shift has now been in meeting the need for personal protectiveequipment (PPE) in response to the recent COVID-19 pandemic.
As the COVID-19 pandemic progresses, the need for affordable and quickly manufacturable personal protective equipment is increasing. We are working in collaboration with BioEngine teams to design a mask ventilation system modeled after Figure 3. Our team has taken responsibility for implementing a blower into the ventilator mask that allows air to continuously flow through a filter and ensures that healthcare workers breathe in clean air without the risk of infection.
Our team also created and implemented design requirements to ensure that the blower system is capable of performing at three different speeds to adapt to different user breathing rates. The blower is easily accessible and delivers up to 50 hours of use with a rechargeable battery that provides instant user feedback regarding battery life.
We have also designed a blower holder (Figure 4) which includes a compartment to secure the off-the-shelf blower and a secondary compartment to integrate the filter holder. The parts are all held together with a threaded lid that secures all the individual components. This holder acts as an adaptor to complete the assembly of all the key components including the face mask, the blower, and the replaceable filter.