My Position:
I joined Peloton Medical first as an engineering consultant designing PCBs, then in September of 2020 I became the lead engineer in charge of designing our product. I have 10% equity in the company.
Peloton Medical Devices seek to prevent Venous Needle Dislodgement (VND), a life threatening event experienced during Hemodialysis. VND: when the venous needle of a patient undergoing Hemodialysis is unintentionally dislodged. When VND occurs, in about five minutes, a patient can lose half their blood. A dialysis machine cannot detect VND. We are currently exploring 2 devices. A device that clamps the venus tubing upon VND detection and a warning system to train patients against potentially dangerous movements.
We are currently looking for funding to perform clinical testing through an IRB in order to get FDA class 2 approval.
VND Detection Device product description:
Take a look at the product page to see visuals. There are two components, the tubing monitor and the clamping system. The tubing monitor consists of two plastics that slide into each other and individually attach to each dialysis tubing. One plastic holds a magnet and one plastic holds a reed switch. When one tube moves far enough in relation to the other, the reed switch activates. Via wires, the reed switch is connected to the clamping system’s PCB. The clamping system has plastic housing which encloses the PCB, 9V battery, and motor. A small clamping mechanism is attached to the motor’s shaft and the venous needle is inserted through the clamp. When the reed switch is activated, i.e. VND occurs, the venous tubing is clamped.
My Process:
I spent the year iterating, iterating, and iterating. Each component of the design went through countless versions. Each time I rethought the device from scratch, I used scientific reasoning and logic from physics equations. To perfect each version, I developed the product mostly from trial and error. I used two 3D printers during this process to create the plastics, easyEDA to design the PCBs, and my home soldering kit to assemble.
Hurdles:
The main hurdle was making the product universal. Each patient's access, where and at what angle the two needles are inserted in the body, looks different. The closer to parallel a patient’s needles are, the closer the product can be placed to their access. The closer the product is to the needles, the more accurate it is. I had to design the product to fit all types of access.
Another hurdle was implementation at a mass scale. The possible misuses, annoyances, and dangers of the product were considered in the design. The user experience was also a core part of the design process. Patients usually undergo dialysis 3-4 times a week for 3-4 hours a time. If the product is a physical or mental annoyance, it is less likely to be implemented. This manifests in the experience of putting on the product and wearing it for the duration of treatment. It was designed to be put on and forgotten about. Another key component is its efficacy. While false negatives are the most important statistic, an abundance of false positives and the product becomes ineffective. Similar to the boy who cried wolf.
While nothing is ever perfect, I feel confident in the product and fulfilled in what the process has taught me.