I worked in the signal processing field for a few years.
For some recent clients:
I evaluated their current signal processing implementation Evaluated the limits to its performance - underlying data quality, algorithmic limits, etc. Identified a development direction Developed an example implementation demonstrating one possible direction for a next generation product
Startup medical device company needed to put in place a quality system and regulatory affairs program and Joe was asked to help. Project had little budget or time.
With Joe’s extensive quality and regulatory experience he was able to assess the companies needs and put together a quality and regulatory plan and process. Using low and no cost quality documents and custom procedures that Joe wrote he quickly created an effective quality system to meet their current needs
It is uncommon for someone to have experience with the full lifecycle of multiple medical devices and accessories from beginning to end. My background provides me with expertise across the entire process. I can assist with any part of bringing a medical device to market, or provide guidance through the full journey. My experience encompasses:
Technology Research: I have researched emerging technologies and evaluated their applicability for new medical device development.
Joe authored the Handbook for Laser Beam Scanning Products and wrote simulation, modeling, and support tools to explore design options, improve performnace, and obtain a safe and approved product. The handbook is available for use by Zedtech’s consulting clients.
No laser beam scanning is not so complicated as this picture. While yes it is a complex system of optics, electronics, software, and mechanics, it can be very small, cheap, and simple
Medical device client had a large FPGA code base with a complex processing data flow. The code was written by a design firm and relied on a set of legacy libraries. A contractor had been hired to make the changes needed to support completing the medical device development.
The code was not well documented and the original engineers were no longer available. The code was not well structured and was difficult to understand.
For a recent client, evaluated their product design and recommended product improvements and development strategies to quickly and inexpensively obtain better performance and improve product design.
Joe quickly evaluated the product and the design decisions made. Made a list of technical and management recommendations to improve the product and the product development process. The client was able to quickly implement the recommendations and improve their product and continue on to their next milestone.
AV500 with green projection laser. Note the updated simplified user interace with sealed keys.
Joe managed the product development and was the lead engineer.
While the existing product was very successful and still selling well supply chain issues were becoming a problem. The company needed to find a new supply chain for critical and end-of-life components. In addition the product needed to be upgraded to improve reliability, robustness, and performance.
Joe managed the product development and was the lead engineer. He was responsible for the overall system design, electronics, software, and user interface. He also managed the regulatory and safety compliance. He was responsible for the product from concept to production. He managed the development team and the contract manufacturers. He was also responsible for the product cost and schedule.
The AV400 need was to upgrade an existing product to better meet customer needs.
First product development for a brand new medical device company
Company had gotten funding on a technology based prototype, but had created no customer products needs analysis, written no product requirements, and had no inhouse product development experience. There was no product development team, no consideration of medical device requirements had been given during prototyping, and there was no manufacturing, quality, or regulatory infrastructure.
Selected strategy was to partner with a design firm.
As an engineering manager for a large mobile computer company, Joe was asked to develop a rugged mobile computer for a new customer.
The challenge was that this was a competitive bidding situation and the customer required a fully functional prototype and proposal in 3 months. The company had an in-house product development team, but they were not available. All that had been done before Joe took on the project was that the company had created a Power Point presentation on possible product attributes and what the product could look like.