Unleashing Innovation: A Journey of Safety and Life-Saving Solutions

Asignificant preparation for my work in medical devices started years earlier when I learned to fly. This laid a firm foundation of life critical procedures, methods, and the need for a profound knowledge of the underlying operations. My God given talents being the understanding of all things mechanical, electrical and magnetic, lead me to dive into aircraft mechanics and controls. Here once again I learned the importance of life critical methods and procedures as I would be flying in the planes I worked on over the jungles of South America. Some years later I was blessed to work for Honda of America Mfg. Inc. in Marysville, Ohio, where Honda designs (CATIA), develops, and manufactures in large scale fine automobiles. Honda is a highly disciplined organization where everyone wears “Whites”, a white uniform. One of Honda’s tools is the PDCA cycle, Plan, Do, Check, Act, where you do your best and then you go back over it and make it better and better before any production until the failure modes have been worked out “Hard Side”, actual tangible items, not documentation. Honda also has excellent root cause analysis tools that are very applicable to medical devises. Once again safety first is drilled into the process from the concept.

I started at Oscor Inc. in Palm Harbor Florida on December 3rd, 2007 where Oscor wanted to launch a full line of breakaway, peel away introducers. My challenge: they would not break, or peel. These introducers (Pressure Products Safe Sheath Ultra) also had integrated breakaway hemostatic valves. These would not perform either. Success came one step at a time as I had a complete knowledge of plastics injection molding, extrusion, tooling, and automation. I designed the injection molds to have 2 gates and make a knit line where the break line needed to be so this made them break at the right place and at a lower break force. Similarly, with the sheaths, designed the extrusion tooling to create a knit line where the peel of the sheath was needed. As for the Hemostatic break away valves, I designed a custom automation and process with built in PDCA to control the variables closed loop. Oscor has sold millions of these introduces all over the world. Then the opportunity came to design a much larger introducer for Abiomed to implant the Impella heart assist device.

The prior experience was very valuable to design and develop the Abiomed Introducer kit. This also has sold large quantities. I have designed many medical devices, but many are protected by non-disclosure agreements, and I cannot share their beautiful stories. I was awarded Advanced Technology First prize by the minister of health in Japan for one of the devices I developed. Currently doing the Design History File documentation, so I have hands on experience from concept, invention, design, 3D CAD SolidWorks Modeling, etc., all the way to the final approved documentation.

I would like to share some of the devices I hope to bring into this world. I was profoundly impacted when I read an article of a Cardiologist who developed a brain tumor due to excessive exposure to ionizing radiation. I am interested in developing a new imaging system that is based on “Longitudinal Energy” that is not harmful to the patient or the physicians. This energy transverses the body and can be detected and imaged continuously for example, a real time continuous imaging of the procedure.

I also want to develop procedures for treatment with a combination of light and vibration. This can be tuned to the need and can dissolve / disrupt on the cellular level without any medication.

I also want to develop “Sympathetic Resonance Cellular Disruption”. This system couples an electromagnetic pulse to the resonant frequency of the cellular structure and depending on the amplitude, readily disrupt this reproduction and not affect adjacent tissue noninvasively.

So, just one more soldier in this army against disease, making every device as if it will be utilized on myself or my loved ones. It is an honor to work in the Medical Device Industry!