Ira Spool specializes in the design and development of novel medical devices which meet the needs of clinicians and their patients. He is skilled at successfully leading electro-mechanical product development efforts from inception to product launch:
- Fast turn prototyping for engineering proof of concept
- Laboratory and pre-clinical evaluations of product performance
- Collaboration with clinicians, KOLs, marketing
- Regulatory processes and GMP (FDA, ISO)
- Design for manufacturing (DFMA)
- Launch of new medical products that are successful in the marketplace
With over 15 years experience, projects have included implants, surgical tools, wearables, as well as other medical and consumer products. A selection of Ira’s projects are described below. (Some projects are not shown here since they include confidential information).
Ira is interested in collaborating on new projects and welcomes inquiries.
Angioplasty Balloon Inflator
Schnieder-Namic Inc (boston Scientific)
Designed patented angioplasty balloon inflator with a novel mechanism for controlling balloon pressure. Designed for Schnieder-Namic Inc which later became part of Boston Scientific. Received patent for mechanism and ergonomics of the handheld surgical device.
Intracavitary Brachytherapy Applicator
nucletron bv
Designed and developed innovative medical devices for radiation oncology. Our team included myself, a radiation oncologist, a radiation physicist, and a chemist. The project shown above is the “Adaptive Intracavitary Brachytherapy Applicator” for the treatment of cervical cancer. Received a patent for its internal mechanism which allows the radiation shielding to be adjusted for each patient. The device was licensed by a multinational medical device company based in the Netherlands (Nucletron BV). Patent #7651458, “Adaptive Intercavitary Brachytherapy Applicator”.
Cochlear Implant
Designed and developed cochlear implant modules which significantly simplify surgical implantation and lower the electrode array manufacturing cost. Developed for a new type of cochlear implant which incorporates the microphone and speech processor within the implant, eliminating the external over-the-ear portion of the device. Patent application #20130204340, “Neurostimulation electrode array and method of manufacture”.
Image Guided Surgery System
FROG Design and Z-KAT Inc
Engineering design and development for an image guided surgery system (IGS). Worked with FROG Design and Z-KAT Inc to design a next-generation IGS system for orthopedic surgery. Created prototype system to demonstrate functionality.
Implantable Device for Assisting Human Liver Function
BioEngine Inc
Primary mechanical engineer designing and developing an implantable microfluidic device for assisting human liver function. Developed while at BioEngine Inc which was an early-stage medical device company. Worked closely with surgeons and biologists at Massachusetts General Hospital who collaborated with BioEngine on the project.
- Is an implantable silicone based device which includes a microfluidic channel network. A novel approach was used to prevent blood flowing through the system from clotting.
- Designed and fabricated prototypes of the device for bench-top testing. Assisted with preclinical porcine studies.
- Iteratively refined the fluid system with computational fluid dynamics (CFD) software.
- Blood in the channel network interacts with human liver cells through a microporous membrane.
- Published research in the Journal of Tissue Engineering: “Principles of Biomimetic Vascular Network Design Applied to a Tissue-Engineered Liver Scaffold”
- Patent #8951302, “Biomimetic vascular network and devices using the same”
MRI Radio Frequency Coil Probe
HARVARD MEDICAL SCHOOL
Designed and developed medical devices and scientific instrumentation for Harvard Medical School research laboratories. Worked closely with surgeons and laboratory investigators. The example shown here is an MRI radio frequency (RF) coil probe and animal life support system for cardiovascular imaging studies.
Arthroscopic Surgical Tools for Cartilage Replacement Surgery
Genzyme Carticel
Designed arthroscopic surgical tools for cartilage replacement surgery. Created for the Genzyme Carticel minimally invasive surgical procedure. The flexible tool shown here solved the problem of how to take measurements of knee cartilage during arthroscopic surgery.
Patient Warming System for Surgery
Designed a controller for patient warming in the operating room. Product development included injection mold for enclosure, as well as fluid ingress & heat dissipation testing for product verification, and other aspects of development.
Equilibrium Strain Cell Growth Device
HARVARD MEDICAL SCHOOL
Consultant at Harvard Medical School for mechanical design engineering of unique scientific instrumentation. The example shown here is an equilibrium strain cell growth device for controlling stretching of lung epithelial cells. Designed to be manufactured at low cost for large-scale cell studies. Worked closely with the principle investigator, a cell biologist.
