Ironstone Company overview
Ironstone Product Development (IPD) is an ISO 13485:2016 certified medical device development company. We assist our clients with all aspects of medical and health product development and commercialization. Our team members have successfully commercialized dozens of innovative medical and healthcare products. These products have changed the practice of healthcare and have generated transformative revenue for the companies involved.
We work with entrepreneurs and established companies to help define the right product and find the most efficient way to get it in the hands of the clinicians and patients that need it. Our background includes extensive work in engineering and clinical affairs as well as regulatory strategy. This enables us to understand the details underlying how your product works both technically and clinically while clearly communicating this to regulatory bodies.
Therapeutic Areas
Our team has experience in the development, clinical evaluation, and worldwide regulatory approval of the following product types:
Imaging
MR devices, ultrasound, and impedance based products
Oncology
Radiotherapy equipment and ablation technologies
Neurology
Implantable stents, ablation devices, pain management products, laser based therapies, deep brain stimulation products, and transcranial magnetic stimulation (TMS) systems
Anesthesia & Critical Care
Anesthesia systems, ventilators, patient monitors, and portable equipment
Surgery
Robotic surgery, intra-surgical imaging products, and dermatological surgery products
Wellness Devices
Wearable products for general wellness, neonatal, and gerontological applications