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.
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