Current State of the Art
Competitors stabilizers and heart positioners are single use disposables. After each surgery the hospitals discard $1700 heart stabilizer and heart positioner
The flexible arms must lock up rigidly to support the beating heart. All stabilizers use high strength, expensive plastic or metal links which can be re-sterilized; The plastic pods are hard to clean so the entire device is disposed each procedure.
Many disposable products can (and are) reused. We design the hard to clean, blood contact components to be disposable. The suction pods snap onto a reusable arm. The flexible arm must support the beating heart and is made of high strength materials which can be steam sterilized. We designed the arm to be easily cleaned and sterilized.
A provisional patent for the product has been filed with the U.S. Patent and Trademark Office. A utility patent protecting the three part design should be filed in calendar 2020.
Reusable/disposable technology can be applied to many medical devices. We have identified three fields which total $3.2 Billion in sales which we will enter over the next ten years.
The Regulatory Process
FDA Strategy: Self Certify
- Heart stabilizers and positioners are Class 1 and do not require FDA review or approval. The company will hire auditors to obtain CE mark for European and sales to other countries.
- Company will comply with FDA Code of Federal Regulations CFR 21 part 820
- Founders have already had one device FDA 510(k) approved using proprietary quality system
Will Hospitals Resist Reusable Devices?
Many instruments are reused and resterilized every day. A few examples are shown in the figure below. Johnson and Johnson (at right) and Stryker both reprocess single use devices to reduce hospital waste and save hospitals money.