Specialized Orthopedic Solutions only sources its products from trusted manufacturers that have earned a reputation for creating leading edge medical devices in the DME and O&P industry. We have relationships with all the leading manufacturers and we are committed to providing only the best options to patients charged with our care. When determining whether or not to add a product to our catalog we rely on several resources to determine if it will meet the high standards we require.
1. We require an FDA determination of “substantially equivalent” (501(k) Clearance) for any medical device designated a Class I, II or III medical device.
2. We require FDA premarket approval (PMA) for any Class III medical device.
3. Any additional safety concerns are discussed directly with the manufacturer before moving forward with quality assurance.
Our Quality Assurance
1. We require a face to face demonstration of any new product offered by a manufacturer we have not previously worked with. The manufacturer is required to demonstrate the proper fit, function and/or use of the product and describe their manufacturing and quality standards in order for us to ensure they match or exceed our own standards.
2. We require a face to face demonstration of any product brought to market that is substantially new or different (new technology, product line, product replacement, etc.). The manufacturer is required to demonstrate the proper fit, function and/or use of the product as well as identify key differences, benefits and potential drawbacks of use in comparison to previous products offered or similar products offered.
3. We require the manufacturer to adequately answer any questions and concerns that arise during and/or after the face to face demonstration before moving forward with market research.
Our Market Research
1. After a product satisfies our safety and quality standards we present the product to specialty physicians we currently have a relationship with. During this process we discuss the indications, contraindications, intended use(s), benefits, drawbacks and concerns of the product under review. Our current product offering has been developed over the past 14 years of working with some of the top surgeons and physicians in the U.S.
2. We require the specialty physician to conclude the product under review will provide patients the adequate benefits purported for the products intended use while exceeding safety requirements.
If any of these standards are not met we will either request changes, improvements or increased safety standards before we reconsider adding the product to our catalog. If the manufacturer is unable or unwilling to meet these requirements or requests we will not offer the product.
Once a product meets all of the requirements outlined above we will approve the product for use on patients. However, we continue to evaluate the quality of both individual products and manufacturers as long as we offer an item for patient care. Product recalls and malfunctions, patient and physician complaints, unreliable manufacturing and fulfillment are continually tracked. If at any point we determine the quality standards we set forth are no longer met we will immediately discontinue offering the product in our catalog and may file formal complaints or product enhancement requests with the manufacturer.