Entry into the U.S. market holds high appeal for modern medical device manufacturing companies. The U.S. market is attractive due to the country's large target patient pool paired with high adoption rates for advanced treatment technologies. However, these products, though well-tested and meeting international standards, still need to undergo the FDA application process. And meeting the FDA requirements is easier said than done. To help products enter the U.S. market with the least agony, Paladin Medical^®, Inc. offers expertise based on over 40 years of experience in the medical device industry. The company specializes in a full range of medical product regulatory, clinical, and technical contract services for FDA and international premarket applications as well as support to regulatory compliance for the medical device regulations.

“We stay on the cutting edge of both biomedical engineering of new medical products and the regulatory science that goes with getting those products to the marketplace,” states Elaine Duncan, President, Paladin Medical^®, Inc. The company typically caters to start-up device manufacturers or the established companies with emerging new technologies. Even existing clients may not be familiar with the changes in the FDA regulations and practices. Paladin Medical^®, Inc. starts with a regulatory assessment that informs the client about current product regulations that may impact the path to market, how the new product compares to others in the market and if their technology could cause the new product to trigger a different regulatory path. The company empowers clients to incorporate project planning, design control, and review according to FDA requirements as part of their new product race to market. Early regulatory assessments and adoption of QSR 820.30 help the client remove the uncertainty inherent with medical product development, and support the client who may be looking for outside investors or government grants.

Paladin Medical^®, Inc. also supports clients to develop quality oversight programs and offers due diligence expertise. “In the case of an acquisition or merger, we help the purchasing company by conducting regulatory diligence to confirm that the products to be acquired are compliant with modern-day FDA regulations,” says Elaine. A common problem with target companies is that mature products that have been on the market for many years, may have undergone change in design, materials, and even labeling such that the product for sale now may have surpassed the scope of the original 510(k) submission. An acquiring company may not perceive the gaps by just looking from the outside in. Companies may also have medical products for new indications or products using new technology that may introduce new risks which need to be assessed in the light of new regulations.