Paladin Medical^®, Inc.
Speeding Medical Products to Market and Keeping Them There

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.

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

Hence, Paladin Medical^®, Inc. can provide an independent regulatory diligence review of the facilities and the product portfolio to confirm that the target company is up to date on FDA regulations and how any gaps could affect valuation.

Paladin Medical^®, Inc. helps clients determine the verification and validation required for new product introduction. For instance, the company helps clients determine very early the level of biocompatibility testing and possibly animal performance testing. Based upon training and experience, Elaine guides clients on why certain tests should be conducted while others may be avoided. Certain in-vivo testing can be very expensive and time-consuming, and without a sound biological risk analysis, the new medical device company can conduct the wrong tests, or the correct tests before the formulations and components are fully characterized. In addition, Paladin Medical^®, Inc. may be able to recommend appropriate laboratories to provide those tests based on the test outputs required to meet the FDA requirements for the new medical product.

In the wake of uncertainties during a time of worldwide pandemic, Paladin Medical^®, Inc. continues to provide services to clients around the globe. If a client wants to import products which may help to fight a disease, such as test kits and protection equipment into the U.S., the company helps the importer in this process. Elaine cites a client who wished to import N95 respirators into the U.S. to help people deal with the coronavirus pandemic. Despite FDA having made strict provisions for such import, Paladin Medical^®, Inc. identified all the information the client needed to meet the FDA regulations in the current COVID-19 situation. Consequently, the client was successfully able to import approximately 70,000 respirators in the most critical early days.

The efficient work of Paladin Medical^®, Inc. is driven by the expertise of the company’s leadership. The president of the company has a background in mechanical, biomedical engineering with years of experience in product development. Elaine is also a certified regulatory affair professional. Working closely with clients, she conducts presentations and weekly meetings about their next step and offers procedure templates that help clients to quickly adopt best practices yet and adapt the procedures to their own needs to fulfill quality systems requirements.

Striding ahead, Paladin Medical^®, Inc. places a high value on the importance of staying current on new regulations, FDA guidance documents, national and international standards, and best practices. The company prioritizes the maintenance of the quality of service to their clients. “If clients need more and more services, we will try to provide them as the demand comes,” concludes Elaine.