Hopkins Medtech Compliance
The Concept-to-commercialization Partner for IVD Manufacturers

An unprecedented situation arose in the U.S. with the spread of COVID-19. As the government rushed to contain the pandemic by testing large swathes of populations for SARS CoV-2 infections, an unsettling fact surfaced—over-the-counter (OTC) rapid antigen test kits, a type of in vitro diagnostics (IVD) medical device, are in painfully low supply.

Even as foreign IVD manufacturers ramped up their production, there was a lack of American clinical research organizations (CRO) specializing in IVD to offer guidance on the FDA’s strict guidelines and intricate processes. It made regulatory approval for international companies producing OTC testing products a significant challenge, perpetuating the persistent shortage. This is where Hopkins MedTech Compliance (HMC) steps in, helping foreign manufacturers navigate the U.S. clinical research landscape and assisting with the FDA submission process.

As a CRO catering solely to the IVD industry, eliminating the market scarcity of test devices is an ongoing endeavor for HMC. It assists IVD device manufacturers to successfully navigate the FDA guidelines for rapid product launch, with a hands-on approach to support their go-to-market strategies.

HMC’s capabilities are the result of a team of regulatory compliance experts with extensive knowledge of the latest regulations governing IVD product manufacturing and marketing. They guide manufacturers throughout the IVD product lifecycle—from product development, regulatory strategy, quality system formulation, protocol design, Institutional Review Board submission/ approval, clinical site selection/training, clinical trial conduct, central laboratory oversight, data analysis and clinical trial submission to the FDA for either EUA review or 510K review, in an effort to obtain market clearance.

“We help foreign manufacturers move their IVD products through all stages of clinical studies and secure FDA approval for commercialization in the U.S.,” says Dr. Homer Wu, founder and CEO of Hopkins MedTech Compliance.

The Far East Beckons

As an international company, HMC has a large clientele of global IVD manufacturers seeking FDA approval and U.S. market launch for their OTC testing devices. A sizeable percentage is made up of Chinese clients, as China currently has the greatest number of IVD product manufacturers. With top-quality products, mass production, and affordable pricing, Chinese IVD products are just what the U.S. market needs.

Dr. Wu realized this and decided to leverage his experience in finance and IT, and connections with pharmaceutical companies in his home country of China to pivot to medtech compliance. HMC is the answer to his long held entrepreneurial calling and drive to better collective human health.

Today, HMC acts as the bridge between U.S. regulatory bodies and Chinese manufacturers for launching novel IVD testing products for COVID-19 and a host of other diseases.

Breaking New Grounds

HMC is excellent at helping IVD manufacturers tread the U.S. regulatory landscape by consulting with resources both within the FDA, and with experts who have had previous FDA experience.

This communication ensures that clinical sites stringently follow all guidelines to expedite the potential approval and launch of these products. HMC’s experts regularly participate in conferences and forums held by the FDA to deepen their knowledge of the continuously changing regulatory requirements. HMC has been working hard to establish a strong lead in the world of OTC testing.

HMC is well aware of the various submission processes the FDA has in place to determine the safety and viability of medical devices slated for market launch, such as 510k pre-market notification and premarket approval (PMA) and De Novo classification. These processes are often time-consuming. In times of urgency, the FDA’s emergency use of authorization (EUA) is an expressway through which novel therapeutic drugs and devices could be launched faster. HMC is well-versed in taking this expressway to expedite a client’s product launch.

“We work closely with the FDA to understand their exact requirements in EUA submissions, and utilize that information when catering to clients’ IVD product development and market clearance needs,” says Jennifer Stanford, director of clinical operations at Hopkins MedTech Compliance.

Driven to be a partner to clients at each step, HMC provides the full gamut of CRO services, from product development to packaging details. It conducts clinical and lab performance studies to test the IVD products of foreign manufacturers, guides them in formulating their test protocol, and writes product instructions. HMC also creates all documents used in clinical studies related to the IVD product for each manufacturer and presents them to the FDA. In addition, it gathers relevant information about the manufacturer, showcasing their credentials for mass producing quality rapid antigen testing kits to qualify them for EUA clearance.

In order to conduct successful clinical trials, HMC seeks out healthcare sites with access to the targeted test population for conducting these device trials. HMC is responsible for selecting and training qualified sites to perform the clinical trials and they provide the supplies and all required materials for the clinical study. The team at HMC is also responsible for ensuring clinical sites enroll qualified patients and conduct monitoring and review of the study data on an ongoing basis. Once a trial is completed, HMC packages the data in the proper format and sends the clean data for FDA review.

Once the IVD product is submitted for review, HMC engages with the FDA in a series of question-and-answer sessions to help the latter gain in-depth insights into the device’s specifications. HMC also creates product presentations to help clients answer the FDA’s queries. The goal is to ensure everyone is on the same page regarding product market approval and launch, with full adherence. HMC performs all this, deeply considering each client’s unique product requirements and go-to market strategies.

Treading the Extra Mile for the Future of Diagnostics

HMC distinguishes itself by going the extra mile to acquire the appropriate clinical trial participants for its clients. Case in point, HMC is currently assessing “hot spots” around the U.S. where Flu B is most prevalent currently.

If necessary, HMC would consider identifying clinical sites in South American countries where Flu B is more prevalent in order to enroll subjects on behalf of their clients for an oncoming combo IVD product—a multi-analyte OTC test device for home testing of COVID-19 and two major flu strains, Influenza A and Influenza B, at one time. Given the lack of Flu B cases in the U.S. and Europe, HMC experts are willing to engage in highly creative, out-of-the-box thinking, and would work closely with the FDA to discover the optimal method to meet enrollment requirements for this much less frequently diagnosed influenza strain. These three respiratory viruses present with similar symptoms and can be a challenge to diagnose exactly what a patient is suffering from, and the treatments required are different.

The multi-analyte OTC test devices are posed to have the capability to test for the respiratory syncytial virus and other common forms of respiratory infections using just one nasal swab, relieving patients of having to undergo multiple tests. HMC is playing an instrumental role in making these capabilities available to the masses soon, which may lead to a faster diagnosis, less pain and suffering for patients, and less financial burden with reduced testing requirements.

Catalysts for Bridging Cultural Gap

HMC shines as an example of leveraging cutting-edge science and a deep understanding of multiple cultures to foster and mediate trust between U.S. regulatory bodies and Chinese IVD product manufacturers.

HMC experts come from multinational backgrounds and make this possible by taking into account the cultural differences and unique work methods that govern the processes for IVD device market approval in U.S. and China. They successfully address the queries of Chinese manufacturers who, despite developing top-quality IVD devices, usually feel apprehensive about facing the FDA and launching their products in the U.S., due to not fully understanding how to navigate the FDA processes and the language barrier the Chinese developers face.

Simultaneously, HMC strives to make the U.S. regulators more open-minded toward the Chinese manufacturers by listing the advantages the home population will gain with access to a vast pool of affordable OTC testing devices.

We work closely with the FDA to understand their exact requirements in EUA submissions, and utilize that information when catering to clients’ IVD product development and market clearance needs

Striking a balance between the requirements of U.S. regulators and Chinese product manufacturers forms the core of HMC’s approach to foster a future of collaboration between the two countries. To that end, HMC focuses on the shared goal of both parties—to improve healthcare and its access to the masses.

With newfound infectious diseases like COVID-19 coming into the picture and old ones like monkey pox resurfacing, HMC looks forward to using advanced science to help IVD product manufacturers build and market better test devices. All the while, HMC remains steadfast in its mission to empower patients with fast and easy access to the best the world’s IVD product manufacturers can offer, over the counters nearest to them.