Regulatory Pathways Group Has a Plan to Build on Mentor’s Work
In the wake of the retirement of Judy Gordon, DVM (see related article here), three principals of the company she founded in 1998, ClinReg Consulting Services, have formed a new entity, Regulatory Pathways Group. In addition to the consultative services ClinReg provided, the new group has added subject-matter experts in areas such as:
• Quality assurance related to biocompatibility, toxicity testing, and risk assessment.
• Labeling approval and compliance services.
• Human factors and usability testing.
• Research and development engineering.
The three ClinReg principals and founders of the new Regulatory Pathways Group (RPG) are Lee Kramm, MD, MSE, who will serve as president/chief strategist and medical officer; Debe Deck, senior vice president of program management and client services; and Maureen Johnson, RN, senior vice president of consulting resources and operations.
With their background at ClinReg, the founders of RPG aim to help medical device developers navigate the Food and Drug Administration regulatory gauntlet with regards to:
• Premarket approval (PMA) applications, for which their experience includes ocular implants for glaucoma and for intraocular refractive and therapeutic applications; lasers for corneal refractive procedures; and nonocular diagnostic imaging systems.
• 510(k) premarket notifications for selected novel technology. In this area their portfolio includes refractory glaucoma implants; a photocoagulation laser; and femtosecond lasers for cataract and refractive surgery.
• Class II de novo petitions, which they’ve filed for smart contact lenses, and neurostimulation and light-based therapy devices for dry eye disease.
• Humanitarian exemptions, which include orphan device designations and approvals for corneal therapeutic devices, intraocular lenses, and devices for stroke prevention and pulmonary indications.
• Investigatory device exemptions. Their background here includes applications for first-in-kind Class II and III devices such as implants and manual instruments for treating glaucoma; radiation therapy for age-related macular degeneration; phakic and aphakic intraocular lenses; femtosecond lasers for refractive surgery; and devices for many other ophthalmic and nonophthalmic applications
An International Virtual Network
“We intend to maintain our current global-network structure of not having a centralized, physical headquarters,” Dr. Kramm told OIS Weekly. “The virtual office model allows us to have consultants in a number of international locations and to serve our clients who are located around the world.”
In addition to finding widespread application by all kinds of businesses during the Covid-19 pandemic, the virtual model will allow RPG to attract and retain top talent unconstrained by physical locations, Dr. Kramm noted. “Being virtual has the added benefit of reducing our carbon footprint,” he said. “Particularly now, in light of continuing pandemic restrictions and with many regulatory agencies worldwide still operating without in-person meetings, a virtual office offers the most flexibility to service our global clientele.”
RPG has expanded its consultant roster in the areas of medical writing and quality assurance related to biocompatibility, toxicity testing and risk assessment, R&D engineering, labeling and compliance services, and human factors and usability testing. While the group is not ready to identify new team members, Dr. Kramm noted that they represent “decades of clinical and regulatory affairs experience in the medical device industry.” Dr. Kramm said a new website, which will include consultant profiles, should launch soon.
Sustainability over Profits
Dr. Kramm holds financial goals close to the vest. “One of our primary goals in founding the company was to prioritize sustainability over straight profitability—sustainability of our valued client base as well as our strong roster of consultants,” he said. “Being cognizant that rapid, unfocused growth can be counterproductive, we strive to partner with clients on projects where we believe we can add value and benefit society.”
RPG, he noted, will select projects that interest team members and ultimately lead to more medical treatment options for patients. “It goes without saying that a business needs to be profitable,” Dr. Kramm said, “but it is equally important for us to continue working together. Our network of accomplished consultants is our greatest strength. By following Judy Gordon’s example of enthusiasm, passion, and integrity, we feel confident that our business will continue to grow at a steady pace over the next few years.”
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