NAMSA APEX PROGRAM Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings

Research Challenge

Solvay Specialty Polymers USA, LLC, a worldwide provider of biomaterials, is the leader in serving diversified markets around the globe. From consumer goods to energy, their goal is to improve quality of life and customer performance through a wide portfolio of advanced polymers. Traditionally, Solvay has been a supplier of biomaterials to the healthcare sector, but identified a significant market opportunity within the dental marketplace.

The dental industry has observed little advancement in the removable partial dentures (RPDs) space over the last 50 years, as metal has existed as the ‘gold standard’ material for RPDs. Currently, over 80 percent of RPDs are comprised of metal frames, presenting many health issues for users such as heat and cold sensitivity, allergens and inflammation and irritation of oral tissues.

Recognizing a strong need for new and innovative materials within the denture sector, Solvay sought to accurately assess the market opportunity for a polymer solution, while also evaluating the associated product development and commercialization requirements, timelines and costs.

To assist with the development of this novel device, Solvay required a Contract Research Organization (CRO) that possessed vast dental product expertise within all phases of the medical device development lifecycle. They also needed a partner that had deep-rooted expertise in successfully navigating the U.S. Food & Drug Administration (FDA) 510(k) submission pathway for first-time market entrants. This would require the proper clinical research and regulatory strategies to accelerate Solvay’s push from a supplier of raw goods to a medical device manufacturer.

“From preclinical testing, clinical trial management and regulatory strategy, NAMSA is truly expert at delivering high-quality outcomes throughout the entire medical device development continuum. Start to finish, NAMSA understood the required activities for accelerated development and efficacious market introduction.

Undoubtedly, NAMSA played a critical role in Solvay’s successful product commercialization, all the while providing significant cost savings throughout our program.

I would highly recommend NAMSA to any medical device Sponsor that is looking to achieve expedited, cost-efficient development outcomes.”

— Shawn Shorrock Former, Global Director Solvay Dental 360TM

The Solution

Upon completion of Solvay’s CRO qualification process, NAMSA® was identified as the premier MedTech development partner of choice based on the following attributes:

  • Existing relationship with NAMSA and familiarity with the organization’s NAMSA APEX ProgramTM: a unique strategic process which provides guidance and tactical support for the full development continuum, including regulatory strategy, medical device testing, preclinical and clinical research, and commercialization strategy.
  • NAMSA’s collaborative history with Pointward, a leading medtech marketing firm possessing a proven track record of successfully bringing products to market in an expedited manner.
  • Positive working relationships and established experience with the U.S. FDA, including:
    • 300+ 510(k) submissions
    • 100+ Pre-Market Approval (PMA) submissions
  • One dedicated point-of-contact (NAMSA APEX Program Manager) who possessed applicable therapeutic and regulatory expertise within the dental product space and could deliver proactive, timely communications.
  • Proven track record of judiciously utilizing Client resources to achieve expedited timelines and decreased costs.

Implementation

Upon project kick-off, Solvay engaged in a five month exploratory market and risk assessment to determine the market potential and viability of a polymer RPD device, what would be considered a first-of-its-kind product. The market evaluation, conducted by NAMSA’s marketing partner, Pointward, substantiated the need for a new and innovative material within the RPD dental space.

Following, Solvay was provided with an extensive product development, commercialization and post-market plan which addressed the integrated challenges of bringing a disruptive product to market. These potential challenges would be proactively addressed through the NAMSA APEX Program, a process whereby testing, clinical research and regulatory strategy initiatives occur simultaneously to achieve expedited timelines and lowered costs. (See Figure 1)

“None of this would have been possible without the consistent and thorough partnership of NAMSA, virtually from our beginning and continuing today. Our development program benefited greatly from having one point-of-contact at every turn vs. managing multiple vendors at once.”

— Jeff Blair, Co-Founder and Chairman ICHOR

The Solution

Upon completion of ICHOR’s Contract Research Organization (CRO) qualification process, NAMSA was selected as their medical device development partner of choice based on the following criteria:

  • Existing relationship with NAMSA and familiarity with the organization’s NAMSA APEX ProgramTM: a unique strategic process that provides guidance and tactical support for the
    full development continuum, including medical device testing; preclinical/clinical research services; and quality, regulatory and reimbursement consulting.
  • NAMSA’s positive working relationships and established experience with the U.S. FDA, including (cumulative):
    • 300+ 510(k) submissions
    • 100+ Premarket Approval (PMA) submissions
  • One dedicated point-of-contact (NAMSA APEX Program Director) who possessed extensive product development experience, applicable vascular device knowledge, and relevant regulatory expertise with FDA processes, including pre-submission meetings and 510(k) regulatory submissions.
  • Proven track record of judiciously utilizing client resources to achieve expedited timelines and decreased costs, while delivering proactive, timely communications surrounding program progress.

Figure 1: NAMSA APEX ProgramTM

Implementation

Upon program kick-off, the dedicated NAMSA APEX Program Director worked closely with ICHOR’s virtual team to discuss program requirements and how these would be managed to deliver optimal outcomes. Soon thereafter, the NAMSA / ICHOR Team created a full Product Development Plan (PDP), established how program updates and communications would be distributed, identified milestones whereby success would be gauged, and laid out a clear budgetary plan to achieve all activities.

Further, the PDP and financial plans were utilized as part of ICHOR’s investor presentation for subsequent fundraising efforts, creating further credibility and confidence for investors given NAMSA’s track record of efficiently and cost-effectively bringing 510(k) products to the market.

Results

The NAMSA Team quickly ramped up to execute the agreed-upon PDP, conducting the majority of development initiatives concurrently, while also providing contingency plans to proactively meet unforeseen challenges head-on:

In summary, ICHOR achieved significant time and cost efficiencies, based on the following key factors:

  • NAMSA served a key partnership role while involving ICHOR stakeholders during critical development meetings and milestones. This allowed the ICHOR Team to focus on important fundraising efforts and start-up tasks.
  • ICHOR eliminated costly administrative overhead expenditures by operating as a virtual company and allowing the NAMSA APEX Program Director to lead the program from kick-off to closeout. This provided the ability for ICHOR to utilize start-up investment dollars for only the most value-added tasks and processes.
  • Based on NAMSA’s experience with over 300+ 510(k) submissions, the internal team of regulatory experts identified historical, potential risks that would likely be of concern for the government agency. To prepare for these risks, NAMSA pre-emptively prepared applicable information and test methods to properly confront all issues of concern.
  • NAMSA was able to pivot the program and provide further support when ICHOR encountered a contract manufacturing transition. While this caused a 9-month delay in the project, NAMSA was able to identify the need for significant design changes to allow for improved product performance and efficacy. This process necessitated a repeat of all bench testing (and a further delay in development). However, NAMSA leveraged use of prior designs for preclinical studies, biocompatibility and sterilization, which ultimately reduced overall program costs.
  • ICHOR was equipped to fund the business with improved terms by achieving key milestones on time and on budget. Specifically, 510(k) clearance was granted well in advance of expected timelines, which provided ICHOR and potential investors tremendous confidence.

NAMSA APEX Program delivered ICHOR significant time and cost savings in contrast to industry averages for 510(k) development timelines and expenditures.

Timelines

The average time from company inception to 510(k) approval is more than 67 months6. NAMSA, with proven solutions for the complete continuum of development activities, assisted ICHOR in achieving clearance in just 46 months6, cutting more than 30 percent off average development timelines.

Figure 2: Time from Start-Up Inception to Clearance—Industry Average vs. NAMSA APEX ProgramTM

(Source: “How Long it Takes the U.S. FDA to Clear Medical Devices via the 510(k) Process”6)

Expenditures

Furthermore, the average cost of bringing a 510(k) to the U.S. market is approximately $31M1. With NAMSA’s expert services and solutions, ICHOR achieved 510(k) clearance for less than $5M5.

Figure 3: Cost to Achieve 510(k) Clearance—Industry Average vs. NAMSA APEX ProgramTM

(Source: “The Medical Device Milestone Gap”1 and “NAMSA and ICHOR Company Records”5)

Key Benefits

  • Accelerated Timelines
  • Reduced Expenditures
  • Trusted Partnership
  • Greater Device Adoption and Market Share
  • Positive Investor Return and Growing Company Valuation
  • Increased Positive Patient Outcomes

References

  1. Hirsch, R.; The Medical Device Milestone Gap (December, 2013)
  2. Centers for Disease Control and Prevention; Division for Heart Disease and Stroke Prevention; Peripheral Arterial Disease (PAD) Fact Sheet
  3. Vascular News; Major Amputation Over Utilized Globally for Critical Limb Ischemia (July 2016)
  4. Baser O., Verpillat P., Gabriel S., Wang L.; Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare Population (February 2013)
  5. NAMSA and ICHOR Company Records (November 2019)
  6. How Long it Takes the U.S. FDA to Clear Medical Devices via the 510(k) Process; Emergo (March 2017)
  7. FDA Impact on U.S. Medical Technology Innovation; Stanford University, Medical Device Manufacturers Association (MDMA); National Venture Capital Association (2010)

Let’s Talk About Your Project

Ask a question or request a meeting with a NAMSA expert to discuss your specific project. We will follow up as quickly as possible. Also, please tell us how you heard about NAMSA.

    By choosing to submit your information to contact NAMSA, you are providing NAMSA consent to process and store your information on the NAMSA Network. At any time, you can submit a request to withdraw your consent for the use of information provided by you. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.