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Company attracts senior medical products and services executive, acquires leading human factors provider
WILMINGTON, Del., Jan. 30, 2023 /PRNewswire/ -- ClariMed, Inc., today announced the launch of the first MedTech services partner to take an integrated, human-centered approach to medical product development. The company also announced today the acquisition of San Jose-based UserWise, LLC, and the appointment of Kelley Kendle as CEO and Chairman of the Board of Directors. The company was incorporated in association with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.
ClariMed was created to meet the growing need in the medical technology industry for an integrated partner focused on regulatory and development services. ClariMed takes a human-centric approach to the MedTech product lifecycle, taking an integrated approach that differs from the current fragmented support ecosystem sponsors face when bringing products to market and meeting regulatory requirements. . With the growing variety of medical product users and increasing regulatory requirements, MedTech innovators struggle to find partners who can understand, coordinate, and meet emerging requirements for human-centered product design and development.
Today, sponsors must go to multiple vendors and coordinate these complex efforts themselves, requiring time and resources, while sacrificing continuity and an integrated approach. ClariMed aims to address this unmet need by integrating the best design, engineering and product development service partners in an interdisciplinary approach that incorporates human factors and regulatory disciplines at its core.
The ClariMed team brings an essential understanding of users' needs and capabilities in the context of their environments and systems spanning the entire product lifecycle, ensuring the right balance of risk and benefit.
ClariMed's goal is to provide sponsors with a clear path to market, accelerate that path through iterative training steps and scalable development services, and ensure risk mitigation through an integrated approach. This accelerated approach allows for greater efficiencies and leads to better regulatory, go-to-market, and usability outcomes.
With the appointment of Kelley Kendle as CEO and Chairman of the Board, ClariMed is led by an executive with extensive experience in service-based businesses for pharmaceutical and medical device companies. She previously held executive positions as President and CEO of Synchrogenix (a Certara subsidiary), as Director of Solutions at Certara, a strategic regulatory services firm focused on the pharmaceutical industry, and as CEO of a European medical device CRO.
Kelley Kendle, CEO and Chairman of the Board of Directors, commented:
"Evolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating sponsors of medical products to continue to focus on risk mitigation. These sponsors need a strategic partner with a differentiated platform of services to guide them through development milestones while maintaining a constant awareness of evolving agency expectations.The ClariMed team will help our clients balance the risk-benefit ratio and get usable product to market faster. We will bring together experienced companies with differentiated services to provide a complete offering and a multi-regional presence. I look forward to building a team that will have such a significant impact on people's lives."
ClariMed was formed in association with NaviMed Capital, an investor focused on healthcare. "Recognizing MedTech funders' significant need for a service-focused and agile partner, NaviMed is proud to partner with Kelley Kendle and the ClariMed team," said Josh Boylan, ClariMed Board Member and Vice President of NaviMed Capital.
San Jose-based UserWise is the leading independent provider of human factors. Offering usability and human factors engineering services, usability study recruitment, market research/simulation facilities, and IRB services, UserWise has built a reputation as a thought leader in the human factors space. ClariMed's acquisition of UserWise is an exciting step as ClariMed builds on its human-centric approach to the MedTech product lifecycle.
Shannon Clark, founder and CEO of UserWise, commented:
"We have attracted the best and brightest next-generation human factors engineers and participating recruiters as we focus on building a world-class organization. We are experts in human factors for medical product development and leverage our individual experiences , ranging from Fortune 500 medical product companies to leading start-ups, to empathize with internal innovators and work seamlessly with their teams This broader perspective that human factors is one small piece of a larger puzzle it is the key to developing successful and useful medical products. We are delighted to have ClariMed's support as we continue to pursue our common goals of maximizing the health, well-being and safety of patients and users of medical products."
"We are delighted to partner with UserWise given the breadth of their expertise in medical products, including robotic surgery, at-home products, combination devices, etc." said Brian Canann, ClariMed Board Member and CEO from NaviMed Capital.
About ClariMed
ClariMed is a human-centered regulatory and development practice for medical products developed by pharmaceutical and medical device manufacturers. Our best-in-class professional services cultivate innovation while ensuring the safe and effective use of medical products. Visit us at www.Clarimed.com.
About UserWise
UserWise is committed to improving the results of medical products through human factors and usability engineering. Our in-depth understanding of human-centered design, testing, and engineering ensures best-in-class medical products, delivering safe and unrivaled medical innovation. Visit us at www.userwiseconsulting.com.
About NaviMed Capital
NaviMed is a Washington, D.C.-based private equity firm with more than $400 million in assets under management, focused exclusively on the healthcare industry. NaviMed invests in fast-growing healthcare companies in lower-middle markets that NaviMed believes are poised to benefit from technological reform and innovation that are reshaping the healthcare industry. The company focuses on healthcare services, healthcare IT, hospital products and pharmaceutical services. NaviMed focuses on profitable private companies with EBITDA up to $10 million and double-digit revenue growth. NaviMed's senior investment team has a track record of creating value that collectively spans dozens of investments and more than $11 billion of business value created over the course of their combined careers.
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