ClariMed, Inc., announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development. The Company also announced the acquisition of San Jose-based UserWise, LLC, and the appointment of Kelley Kendle as Chief Executive Officer and Chair of the Board of Directors. The Company was formed in partnership with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.
ClariMed was formed to meet the MedTech industry’s growing need for an integrated partner focused on development and regulatory services. ClariMed embraces a human-centric approach to the MedTech product lifecycle, taking an integrated approach that differs from the current fragmented support ecosystem that sponsors face when bringing products to market and meeting regulatory requirements. With the increasing variety in users of medical products and growing regulatory requirements, MedTech innovators are struggling to find partners who can understand, coordinate, and meet the emerging requirements for human-centric product design and development.
Today, sponsors must go to multiple vendors and coordinate these very complex efforts themselves, requiring time and resources while sacrificing continuity and an integrated approach. ClariMed aims to address this unmet need by integrating best-of-breed services partners across product design, engineering, and development services in a cross-disciplinary approach that embeds human factors and regulatory disciplines at its core.
The ClariMed team brings an essential understanding of user needs and abilities within the context of their environments and systems that spans the entire product lifecycle, ensuring the right risk-benefit balance.
ClariMed’s goal is to provide sponsors with a clear path to market, accelerate that path through iterative formative steps and scalable development services, and ensure risk mitigation through an integrated approach. This accelerated approach enables greater efficiency and leads to better regulatory, marketability, and usability outcomes.
With the appointment of Kelley Kendle as CEO and Board Chair, ClariMed is led by an executive with a wealth of experience in service-based businesses targeting medical device and pharmaceutical companies. She previously held executive positions as President and CEO of Synchrogenix (a subsidiary of Certara), as Chief Solutions Officer of Certara, a pharma-focused strategic regulatory services business, and as CEO of a European Medical Device CRO.
Kelley Kendle, CEO and Board Chair, commented:
“Evolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating medical product sponsors to continue their 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 risk-benefit and get a usable product to the market faster. We will bring together experienced firms with differentiated services to provide a comprehensive offering and a multi-regional footprint. I look forward to building a team that will have such a significant impact on people’s lives.”
ClariMed was formed in partnership with NaviMed Capital, a healthcare-focused investor. “Recognizing the significant need from MedTech sponsors for an agile, services-focused partner, NaviMed is proud to partner with Kelley Kendle and the ClariMed team,” said Josh Boylan, ClariMed Board Member and Vice President at NaviMed Capital.
UserWise, based in San Jose, is the leading independent human factors provider. Offering human factors and usability 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 & CEO at UserWise, commented:
“We have attracted the best and brightest of next-generation human factors engineers and participant 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, which range from Fortune 500 medical product companies to leading start-ups, to empathize with in-house innovators to work seamlessly with their teams. This broader perspective that human factors is a small piece in a greater puzzle is the key to developing successful, usable medical products. We are excited to have the backing of ClariMed as we continue to pursue our common goals of maximizing the health, well-being, and safety of medical product patients and users.”
“We are excited to partner with UserWise, given the breadth of their expertise across medical products, including robotic surgery, home-use products, combination devices, and more,” said Brian Canann, ClariMed Board Member and Managing Director at NaviMed Capital.