ClariMed, Inc Announces Integrated Service Partner For Medical Devices

ClariMed, Inc. today announced the launch of the first MedTech service partner to take an integrated, human-centric approach to medical device development. The Company also announced today the acquisition of San Jose-based UserWise, LLC and the appointment of Kelley Kendle as Chief Executive Officer and Chairman of the Board of Directors. The company was founded in partnership with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.

ClariMed was founded to meet the MedTech industry’s growing need for an integrated partner focused on development and regulatory services. ClariMed prioritizes a human-centric approach to MedTech’s product lifecycle & follows an integrated path that differs from the current fragmented support ecosystem that sponsors face when bringing products to market and meeting regulatory requirements. With the increasing diversity of medical device users and growing regulatory requirements, MedTech innovators are struggling to find partners who can understand, coordinate and meet the growing demands for human-centric product design and development.

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Today, sponsors have to reach out to multiple vendors and coordinate these very complex efforts themselves, taking time and resources while sacrificing continuity and an integrated approach. ClariMed aims to address this unmet need by integrating best-of-breed service partners for product design, engineering and development in an interdisciplinary approach that focuses on human factors and regulatory aspects.

The ClariMed team brings a fundamental understanding of the needs and capabilities of users in the context of the respective environment and systems. It covers the entire product life cycle and ensures the right risk-benefit ratio.

ClariMed’s goal is to provide sponsors with a clear path to market, accelerate this 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 results in terms of regulation, marketability and usability.

With the appointment of Kelley Kendle as CEO and Chairman of the Board, ClariMed will be led by an executive with extensive experience in service-based companies focused on medical devices and pharmaceutical companies. Previously, she held leadership positions as President and CEO of Synchrogenix (a subsidiary of Certara), Chief Solutions Officer of Certara, a strategic regulatory services company focused on pharmaceuticals, and CEO of a European medical device CRO.

Kelley Kendle, CEO and Chairman of the Board, commented:

“Evolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating medical device sponsors to remain focused on risk mitigation. These sponsors need a strategic partner with a differentiated platform of services that will allow them to be guided through the milestones of development while keeping an eye on the evolving expectations of the authorities. The ClariMed team will help our customers balance the risk-benefit factor and bring a usable product to market faster. We will bring together experienced companies with differentiated services to provide a comprehensive 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 founded in partnership with NaviMed Capital, a healthcare-focused investor.” NaviMed recognizes the significant need of MedTech sponsors for an agile, service-oriented partner and is proud to partner with Kelley Kendle and the ClariMed team,” said Josh Boylan, Board Member and Vice President of NaviMed Capital.

Based in San Jose, UserWise is the leading independent human factors provider. UserWise provides services in human factors and usability engineering, usability study recruitment, market research/simulation facilities, and IRB services, and has built a reputation as a thought leader in human factors. ClariMed’s acquisition of UserWise is an exciting step as ClariMed builds on its human-centric approach to the MedTech product lifecycle.

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Shannon Clark, founder and CEO of UserWise, commented:

“We have attracted the best and brightest next-generation engineers for human factors and participant recruitment while focusing on building a world-class company. We are human factors experts in medical device development, leveraging our individual experience ranging from Fortune 500 medical device companies to leading start-ups. We want to empathize with internal innovators so we can work seamlessly with their teams. This broader perspective, that human factors are a small piece in a larger mystery, is key to successful development of usable medical devices. We are pleased to have ClariMed’s support as we continue to pursue our shared goals of maximizing the health, well-being and safety of patients and users of medical devices.”

“We are pleased to be working with UserWise as they have the breadth of their expertise in medical devices, including robotic surgery, home products, combination devices and more,” said Brian Canann, board member and managing director of NaviMed Capital.