Clarity for MedTech
Empowering digital health innovation with purpose-driven precision.
About
My name is Nikki Batista
My goal is to drive digital health forward with experienced insight, principled leadership, and a heart for meaningful impact.
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BS, MEng Biomedical Engineering
11+ years of medical device experience as FDA regulator, consultant and industry leader.
Drawing on deep expertise in regulated product development, regulatory strategy, usability engineering, and cross-functional leadership, I help translate ambitious ideas into market-ready solutions. I blend strategic foresight with hands-on execution to guide clients toward regulatory clarity and operational confidence—equipping them with the knowledge and tools to lead independently and thrive long after our engagement ends.
I specialize in supporting digital health startups navigating the ever evolving regulatory and compliance landscapes of regulated software and connected devices. I am drawn to teams who value collaboration and approach innovation with integrity. My passion lies in supporting teams tackling real-world clinical needs with technologies that truly improve health outcomes and promote health literacy.
Free the fundamentals.
Pay for precision.
Companies should have access to free tools and templates that provide fundamental knowledge and guidance to successfully navigate regulated product development. I have created a library of resources that you may use however you'd like! No paywall, no contact info required.
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Want customized support? Check out the service offerings below!
Services
Trusted advisor. Authentic leader. Kindred mentor.
Strategic Advisory
I offer advisory services tailored for organizations navigating critical business decisions. Picking a predicate device, evaluating digital health regulations against your product roadmap, designing a study, exploring a strategic partnership or investment - whatever it may be - my guidance bridges technical depth and business acumen.
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Billed at an hourly rate.
Fractional Executive
In this embedded role, I lead regulatory and quality functions, helping shape long-range strategy, build scalable systems, and align execution with FDA, ISO, and IEC standards. From hiring and mentoring internal staff to vetting vendors and guiding organizational change, I provide full-spectrum executive-level support tailored to each company's pace, culture, and mission.
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Billed at a monthly retainer fee.
MedTech Mastery
I design and deliver company-specific workshops that translate complex regulatory and engineering concepts into accessible, team-ready knowledge. Each session is customized to reflect the organization’s product maturity, market goals, and internal workflows—connecting theory to execution in areas like risk management, usability engineering, or design controls.
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Billed at a flat-fee per workshop.
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