Is it possible to leverage technology and AI to improve Compliance and Certification in Healthcare, specifically in the software and device space?
We’ve talked on this show before about the confluence between consumer technology & medical devices/software. With this comes an increasing emphasis on regulatory compliance, FDA certification, and the like. For example, with Remote Therapeutic Monitoring (RTM), providers must use an approved Software as a Medical Device to deliver that service to patients. And, for many of the clients I work with in the healthcare technology & innovation space, the discussion around FDA approval and certification plays a key role in the go to market strategy. And, historically, it required a lot in the way of man hours and financial resources to put together the required literature reviews, clinical evidence, and clinical evaluation reports (CER) for submission to the regulatory body. However, technology could potentially play a roll in streamlining and improving the efficiency required in compliance and certification in healthcare.
So, this week, I sit down with Ethan Drower from CiteMedical to talk about how artificial intelligence (AI) and software can cut down the required time, energy and resources needed to remain compliant and gain approval or certification from necessary regulatory bodies in healthcare.
What we cover in this Episode:
- Requirements that software companies, startup and devices need to become approved or certified as medical solutions
- The importance of gathering the necessary clinical evidence to support marketing claims in healthcare
- How much this process costs and requires from the companies seeking compliance and certification in healthcare
- How artificial intelligence can help streamline the regulatory process
- The pros and cons of launching in the consumer market first and then branching into medical vs diving right into the medical market
- Achieving Better Outcomes by leveraging technology to streamline processes and reduce costs
We post videos of certain podcast episodes, including this episode, which can find on the YouTube Channel.
Connect with Ethan & CiteMedical
For More:
If you enjoyed this episode: Join Rafael E. Salazar II, MHS, OTR/L (Rafi), principal of Rehab U Practice Solutions and host of The Better Outcomes Show as he explores the possibilities of a new healthcare. Guests range from clinicians trying new techniques and treatments to executives and entrepreneurs exploring new service delivery methods, business models, and organizational structures. You can sign-up to receive new episodes delivered directly to your inbox by filling out the form below. Learn more about Rehab U Practice Solutions by reading The Manifesto for a New Healthcare, or listen to Episode 000. Or, grab a copy of the book: Better Outcomes: A Guide to Humanizing Healthcare.
Are You Ready to Humanize Healthcare?
If you run an innovative healthcare company and are looking to develop a strategy that leverages best practices, new technology, and marketing/messaging in a way that returns the focus of healthcare to people, please reach out. I’d love to talk with you about how Rehab U Practice Solutions can help help you craft an business development strategy that leverages positioning, market research, UVP stakeholder alignment to drive business development strategy for specific healthcare stakeholders.
Rafael E. Salazar II, MHS, OTR/L (Rafi) is a healthcare consultant, speaker, and host of he Better Outcomes Show. He helps healthcare startups, SaaS platforms, and organizations craft clear positioning, humanize the patient experience, and go to market effectively. He’s the author of Better Outcomes: A Guide to Humanizing Healthcare and principal at Rehab U Practice Solutions. His work on Telehealth has been discussed in Forbes, and he’s advised on projects ranging from digital health product launches to multi-million-dollar healthcare transformation initiatives.
Today, Rafi helps innovative healthcare companies like technology startups, platforms, SaaS companies & innovative healthcare organizations develop effective positioning strategy and business development plans through his consulting work. He also leverages his experience as a professor and academic to speak and train on the topics around humanizing the healthcare experience & healthcare innovation. In addition, Rafi also owns and operates ProActive Rehabilitation & Wellness, a multidisciplinary outpatient clinic treating patients with musculoskeletal pain.
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Work With Me
Are you building something innovative in healthcare—like a digital health product, service, or platform that’s aiming to truly improve the patient experience?
I help healthcare startups, SaaS platforms, and forward-thinking provider organizations develop clear positioning strategies, identify high-value offers, and build go-to-market plans that actually resonate with both users and buyers.
Whether you're launching a new product, scaling an existing service, or navigating digital transformation, I bring 12+ years of experience across clinical operations, healthcare innovation, and strategic development.
How I help:
- Clarify your product/service positioning so customers “get it”
- Align your offer with real market needs
- Build a Digital Health Roadmap to scale your healthcare organization effectively
- Support business development with industry-informed strategy
I’ve consulted on projects from multi-million-dollar state initiatives to early-stage product launches. My work’s been featured in Forbes, and I also speak at healthcare events and conferences on topics like innovation, digital health, and humanizing care. I also speak and train at healthcare conferences, events, and organizations on topics related to technology-enabled care, healthcare innovation, healthcare positioning, and humanizing the healthcare experience.
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