Welcome back to Health Unlocked! In today’s episode, Jasen Petersen explores a fascinating and refreshingly practical side of health innovation: how medical devices like IBAL are rewriting the rules of bringing new interventions to market. If you’ve ever wondered why some health-supporting products aren’t classified as drugs or supplements, or how the FDA draws that crucial line, you’ll love this discussion.
Jasen, speaking from both professional and personal experience (post-lithotripsy, no less - ouch!), walks us through the surprising world of medical device regulation. He explains why IBAL, a micronutrient matrix designed to restore foundational cellular health, qualifies as a medical device rather than a drug and why that distinction could make innovative treatments far more accessible, affordable, and fast to reach those who need them most.
Along the way, you’ll hear about strange regulatory quirks (like how toothpaste can be a cosmetic, a drug, or a device!), learn what it truly means for something to have a “PMI mechanism,” and get a behind-the-scenes look at how shifting the regulatory path from drugs to devices could transform healthcare innovation for both patients and investors.
By the end, you’ll have a whole new appreciation for how creative science, regulatory strategy, and a bit of bold thinking can work together to unlock better health for everyone. Let’s dive in!
Timestamps:
00:00 "IBAL: Redefining Medical Regulations"
04:23 "Foundations of Immune Healing"
08:50 Drug vs. Device Development Timelines
11:01 Drug vs Device Development Differences
15:20 Biotech Confidence in Non-PMI Drugs
20:01 IBAL Ingestion Risks and Alternatives
23:30 "Possibilities for Medical Innovation"
27:43 "Medical Device Outperforming Drugs"
28:48 Drug vs. Device Approval Risks
32:46 "Ion Gel Medical Device Approval"
36:07 Tokenized Research for Immune Continuum
39:26 "Grateful Acknowledgment"
How Medical Devices Are Fast-Tracking Health Innovation: Insights from Jasen Petersen
In the latest episode of the "Health Unlock: the Power of Salutogenesis" podcast, Jasen Petersen explores an important and often misunderstood aspect of medical innovation. The focus is on IBAL, a cutting-edge product poised to reshape how health solutions reach the market by choosing the medical device pathway over traditional drug development. If you care about faster, safer, and more accessible healthcare interventions, this conversation is packed with key insights.
Why IBAL Is Not Just Another Drug or Supplement
Most people are used to thinking that if something promotes health, it is either a drug or a supplement. However, as Jasen explains in the episode, "IBAL's really different than both of those." Unlike drugs, which change our biology through pharmacological, metabolic, or immunological mechanisms, IBAL simply supplies missing cofactors that the body already uses to maintain a resilient vocal terrain. Jasen describes it as scaffolding: "It doesn't build the wall, it just holds the structure so that the wall can be set."
In terms of FDA regulation, this means IBAL qualifies as a medical device, not a drug or a supplement. The FDA focuses on the mechanism of action rather than the outcome, so if a product is restoring biological conditions instead of forcing pathways, it may fit under device regulations.
Understanding FDA Classification: Drugs vs. Medical Devices
The pathway to market is largely determined by how a product works. According to Jasen, "If the product actually changes your biology through pharmacological, metabolic, or immunological routes, then it's a drug." By contrast, if it supports the body's natural functions without directly altering metabolism or immune response, it can qualify as a medical device. IBAL restores nutrient sufficiency and helps balance redox, mitochondrial flexibility, and resolution competency, but does not force these capacities. That distinction speeds up regulatory approval and opens new routes for health interventions.
Medical Device Development Means Faster, More Affordable Access
One of the episode's standout insights concerns the difference in time and cost between drug and medical device development. Jasen points out, "Drugs typically take over a decade and can cost north of a billion dollars. Devices are often cleared in just a year or two for under a few million dollars." The implication for patients and innovators is enormous; medical devices offer a pathway to bring effective treatments to market much faster and at a fraction of the cost.
Real-World Examples: Surprising Medical Devices
The podcast highlights how classification isn't just academic. Jasen shares that something as simple as toothpaste can fall into different regulatory categories: natural toothpaste is a cosmetic, fluoride toothpaste is an over-the-counter drug, while toothpaste for sensitive teeth can be a medical device if it acts physically by blocking nerve stimulation. IBAL finds precedent among wound healing products that use metal ions to kill microbes. The team behind IBAL is optimistic, noting, "There are multiple predicate devices especially for the ion gel ZCM25 which is currently the only IBAL based medical product."
Advantages for Access, Equity, and Innovation
Faster approval, lower costs, and straightforward safety testing mean medical devices can improve access and equity. As Jasen states, "From a humanitarian perspective, it could save lives much more quickly." The regulatory flexibility also supports decentralized science, encouraging broader community involvement and investment.
Looking Forward: The Impact of Medical Device Pathways
As the episode wraps up, Jasen is confident: "We can take the ion gel and go through the medical device 510k process in the US, get that approved as a medical device. It's already approved in Mexico and the UAE." With proven efficacy and ongoing efforts to secure funding, IBAL is set to be a game-changer.
Please stay tuned for more updates on IBAL’s progress and learn how you can get involved in supporting this remarkable health innovation. The promise is clear: thanks to medical device pathways, the future of faster, safer, and more affordable healthcare is closer than you think.
“Disclaimer: Informational only. Not medical advice. Consult your doctor for guidance.”
Show Website - https://powerofsalutogenesis.com/
Ionic Alliance Foundation Website - https://iaf.care/
Jasen Petersen's LinkedIn - https://www.linkedin.com/in/jasenepetersen/
TopHealth Media Website - https://tophealth.care/