Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain.

• The medical world works on 2-D pharmaceutical schematics, but doctors’ minds work on three dimensions. Physician inventors see the whole body, person, and need to develop effective medical products.
• Physician inventors think they know everything, so it’s difficult for them to follow ISO 13485 and painstaking medical device development and not get frustrated. 
• The time duration for Amy’s innovation and invention journey took years to get patents, meet regulatory requirements, and address the opioid crisis. 
• Pain management is esoteric and subjective. Amy encourages physician inventors to fall in love with their problem, not their solution. Pain, chronic or not, is a real problem. 
• Amy shares life lessons for physician colleagues with innovative ideas. Find a group like Greenlight Guru or GCMI to understand navigation early on. Branding matters, so choose wisely.
• Also, Amy advises physician investors to not get hung up on non-disclosure agreements (NDAs). Nobody steals an idea, they steal a medical product.
• Amy expects the future of pain management to include multiple specific energy devices in people’s medicine cabinets to use before and after surgery. Mechanical stimulation will be the primary one because it’s easy and safe to use.
• Buzzy® is a palm-sized device that combines cold and mechanical stimulation to block pain and improve muscle soreness, blood flow, and recovery. The VibraCool® Cryo-vibration product, VibraCool’s M-Stim, is 2-3.4 times superior to electrical stimulation (TENS) for physical therapy. It has demonstrated 35% fewer opioid tablets. Also, a lower back pain device is in clinical trials and expected to be released this year.

“We see the whole body, we see the whole person, and we see the need.”

“The downside of being a physician inventor is that we both feel like we know everything.” 

“Wanting to be able to do something is really the push that puts a lot of physicians into the entrepreneurial space.”

“Fall in love with your problem, don’t fall in love with your solution.”

“Try your idea out on someone who does not love you.”

Pain Care Labs

ISO 13485 - Medical Devices

ISO 14971 - Application of Risk Management

FDA - Part 11

EU MDR

NIH Small Business Innovation Research (SBIR))/Small Business Technology Transfer (STTR) 

Mayday Foundation

Global Center for Medical Innovation (GCMI)

Dr. Richard Melker

Medical Device Podcast, Ep 186: Building a Startup in the MedTech Industry 

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru