11 min reading time

This week I’m inviting group comments about medical devices intended to reduce pain without drugs, and your experience with these devices if you suffer.

Recent CDC statistics: As many as 1 in 4 on prescription opioids struggle with addiction. 64,000 drug overdose deaths in 2016, the highest recorded in the US.

I wondered, what’s our community doing about it?

Turns out, quite a bit.

Researching today’s post, I learned 50-60,000 US patients get spinal cord stimulators each year.

According to one projection, the neurostimulation devices market will exceed $13B by 2023, led by Medtronic, Boston Scientific, Cyberonics, Neuronetics, Codman, St. Jude, and others.

MedDeviceOnline editor Bob Marshall published an interesting Oct 9 story about SPR Therapeutics, makers of the only FDA-cleared percutaneous peripheral nerve stimulation system. See http://bit.ly/SPRTher for Bob’s story.

SPR was among three mentioned in an MIT Technology Review story called “New Devices Promise to Fight Pain without Opioids.” Relative newcomer Nevro gained FDA clearance in 2015 with a device which delivers “high-frequency stimulation that can’t be felt by the patient.” And the Neuro-Stim System Bridge, attached behind the ear, stimulates the brain’s pain center.

In cranial electrotherapy stimulation (CES), Alpha-Stim is probably the best-known brand among many competitors. I didn’t reach them in time for this story. What’s your experience with CES?

My short write-up surely misses a number of pain-fighting devices. What can you share in today’s comments?

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More seats added: Hundreds have registered for Beth Brooks’ webinar with us next week entitled, “How to Get Past the Value Analysis Committee,” so we added more seats.

Register now at https://medgroup.biz/vac for smart tips how to sell more devices into hospital systems.

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Joe Hage
Medical Devices Group Leader

P.S. If you or a loved one suffers from opioid addiction, please visit and get help.

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Great comments, folks, keep them coming. John Saringer, you’re welcome to post a link or information on this thread since you seek critical feedback.

Michael Murphy, thank you for sharing your personal story. I’m intrigued, how often do you have to recharge? How long does the charge hold? How disruptive is this extra burden to your daily routine?

Julie Omohundro
Principal Consultant at Class Three, LLC
Potential side effects of neurostimulation:

• Allergic reaction to medications during implant surgery
• Infection at implant site
• Cerebrospinal fluid (CSF) leakage
• Damage to the nerves
• Movement of the implanted generator or leads
• Pain after surgery
• Interference with pacemakers, defibrillators, MRI, can result in severe burns, other serious injury, or death.
• Skin irritation, redness, hives, or welts on electrode site
• Lung atelectasis, edema, paresthesias, pain, seizures
• Nausea, dizziness

I would challenge the industry to come up with an effective alternative to opioids that does not involve implantation of an active device.

Julie Omohundro
Principal Consultant at Class Three, LLC
No implants, please.

Michael Todd
Sr. Retina Territory Manager at BVI Medical
Gary Dulak – Agree 100%. Chronic Pain will be treated w electrical stimulation of the nerves. The next frontier!

Michael Fegley
Sales Director at Electromedical Products International
Thanks for the mention Joe, and an excellent conversation to have. As Sales Director for EPII (Alpha-Stim), I can tell you there is a significant increase in need, coming from both practitioners and patients that have interest in devices that reduce pain, as well as the comorbidities of pain which include anxiety, insomnia and depression. They are looking for a treatment that is that is non-addictive and non-invasive. The ability to treat these conditions does set us apart from any other device on the market. The Alpha-Stim treats anxiety, insomnia and depression with CES (Cranial Electrotherapy Stimulation) as well as pain with MET (Microcurrent Electrical Therapy). I believe the reason for the significant growth of our company, aside from having a good product with research, is exactly what you mention above, and there is definitely a spiral downhill once the patient is addicted. The medical community is catching on and patients are proactively looking for alternatives to meds.

Amy Baxter MD FAAP FACEP
Founder & CEO at Pain Care Labs (formerly MMJ Labs)
I quit practice when one of my colleagues used Buzzy to avoid opioids for his knee replacement, and reconfigured our external neuromodulation cold/high frequency vibration device to be a bigger VibraCool. Turns out vibration actually speeds repair of bone/tendon/decubitus ulcers in several studies, while both cold and vibration address pain. I’ve prototyped my low back pain device, and am trying to advocate for OTC neuromodulation and retraining MDs to advocate for numerous physical solutions for physical pain problems. I made an infographic of evidence based pain solutions, working to get it incorporated in pain prescribing programs.

Dennis Kroft
Senior Communications and Marketing Leader
Timely and relevant.

John Eckberg
Media Relations
I know a psychologist who claims Alpha-Stim has never failed to treat substance abuse…and POST traumatic stress.

John Eckberg
Media Relations
I know a psychologist who says Alph Stim has never failed to work on his addicted patients or those with PTSD. A similar technology has kept Keith Richards clean for three decades.

Gary Dulak
Excellence in Medical Device realization for patient benefit
To answer your question, absolutely MedTech can help. Our bodies are electric and we have just clipped the tip of the iceberg of possibilities with electrical stimulation and neuromodulation. It is time to start considering these options more seriously and decrease the number of pills we are popping. Some of the great upsides is electricity does not have system toxic effects, can treat pain locally and is non-addictive. There is good electrical technology in the marketplace and even better in the pipeline. Even over-the-counter TENS units like Icy Hot are not used nearly enough. Some of us that are close to it know it’s power (pun intended) and it is our duty to generate the top-tier clinical evidence that demonstrates it’s efficacy.

Roger Cepeda, JD, MBA, RAC
Medical Device and Biotech Attorney
Looks like Innovative Medical just obtained FDA clearance for a device that seems to help with opioid symptoms. Originally cleared for use with acupunture, it goes behind the ear. Joe- you were prescient with this conversation. 🙂 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm

Amy Baxter MD FAAP FACEP
Founder & CEO at Pain Care Labs (formerly MMJ Labs)
Walter Flicker, I totally agree. There are a few truths which should inform medical device creation. 1) physical problems need physical solutions. I wrote about this here: https://www.linkedin.com/pulse/stopping-opioid-epidemic-pain-physicians-payment-simple-amy-baxter-md (has the infographic)

2) our fear of pain and quick fix society have to change before effective non-drug treatments will really catch on: https://www.linkedin.com/pulse/avoid-opioid-addiction-face-pain-like-dancer-amy-baxter-md

3) anything that stimulates the ABeta nerve (high amplitude stim, vibration, massage) will decrease pain. Anything that stimulates the g-protein gated ion channels (stim, vibration, pulsed electromagnetic fields, ultrasound) will speed repair. Different embodiments help different body parts and lifestyles and people, and understanding WHY these things work (it’s mechanical, not some mystical “filling of the body with electricity”) will help them all gain acceptance among physicians .

Katie Bates
CITO MEDICAL – Biotech & Medical Product Development
Thanks Joe!

Michael Murphy
President at Conatus Consulting, LLC
I have a spinal cord stimulator from Boston Scientific. I know it is a very difficult decision for patients due to the fact that it is “permanently” placed in the spine and back. The most difficult aspect is trying to keep the stimulator charged. The current technology requires the patient to lay absolutely still while charging to keep the charger in close proximity to the generator. Bottom line is that they work and do help reduce the need for oral analgesics.

Katarzyna Zofia C.
Senior Quality Assurance & Regulatory Affairs & Clinical Affairs (BE + MSc + MBA Student)
@stefania MariaClelia de Matteo

Dr. Patricia Chinwe Onuoha PhD,MSC, MD,BCCS
P&A HEALTH ASSESSMENT AND MANAGEMENT LLC , MEDICAL DIRECTOR/CEO at Health Clinic
Medical devices can help in reduction of opioid challenges and could also promote the challenge.
Yes, packaging and repackaging could be the sole of success in this opioid challenges globally.
We can use devices to mentor and educate opioid users against it or for it.
There is a saying that eyes sees and tell the mind and mind consume and prepares as well as executes actions.
Is there a way or pattern of packaging devices that could bring discouraging messages to opioid users in sight!once done l believe we will hit the target !
Thank you.

Anila Cake
University of Medicine, Faculty of Medical Sciences Tech
Given the side effects of Opioids, such treatment would significantly prevent complications from Opioid.

Joel Bradus
Managing Partner
The brain processes physical trauma and emotional trauma in much the same way. Nexalin was originally developed as an electronic analgesic. The ability to alleviate insomnia, depression and anxiety (Ativan) led to FDA clearance. Nexalin activates what I refer to as the endogenous opiate system of the body. Endorphins increase, enkephalins increase, substance P associated with pain decreases, and neurotransmitters like serotonin, norepinephrine and dopamine flow better. Like an opiod without the high, addiction or side effects. I just successfully treated a complex regional pain syndrome sufferer. The results are life changing.

Craig Herron
Managing Partner at iSelect Fund
Take a look at Neuros Medical (www.neurosmedical.com). From an article, “The company’s device is a small implant that the patient turns on with a remote to electronically block selected nerves from sending post-amputation pain signals to the brain. “We’ve conducted studies in which patients have used the device over 4,300 times, with 95 percent reduction of pain medication usage. Some patients who were taking over a dozen pills per week stopped taking their pain medication altogether after using the device,” said Jon J. Snyder, president and CEO of Neuros Medical. http://www.neurosmedical.com/images/Neuros_Medical_Eases_Pain_Without_Pills_TechOhio_June_2016.pdf

Karen Kloser
We’re back in R&D on the next generation of our external jaw support dental device with up to $1.2M in STTR funds.
Jaw pain is the second most common chronic pain condition (back pain is first) (nidcr.nih.gov). Dentists are the fifth highest prescribers of opioids. Our product, the Restful Jaw® support device, is clinically proven to minimize jaw pain and fatigue from dental procedures. It’s non-invasive, non-surgical, reusable, universal fit and comfortable. In clinical trials, patients overwhelmingly wanted to use the device for their next dental appointment. If your dentist doesn’t offer the Restful Jaw device, ask him/her to get one. Who doesn’t want less pain after seeing the dentist?

Bill Stamm
Vice President at General Digital Software Services
Yes! My team at General Digital just completed the Prototype phase as a prime contractor for a medical device that will change the way health professionals manage pain and administer pharmaceuticals, among other capabilities…it will change the world in this regard. Stay tuned as this device is tested and it hits the market.

Jason Assad
President C&H Capital, Inc.
Chronic lower back pain is a leading driver of opioid prescribing habits. Our team @Medovex has a device now CE Marked and being used by Dr.’s to treat pain associated with the Facet Joints, which covers about 31% of all back pain.

Our DenerveX is a non-narcotic, non-steroidal, non-addictive alternative to opioids that can restore a patient to a more normal, active lifestyle. #DenerveX #backpain #facetjointsyndrome #opioids

Justin Pickering
Experienced Medical Sales Consultant and business owner
Alpha-Stim… look it up or message me for info.

Pamela Calad
Results-driven Digital Marketing & Communications Manager
This is a great topic, given the prevalence and tragic impact of opioid overuse. Another assitive device that’s clinically proven to reduce pain without the use of drugs is Össur’s knee & hip braces for patients struggling with osteoarthritis – Unloader Braces (https://www.ossur.com/unloader-braces). Össur has made a name developing innovative prosthetic devices and is leveraging that innovation to improve OA patients’ mobility and quality of life. Whereas pain meds like opiods just mask the pain, Össur’s Unloader braces actually address the cause of the pain – the bone on bone contact – and bio-mechanically relieve contact within the joint, allowing patients to get back to doing what they love, pain-free, BUT without the worry of causing further joint damage.

John Saringer
CEO at Saringer Research Inc
We’re coincidentally launching a new contrast therapy pain relief device in the next few months. We’re looking for critical feedback. We hope to offer the product online for $99 US. Best results are for the treatment of localized chronic pain or migraines. Typical relief following a 20 minute treatment is for a few hours to 2 days and we expect up to 50% reduction in the need for drugs.

Walter Flicker
Principal at Walter Flicker Consulting
One drastically overlooked CURE is appropriate exercise/spinal alignment programs. These cost very little, but require a lot more effort than popping a pill (which make them unattractive to most Americans).

Avigail Berg-Panitz, MA
Wellness expert and TheSoundWell-Vibroacoustic therapy Owner,
We provide integrative wellness vibroacoustic therapy – low sound frequency equipment – mats and pillows- Therapy invented in Nordic countries – Norway / Finland . the following study was done with our solutions
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4325896/
we will be happy to collaborate in research and integrative approach.
Avail http://www.vibro-therapy.com/research and more studies from around the world Nordic countries , Canada:https://drive.google.com/file/d/0ByfSfYOMMG5XMTY2M3Y5NnYzVUU/view?usp=sharing

Rob Lloyd
Managing Director at Rophi Cushions Limited
Excellent article. It just shows you that, if you investigate the real reasons to the CAUSE of the pain. you can assimilate your findings and ‘reverse’ the causes and locate the true source. The Rophi Spinal Alignment Cushion, now a UK fully funded prescription, endorsed by the National Institute of Health and Care Excellence, does just that, without breaking the skin and having NO side effects. Rophi Cushions Limited is now seeking partners to introduce the Rophi to the USA. If you are interested, please visit www.rophi.co.uk for full contact details.

Charles Marlin
Professional Liability Underwriting, Energy Reduction Solutions and Financing, Healthcare Technology Advocate
Joe – I am a patient as well as a representative for a company that has had technology in the market for 20 years that delivers electrical anesthesia. In most patients it takes them out of pain, or lowers the level of pain by 50% or more in 25 minutes. The duration of relief with an initial treatment varies, and can last anywhere from hours to days. A series of treatments will often keep the patient out of pain for many months. The company is NeuroMed,Inc Please do not confuse this with a simple TENS unit. The device is designed to treat acute pain as well as chronic disease pain in the many forms that it manifests itself. The technology is used by a number of NFL teams to treat multi-million dollar athletes, and college athletes as well. There are over 2,500 physicians using the technology to treat patients across the US, and 20 prestigious hospitals. Ask me why and I’ll share why such an effective form of treatment has been eclipsed in favor of less effective solutions.

Rob Lloyd
Managing Director at Rophi Cushions Limited
We have been researching and developing an inexpensive, inexpensive, totally drug free solution to the curse of low back pain. In the UK, cost is now battleground with our National Health Service doing all it can to reduce the repeat prescription issue for NSAID’s and Opioids which not only costs the UK taxpayer millions of pounds a year but also then has to fund the after effects of the often debilitating side effects, without actually solving the low back pain issue. Our Rophi Spinal Alignment Cushion has now been approved by the NHS as a funded prescription device as well as being endorsed by the National Institute of health and Care Excellence, the UK body that agrees to the funding. You may think the Rophi is a simple solution but, as so often happens, it’s the simple solutions that are the most effective. We are now looking for a USA Partner to introduce the Rophi to the American public. Anyone interested?

Sean Hägen
Principal, BlackHagen Design
Yes, I might rephrase the question just a bit, to ask can Design help? But from my perspective one potential solution does involve devices but requires addressing design help with workflow and protocols in the OR, recovery and post-surgical/post-hospital care. By reducing the use of opioids in the OR from the start by using nerve blockers, localized pain management rather than systemic, opioid- free or opioid- sparing anesthesia and analgesia; studies are showing great progress with reduced PACU time and less prescription opioid requirements.
The device involved is a take home drug pump that delivers a controlled medication localized to the surgical site. These are currently, well, less than optimized devices for both the clinician and the patient. But if they were used more often, i.e., higher volume product, there might be economies to optimize…

Jerrold Shapiro
President and CEO, Fem-Medical LLC
Joe, MDG (the Medical Development Group) is putting on a half-day seminar on this topic this Spring. We are recruiting speakers now.

A few days ago we learned about an implanted spinal cord stimulator to reduce chronic pain and reduce the need for opioid pain medication. Details are at http://www.medicaldesignandoutsourcing.com/first-spinal-cord-stimulator-implanted-to-curb-opioid-prescriptions/?spMailingID=12137017&spUserID=MTU0MTA0MDg4NDQ1S0&spJobID=1261169753&spReportId=MTI2MTE2OTc1MwS2

Jerry

Maud Mader
Researcher in Physics
Here is another transcutaneous neurostimulation patch (I have no experience with it) http://liten.cea.fr/cea-tech/liten/en/Pages/Liten%20text%20(general%20corporate%20text)/Stimflex.aspx

Xuan Kong
VP Research at NEUROMetrix Inc
Joe, thanks for highlighting the need for drug-free alternatives for fighting chronic pain. In addition to the class of implantable neurostimulation devices, transcutaneous electrical nerve stimulation (TENS) devices have worked for many as well. Quell by Neurometrix is such an example. A clinical study (Gozani, J Pain Research 2016) showed that after 60 days of use, 4 out of 5 users reported improvement in their chronic pain and two-thirds reported a reduction of their pain medication. A pilot study by U Rochester researchers (Gewandter, presented at American Pain Society meeting, 2017) also showed promising results of using Quell in a group of cancer survivors suffering from chronic chemo-induced painful peripheral neuropathy. More details can be found at quellrelief.com [Disclaimer, I work for Neurometrix]

Sarah Gothard BSN, RN
Case Manager Palliative Home Care Beaumont Health
I am RN who did programming with spinal cord stimulators. I also have a background in emergency medicine, medical sales, pallaitve care, and injury prevention with education efforts on opiods. I am excited for this technology to grow. When programing patients and the abilty to reprogram to help “chase the pain” as new pathways were delveoped gave people their life back. Some would have tears and would not want the temporary removed . I am very interested in learning more about new neurostimulation products for pain management. With the new restriction on opoids, the pallative patients need to pick up the scripts and find a drug store that has the opiod in stock is becoming more difficult. The side effects for the pallatice patient are very difficult. The side effects of the opoids are constipation slows the bowl within 30mins. The pallative care patients I am working with get chronic constipation, bowl obstructions, and some do not like other side effects of the drugs.

Kirk Becker
Sales for the Plastic Injection Industry & CNC machining
Hey Joe, talk to Avacen Medical
https://avacen.com/
They have a very promising technology.

John Saringer
CEO at Saringer Research Inc
Benepod is a device we’re launching in a few months. It provides symptomatic relief of chronic localized pain and can reduce the dependance on opiods by up to 50%. We can provide a sample for critical evaluation and feedback. The product will be launched on Amazon For US $99

Melanie Joan Dunn
Helping employers develop apprenticeships and on-the-job training programs.
It’s not a device but The Feldenkrais Method has great results with pain of all kinds, including TMJ, chronic back pain and fibromyalgia