Understanding the Cost of Care: Why Medical-Grade Stimulation Devices Outprice Consumer Units

30 Jul

Many years ago I was accused of being a snake oil salesman. Ok, I have been called worse things. We were offering a first-generation FES cycling system, and the individual "on my case", was complaining about the cost of the stimulator. He saw what appeared to be a small handful of electronic components and clearly didn't equate the value of what we were doing with the cost of the product.

You can understand that when comparing medical electrical stimulation devices, priced at £1,500-£12,000, to consumer TENS units, which retail for as little as £25 to £150, the disparity can seem staggering. Yet, this price gap isn’t arbitrary - there are reasons and its not down to profiteering.

Of course, there are always going to be questions about the alignment between value and cost. Those of us working in rehabilitation would love to see many more people able to embrace the benefits of the electrical stimulation technology that's available now. We always feel that this technology is greatly underused clinically. In this article, I'm going to look at some of these reasons why electrical stimulation devices, that are regulated medical devices, cost what they do.

What components are needed?

An electrical stimulation device essentially uses controlled electrical pulses to make muscles contract. Here are the basic electrical components you would need to build a simple muscle stimulator:

Power source: Usually batteries (like AA, AAA, or rechargeable lithium cells) that provide the device with energy. You can use mains power, but then extra care needs to be taken to ensure that the user is always isolated from this potential fatal source of energy.
Microcontroller or pulse generator: Creates the specific pattern of electrical signals (pulse shape, width, frequency) needed for muscle stimulation.
Current or voltage regulator: This controls the strength and consistency of the signal delivered to the muscles, ensuring safe operation.
Amplifier circuit: Increases the voltage or current of the pulses so they can stimulate muscle tissue effectively.
Output stage (H-bridge or switching transistors): Sends the controlled pulses to the electrodes with the correct polarity and timing.
Electrode cables, electrodes and connectors: Pads or wires that deliver the electrical pulses to the skin over the muscle you want to stimulate. Electrodes providing the medium through which the energy penetrates the skin which presents a barrier to that energy flow.
Safety and protection components: Basic items like resistors to limit maximum current, and sometimes fuses or feedback circuits to monitor output and shut down in case of a fault.
Adjustable controls: (optional) Dials, buttons, or knobs for changing intensity, duration, or frequency of the pulses.

Many modern systems utilise software for control purposes, introducing convenience, and unfortunately, another level of complexity and potential reasons for higher development cost

This list of course, is something of a simplification. The devil is in the detail, particularly when it comes to safety. However, when you view the list of potential components, to a layperson, it doesn't seem like it's all that complicated.

Regulatory Compliance: A Foundation Built on Safety

I consider myself fortunate to have studied anatomy in the dissection rooms of Glasgow University. This is also the site of some pioneering work in the application of electricity to the human body, referred to at the time as Galvanisation.

The story of Andrew Ure at Glasgow University is a remarkable one and you can find it on the internet. On November 4, 1818, Ure—a Scottish physician and chemist—participated in a public demonstration at the University of Glasgow involving Matthew Clydesdale, a recently executed murderer. (I wasnt present at the time in case you wondered). Ure and Professor James Jeffray used a large voltaic battery (an early kind of electrical pile) to apply electrical current to exposed nerves and muscles of Clydesdale’s cadaver.

When the rods touched certain nerves, the dead man’s body violently convulsed, his chest heaved, his arms moved, and his face grimaced and even appeared to "smile." At one point, Ure described the fingers moving "nimbly, like those of a violin performer" and the facial muscles displaying expressions of rage, horror, and ghastly smiles. The spectacle was so shocking several onlookers reportedly fled in terror.

This was the era in which Mary Shelley's Frankenstein was published, and scientists at the time were actively exploring the link between electricity and life.

It's kind of obvious to everyone these days that applying electrical energy to the body is something that should be treated with caution.

Would you trust a device with your health if it hadn’t been rigorously tested? Medical quality electrical stimulation devices meet exacting regulatory standards ensuring safety and efficacy—something consumer-grade devices simply don’t face.

The CE Mark

Obtaining CE marking, a legal requirement for medical devices in Europe, involves meticulous assessments by Notified Bodies, clinical trials, and post-market surveillance. These steps can cost anywhere between €50,000 and several million euros, depending on the device "Class" which relates to its complexity and mode of applcation.

Under the EU Medical Device Regulation (MDR 2017/745), manufacturers must also ensure continuous compliance, involving technical documentation updates, quality system audits, and reporting protocols. Even small components must pass stringent standards like biocompatibility testing per ISO 10993, far surpassing the minimal demands consumer devices face. This regulatory effort ensures that the devices patients and clinicians rely on are safe, consistent, and reliable, even under demanding conditions.

Technical Superiority Drives Better Outcomes

So what separates consumer-grade devices from medical-grade alternatives? On the face of it, both typically use a pair of electrodes applied to the skin and the electrical energy flows between those two electrodes, creating a physiological effect in both cases.

The answer lies in their fundamental design. Consumer units often use basic voltage controls, whereas professional devices employ current-controlled stimulation—offering superior precision and therefore therapeutic impact.

What Does Current Control Achieve?

Consistent therapy: Compensates for changes in skin moisture or electrode positioning. This means consistent results.
Personalised care: Tailors treatments according to patient-specific impedance without compromising safety or efficacy.
Wider variability: Allows fine adjustments across parameters like frequency (1–300Hz) and current amplitude (up to 150mA).

Consumer-grade devices are limited by simple preset controls, offering far less therapeutic scope. Medical devices also comply with IEC 60601 safety standards, implementing robust protections like electrical isolation, fault detection, and electromagnetic compatibility.

The result? Medical electrical stimulation devices deliver predictable, measurable outcomes proven through clinical research—critical for patients recovering from neurological disorders or managing chronic pain.

Manufacturing Standards That Save Lives

How is a device designed for professional healthcare markets built differently? Every stage of manufacturing for medical electrical stimulation devices adheres to stringent standards such as ISO 13485. These processes include supplier qualification, component traceability, and rigorous quality control testing.

Additionally, components used in clinical devices often need to last 10+ years, unlike consumer electronics, which are designed for brief lifespans. Cleanroom manufacturing further elevates costs, requiring sterile conditions to assemble products safely.

Mass production drives down costs for consumer devices, but medical devices, serving smaller healthcare markets, rarely benefit from such economies of scale. The NHS's specialised procurement processes further limit production volumes, amplifying these price dynamics.

NHS Procurement Dynamics and Value-Based Pricing

The NHS evaluates medical devices not on cost alone but on their ability to improve patient outcomes and deliver long-term savings to the healthcare system. This is entirely the way it should be.

Clinical Commissioning Groups (CCGs) and NHS procurement frameworks apply evidence-based commissioning—favouring products with strong clinical performance.

For instance, NICE technology appraisals consider cost-effectiveness based on quality-adjusted life years (QALYs). A device that prevents hospital readmissions or accelerates rehabilitation might well be seen as worth its upfront cost.

Medical devices must also include extensive clinical training, continuous technical support, and integration with NHS systems—factors absent in consumer products sold directly to individuals.

Economics of Innovation and Emerging Technologies

Medical electrical stimulation devices emerging today might incorporate cutting-edge technology such as closed-loop stimulation systems and brain-computer interfaces. Some will incorporate inertial motion sensors, EMG sensors, or EEG sensors.

Developing these features entails investments ranging from £400,000 to over £12 million per project. Compliance with additional standards, like the EU AI Act for devices employing artificial intelligence, only adds to these costs.

Advanced features like real-time feedback using EMG sensors or interoperability with NHS digital platforms offer exciting possibilities for future care. However, the costs of developing, validating, and integrating these technologies remain a significant factor influencing pricing.

Economic Justification of Premium Pricing

The higher cost of medical devices is an investment in safety, efficacy, and clinical outcomes—ensuring patients receive treatments proven to work. Clinical trials, regulatory approvals, and adherence to rigorous safety standards guarantee a level of care that consumer devices simply do not.

For healthcare systems like the NHS, which operates within resource constraints, these devices represent value. By enabling earlier discharges, better rehabilitation, and fewer readmissions, they address both patient needs and economic pressures.

Of course, there are attitudinal barriers still to overcome. Not every institution, whether private or public, considers spending today to save tomorrow as a good choice.

Understanding the Bigger Picture

The price disparity between consumer TENS units and medical-grade devices may seem vast, but it is grounded in real, tangible differences. By demanding higher standards for quality, efficacy, and patient outcomes, medical electrical stimulation devices play a critical role in modern healthcare. Next time you encounter the steep price of a medical device, ask yourself—what’s the price of safety, innovation, and a clinically proven outcome?

I am aware of some manufacturers who previously created electrical stimulation medical devices now withdrawing from this activity. Developing such systems represents a significant and growing investment. If manufacturers can't sense that a return on investment is possible, then of course they will withdraw from that activity, and this is my fear. We want constantly to drive improvement and therapeutic value and provide this for the many but it is increasingly challenging to do so.

7 minute read

Derek Jones