Challenges Faced by Med-tech Companies Disrupting the Industry

It's not easy to disrupt the med-tech industry. We outline some of the main challenges that med-tech companies need to be aware of when entering the market.

Med-tech companies are constantly disrupting the healthcare industry, bringing new products and services to the table that weren’t available before.

However, penetrating this competitive field isn’t an easy feat. Med-tech disruptors must overcome a host of challenges from the earliest stages of research and development, including navigating complex regulations to accessing the expensive tools of the trade.

At eMoyo, we have first-hand experience of this: Since launching our Kuduwave portable audiometer, we have had to overcome a plethora of obstacles. It takes resilience and strong belief in your work’s purpose to keep going.

In this article, we outline some of the main challenges that med-tech disruptors need to be aware of when entering the market. We also look at two particular med-tech companies disrupting the market today.

med-tech companies and audiologist
Med-tech companies develop and manufacture life-changing and saving devices.

Four Major Challenges Faced by Med-tech Companies

Introducing innovative new products to the med-tech industry isn’t easy. Med-tech companies develop and manufacture life-changing and saving devices, and automate and integrate back-office processes to improve healthcare quality worldwide.

With this territory comes several complicated challenges that med-tech innovators must overcome to see their products implemented:

1. Complex and Changing Regulations

Regulations can be a significant challenge for med-tech startups. The company must determine the legal category of their product or service and apply it to correct regulations. Drugs and medical devices are particularly heavily regulated. At various stages throughout the process, the product might fall under regulations for:

  • Research and development
  • Product approval
  • Certification
  • Marketing and sales activities

Unlike traditional healthcare providers, who often have access to a vast network of clinical labs and regulatory professionals, med-tech companies often must navigate an unfamiliar and constantly shifting regulatory landscape to bring their products to market.

When a product falls in a grey area between two categories, for instance, between being a medical product and a medical device, innovators are often tasked with forging a new regulatory pathway for themselves, which can be extremely difficult.

An example of this challenging territory is Genus Medical Technologies’ contrast agent Vanilla SilQ, which lies in the overlap between a drug and a medical device. It was initially classified as a drug by the FDA, but the US Court of Appeals ruled to reclassify. The difference in classification saves Genus around $440,000 in pre-market approval costs.

2. Marketing to Medical Decision Makers

The very nature of the medical technology market can also pose significant challenges for med-tech companies introducing their new products. It’s rare for a patient to choose a product or procedure independently. More often, the decision is made by their healthcare provider in conjunction with the insurance company and recommendations made by medical societies. This makes it difficult to disrupt the status quo with something new.

Without an existing reputation and credibility, convincing these medical decision-makers of the merits of a new product can take a long time.

A concerted and prolonged effort is often required to gain the attention and recognition that a new med-tech product needs to succeed.

3. The Costs of High-Tech Tools

Med-tech companies often face another barrier to accessing the high-tech tools they need to excel. As many as 70% of startup technologies include digital capabilities such as artificial intelligence (AI) and machine learning. But unlike large, established med-tech companies, which have access to a large pool of these sophisticated tools, it can be difficult for startups to maintain the associated service costs within their limited budget.

This makes it immensely challenging to ensure that their innovations are as connected and accessible as possible. As a result, some med-tech companies collaborate with more prominent industry players to access the resources they need. Still, others may find that the dangers of doing so outweigh the benefits.

4. Industry Competitors

As a company that invented, and now manufactures and sells a truly revolutionary product, we have become acutely aware of the damage inflicted by what we might refer to as artificial harmony. At a glance, or on the surface, all seems well in our hearing healthcare community, and it appears to be business as usual.

Yet, because the Kuduwave is a true med-tech disruptor that absolutely has the potential to revolutionise the hearing healthcare industry and its business model, both our company and our flagship product posed a threat to other hearing healthcare companies, manufacturers in related industries, and others.

It was a years-long journey to get the Kuduwave accepted and recognised for the revolutionary piece of equipment it is. Still today, we are up against competitors spreading misinformation.

The effects of artificial harmony in our hearing healthcare community hinders growth, slows progress and ultimately prevents quality, affordable healthcare from reaching those who need it the most.

Our approach to this challenge has always been to face it head on. Keep gathering invaluable testimonials and success stories, and keep educating both professionals and the public about your products’ standards, certifications, awards and benefits.

Learn more about the Kuduwave’s powerful screening and diagnostic abilities.

Two Med-tech Companies Disrupting the Industry Today

Despite all the challenges, some of the most innovative companies in the industry are still forging ahead in creating new technology to improve patients’ lives everywhere, from the operating room to outer space. No matter what they’re developing, these small companies all persevere through the obstacles with the same goal: helping to move the healthcare industry forward.


The 2021 Medical Device Engineering Breakthrough award winners are exciting the industry. Their pre-clinical studies show how targeted programmed spinal cord stimulation could restore hand, arm, leg, and other movements to people with a spinal cord injury. Their technology is called ARC and comes in both a non-invasive, wearable stimulator (ARC-EX) for hand and arm function, and an implantable pulse generator (ARC-IM) targeted at standing and walking with little or no assistance.

Based in the Netherlands, Onward is currently running its Up-LIFT study to evaluate the safety and effectiveness of ARC-EX at sites across the US, Canada, the UK, and Europe. This could prove to be life-changing technology for the approximately 296,000 people living with a spinal cord injury in the US today and has wide-reaching implications for spinal cord injury specialists everywhere.

Alva Health

Their wearable real-time stroke monitor won Alva Health the 2021 MedTech Innovator Global Award. The Connecticut startup aims to meet a significant clinical need for older Americans living with a high risk of stroke.

This patient-worn device would help the nearly 700,000 Americans who suffer an ischemic stroke annually. It aims to overcome the problem of identifying stroke symptoms and activating emergency response which remains a significant challenge despite widespread public health campaigns. With the device, stroke detection can prevent disability and death and give those with high stroke risk peace of mind.

Discover more emerging medical devices.

Integrate the Latest Med-tech Into Your Practice

Med-tech companies are developing breakthrough products that can help healthcare providers deliver better care to their patients every day, and eMoyo is proud to be one of them.

Our flagship product, the Kuduwave, is a revolutionary audiometer and is the first device to offer simultaneous, bilateral tympanometry. In 2021, a modified version was launched into space aboard NASA’s CRS-15 Cygnus spacecraft to help astronauts perform hearing tests on the International Space Station.

Whether you’re an audiologist, an occupational health practitioner, an ENT, or a philanthropist looking to make a difference, eMoyo can offer you medical devices that serve to break down barriers between people and quality of life.

Book a free product demo to experience it for yourself.

Join our community