8 impressive medical device startups to watch [2022]

As history has shown, it only takes one ground-breaking MedTech startup to change a product category forever.

Back in 2006, serial entrepreneur Steve Kelly partnered with MIT researchers to take an anti-bleeding gel product to market. The biodegradable gel was a significantly better option for many hemostat applications, compared to alternatives like bandages, surgical clamps and tissue adhesives. Today, topical hemostatic agents are considered the most effective and safe option to stop bleeding in many patients and conditions. Of course, innovation in the medical device industry is exciting, but it can also make your company obsolete.

Keeping an eye on the new players in the medical device industry can help you position your own company for success. Take a look at this list of medical device companies on the move and get inspiration in your pursuit of better medical device solutions.

RELATED READING: FDA medical device classifications explained

8 innovative medical device startups

Cutting-edge medical device startups have a few factors in common, according to McKinsey research. First, they all have an idea that can provide consistently superior experiences to all users, including patients, caregivers and clinicians. They will also “reimagine processes to dramatically reduce costs and accelerate decision making.” The most successful medical technology companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer and more convenient.

In order to get close to the patient, medical device startups need to achieve velocity in the early stages to provide proof of concept, secure funding, and demonstrate clinical safety for regulatory approval. There’s no room for mistakes or delays in the hyper-competitive world of medical devices. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE Mark.

RELATED READING: 13 essentials of a quality plan for medical device companies

The following 8 companies have caught our eye for their impressive medical devices, from digital health tools to AI-powered diagnostics.

1. LegWorks

LegWorks is a medical device company providing quality prosthetic knees and making them affordable to everyone. According to LegWorks, 90% of amputees in developing countries don’t have access to prosthetic devices. CEO Brandon Burke lost his leg above the knee at age 18 and found that he would end up destroying his prosthetic knees and wanted to create a new option. He partnered with Jan Andrysek, chief technology officer, to create their All-Terrain Knee. They also offer other types that are saltwater safe or ones that offer the ability to jog and/or run. The company's goal is to offer prosthetic knees to those people who otherwise wouldn’t be able to and works with nonprofits to distribute its products.

2. ComeBack Mobility

Ukraine-based ComeBack Mobility is focused on make it easy for patient care teams to monitor progress throughout the entire rehabilitation process after sustaining a leg injury. The company offers a product called Smart Crutch Tips that measures how much weight a patient puts on their leg while they use crutches to move around. If the patient puts too much weight on their leg, the crutch tips provide instant feedback so that the patient can adjust accordingly. The crutch tips also come with an app where patients can track their weight-bearing progress. With this data, healthcare providers can advise the patient on the best rehabilitation plan so that they heal quickly and correctly. They can also send new rehab advice straight to the patient through the mobile app.

CEO Ilya Popov, the co-founder of ComeBack Mobility, was inspired to create this tool after going through his own injury. He raised the seed round of funding himself during the COVID-19 lockdown and recently gave an interview about maintaining a medical device startup during wartime.

3. Proov

Proov’s rapid response progesterone test strips were invented by Dr. Amy Beckley after she experienced three years of infertility, two rounds of IVF, and seven pregnancy losses. She found out her fertility issues were caused by low progesterone and created these test strips to help other women detect their progesterone levels so they could avoid the same issues and long diagnosis process she went through.

The FDA has authorized these tests, which provide women with information that would otherwise be available only through a blood test at their doctor's office. As of December 2021, the FemTech company had raised $9.7 million in Series A funding, according to Crunchbase.

4. Senzo

Senzo, a UK-based startup, is developing an amplified lateral flow (ALF) rapid antigen self-test for COVID-19, which the company says it has the same accuracy as PCR tests. In a recent blinded 3rd-party study, the tests were shown to have 100% accuracy. Senzo also has plans to apply the ALF system to other testing requirements in the future, so people around the world can get accuracy previously only found in laboratories.

In July 2022, the company announced a a Pre-Series A round of funding that "will be used to bring the Amplified Lateral Flow (ALF) COVID-19 at-home rapid test through regulatory approval and to market, increase manufacturing capabilities, and advance the development of a range of new tests to significantly improve the diagnosis of the world's most prevalent and deadly diseases."

5. Polycarbin

Life sciences use a lot of plastic, between syringes, DNA extraction kits, and more. In fact, over 12 billion pounds of scientific plastic waste is produced each year, according to Polycarbin, and its goal is to put a stop to that. Founded by two friends who left medical school to start the company, Polycarbin remanufactures laboratory equipment, such as pipette tips, from post-consumer lab plastic. The company helps labs reduce carbon emissions and also provides ways to recycle plastic waste. Its mobile app gives scientists data about reducing their waste, lets them schedule recycling pickup, and more. Labs can also order recycled equipment from Polycarbin. In January 2022, it raised $2 million in seed funding, per Crunchbase.

6. ABLE Human Motion

ABLE is a Barcelona-based medical device startup and the world’s first manufacturer of robotic exoskeletons, with a goal of improving quality of life for individuals with disabilities. The award-winning startup began by studying the human gait extensively to create a product that allows wheelchair users to stand up, walk, and sit down without any assistance. The battery-powered, 8 kg exoskeleton has parameters for smart device configurations, which can allow for remote monitoring by physical therapists and physicians.

The lower-body exoskeleton is the first home-use product for individuals with lower-limb paralysis. In mid-2021, they obtained ISO 13485 certification for the design, manufacturing, and sales of their exoskeleton. In July 2022, the company announced that their exoskeleton would be available commercially in Europe in 2023.

7. Garwood Medical Devices

Garwood Medical is an advanced MedTech startup based in Buffalo, NY, with a mission of improving clinical outcomes for infections and wound healing. Garwood’s products include the BioPrax™, a minimally invasive device designed to prevent biofilm infections on prosthetic knee implants by using electrodes to prevent microbe growth. It was granted Breakthrough Device designation by the FDA in 2019.

Garwood’s Series B round closed in late November 2019 at $3.7 million. These funds added to the September 2016 Series A round, which raised $3.6 million. “We appreciate the confidence and support from our existing and new investors,” says Garwood CEO Wayne Bacon. “Few people other than physicians and impacted patients understand the tremendous suffering and high treatment costs associated with [periprosthetic joint] infections, which strike tens of thousands of Americans per year [and cost] many billions of dollars.” The company plans on starting human clinical trials in 2023.

8. Parasym Health

Parasym is a UK-based medical device startup that provides neurostimulation products to improve the quality of life for patients with inflammatory disorders and chronic pain. Its first product uses micro pulses of electrical current to target the vagus nerve through an ear clip electrode. The Parasym Device is currently CE-marked and has been designated a non-significant risk (NSR) by the FDA.

In 2022, the company completed a clinical trial that revealed promising results for patients dealing with cardiac inflammation and potential heart failure. Sophie Dundovic, Co-Founder at Parasym shared: "The results...show the incredible potential that Parasym's neuromodulatory technology can have in a condition where there is an urgent unmet clinical need for new treatment options. We are incredibly proud of the trial results and hope to continue to demonstrate the positive impact of neuromodulation in healthcare."

Medical device startups take disruption head-on

All of the medical device startups in this list began by recognizing a real problem in current treatment options. They each utilize cutting-edge technology to develop their products and show a dedication to their cause. These companies represent the hope for a better future in healthcare, one that is filled with less pain, more mobility, and fewer infections. We can’t wait to see what these startups do next.

Are you a medical device startup looking to scale? Qualio's eQMS for medical device companies streamlines your product development while keeping your teams compliant. Get a demo today.