Is disruption on the horizon in your medical device category?

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, tissue adhesives, vasoconstrictors, and cauterization. Today, topical hemostatic agents are considered the most efficient, effective, and safe option to stop bleeding in many patients and conditions.

Don't let your company be like one of those that Steve Kelly's innovation made obsolete.

Keeping an eye on the new players in the industry and the growth paths they’re taking can help you position your own company for success. Take a look at this list of medical device startups on the move and get inspiration to get to or keep your company on top.

The Top 10 Medical Device Startups in 2020

Winning 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 MedTech companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer, more convenient, or somehow just a better option.

In order to get close to the patient, MedTech 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 a hyper-competitive market space. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE Mark.

That's one of the reasons we exist. Qualio is quality management software for the life sciences ecosystem. It unites a company's team, processes, and data so they can bring products to market quickly and scale successfully. Our easy to use platform empowers quality teams, bringing them out of paper and spreadsheets so they can support the business without distraction. Click here for a demo.

1. ABLE Human Motion

ABLE is a Barcelona-based device startup and the world’s first manufacturer of robotic exoskeletons, with a goal of improving quality of life for individuals with disabilities. The lower-body exoskeleton is the first home-use product for individuals with lower-limb paralysis. ABLE is uniquely lightweight and easy-to-use, which provides an affordable option for individuals in wheelchairs to be fitted to an exoskeleton and begin walking.

ABLE began as a concept in response to an unmet need in 2015 and has moved quickly to its current status of clinical evaluation. The startup hopes to complete clinical evaluation activities in 2020, and begin presales in 2021. 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.

RELATED READING: Quality Management Software for Medical Devices: The 8 Essential Requirements

2. AbiliTech Medical

AbiliTech is a Minnesota-based device startup with a goal of restoring independence to individuals with upper-limb neuromuscular conditions or injury. The startup is creating a range of functional assistive devices to provide support in the types of everyday activities that allow individuals to achieve social, physical, and economic autonomy. 2020 will mark the official launch of the Assist device, a wearable device that provides supported arm movement for patients with limited strength or range of motion. Other products in active development include the AbiliGRIP, an assistive device for patients with limited hand function.

In late November 2019, Abilitech announced they had successfully raised $7.5 million in a fundraising round. 2019 was a noteworthy year for the startup, who also beat out more well-established MedTech companies for the Minnesota High Tech Association's Tekne Award.

“In the U.S., there are hundreds of thousands of people who can't perform simple tasks, such as feeding themselves or brushing their teeth, because of arm limitations," says Angie Conley, founder and CEO of Abilitech. Her company's products have "the ability to have a physical, social and economic impact that will change many lives." New call-to-action

3. 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 recently granted Breakthrough Device designation by the FDA.

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."

4. Parasym Health

Parasym is a medical device startup that provides neurostimulation products to drastically improve the quality of life for patients with inflammatory disorders and chronic pain. Their 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. It has been given an investigational device exemption (IDE) for several research indications and may soon be available in the US outside research settings. Users describe the Parasym device as life-changing. “I’ve gone from a 5/10 quality of life to a 10/10,” says Adeita P.

RELATED READING: 5 Staggering Medical Device Recall Statistics That Should Concern Everyone

5. Signum Surgical

This Galway, Ireland-based MedTech startup is developing innovative implant technologies to promote healing post-surgery and prevent infection in colorectal patients. Current treatment options for Signum Surgical’s target patient population have unsatisfactory patient outcomes, including slow healing, infections, and repeat surgeries. In the future, Signum Surgical hopes to expand its range of products to treat other colorectal disease conditions.

In April 2016, Signum Surgical announced they raised €3.6 million (approximately $3.97 million USD) through two grant funding awards to take the BioHealx device to market. These funds will be used to support a 12-month clinical study on BioHealx, pursue a CE mark, and submit a 510(k) submission.

6. X-Cor Therapeutics

X-Cor is a Boston-based medical device startup that created the first commercially-available CO2 removal device, which provides a more cost-effective, safe, and widely accessible option to treat patients with acute respiratory failure. Machine learning created a hybrid approach to treatment, in which patient’s blood is drawn at <300 ml/min flows through small catheters, which can be placed by nursing staff. Not only is the X-Cor product less invasive than existing approaches to treating acute lung failure, it requires less training and can be used outside an ICU setting to treat patients with COPD, cystic fibrosis, and other acute conditions.

Alira Health Ventures announced X-Cor would be joining its portfolio in November 2019. Alira manages a wholly-owned incubator of breakthrough medical technology companies. The partnership hopes to help X-Cor “make a strong transition into their clinical stages and be positioned well for future commercialization,” says Alira CEO Gabrielle Brambilla.

RELATED READING: How to Shrink the FDA Medical Device Approval Timeline

7. Rubi Life

Rubi Life is a startup founded by Brigham Young University student Eric Stopper. The MedTech company uses nanotechnology attached to an elastic maternity band to track fetal activity in high-risk pregnancies, including monitoring kick count, fetal heart rate, and position. The monitor can send alerts to an expectant mother’s smartphone in the event of a risk to help prevent stillbirths, premature birth, or other negative pregnancy outcomes.

Stopper won first prize in the 2017 Utah Entrepreneur Challenge, which he planned to use to launch the Rubi Life phone app. In 2018, the startup launched a Kickstarter to further product development in hopes of bringing “peace of mind” to expectant mothers worldwide.

8. Day Zero Diagnostics

This Boston-based startup is using machine learning to create rapid, whole-genome sequencing diagnostics to provide greater insight into the profile and treatment options of life-threatening bacterial infections. The MedTech startup is dedicated to creating faster, more effective clinical support systems to diagnose and treat fast-acting infections such as sepsis, which can lead to a patient’s death in 2-5 hours.

Day Zero Diagnostics, or DZD, completed an $8.6 million Series A round in April 2019. The startup hopes to use these funds to accelerate prototype development and introduce sequencing-based diagnostics for clinical settings. “We are excited to partner with investors who share our vision about the potential of genome sequencing and machine learning for changing the field of infectious diseases,” says DZD CEO and co-founder Jong Lee.

9. Flatiron Health

Flatiron Health is a pioneer in developing community oncology products in the cloud to create a shared technology platform for oncologists, academics, hospitals, researchers, and regulators. OncoCloud is the most comprehensive suite of software and cloud services for oncology practitioners who treat patients in the community. In addition, Flatiron is working closely with regulators, academics, and hospitals to improve cancer treatments through billions of patient data points.

The FDA Information Exchange and Data Transformation (INFORMED) Program announced a two-year renewal of their research collaboration with Flatiron Health in February 2019. After the success of early collaborative research, the FDA hopes to work with Flatiron to continue to understand the real-time impact of cancer treatments on real-world patient populations. “We believe that regulatory-grade real-world data can help inform our decision-making so that we can provide cancer patients with better care,” says Dr. Richard Pazdur, director of FDA’s Oncology Center of Excellence.

10. Livongo

Founded in 2008, Livongo is a publicly-traded pioneer in the use of applied health signals to create personalized care for patients with chronic conditions. The platform provides the capability to provide support for diabetics, weight management, hypertension, diabetes prevention, and behavioral health. Patients can gain the ability to proactively manage health conditions through a smartphone app and connected devices, such as a connected blood glucose monitor or fitness tracker, while their progress is monitored by a health coach or clinician.

Livongo was the first company to apply mHealth and data science techniques to proactive disease management, including interactive prompts that advise patients to take actions that are most likely to have a clinical impact. After raising $237 million from investors, Livongo went public in July 2019. At the time of their IPO, Livongo had nearly 700 corporate clients. Livongo is gaining traction as an at-risk population management tool for insurers and corporate wellness programs.

Take a Disruptive Approach to Create Better Patient Outcomes

All of the medical device startups in this list began by recognizing a real problem in current treatment options. For example, in Day Zero's case, the company identified the fundamental mismatch in the time to deliver treatment and the speed in which the disease could lead to patient death. Even though fast-acting infections like sepsis could lead to patient death in 2-5 hours, physicians were forced to rely on trial-and-error to treat infections because test results were often unavailable for 2-5 days. DZD and other innovators are taking dramatically new approaches to solve problems that affect thousands of patients and care providers each year.

Machine learning, mobility, and the cloud are just three of the emerging technologies the most innovative MedTech startups are using to revolutionize treatments, diagnostics, and long-term disease management. Once approved for the market, these ten startups have the potential to create dramatically better outcomes and quality-of-life for patients worldwide.

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Published by Robert Fenton June 16, 2020
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