Alfons Carnicero: “ABLE Human Motion was created almost 6 years ago with the vision of democratising robotic exoskeletons. After launching the product for clinical use we are now working on a new robotic exoskeleton for private use, which we plan to launch on the market in the second half of 2026”.

Alfons Carnicero is an entrepreneur in the use of new technologies to support people with disabilities in overcoming the barriers they face every day. Alfons has a master’s degree in industrial engineering (specializing in Biomedical Engineering) from the UPC and has taken several courses at Cambridge Judge, EADA and ISDI business schools. He started his professional career at Implantcast (German joint prosthesis manufacturer) and Institut Guttmann (neurorehabilitation hospital). In 2018 he co-founded ABLE Human Motion, a Barcelona-based company with the mission to democratise robotic exoskeletons where he holds CEO responsibilities. He has been awarded by MIT Technology Review with the Innovator Under 35 award and “Young Relevant” by the Equestrian Circle. He is a member of the Steering Committee of the International Society for Advanced Rehabilitation Technology.

The exoskeleton that ABLE markets is CE marked for rehabilitation in a clinical environment. What difficulties has ABLE encountered so far at the regulatory level?

Our current exoskeleton is certified for clinical use, so our customers are hospitals, clinics and neurological rehabilitation centers that use the device to perform effective gait training with their patients. Currently, it is certified for patients with spinal cord injury between levels C5 to L5, and soon also for multiple sclerosis, neuromuscular diseases and stroke.

With the advent of the new European Medical Device Regulation (EU MDR), the regulatory has become more complex. Bringing a medical device to market now requires a lot more resources and time, which is a big challenge for small companies like ours. You have to create a device that is inherently safe, taking into account how the patient and clinician interact with it, develop a detailed risk matrix and implement measures to mitigate those risks, verify the design following applicable standards and through laboratory testing, and generate a lot of technical documentation for the device, especially for the software-related part. In addition, the clinical evaluation part has now an important weight: a systematic literature search must be performed, clinical trial data must be presented to support the good performance and safety with each pathology, and each of the claims to be made later at the marketing level must be justified. It has become more regulated than in the past, but in the end I think it is something positive and necessary to ensure that products are safe, for the benefit of the patient and society in general. For this, something that has helped us a lot is to implement an effective quality management system according to ISO 13485, with well-defined processes and as efficient as possible.

Are you considering the development of the robot for private use? What challenges do you face?

We created the company almost 6 years ago with the vision of democratising robotic exoskeletons, so that many more patients can benefit from this life-changing technology, improving their mobility, health and quality of life. After launching the product for clinical use, we are now working on a new robotic exoskeleton for private use, even lighter and significantly cheaper, so that people with mobility problems can acquire it and use it in their daily lives, both at home and outdoors, being able to socialise standing up and take a walk in the street or in a park. But expectations must be managed: it is not a substitute for a wheelchair (since the technology is not yet ready to be able to achieve this), but a device that will allow walking and physical exercise while standing for 2 or 3 hours a day, with the clinical and psychological benefits that this entails.

The great technological challenge of this new product is to move in much more complex environments, such as ramps, uneven terrain or climbing stairs, in a more independent way, since the user will not have the support of a clinical professional, but only a companion for emergency situations. Achieving all these functionalities while reducing the price by half is the biggest challenge we face, but with the great team we have assembled, I am sure we will succeed. In fact, we already have the domestic prototype quite advanced and in March 2025 we will start a clinical trial to validate its performance and safety, where 10 patients will take it home and use it for 4 months. Then we will start the regulatory process, and we hope to be able to launch it on the market in the second half of 2026.

In which countries is it currently marketed? How is it carried out this marketing with ABLE own resources?

The CE marking allows us to market the exoskeleton to rehabilitation centers throughout the European Union. In Spain we do it directly with our marketing and commercial team, financed with the company’s own resources from the last investment round of 850,000 €, that we closed last year. Once the interest of a clinic is confirmed, visits and commercial demonstrations are organized with our clinical specialist, so that they can test the exoskeleton with their patients. We also attended several congresses and fairs to promote the exoskeleton, such as the National Paraplegia Congress, the International Spinal Cord Injury Society (ISCoS) Meeting or the Annual Meeting of the Spanish Society of Neurology (SEN).

In other countries such as Italy and Poland, marketing is done through distributors. In the coming months we expect to close distribution agreements in other countries such as Germany and the United Kingdom.

Do you think that having CE marking and initial sales traction is enough to open the door to being acquired by a large company in the sector? Or do you think it is necessary to have more value in the project to reach this exit scenario?

No, to achieve something like this we need to take the project to a more mature stage: to have a differential technology protected by a broad portfolio of patents, to have clinical trials in reference centers that demonstrate the clinical and economic benefits of using the exoskeleton, to have the backing of international Key Opinion Leaders and, above all, to achieve a considerable market share, so that the big players put us on the map. And for that we still need to invest a lot of time and effort! But for the moment we are getting very good traction in the domestic market, and we hope to replicate this in other countries through distributors.

What advice or lessons learned would you tell today to the Alfons Carnicero of 2018 when he was starting ABLE?

Don’t be so optimistic and deluded, bringing a medical device to market is much more complex than I thought when I started! The idea is 1% of the project, the rest is execution: development and validation of prototypes to find the product-market fit, building a portfolio of patents, strategic alliances with leading hospitals for clinical trials, quality and regulatory documentation to achieve certification, industrialization, business plan…

Other tips:

• It is a hard and very intense process. Everything seems easier and faster than expected – multiply your estimated times by at least 2! This makes the search for financing a key factor. We have been five years without being able to invoice anything (not having the certification), with the pressure of seeing how you are running out of money, of spending months without being able to get paid… We had limited resources, and the technical challenge was very complex, we needed to find people who shared our purpose and who had a special talent.
• It involved a significant patient sample from the beginning. At the beginning we did the usability tests with only 5 volunteer users and, after getting it to work very well with them, we thought the exoskeleton was ready. But then we did a clinical trial with 50 patients and found that it was not, that a large majority of the patients could not use it properly. We had to go back and keep developing prototypes.
• Co-create with clinicians and patients. Engineers are very good at creating solutions, but they have to tell us what the problems and needs are. Get out of the office and ask the right questions: learn fast, improve your product and test again. Customers and the market are always right, don’t be afraid to pivot! We have had to create 7 different prototypes until we got a product that solves the needs in an optimal way (which is nothing like the initial prototype), and we have done it by collaborating with more than 200 neurological patients and more than 30 clinicians.
• Team recruitment is one of the most important and difficult tasks. Give it the time it deserves. Define your values, and select people who believe in the project, share those values and are excellent professionals. Proactive people, who think in solutions and not in problems (which, as you will see, will already be many) and above all, who have the ability to learn quickly. Look for people who are better than you!

What role do you think biomedical consulting companies, such as GENESIS Biomed, play in the emergence and consolidation of start-up/spin-offs?

Companies like GENESIS are fundamental in the beginning of any start-up. Firstly, with access to funding: they know perfectly the whole panorama of accelerators and public funding in the field of health, both nationally and especially internationally, and they can guide you to find the program that best suits your project. Access to public funding is one of the ways I recommend the most for early-stage healthcare projects, as it allows you to improve prototypes and validate the idea without the pressure of an institutional investor such as Venture Capital (VC). In our case, GENESIS was key to obtain a project from EIT Health (European Institute of Innovation and Technology), with which we were able to mature our ABLE exoskeleton and conduct clinical trials collaborating with 2 reference hospitals in spinal cord injury: Institut Guttmann (Badalona, Spain) and the University Hospital of Heidelberg (Germany).

In addition, they also manage a private investment vehicle with which they can participate in pre-seed and seed investment rounds. In our case, their vehicle invested €50,000 in our first investment round in 2019, joining other investors such as Banc Sabadell BSTART-UP or other business angels.

Not only that, but they are also experts in biomedical field consulting and can help you perform market analysis, define market access or commercialization plans to introduce your innovation in the market.