✨Spotlight: Guideways – Automating regulatory, quality management, and reimbursement with AI
What if health technology could move at the speed of discovery?
Guideways is making it happen. Their AI agents take on the time-consuming work of regulatory approval, compliance, and reimbursement so innovators can focus on building healthcare breakthroughs.
“The faster the process, the sooner patients benefit”
Founded in 2025 by Alexander Habermeier and Sander Denissen, Guideways specializes in supporting medical devices and software in the United States (FDA) and Europe (EU MDR).
‘’Guideways was born from the personal experiences of Sander and I’’
Alexander brings 16 years of experience in health tech innovation. After starting his career at a pioneering surgical robotics startup, he went on to develop, launch, and scale breakthrough devices across orthopedics, neuro, and cardiovascular fields at startups, scale-ups, and large medtech companies.
“My mission has consistently been to bring breakthrough innovations to patients,”
Sander contributes 20 years of experience in health tech. Fascinated by technology from a young age, he built his career at Philips, taking on roles as software architect, system architect, and engineering team lead, working on first-in-class innovations in image-guided therapy. His background is in machine learning and AI.
The idea for Guideways grew from Alexander and Sander’s shared experiences.
“We realized that approval, compliance, and reimbursement are often the biggest bottlenecks preventing innovations from reaching the market,”
“With AI, we are working to remove these barriers so the health technology ecosystem can deliver more life-saving solutions to patients.”
What inspired you to focus on automating regulatory, quality management, and reimbursement instead of other parts of the healthcare innovation process?
Sander and I have extensive experience bringing breakthrough innovations from just a concept to patients. Through that experience across both the technical and business side, we have come to realize that these processes often are the major bottleneck preventing innovations from reaching patients.
It’s much too complex, much too slow and much too expensive, leading to the following issues:
Time-consuming: Long, multi-year timelines for regulatory approval. It takes 31-66 months to go from medical proven concept to approval depending on the risk profile.
Costly: Prohibitive investment is required. 30 to 75 % of development costs from working medical device concepts to market are related to regulatory activities.
Inefficient: The process is complex, leading to a lot of mistakes and delays. 1/3 of applications are rejected outright, 2/3 of the remaining require re-work.
As we experienced these issues again in our respective projects in 2024, me on FDA approval, Sander on EU MDR, we stepped back and realized that there has to be a better way. This is how Guideways was born!
How does Guideways’ AI adapt to different international regulations like FDA and EU MDR without slowing down approvals?
We develop deep AI agents that are specialized in streamlining the process for medtech / healthtech innovators to get approval, remain compliant and gain reimbursement.
The Guideways agents have in-depth knowledge of the regulation, guidelines and standards as well as data from the devices already approved. As an example, our FDA approval strategy agent uses more than 100k reference documents!
Our AI agents help customers throughout the process, enabling them to start from just a few lines of description of their medical device or software. The agent then guides them step by step, analysing the applicable requirements in a way that is tailored to each specific innovation as an expert would.
As a result, innovators benefit from faster time to market at lower cost because they can:
- Optimize their positioning from the early concept
- Save months on time to market for their next innovation
- Avoid costly rework and product holds due to compliance issues
What kind of impact do you expect this technology to have on how quickly patients can access new treatments in the next five years?
Our mission is to get 10 times more health technology innovation to patients. Our AI agents do that by accelerating the approval, compliance and reimbursement processes because they can do weeks of work in just minutes and remove expertise bottlenecks preventing innovations to get to market. This benefits the whole ecosystem:
- Patients benefit from having access to more advanced diagnostic and therapy options
- Healthcare providers benefit from solutions that reduce the burden on clinical teams and can provide more options to patients
- Payers benefit from being reducing costs through solutions that allow for more efficient care delivery (reduce burden on clinical teams, earlier diagnosis and treatment leading to lower follow-up costs, …)
- The health tech industry benefits from faster time to market at lower cost
Follow their journey on LinkedIn: https://www.linkedin.com/company/guideways/?originalSubdomain=nl
