Simplifying Compliance in the MedTech Industry: The AI-Powered Solution by

By Grace Williams | Berlin Founders Fund

Discover how Spencer and his team at are revolutionizing the way medical device manufacturers navigate regulatory documentation with their innovative software platform.

I interviewed Spencer Todd, from Formly, who told us all about his path to founding and developing their product.

A bit of background

In the dynamic realm of healthcare technology, Spencer is a visionary entrepreneur dedicated to revolutionizing the medical device industry. As the co-founder and CEO of, he is leveraging his background and using artificial intelligence and machine learning to drive transformative change in the MedTech industry.

The traditional and manual process for registering medical devices means companies often face efficiency, accuracy, and compliance challenges. Recognizing these limitations, Spencer founded with a mission to streamline and simplify the medical device compliance process.

Annapolis Roots and the Journey to Formly

Tell us a bit about yourself and your background.

“I’m a co-founder of, and I was born in Annapolis, Maryland, just outside of Washington, DC. I attended school in Charleston, South Carolina, where I currently live. I did my PhD in Baltimore, Maryland, studying toxicology, specifically neurotoxicology and how pesticides affect neurodevelopment.”

How did you transition from toxicology to co-founding Formly?

“While working in the lab, I realized that I didn’t want to spend my entire career there. I started working at the FDA in Washington, DC, where I gained firsthand experience with device regulatory processes. I observed how much companies paid to complete regulatory documentation, and that’s when the idea for Formly started taking shape.”

What was your first job?

“Delivering newspapers when I was 12. I had to go collect money from people for newspaper subscriptions so it kind of forced me to talk to people which I think helped to hone my people skills from the very beginning”.

How did you meet your co-founder?

“I actually met our CTO Severin Hoegl, I met him through Silicon Allee. He’s great because he has worked in regulated healthcare for a while. Him and I hit it off and understood the issues that people were facing”.

What are your personal interests or hobbies?

“I surf a lot and I also sail. I grew up in Annapolis which is the sailing capital of the U.S, so actually my whole family sails. So I guess that’s the crazy part of me, I’m almost a sailing junky”.

Which book are you reading right now?

“I’m reading all of the LOTR, I’m a big fantasy junkie. During the pandemic, I read every single Harry Potter book!”

What’s the best superpower for a founder?

“I’m dancing between saying confidence and having no fear. Sometimes it’s understanding the fear of going out there and putting yourself out there as a founder, and talking to users can be scary, but it’s absolutely what you have to do”.

“In order to be successful you have to take on risk and get out there. You have to have no fear in going out there and selling yourself”.

Harnessing Artificial Intelligence to Simplify Compliance

How does Formly utilize artificial intelligence (AI) to simplify medical device compliance?

“AI plays a crucial role in our platform in two ways. First, it makes regulations easier to understand by providing simplified explanations of the necessary compliance requirements. Second, it automates the documentation process. It reads through existing documents, suggests ways to fill in missing information, and provides templates for required documents. The goal is to streamline the complex process and guide users through it, similar to how tax software simplifies filing taxes.”

Formly: Simplifying Regulatory Documentation for Medical Device Manufacturers

Could you explain what Formly offers and how it solves the problem of regulatory documentation?

“Our product is a software platform that operates on a software-as-a-service model. It simplifies the regulatory documentation process for device manufacturers and consultants. Users upload their documentation, and our platform automatically generates the final form required for submission to regulators. It streamlines the creation of regulatory documentation and offers regulatory strategy assistance for those unfamiliar with meeting regulations.”

Have there been any challenges you faced during your startup journey, and how did you overcome them?

“When we initially started, we had an idea of the market’s needs, but we underestimated the size of our target user group. By engaging in conversations and receiving feedback early on, we realized that we needed to adjust our focus. We made sure to refine our prototypes and have discussions with potential customers to understand their pain points better. This approach allowed us to find the right user group for our initial software version.”

What’s your experience with the Berlin Founders Fund (BFF) and how it has impacted Formly?

“My favourite part has been the mentorship, there are many mentors you can choose from. They all have very broad experience but also niche experience. Having someone who understands exactly the type of issues you’re going through is really helpful. They helped us with everything from marketing, sales, user groups, AI development, and regulatory issues. As a co-founder not based in Berlin, I appreciate the connection through online channels and the support we’ve received from the BFF community. They have helped us fine-tune our product strategy, expand our network, and gain insights into the European market, which is crucial for our growth.”

The Future of Formly and Impact on the Medical Device Industry

What are your future plans for Formly, and how do you see it impacting the medical device industry?

“Our primary focus right now is on expanding our user base and fine-tuning the platform based on user feedback. We aim to become the go-to solution for medical device manufacturers and consultants when it comes to regulatory documentation. By simplifying and automating the process, we can save companies significant time and resources, enabling them to bring innovative medical devices to market faster while maintaining compliance. Ultimately, we want to contribute to advancements in healthcare technology and improve patient outcomes.”

Thank you, Spencer, for sharing your insights and the exciting work you and your team are doing at We wish you continued success in simplifying regulatory documentation for medical device manufacturers and making a positive impact on the industry.