Choosing what to work on is no small decision. We often ask our customers why they’re working on a particular product innovation. Similarly, we’re often asked about what inspired us to build Ultralight. Of all the problems we could have worked on, why software tooling for medtech? This post summarizes the insights that led to the founding of the company. If anything resonates with you, please reach out!

Opportunity

“We just have a sort of makeshift system in place, and we spent quite a bit of money on consultants to put it together. It keeps me up at night.” 

In 2022, we were spending countless hours with medical device teams to understand how such complicated, regulated products are brought to life. When we asked “what sucks” about the day-to-day work, we noticed a pattern of pain that was hard to ignore. We met brilliant engineering teams building novel products in the backdrop of mounting compliance burden, but with tools that were so outdated that we wondered how these devices could ever make it to market.

As a healthcare entrepreneur, I became particularly interested in medtech innovation during the pandemic. Our collective and individual health, longevity, quality of life all have a huge reliance on medtech innovations, and most of the constraints are on the supply side of the innovation pipeline since the market needs much product innovation for better diagnostics and monitoring and imaging and software for clinical decision support and implantables, and so on and so forth.

When I spent time with medtech teams, I was shocked at just how much human bandwidth was taken up by tasks that could be simplified with software: organizing a complicated set of product requirements, interpreting and conforming to a long list of standards, generating documentation for submission and audit readiness, etc. It seemed like only 10% of time was spent on the value add work!

Given that I’ve focused my career on building health tech startups (companies like Garner Health & Maven Clinic), I have a deep empathy for how hard healthcare innovation is and the way that medtech entrepreneurs were needlessly spending their resources caused a visceral reaction. I had to do something about it.

During my exploration, I was introduced to Shiv Ghai, a product-minded software engineer who had built everything from data pipelines to distributed systems to machine learning models at scale and in highly technical environments like Meta, Bloomberg, and Two Sigma. Throughout Shiv’s career, he always had access to the best tooling to help abstract away complexity and rote tasks so that he could focus on meaningful work. When we met, Shiv had recently been chatting with a family member who was building an FDA-regulated clinical decision support tool, and Shiv couldn’t believe the differences between how software engineers worked in the world of big tech versus medical devices.

Together we wondered how many important medical devices weren’t making it to market, and how we could leverage our own experiences building regulated products (from 0 to 1 startups to big tech) to design tools that would supercharge medtech innovation. 

We started Ultralight with the vision of building a single source of truth for product data, to make medtech R&D, compliance, and manufacturing more efficient, effective, and collaborative.

The premise behind our software is simple. Currently, medical device teams are disorganized in even the most common tasks like writing requirements and conducting testing. They are also confused about how to meet compliance requirements like setting up a quality system and generating design history.

Ultralight gives medical device teams a centralized hub for project management and compliance automation. All stakeholders–from engineering to quality to management–can collaborate in the platform to work much more efficiently and effectively.

Opportunity Cost

Building a medical device is a multidisciplinary engineering effort, and involves a long list of regulations and standards to be followed and documented. The diagram below, which is perhaps difficult to follow, is actually a gross oversimplification of how device companies need to manage their data & documentation flows for just their quality management process, which is a small subset of a much larger set of requirements.

1 Design Controls are a critical part of a broader Pre-Market Approval software offering

2 FDA regulates US medical device products. Other regulatory bodies exist in most major geographies.

3 Quality Management System

Not fun. And imagine doing this by hand without good tooling. Most medical device teams navigate these product development and documentation workflows via manual, paper-based processes or clunky point solution software systems that are built for experts and for old-school products. In either case, lots of human resources are wasted. And product data & workflows are siloed across different teams & systems.

The cost of disorganization is extremely high for medical devices. Below are just a few of the commonly cited concerns we learned about from industry experts with not having good systems in place.

1. Product development & project delays are the status quo in this industry. And not having good systems in place leads to expensive delays when efficiency is paramount, compounded by the fact that regulatory approvals processes are already slow.

2. Even if firms use incumbent software systems, those solutions are built for experts and not consumer-grade, and so still require lots of consultant time & manual workflows, such that even small startups have to spend tens of thousands of dollars on expensive consultants & administration. There’s no software that actually makes teams more efficient.

3. Mistakes are very costly, which speaks to the reason these devices are regulated in the first place. Every month, we see big medical device manufacturer recalls that can cost upwards of hundreds of millions of dollars in damages. These poor outcomes could absolutely be avoided with better upstream processes.

Medtech operators are spending too much of their time on the wrong stuff. And most, especially modern teams, are waking up to this issue.

Why Now

The medical device industry is at the beginning of a major renaissance. There is a complex regulatory framework in place that’s only getting more complicated with new device types. Billions of people around the world rely on medical devices every day, and the pandemic further exposed the weaknesses of the entire supply chain. And medical devices increasingly include modern components like software and algorithms in addition to more traditional hardware and electrical components.

In the very near future, nearly all new medical devices will have software, data, and algorithmic components. The way in which these devices are built, and the teams by which these devices are being built, require an entirely new set of software tools.

In order to serve modern medical device product development, software needs to be consumer-grade, intelligent, appropriately configurable, and as automated as possible. Incumbent vendors do maybe one of these things well, but Ultralight’s goal is to do all four well.

Additionally, most vendors stop at building just one capability or serve just one stakeholder (e.g. quality management). Medtech teams don’t want to buy software from multiple vendors, and product development is cross-functional.

That’s why Ultralight’s product vision is a single source of truth for product data. And on top of this data set, we can layer workflow capabilities to make design, development, compliance, and many other related workflows much more seamless.

We spent 2023 building the best platform for medtech quality management and requirements management and commercializing this solution with a strong cohort of early adopters. In 2024, we’re going to continue to integrate adjacent workflows into our system, supercharge workflows with AI capabilities, and continue to onboard the most innovative and ambitious medtech teams who are starving for better tooling.

If you’d like to learn more, are unhappy with your current systems and processes, or otherwise want to join the ride, please reach out!