The compliance tool buffet is growing, but are they enough to get the job done?

Good enough isn't always good enough.

Early stage MedTech companies have a habit of following the same path. Runway is limited and you try to hack together your regulatory documentation to save on those hourly regulatory consultant costs.

In terms of capital efficiency, this makes running a MedTech company doubly difficult, as so much time is spent pre-revenue waiting for clearance so you can start to sell.

So, you try to start early, in an inexpensive way. It is understandable.

So, you stick your CTO on building all your regulatory documents using Claude or do a trial of one the 100 new compliance platforms with a special regulatory agent, and get to creating your documents for regulatory submission.

One of the most common reasons MedTech companies fail is they don't achieve efficient regulatory clearance. This isn't because they couldn't make a quality management system or technical documentation to submit to regulators. It's because the built the wrong one for their product, their company, or the regulatory pathway they chose for the market.

What are you buying in MedTech compliance software?

Most platforms are genuinely good at workflows, like document storage, version control, approval routing and audit trails that support ISO 13485, 21 CFR Part 820, and general quality requirements.

Most software also now incorporates AI too to make those processes even faster, and some platforms even come preloaded with the regulations and guidance documents themselves. These are all advantages, until one day, that voice sends you confidently down the wrong path. As sophisticated as MedTech compliance software has become, what the software can't do is be your regulatory expert when FDA or an EU Authority knocks on your door.

One of the most valuable things experienced regulatory and quality consultants can do is guide your team on what work is or is not needed. You learned this through experience. We've sat across from failed audits, thin technical files and remediation projects that could have been avoided with an earlier decision, saving time and money.

This shifts constantly too, as new regulatory reviewers come and go and policy changes.

Buying for efficiency and data management is good. To expect it to completely replace your need for quality or regulatory experts is a dangerous strategy.

Also, full disclosure, I'm not saying go out and hire a big quality regulatory team or drop $500K on consulting hours for regulatory, just be realistic about what you can accomplish given your team and find a partner you like that you think enables you.

Avoiding compounds errors.

To avoid compounding errors, it really is best to get an expert involved early, preferably starting at the beginning of the process. Errors compound because each downstream document or requirement depended on the previous one.

Here is an example. Let's say I came up with an intended use for my product that "predicts when you'll have a migraine". Sounds like an amazing product, but for that claim, you'll need some very compelling clinical evidence to show that you can predict. This likely requires prospective clinical data and some long development time.

Instead, did you consider you could bring a similar product market that helps users "understand triggers for their migraines". This is could be a version of the "predict" product you want to build but would require less evidence and may not even be a medical device in some markets.

Starting with a device under that intended use would allow you much faster time to market and less evidence. I found the frontier models and compliance agents out there are not great at giving you this kind of advice or similarly considering all available business and regulatory options for the product.

You can imagine building a product that predicts migraines vs educates users on triggers has very different product requirements and development timelines. One would take multiple years while the other could be done in under a year possibly.

This is why making an error at the beginning can have such drastic and lasting effects on your company, and may even be the determining factor if you make it to your next fundraising round with something rosy to show investors.

Avoiding errors like this is what you can get with chatting to (the right) experts in the beginning. At least we do this quite a bit with our clients.

What it costs founders.

The worst part about using Claude or other compliance agents blindly is you wont know what is right or what is wrong. This is for a few reasons:

i) AI is most frequently confidently wrong, so having it spot it's own error immediately isn't likely,

ii) AI is great at producing competent sounding technical outputs which subjectively sounds good at first glance, and

iii) regulator preferences often dictate what will pass vs what wont. Each department at FDA, for example, has different viewpoints on reviewing the same categories of products. That isn't in any regulations or guidances.

So your team starts doing work without knowing they might be slowly killing your chances for regulatory success. Compliance software can help manage the data and even draft the documentation sometimes but the hard questions remain: is the justification for this device class defensible? Is the ISO 14971 risk file actually appropriate? What will the FDA reviewer or notified body auditor push back on first?

McKinsey estimates that the cost of quality and compliance sits between 6-9% of medical device sales revenue. That is a lot of money, considering MedTech, pharma and biotech record over $2 trillion in sales revenue.

The worst part? That spend starts on day one, before there's any revenue to measure it against or even a product on the market.

Being smart about compliance spend.

Early stage companies can, and do, spend hundreds of thousands of dollars on eQMS implementation, software validation and compliance maintenance before a single device is sold. Often, that spend buys more infrastructure, not better outcomes. So, what's the solution?

I like to think about it as separating the two jobs compliance actually requires. Software handles the administrative quality work, and it does that well, but regulatory judgment still needs people who have done this before, and that shows up in two specific ways.

First, being physically in the room with FDA reviewers and EU auditors, during inspections and conformity assessments, not just filing the paperwork and waiting for a response. From my years with the FDA, I know this matters and while I've seen some first timers do it, having a practiced hand here can go a long way in making you efficient and don't waste time on avoidable mistakes.

Second, the nuance that only comes from having done this before and continuing to stay up to date on it. For example, how many subjects a study actually needs, or how to create a regulatory strategy for a product to reach market fast without it breaking down 2 years from now when you plan to release a massive new feature.

None of that is written down anywhere official. Guidance documents don't publish it because it isn't a rule, but the expertise is earned one submission at a time.

That's the real regulatory problem MedTech companies face. They expect software to supply that judgment on its own, and it can't, no matter how many regulations it's been trained on. We help companies separate the two jobs early, and they spend less and move faster toward clearance.

The shortest path to market

Our Envoy service helps you find the best path and avoid all these errors. By knowing the terrain well enough to skip the detours: the rework, the re-submission, the avoidable rejection. Real experts in the room, a validated eQMS and a regulatory intelligence layer behind them, and no in-house team to hire before you're ready.

If you're building a medical device and the regulatory path is the thing standing between you and the market, that's exactly what Envoy is for.

Dr Spencer Todd is the CEO and co-founder of Dovetail (formerly FormlyAI), a regulatory partner for medical device companies. Before founding Dovetail, he spent years at the FDA and as a medical device consultant.