The Sales Trap That’s Costing You Clients: Q&A with Michael Nilo on The Business of Learning Podcast
When you sell expert services, it’s dangerously easy to become “the person who says no.”
No to risky shortcuts.
No to unrealistic timelines.
No to anything that doesn’t meet regulatory, clinical, or quality expectations.
All of that is necessary, but it’s not enough.
In this episode of The Business of Learning Podcast, host João Camargo talks with NMCG President & Principal Consultant, Michael Nilo, about the sales trap that quietly repels potential clients: stopping at “you can’t do that” instead of helping them see what is possible.
Drawing on nearly a decade of leading a boutique medtech consulting firm and earlier years as an FDA scientific reviewer, Michael unpacks how NMCG approaches client education, risk, and pricing in a way that builds trust instead of fear.
Below, we’ve summarized the conversation in a clean Q&A format, focused on the most useful lessons for expert service providers and medtech leaders alike.
_______________________________________________________________
João Camargo (Host):
Michael, thanks for being here. To kick us off, can you share a bit about your background, how Nilo Medical Consulting Group came to be, and the core problem you’re helping clients solve?
Q: How did NMCG get started—and what do you focus on today?
MN: I’m a biomedical engineer by education. The first step on my career journey after grad school was working at the FDA as a pre-market reviewer for medical devices—first in dental, then spending most of my time in cardiovascular, working on things like drug-eluting stents, valves, and balloons.
Eventually, I did the classic government move: I left the FDA and relocated to Oregon to work in industry for a company that I was regulating. After some corporate restructuring, I suddenly found myself without a job.
I started my own consulting company thinking, “I’ll do this for a couple of months while I look for a real job.” That was November 2016. Nine years later, it turned out this was the real job. People were willing to pay for my knowledge of navigating the FDA process, and the work kept coming.
Today, NMCG helps companies pull together everything needed to bring a medical device through the FDA:
Regulatory strategy and submissions (510(k), De Novo, PMA, IDE, etc.)
Quality systems and risk management, often in collaboration with our Regulatory Services team
Clinical strategy and execution, through our integrated Clinical Services / CRO offering
We meet clients wherever they are. Sometimes that’s just defining the regulatory pathway; other times we’re effectively their fractional regulatory, quality, and clinical teams.
Q: When a new client comes in the door, what are the biggest things you simplify for them?
MN: Most clients come to us in new product development. That’s where we add the most value.
We usually start with a preliminary regulatory strategy:
What’s the regulatory pathway—Class II, Class III, 510(k), De Novo, PMA?
Do you need clinical data?
What bench, biocompatibility, and verification/validation testing will be required?
How do regulatory, clinical, quality, and business goals tie together?
From there, we build out a plan and flex around what the client actually needs and can support:
Some teams just want the strategy and can execute themselves.
Others ask us to become their fractional regulatory or quality department, or to run their clinical trial end-to-end.
For some companies, we’re ongoing advisers they call whenever they hit a complex decision.
Ideally, we get involved early—right at the strategy stage—so we can help execute throughout the entire process instead of trying to fix things at the 11th hour.
Q: What are the most common mistakes you see medtech companies make before they find you?
MN: A few patterns show up over and over again:
Not truly understanding their user and problem
In medical devices we talk about design controls—starting with user needs, then defining design inputs and specifications that flow from those needs. A lot of early-stage teams skip the anthropology part. They know what they want to build, but not why in a traceable way. That gap matters: it drives your risk profile, your testing strategy, and ultimately your regulatory story.Treating the FDA like a bogeyman
People assume they should be afraid of the FDA—hide from them, avoid asking questions, treat them as the enemy. I’m biased, but most reviewers are scientists, engineers, and clinicians who genuinely care about public health. They can be frustrating, but they’re usually willing to work with companies to find a path that’s safe and effective. Talking to FDA early through programs like Q-Subs, Breakthrough Devices, or Safer Technologies (STeP) can save enormous time and cost.Believing “once we get FDA clearance, we’re done”
Many founders think FDA clearance is the final boss. In reality, it’s just one gate. If you haven’t thought about reimbursement, market access, and who actually pays, you can end up with an approved device nobody buys. You don’t want to spend years on bench testing, clinical work, and submission prep only to clear a product that doesn’t fit the market.
Q: You mentioned your consulting business started as a short-term experiment. Was there a moment you realized, “This is real—I need to build an actual company”?
MN: Yes, there were two big inflection points.
The first was about six months in. I realized I hadn’t applied for another “real job” because I was busy doing client work, and my income matched what I’d earned in my prior full-time role. At that point, I thought, “What happens if I actually treat this like my job instead of a side gig?”
Once I flipped that switch—started actively building relationships, saying yes to the right projects, and then learning to say no—I quickly got to the point where I had more work than I could handle alone. That led to hiring, starting with my younger brother and then expanding locally.
The second inflection point came when we decided to add boutique clinical trial services. I made a big hire: Megan Lamberti, now our VP of Clinical & Regulatory Affairs. It was a meaningful financial commitment, but it expanded what NMCG could do overnight.
Since then, we’ve essentially doubled the full-time team and grown our subcontractor network from the mid-20s to nearly 60 people. That decision took a big swing, but it unlocked a whole new level of capability and impact.
Q: On the business side, what challenges come with growing a boutique consulting firm?
MN: Growth introduces a different type of risk.
When you work with small projects, if a client disappears, maybe you’re out $10,000. It hurts, but it’s survivable. As you move into larger programs like complex clinical trials or Class III submissions, you may be billing hundreds of thousands per month.
Those clients are still in a volatile space. Just like restaurants or airlines, medtech startups can run out of money very quickly. That exposure forces you to think more carefully about cash flow, payment terms, and how far out over your skis you’re willing to go.
That’s something I’m still actively learning and refining as we grow.
Q: Let’s talk about the sales trap. How do you approach those early prospect conversations so you’re not just “the person who says no”?
MN: This is the core of the episode—what I’d call the sales trap that’s costing consultants clients.
In expert services, it’s incredibly easy to tell potential clients what they can’t do.
“The law says you can’t do that.”
“FDA won’t accept this.”
“Your trial design will never fly.”
Sometimes that’s true—and it’s our responsibility to say so. But if all you bring is “no”, you’re not going to win much business.
What we try to do at NMCG, and what I’d recommend to any consultant, is to always pair “you can’t do X” with “here’s what you can do instead.”
We’ll say, “Here are the lines on the field of play. Within those constraints, here’s how we can navigate to your goal without breaking the rules.”
That mindset shift from gatekeeper to guide is huge. It lets you stay compliant while still helping clients move forward.
Q: How do most clients find NMCG today?
MN: For a long time, it was almost entirely word of mouth. The medtech world is relatively small and clustered in hubs like Boston and Minneapolis. Companies talk to each other. If you do good work, your name circulates.
This spring, we added a marketing consultant to help us strategize and be more intentional about our online presence. Posting consistently on LinkedIn, updating our website, participating in podcasts, and speaking at conferences have led to a noticeable increase in business and notoriety. We even had a client say they found us through ChatGPT, which only happens because we’ve put in the work on SEO and content.
That said, word of mouth is still our strongest channel—it’s just now supported by a more professional online footprint.
Q: How do you think about hourly vs. project-based pricing, especially when you’re deeply embedded with clients?
MN: It’s a real tension.
We usually start with time-and-materials (hourly) billing, especially for new clients. Early on, neither of us fully knows how the client’s team works, how complex the project will actually be, or where the real gaps are.
Once we’ve built trust—often by the second or third scope—we’re more comfortable quoting project-based or milestone-based fees. At that point, we understand their capabilities, they understand ours, and we can confidently say, “Here’s what it will take to get to this milestone.”
For larger clinical programs, we’re experimenting more with milestone-based structures. That helps us manage risk on both sides—cash flow for us, predictability for them.
We’re still learning and refining, but the pattern is: Start with flexible hourly work to build trust, then move into defined projects and milestones once both sides know how the relationship functions.
Q: If you could wave a magic wand and solve one challenge in the business that would unlock the next level of growth, what would it be?
MN: The cheeky answer—the one every small business owner gives—is every client pays on time. That alone would remove a lot of stress.
Within what I can control, though, the big unlock would be better access to larger, long-term clients—the teams that want us to:
· Run their full clinical program
· Lead their Class III or complex submissions
· Partner from “idea on a napkin” all the way through to market
Those are the relationships where we can add the most value and have the deepest impact. The challenge is convincing those companies to choose a boutique firm over larger, more familiar names.
We know we can often move faster, with better quality, and with more attention—they’re not just another number to us. So the magic wand would give us more opportunities to prove that at scale.
Q: What makes NMCG the best place to work?
MN: Hands down, the people.
We recently got our entire team together in person for the first time at a conference, and it reinforced how strong the culture is. Day-to-day, we have a supportive, collaborative environment where people genuinely enjoy working together and solving hard problems.
For a consulting group, that’s not a given. I think that positive culture is a key differentiator versus larger firms in our space.
Why It Matters—and How NMCG Helps
If you’re building or scaling a medical device company, you live in tension every day:
You have ambitious timelines, investor expectations, and commercial milestones.
You also have to satisfy FDA and other regulators, protect patients, and generate credible data.
That push and pull can make every decision feel like a tradeoff between speed and safety, innovation and compliance, or clinical reality and investor expectations.
At NMCG, our job is to remove as much of that friction as possible.
Because our team has sat on both sides of the table—inside FDA and inside industry—we help you:
Define a regulatory and clinical strategy that matches your real-world constraints.
Build the right design controls, risk management, and quality foundation early, so you’re not rebuilding under pressure later.
Design and run fit-for-purpose clinical studies that satisfy regulators and align with market and reimbursement needs.
Move from “we hope this will work” to a clear, defensible plan from early development through submission and beyond.
We don’t just tell you what you can’t do. We show you how to move forward confidently, within the lines, toward a device that regulators can clear and clinicians will actually use.
