Episode 413

#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it.

Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.

Key Timestamps

02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups

06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting

10:20 – Why software and compliance tools get left out of early budgets

14:12 – How missing budget detail impacts product quality and time-to-market

19:04 – Red flags investors look for in MedTech startup budgets

23:30 – How to improve budgeting accuracy without a CFO

28:10 – Critical cost categories MedTech founders often overlook

35:55 – Advice for recovering from a budgeting oversight

39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)

45:00 – Final advice: why networking trumps isolation for smarter budgeting

Standout Quotes

"Relying on the status quo is never good. There are always ways to do things better."

Jon reminds founders and compliance professionals alike that innovation doesn’t stop at the product level—it also applies to budgeting, systems, and team empowerment.

"Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."

This quote highlights the investor’s perspective on sustainability and long-term thinking—crucial traits in any fundable founder.

Key Takeaways

  1. Broad Budget Buckets Signal Inexperience

Lumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.

  1. Software and Tools Are Not Optional Extras

Founders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.

  1. Budgets Must Reflect Time and Scale Realistically

Flat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.

  1. Outsourcing ≠ All-Inclusive

Many startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what’s included—and what’s not.

  1. Recovery Is Possible—If You Own It

If your budget’s off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.

References

MedTech 101

Why “One Line for Compliance” Doesn’t Cut It

Think of compliance like building a house. You wouldn’t budget for the entire construction under “tools and materials”—you’d break it out by framing, plumbing, electrical, permits, inspections, and more. In MedTech, the “compliance house” includes QMS platforms, regulatory consulting, ISO standard licenses, clinical software, and ongoing post-market surveillance costs. Each of these is a critical structural element—and each has its own cost profile.

Poll Question:

What budgeting category do you think is most overlooked in early-stage MedTech startups?

  • Clinical trial costs
  • Regulatory software/tools
  • Consultant scope and fees
  • Post-market surveillance

Have you ever discovered a major budget blind spot after launching your MedTech project? Tell us what you missed and what you learned—email us at podcast@greenlight.guru. We might feature your story in a future episode.

Feedback

Enjoying the podcast? We want to hear from you! Share your thoughts, leave a review, or suggest a topic you’d love to hear about next. Reach out at podcast@greenlight.guru for a personalized response from our team.

Sponsors

This episode is brought to you by Greenlight Guru, the MedTech lifecycle platform trusted by medical device companies worldwide. Whether you're budgeting for your first study or scaling to new markets, Greenlight Guru Quality and Clinical helps you move faster while proving safety and effectiveness. Learn more at greenlight.guru.

Transcript

Jon Bergsteinsson: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Innovation thrives when true quality is the focus. Instead of documentation for documentation's sake. Greenlight Guru Quality and Clinical gives engineers and clinicians one real time platform. Build faster and prove safety sooner.

Join the leaders at www.greenlight.guru.

Jon Bergsteinsson: Hey everyone.

Etienne Nichols: Welcome to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode and one thing I've heard that is for a lot of early stage medtech startups, budgeting can sometimes be a bit of an afterthought when it comes to things like qms, regulatory clinical operations,

which if you think about it kind of makes sense. Especially when you're heads down building a product or chasing your first round of funding. It's easy to push those things on the back burner.

But from an investor's point of view, I'm curious whether those omissions raise any red flags or if they just raise the eyebrows or, or what exactly happens there. So today we want to dig into that mindset, the investor's mindset, why these areas get overlooked, what the impact is and what founders can do to course correct.

So we'll also talk about the tools and strateg that can help startups set their budgets, set them up for long term success. But to talk about this today, I'm joined by someone who's worn just about every hat you can imagine in the medtech world.

Founder, investor, regulatory advisor and even blockchain enthusiast if I remember correctly.

Joan Briggs Diensten is the voice of medtech when it comes to clinical data and commercialization. He's the founder of Smart Trial, which many of you know was acquired by Greenlight Guru.

Now he's helping shape the future of medtech innovation through his work with Leaf Adventures and Iceband. Yoon brings a rare blend of deep regulatory and clinical know how with a sharp eye for what it takes to scale a medical device company from both the inside and the investor seat.

So I'm excited to dive in with him today and talk about some of the budgeting blind spots that can make or break a startup. Yon. How are you doing today?

What did I miss or leave out?

Jon Bergsteinsson: Hey, good to see you again. It's been a while. Thank you so much for that wonderful introduction. That's beautiful written. I couldn't have, couldn't have written it better myself. Thanks for that.

Happy to be here.

Etienne Nichols: It's great to be with you. I'm curious, so from your vantage point, because you are now in the investor seat and you've also worked with, I don't know,

have you counted how many medical device companies you've worked with? I mean,

yeah.

Jon Bergsteinsson: So my role has changed a lot. I've spent the last decade in the medtech industry from the service and consultant side of things, helping hundreds of companies evaluating their clinical data collection strategies for their market access approvals through Greenlight, Guru Clinical and Smart Trial.

And now for the last couple of years, I've been digging a little bit deeper into how I can help continue making an impact in the medtech industry on a broader basis.

So for the last couple of years I've been digging a little bit into the Nordic scene here in Europe, try to figure out what it is that meta companies here in the Nordics are missing.

And I've simply found a gap. There's a gap in supporting a lot of those early stage meta companies, building out their initial validations of the products and ideas and getting a little bit, well, getting further ahead into getting the products into market.

Etienne Nichols: So when, when you work with those and you see those, some of those gaps, I mean, we could talk about the different ones that you've seen, but is this budgeting from your vantage point?

How would you describe the budgeting mindset of most early stage startups?

Jon Bergsteinsson: So that's a good question because when I was at in the seed of supporting companies starting their clinical studies and getting started with their quality management setups and all that, I saw it from a vendor perspective being a huge missing piece of a larger puzzle.

A lot of these companies simply hadn't thought about the fact that they might need to have a digitalized system in place to support their operations. And now when I'm in the seat of more of an investor, I'm also looking at the same aspects and seeing the same issues being presented in the budgets.

So when I'm looking at early stage metric companies now primarily in the European area, I'm seeing common issues not just in medtech but also in other industries where you have two types of founders, maybe an experienced founder, and then in other cases a less experienced founder, there's a typically a difference between them.

Where the experienced founder that has maybe had some operational experience or has done made a successful company before, they usually have these budget items and budgets in general pretty well laid out and they do take into account different aspects of the budget that other less experienced founders might not realize.

So the less experienced founder often categorizes different budget items very broadly together. So they have few line items and they pack everything regarding compliance into one single line and they call it quits.

You know, 100k for compliance, that's it. And then we have full time employees and that's it. And then we have it administration and that's it.

But you know, budgeting for compliance or around the compliance efforts in a medical device company is much more complicated than a single line item.

Usually the largest cost item for every company,

unless you're maybe OpenAI which spends a lot of money on just GPUs is full time employees salaries.

Etienne Nichols: Yeah.

Jon Bergsteinsson: And when you're building a meta company you're, you're not just obsessed about the product you're creating and developing, you're also very much obsessed about what is the team that I'm building around myself or around us, if I'm speaking like a founder.

So a lot of the times these founders in the METSI companies, they try to allocate resources to appoint a director or CEO of some sort and then usually maybe a technical founder, a co founder and then maybe a commercial founder as well.

And then usually most of these medic companies, they have appointed a hat towards some kind of a compliance qara person whether it's on a full time basis or not.

But they often tend to forget the cost included in the individual items that relate to supporting that function or services related to supporting that function.

Etienne Nichols: That's a really good point because I'm just thinking, let's say if I go back to my background as a mechanical engineer and I come into a company and they say, okay, we want you to work on the prototype and get it ready for DFM designed for manufacturing.

Which means, you know, you're going to have to start looking at how it can come out of an injection mold or whatever. I'm going to expect to have some ansys, some, some fea, Finite element analysis.

I'm going to expect some, some CAD software, Computer Aided design.

Jon Bergsteinsson: Yeah.

Etienne Nichols: And we don't think, and most people recognize that, you know, you need to give some 3D modeling for a mechanical engineer. But what about this regulatory. Why do you think that is the case?

Why are they just not familiar with the role or what are your thoughts?

Jon Bergsteinsson: Well, in your case you mentioned engineering. If you were a startup, a good CEO or a good founder would usually ask that person before they're hiring them if this is the task to be done for you.

What is the kind of software supportive service that you would need to accomplish that task. Because hiring an engineer would not be enough. You need different kind of software to draw up the science and all that.

So you would probably want to include that in the conversation of your budgeting. But getting back to your point, I think a lot of it has to do with inexperience.

And there's a clear difference between founders that have experience and those that don't. And those that have experience, they can estimate costs better, usually keep better track of the individual items that relate to compliance efforts and so forth.

And the inexperienced founders, they have less oversight and tend to underestimate the costs of getting a product to market because they maybe think that they can appoint that one person to that job and that person just takes care of it.

But they tend to maybe forget to ask the same questions as you may be would do for a software developer or an engineer about the what are the potential services, softwares or whatever it is that you would need to accomplish the task.

And maybe not even further than that. What are the maybe fees related to getting a product to market that relate to everything else?

Etienne Nichols: You know, this is, this is kind of making me put my two hats on right now. I'm thinking of the project manager side where you as a regulatory person, because if, if I shift the conversation from the founder and the startups, because that's not everybody in our audience, maybe a quality or regulatory professional is listening to this and saying,

well, okay, I'm not a founder, I don't have control of the budget. Yes, but you need to be raising these things because they may not be proactively asking these things.

Jon Bergsteinsson: Yeah, even in your interviews, I mean, if you're interviewing for a new position and you, you're looking to be appointed a compliance lead,

you need to be able to ask the questions to the founders or the leaders of the company. Have you budgeted for A, B, C and mention the services or fees that you know that might be relevant to discuss?

That's what I would suggest to do at least.

Etienne Nichols: Yeah.

Jon Bergsteinsson: And I guess inexperienced founders as well, and maybe also sometimes more experienced Mattex founders that have maybe gotten used to working with external consultants or outsourcing a lot of their RIQ efforts.

They just expect that the outsourced part of a role takes care of everything that relates to compliance.

But outsourcing doesn't mean that it's going to cover all the underlying costs of supporting the compliance efforts. It's usually the man hours you're paying for. And that's it.

Etienne Nichols: Yeah, yeah, that's a good point. I One of the things that I I just want to encourage people who are listening is to not be satisfied with the status quo. I I've experienced it where I come into a company and these are the tools that I've been given and I'm not necessarily satisfied.

But maybe I'm going to keep my mouth shut because I don't want to incur an additional cost in the first months that I've been hired. But no, that's a pretty critical time window though too.

Jon Bergsteinsson: Yeah. And I mean, leaders want that. Good leaders want people to raise their voices and tell them what it is that we're lacking and missing in terms of getting better at what we do.

I know that just from personal experience, people that speak up tell us how we could do things better tend to be the best employees.

That's all based on the fact that you do have enough trust to share all your opinions. But relying on status quo is usually never good. There's always ways to do things better.

Etienne Nichols: Yeah, and I'll just add one thing onto that because I really love your point. The ones who bring those things up and make those comments being some of the best employees.

I think that's part of it is because of the ownership mindset. They probably wouldn't bring those things up if they didn't have some sort of feeling of ownership. And there's always edge cases.

Jon Bergsteinsson: But yeah, that's true.

Etienne Nichols: Thoughts on the impact? What do you think about the impact if there is a budgeting oversight and this if it's a startup or a middle market company, what's their ability to scale?

How does that impact them in in an investor's mind and their ability to raise funding.

Jon Bergsteinsson: So what is the cost of oversight? Well, it can be financial cost,

but oversight in general is never a good thing, especially for going to market. Unexpected oversight tends to lead to unexpected costs later on. And unexpected costs, direct costs are never a good thing if you haven't budgeted for it.

And this could put the company at financial risk related to fundraising, getting to market, cash flows,

et cetera. But it can also lead to diminishing of quality of your documentation. Technical filing, regulatory submissions and documentation on all fronts, essentially, but not only that, but also even things related to how you design your device, how risky it will be, or how good it will be in terms of mitigating hazards or overcoming clinical challenges,

stuff like that. Because,

for example, if you do miss the fact that you need to pay for a quality management solution at some point or a design solution at Some point or clinical data management solution at some point will ripple into diminishing or, or lower quality of work for some of those individuals that are working in those areas and that will return usually lower quality work at the,

at the output side of things. This will most definitely impact getting the product to market, impact timelines for regulatory applications and. And so forth. So in general lack of oversight is never good, but it also,

in general it just reduces the amount of oversight that you have as a leader in a company. Whichever division that is impacts your quality of reporting towards the rest of your team, your management and even for those that are leading the company, for your strategic advisors, the board and investors and even future investors.

Etienne Nichols: Yeah, I, I see where you're coming from that when again in project management you have the three have time, budget and scope. And I can see it impacting all three. If, if you're.

And I'll just give a. Maybe a. It might be a generic example. I'm just trying to think of one here. For budget or from, from a scope perspective. If you have a planned study but you are suddenly trying to do a lot of things on paper at multiple different sites or different.

Whatever the case may be now you have to go back and do a whole lot more work. Your scope of work has increased. And so that is. I've seen that so many times in different ways.

Jon Bergsteinsson: Yeah, we could take two examples. So for example clinic, let's take clinical first. So let's say that you're planning for your first feasibility study.

You've made an agreement with a research center to do a small study and they've given you a number and they, you just expect that them to. They take care of everything.

So what you expect is that they do the study and you get some data out of it.

If you don't think about the values of having access to your data, being able to produce reports along the way as needed when you need it, or even just keeping track of the data after study is finished in a closed, secure environment where you have access controls on it,

this can be catastrophic because when the study is done, it's very difficult to get that study or that data into a format that allows you to do that. If you think of quality management and documentation related efforts,

not thinking about ways that you will manage that for the next five or 10 years in a controlled environment of some sort like electronic quality management system that will have a direct impact on your regulatory processes, auditing timelines and stuff like that.

So you need to have an observer mindset in terms of Every single item that you're budgeting for when it comes to your compliance efforts, are there services or software solutions that I might need thinking a little bit further ahead than just that one first study or that first ISO certification?

And what is it that a company like Mines would look like in five years if everything was top notch?

Etienne Nichols: Yeah, I think that's a really good point. So when, when an investor is going through that due diligence, what are some red flags that they look for? Are there any things that stand out?

Jon Bergsteinsson: Yeah, so typical red flags always include, let's say non developing cost, for example.

Etienne Nichols: Okay.

Jon Bergsteinsson: Companies that present budgets that stay the same for the course of the next two or three years are usually very unrealistic. Cost tends to go up, inflation tends to drive higher cost.

This relates to salaries, services and stuff like that. And it's very difficult to just appoint a hundred thousand dollars for a single line item and then just believing that it will stay the same for next two, three years.

So that's, that's, that's where you usually see an experienced founder from an, from inexperienced founder being able to make sure that that is correlating with inflation and stuff like that.

So that's usually a thing that you could train up. But you know, it's a small red flag. Another red flag is usually the fact that they've concluded everything around their compliance effort.

So the metric company might have presented you with their way of getting through a 510k at some point with no delays, not expecting any possible delays, and the cost will just be fixed to a single line item called compliance and it's finished at the end of year two and there's no more cost after that because we cut the product to market.

That's not the case really. Usually you do have delays most of the time. It will take time to get the product to sign freeze before you can prep. I prepare the regulatory submissions and so on.

And costs will not diminish. It will usually keep going up at some point.

Etienne Nichols: Postmark surveillance, all those things.

Jon Bergsteinsson: Yeah, yeah, exactly, exactly. So what happens after you get a submission through? Because like, you know, getting a submission through is just the starting point, you know. But there are other things like missing cost development for full time employees, for example.

You can't expect people to have the same salaries throughout the lifetime of the company. You will appoint more people, you will have to raise salaries at some point and so forth.

Also the transition from a outsourced or consultancy based organization, what you might have outsource some of your regulatory quality parts or Even clinical operational parts of your company,

you would usually want to see that at some point being mounted back into the organization.

You want knowledge to stay within the organization.

You don't necessarily want the knowledge to always be outsourced at every single time during the lifetime of the company. In some cases where companies are developing a very specific product that they know will be a potential strategic exit to a larger metro company, it might make sense.

But if you're developing a more complex medical device and you know that it will have to get up to a certain amount of revenue, you, you're going to have to be a leader within your space.

It's a novel technology. Maybe you will want at some point that knowledge to be included in the organization by default and not being outsourced every single time.

So that's some of the flags that you will, that you look into naturally.

Etienne Nichols: So I'm trying to think from a startup's perspective. When I think about all these different costs that could potentially be incurred, I'm going to expect my chief financial officer or whoever it may be to have some insight on some of these things.

Obviously they should be weighing in pretty heavily on this budget budgeting aspect, but maybe they're, if they're not medtech specific or a medical device background, maybe they don't have some of the knowledge of some of these aspects that you're talking about from a regulatory perspective.

Jon Bergsteinsson: Yeah, and oftentimes you don't even have a cfo. I mean there are very few metric companies that I've met that have a CFO from, from day one. Usually just have somebody to care, take care of their books and that's it.

So it's oftentimes the core founder or the CEO of the, the founder team that usually takes care of it. Most, many of times I've met founders that have advisors besides them that have gone through this process and they usually benefit from that.

So I always suggest that you do have a mentor in place. Mentor can be an investor as well, but it's very often good to have a mentor together with you working as a sparring partner and not as an investor because that does have a bias effect on that relationship as well.

Yeah, but a mentor that has maybe gone through that journey at some point or maybe a recently exited founder can be a very helpful tool to have in your, your network.

Etienne Nichols: Yeah. So my, okay, how do we get to the actual numbers then? What, what specific budgeting benchmarks or categories do you expect to see from an investor ready startup?

Jon Bergsteinsson: Okay, so for anybody that has been an Operator in any kind of company,

you usually been confronted with this question at some point.

So if you want to use a new tool, somebody's going to ask you, so what's it going to cost? Have you gotten quotes? Have you gotten pricing?

And that's usually what you need to do. You just need to open up your mind a little bit and think, okay, who can I ask about what services or cost items that might relate to compliance?

Okay, if I got some idea of that, I have to get somebody myself to look into what they will cost. Simple surges.

Use your AI chatbots to do your deep research for you on those areas that you're interested in. Get some ideas of potential costs and timelines of implementation to get an idea of whether it will impact your budget going forth.

So scouting the market is usually the best way to do.

Could also be helpful if you're part of a network of some sort or you're attending a conference to just ask other people, ask your competitors if they're willing to share that or ask your colleagues that are at the same stage as you are in the medtech industry.

Open up your mind towards being creating relations with other founders and get them to share their costs with you so you get some idea of how that could work or look like.

Etienne Nichols: I think that's a really good answer. You know, we, we oftentimes in the med tech industry, at least in my experiences, people want to keep things really close to the vest when I, which I don't think needs to be the case a lot of these things.

This is not IP we're talking about, you know, how long, how much does it cost to do these different activities. And the other thing you mentioned, competitors. I don't know how many people think about that, but I am a big believer in frenemies.

Jon Bergsteinsson: I do, I'm. Me too. I mean I've had multiple beers with competitors that have shared their opinions on different things that have benefit sides of the puzzle. I mean of the board, it's yeah, frenemies are good.

How is it saying keep your enemies.

Etienne Nichols: Close, keep your friends close and your enemies closer?

Jon Bergsteinsson: I think, yeah, yeah, I think that's very true. It and it does and it can help.

Etienne Nichols: Yeah.

So if we, what if a founder has already gone down the path? They've thought they had everything budgeted but they're sitting here thinking well, okay, yeah, my regulatory line item does drop off a cliff after 5, 10k approval and we have zero inclination after, you know, for full time employees,

etc. They're thinking about all These different things.

Jon Bergsteinsson: Yeah.

Etienne Nichols: How can a founder get back on track if they realize their budget is starting to think that's way off in, in comparison to what an investor would expect?

Jon Bergsteinsson: That's a good question. So the best, the best budgets tend to have a baseline best case and a worst case scenario of some sort. And it doesn't have to be for every single cost item in your books.

It's usually just a good idea to have something like a best case, worst case baseline scenario for different costs that are usually the larger costs in the operations that you have.

So the best companies, they tend to have that plan in place for all these different pathways that you could take in terms of cost. So if you do fall off a cliff, you have to think about it like a risk management project, I guess.

Where can I seek assistance in terms of getting that item back in place, in terms of reducing costs in other places and so forth.

But it's difficult when you're a startup because usually what you do is that you fundraise towards a baseline budget of some sort. Let's say you need 5 million to get through initial regulatory preparations and maybe start a first study of some sort, design freeze.

And that budget is based on cost. That relates that that mirrors 5 million. What a lot of founders tend to do is they do budget maybe for a lot less, not a lot less, but maybe 10, 15, 20% less than that.

So they have a little bit of leeway to take care of those oversights that they might have had. But also preparing your investors and saying this is the number. But just be aware if this delays this much or that happens at some point, or you know, just being able to tell that to an investor at the point you're raising funds,

it will also prepare your potential investors to the fact that they might need to open up the wallets one more time just to save the company if needed.

So you can never prepare well enough. But thinking of the worst and plans for the worst is always good. But at least if you can tell an investor that you thought somewhere along those lines to risk manage some of those aspects, you're always better off asking for more capital if needed.

Etienne Nichols: Yeah. And communicating clearly and early. I can see that being really valuable in that situation.

Jon Bergsteinsson: Yeah. A good leader thinks ahead, he or she thinks a couple of years ahead and shares those thoughts with his investors or her investors.

That gives the investor the perspective that the person knows how to risk manage things.

Because everybody wants to be a. We're always looking forward, we're always looking ahead, we're Always many founders believe that they have the best device in the world and everything will be a success.

But everybody that has run, started a company knows that there are hiccups along the way every single time. Nothing goes up in a straight curve.

Etienne Nichols: Yeah.

Jon Bergsteinsson: So being able to share those thoughts about where you might have risks for costs and stuff like that is very important.

Etienne Nichols: So I might have missed this question. Maybe I should have asked this question earlier in the conversation, but I just wonder if you could just kind of tick through some different areas that you think.

Here's something I think a lot of founders don't think about. Here's another area that I don't think a lot of areas they don't think about and they don't budget this much.

Would you be able to just run through a few items? Yeah.

Jon Bergsteinsson: Yeah. So first of all, I think one of the things that a lot of companies tend to forget are all the standard fees that might be related to just general submission to stuff.

So getting a call from a notify body early on, getting cost assumptions early on about that. For example, what is the cost of just filing stuff through different countries? What is the cost of just getting a test done for electricals or biocompatibility or other kind of testings that your device might need to do?

Is that taken into account?

What are the basic costs for preparing a document into a standardized structure that is required by the organization? Receiving your filing and stuff like that doesn't have to be a lot of high fees, but it is a cost.

Another thing is,

we've talked about this before, which actually sparked the idea for this conversation. Is the software services that you need to have in place in your organization going forward?

What software is needed to keep a documentation system in place that complies with medical device standards? What kind of software do I have to have in place for designs? What do I need to have in place for risk and complaints and clinical data collection?

Stuff like that? These software licenses are cost items that you need to include and then the third thing is usually the consultancy parts. So if you've spoken to a consultant, you need to be very much aware of what it is that they're providing you with.

Sometimes they might help you set up your qms.

Is the QMS cost included in that or is just simply the man hours that you need to include for covering the expenses, the work that needs to be done.

The consultancy might also touch into clinical. It's a clinical study. If you're paying a consultant or getting a quote from a consultancy or a contract research organization or a CRO?

Do they include costs that are paid out to clinicians? Do they include costs paid out to other vendors related to the study efforts as well? Or is it simply project management?

You know, you need to be able to ask those questions when you're in conversations with consultants like that. And it's very easy to get off track when you think about outsourcing and consultancy believing, like I mentioned before, that they can take care of everything.

So you need to be very diligent on asking those questions early on in those conversations.

Etienne Nichols: That's a good, that's a really good list. I like that. I mean, I was just in a conversation yesterday with a guy named Adam Steadman who's working on a new distribution model and he, he just brought up things that I'd never thought about like state level, state in the US State specification fees.

Yeah, something I never really.

Jon Bergsteinsson: Exactly.

Etienne Nichols: Yeah. And so many of those different things. But I think the software is a really powerful one. The data privacy, cloud infrastructure, cybersecurity, all those have line item costs that we don't always think about.

Jon Bergsteinsson: Yeah, I mean, how many solutions do I use on every single basis? I think probably 10 or 15 software solutions. They all cost something. Yeah, but these are the general IT software solutions you might use at your company.

But when it comes to medical devices, you do have a lot more complex software solutions that relate to your R and D efforts, your regulatory preparation efforts, and also your actual regulatory compliance efforts like clinical studies, post market surveillance, capas complaints and stuff like that, and even things like translation of manuals.

Oh, that's good packaging.

What is the initial cost of molding? How long does the mold last? When do I need to buy or pay for a new mold or tool setups? What is the,

this is something that I've recently been looking into actually. What is the lead time on getting something up and running on a production line? If that lead time delays by these many months, what will the cost effects of that be?

For example? Yeah, now we're getting into really nitty gritty details. But these are unexpected cost parameters or parameters that can impact costs very highly.

Etienne Nichols: Yeah, I like that you bring that up because I don't know, you know, the founder mindset. I'm sure they have a lot that they're thinking about getting into the nitty gritty details though.

I think it shows some of the unknown unknowns. I even just, I'll throw one more out there just, just for, I guess, comprehensive sake. UDI fees, just registering a UDI number and all Those different things, that's something nobody ever thinks about to the very end, so.

Jon Bergsteinsson: Exactly. And, and even in Europe, I don't know how it is with all the different states in the U.S. but even in Europe. Different countries in Europe are very traditional. So for example, I learned that in Germany it's sometimes you need to actually show up at these governmental offices and listen to them read through your contract.

You know, that's one or two man hours, then you need to sign something and then you probably need to pay a fee.

There are similar stuff like that happening in the medical device industry that relate to local requirements from the different regulatory offices that might differ very much between one country from another.

Even though these might be low single cost item costs, they do multiply when you want to reach different markets.

Etienne Nichols: Yeah, I think you're giving me the idea of maybe I need to build out a checklist of medical device specific budgeting items that you need to consider that most people probably don't think about.

Jon Bergsteinsson: But anyway, maybe that might be a very beneficial catalog to have.

Etienne Nichols: If I get it done in time, we'll put it in the show notes. But if not, you know, reach out to Yohn or myself.

Jon Bergsteinsson: I mean, I mean stuff like how much do we pay for an ISO standard? Single ISO standard, a PDF.

Etienne Nichols: Yeah.

Jon Bergsteinsson: And you need to have a license for that ISO standard, not just for a single user, but multiple users. That's a couple of thousand dollars at least.

Etienne Nichols: I'll throw out a tip on that. If you are purchasing ISO standards, go to Estonia. They're considerably cheaper than anywhere else. Just a thought that.

Jon Bergsteinsson: But yeah, yeah, I've also seen some cheap ones in the, in the Mexico ISO store.

Etienne Nichols: Yeah, lots of different ways to reduce some of those costs. But regardless, you do need to pay for themselves, so.

Jon Bergsteinsson: That's true.

Etienne Nichols: Any last thoughts or pieces of advice that you'd give these startups or those working in the startup world?

Jon Bergsteinsson: Well, like I said before, one of the things that I do tend to tell everybody to utilize is a network getting active in a medical device or medtech startup network is, is much more valuable than you might think.

Some medtech startups do come or are developed from within an accelerator of some sort, universities maybe as well, where there's maybe a natural network of some kind.

But showing up at these conferences,

which usually don't cost a lot of money for a metric startup where you can't a chance to ask people with experience that you might not have or connect with other individuals at the same level as you are, is so much more Valuable than just sitting in your own Corner talking to ChatGPT.

Etienne Nichols: Yeah.

Jon Bergsteinsson: So I tend to suggest that people do visit conferences, do show up at local networking events or events in their geographical areas.

Etienne Nichols: Yeah, I think that's a very powerful piece of advice. Every time I meet him at a conference and I meet someone, hey, I know he's in the urology space and I know this other person, I mean, let's connect those people because they likely know some things they needed.

Jon Bergsteinsson: Exactly.

Etienne Nichols: Yeah.

Very cool. Thank you so much. Yon. I really appreciate you coming on the podcast and talking about this. This is a. I think it could be a valuable topic and where can people find you if they want to learn more about what you're doing or to reach out?

Jon Bergsteinsson: Yeah, well, first of all, thank you so much for inviting me on the show. I did do love sharing this information with people because it's actually something that I see people fighting over every single day when I do bring this stuff up at meetings.

But if anybody wants to get in touch, I'm on LinkedIn, Joan Berkstenson or John VC,

happy to have a conversation if needed.

Etienne Nichols: All right, we'll put those in the show notes so that you can get ahold of him easily. Until then, thank you so much. And those of you who've been listening, thank you so much for listening and we'll see you all next time.

Everybody take care. Thanks. Etienne,

thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform.

If you've got thoughts or questions, we'd love to hear from you. Email us at podcastreenlight Guru. Stay connected. For more insights into the future of medtech innovation. And if you're ready to take your product development to the next level, Visit us at www.greenlight.guru.

until next time, keep innovating and improving the quality of life.

About the Podcast

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Global Medical Device Podcast powered by Greenlight Guru
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts ...

About your host

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast