In this episode of the Med Device Cyber Podcast, host Christian Espinosa is joined by JJ Amell, CEO and Attorney at Law at Amell Law, a firm specializing in helping Medtech companies navigate the legal complexities of entering the U.S. market. With a unique background influenced by his cardiologist father and a passion for technology, Amell offers a comprehensive perspective on the legal and business hurdles that international and domestic startups face. The discussion centers on the critical importance of strategic planning for U.S. market entry, which Amell argues is the ultimate 'end game' for most Medtech developers. He emphasizes that this process is far more intricate than simply filing paperwork and warns entrepreneurs against the pitfalls of using automated services like LegalZoom or relying on AI for legal guidance, stating that these tools cannot replace the tailored advice of an expert who understands the full scope of a business's needs.
Amell outlines his firm's three core service areas: international corporate structuring, business immigration, and intellectual property. He explains that these elements are deeply intertwined and must be considered cohesively from the very beginning. A significant portion of the conversation is dedicated to the strategic choice of which U.S. state to incorporate in. While acknowledging that Delaware has long been the gold standard due to its established corporate law and favorability among venture capitalists, Amell presents a compelling case for other states, particularly Texas. He cites recent Delaware case law that can be unfavorable to majority shareholders and highlights Texas as a more attractive, pro-business alternative. The hosts also explore why California, despite its high taxes and complex regulations, remains a powerful hub for innovation, attributing its resilience to its deep-rooted infrastructure, access to capital, and a strong history of tech development. Amell stresses that a successful market entry strategy requires a holistic approach, aligning the legal structure with fiscal responsibilities and immigration plans to avoid costly delays, such as being denied entry on the wrong visa type or facing unexpected tax liabilities.
Furthermore, the podcast delves into the practical risks companies face, including scams targeting new businesses immediately after their information becomes public through trademark filings. This underscores the need for a trusted legal partner to manage communications and verify legitimacy. The conversation reinforces the idea that navigating the U.S. market is not a simple checklist; it's a multi-faceted challenge that demands expert navigation across legal, financial, and regulatory domains. Amell's main message is one of proactive and informed planning, urging companies to build a strong, customized legal and corporate foundation with a trusted team to ensure a smooth and successful entry into the lucrative U.S. market, thereby protecting their innovation, investment, and long-term viability.
Key Takeaways
01Entering the U.S. market is a primary goal for many Medtech developers, but the process is filled with numerous legal, corporate, and immigration hurdles that require expert guidance.
02Relying on automated services like LegalZoom or AI for legal tasks is risky, as they provide a one-size-fits-all solution that often fails to offer the proper legal protection and strategic advice needed for complex ventures.
03Strategic planning from the outset is crucial. Companies should align their corporate structure, business immigration plans, and intellectual property protection early to avoid costly delays and regulatory issues.
04The choice of U.S. state for incorporation has significant legal and financial implications. While Delaware is the traditional hub, states like Texas are becoming more competitive and may offer more favorable laws for business owners.
05Despite high taxes and regulations causing some companies to leave (the 'Techxodus'), California remains a dominant force in innovation due to its deep-rooted infrastructure and concentration of venture capital.
06Business immigration must be handled carefully. Attempting to operate in the U.S. on the wrong type of visa can lead to denied entry and significant disruption to business timelines.
07Once a company's information becomes public, such as through trademark filings, they often become targets for sophisticated scams and should rely on their legal counsel to vet any inquiries.
08A holistic approach is necessary for U.S. market entry, integrating legal, fiscal, immigration, and branding strategies to build a solid foundation and mitigate risks.
Frequently Asked Questions
Quick answers drawn from this episode.
In this episode of the Med Device Cyber Podcast, host Christian Espinosa is joined by JJ Amell, CEO and Attorney at Law at Amell Law, a firm specializing in helping Medtech companies navigate the legal complexities of entering the U.S. market.
Entering the U.S. market is a primary goal for many Medtech developers, but the process is filled with numerous legal, corporate, and immigration hurdles that require expert guidance. Relying on automated services like LegalZoom or AI for legal tasks is risky, as they provide a one-size-fits-all solution that often fails to offer the proper legal...
The discussion centers on the critical importance of strategic planning for U.S. market entry, which Amell argues is the ultimate 'end game' for most Medtech developers. It's most useful for medical device manufacturers, cybersecurity engineers, regulatory affairs professionals, and MedTech founders preparing for FDA review.
Entering the U.S. market is a primary goal for many Medtech developers, but the process is filled with numerous legal, corporate, and immigration hurdles that require expert guidance.
Listeners also asked
Quick answers pulled from related episodes.
What does Episode 63 cover about "Why MedTech is the Future of Entrepreneurship with Omar Khateeb"?
In this episode of the Med Device Cyber podcast, hosts Christian Espinosa and Trevor Slattery are joined by Omar M. Khateeb, host of the State of MedTech podcast. With a background that spans medical school, surgical robotics, and marketing, and having produced over 300 podcast...
What does Episode 6 cover about "Avoid the Dumb Tax: Cybersecurity Lessons for MedTech Startups with Steve Bell"?
In this episode of The Med Device Cyber Podcast, the hosts welcome Steve Bell, a seasoned veteran with over 35 years of experience in the MedTech industry. Steve shares his extensive background, which began with a 16-year tenure at Johnson & Johnson where he was part of the...
What does Episode 21 cover about "Integrating Project Management to Strengthen Cybersecurity Outcomes with Steve Curry"?
In this episode of the Med Device Cyber Podcast, host Christian Espinosa, a Project Management Professional (PMP) himself, interviews Steve Curry, the founder of Mustard Seed, a firm dedicated to improving project management within the life sciences. The central theme of the...
Pre-fills with: "Entering the U.S. market is a primary goal for many Medtech developers, but the process is filled with numerous legal, corporate, and immigration hurdles that require expert guidance."
Medical device commercialization is an engineering milestone, but it is also a legal minefield. In this episode, Christian Espinosa and Trevor Slattery welcome MedTech attorney JJ Amell to dissect the critical errors international founders make when entering the U.S. market.
If you do not structure your corporate entities and secure your immigration pathways correctly from day one, federal bureaucracy will burn through your venture capital runway before you ever reach an FDA review. JJ outlines how Amell Law builds robust defensive frameworks around global mobility, corporate liability, and trademark protection.
In this episode, we cover:
* The Legal Zoom Trap: Why automated, check-the-box business formations fail to provide adequate liability shields for multi-million dollar medical operations.
* Delaware vs. Texas: How recent case law regarding minority shareholder control is shifting the corporate gold standard toward the Lone Star State.
* The Business Immigration Clock: Why O-1 founder visas and engineering team mobility must be negotiated at the absolute start of your commercial strategy.
* Automated Pen Testing Failures: The exact financial consequences of submitting cheap security scans to the FDA, resulting in 180-day interactive review holds.
* Public Scraper Scams: How bad actors weaponize public USPTO databases to manipulate foreign nationals during active application windows.
Episode Breakdown:
00:00 - Intro
00:54 - Welcoming MedTech attorney JJ Amell
03:38 - Solving legal pain points for global innovators
06:11 - The three pillars of U.S. market entry
08:33 - The inverse market challenge: Moving from Europe to the U.S.
10:43 - Factoring in fiscal repercussions and international tax consultations
12:57 - State jurisdictions: Delaware standards vs Texas corporate law
16:21 - California red tape and the rise of alternative technology hubs
22:41 - Reverse engineering corporate strategy to avoid late-stage corrections
25:44 - The danger of automated penetration tests and interactive FDA reviews
29:39 - Deportation risks and B-1/B-2 tourist visa limitations
31:24 - Government bureaucracy timelines and USPTO trademark processing realities
33:04 - Public database scraping and the explosion of corporate filing scams
37:37 - AI voice cloning and deepfake vulnerabilities targeting tech executives
40:52 - Code Blue Chart: Documented cybersecurity fatalities in healthcare
44:25 - Closing thoughts and reconnecting with nature
Find JJ Amell here on LinkedIn: https://www.linkedin.com/in/jjamellesq/
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity experts providing essential security solutions for the medical device industry. Learn more by visiting https://bluegoatcyber.com.
If you're interested in our services or partnering with us, schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Operating Officer at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn:
https://www.linkedin.com/in/trevor-slattery-34852b1a9
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
What we're starting to see is that the end game for many medtech developers is to enter the U.S. market.
Christian: It sounds like from a legal entity and visa and structure perspective, they definitely would need someone's guidance because it's not something you can easily navigate it sounds like.
JJ: There's so many hoops and hurdles to U.S. market entry.
Guest: Why is California such a dominant force still in the tech scene even though there's all of this red tape?
JJ: So you're starting to see people migrate to other states, Florida and Texas, but the foundation of innovation, it's just so strong in California that I don't see it leaving anytime soon. If you are that entrepreneur or startup that's trying to get market to the US, could I go down to LegalZoom now and and check boxes? Sure. But you know, you're not getting the proper legal guidance. AI is a great tool, but it's not an legal expert.
Christian: Hi, welcome back to another episode of the Med Device Cyber podcast. Today we have a guest, uh, JJ Amell from Amell Law coming to us from Texas. So we'll probably get a bill at the end of this episode because we are talking to a lawyer. Um, so we'll see how much the bill is. It may not, we'll have to negotiate with him. So how's it going today, JJ?
JJ: It's going extremely well. A very Friday to you guys.
Christian: Yes, it is Friday, we're recording on a Friday. So this is an exciting topic. I think JJ is our first lawyer or attorney we've had and he does work in med tech. Uh, so it would be, it'd be fun to talk to him and pick his brain about some of the legal challenges people face in med tech. We tend to see him at most of the med tech world events. I think you're going to be at the one coming up not too long ago or coming up here in Florida.
JJ: That's right.
Christian: Uh, and I think we saw you in Dubai recently. Was it the last one, wasn't it?
JJ: That's correct. Yeah, back in February.
Christian: Awesome. And uh, are you in Houston proper or like a suburb of Houston?
JJ: Uh, we're just outside Houston. We're in an area called The Woodlands, uh, northern sub suburban area of Houston.
Christian: I did one of my Iron Man triathlons in The Woodlands. I swam in that, that waterway that's like horrible, it's horrible water. It was like really dirty, but it and the roads are really bad. I remember that for the triathlon, but they just had it not too long ago.
JJ: That's right. Yeah. That's right. That's one of our big events here.
Christian: The Woodlands is beautiful, though.
JJ: It is. It's extremely beautiful. I loved I loved uh, one of the reasons why I like being out here. I mean, I grew up in the area, uh, but one of the reasons why I chose to be in The Woodlands because of all the the nature that's here and the beautiful parks. Um, and it's very um, puts me in a place of serenity. And I like to be able to just to, you know, take a break from work, maybe even go to the park or uh, just drive around. Um, having access to nature is important to me.
Christian: I agree. Uh, Melissa, my wife wants us to move to Texas at some point. Uh, her, she's got family in League City, which is a little bit south and uh, Texas City, and she has a condo in Galveston, but I don't tell her this. She but I prefer The Woodlands area better than Galveston. I don't like Galveston that much for some reason.
JJ: Yeah, yeah. Yeah. She already knows that probably, but. Yeah. Yeah, well, you know, and what uh Galveston is another one of my my getaway destinations. Uh, they have great Cajun food, but you know, it's it's the beach that we have. Uh, and um, I, you know, I grew up with with access to Galveston and, you know, that's one of the places that I I love to recharge, um, and get away. Um, I I even a day uh going to the beach um is enough for me to to kind of clear my head and and get back to work. But the beach and, you know, and and nature, those are uh those are critical to to like sustain my my mental health. I'll I'll put it that way.
Christian: I agree. Yeah. Awesome. So what what kind of things do you mainly help medical device manufacturers with? I know there's like intellectual property. I know you've helped us with trademarks. There's like a number of, you know, things I, I know intellectual property is a big deal. A lot of people want to protect their IP when they're coming up with a new innovation, but like what are like the main, I guess, pain points you solve for Medtech innovators from a legal perspective?
JJ: Yeah, sure. So, uh let me share a little bit of my background. I think that will kind of segue into like how I I I got into the MedTech sector. So, you know, I grew up in Houston, Texas. Uh my father was a cardiologist, and um when I was wrapping up law school, we were seeing a lot of, um, I mean, this is, you know, 20 some on years ago, but we were seeing the the proliferation of electronic medical records, electronic health records and the digitization of the whole healthcare system. And I was a real uh, computer geek. I mean, I love building computers and my father was too. In fact, uh, in he had a part, uh, he had four or five partners, and then a 38,000 square foot facility and he built all the computers. And when this advent was coming, um, you know, he said, you know, we have to, um, make a, a pivot or a shift in the way we practice. And he onboarded me to be the in-house counsel as well as project manager, and so I started to see a lot of these trends and I started also working with service providers such as uh Boston Scientific, Medtronic and I got to I wouldn't say I was you know, I I understood completely all the lexicon of the industry, Medtech industry, but I felt comfortable talking with Boston Scientific, Medtronic on on a regular basis. And then, um, I, I pivoted myself, uh, career change into, you know, wanting to do do more traditional law. And so I eventually opened my own practice and, um, I got invited to Medtech World Malta uh, a few years ago. And I started to see uh a gap, um, in in the industry, uh, a legal gap and I thought I could help be a facilitator and and fill in certain niches. And our law firm, uh our our main drive or the way we describe our law firm is that we're US market entry for Medtech industries. And we're starting to see as, you know, the endgame for many Medtech uh uh developers is to enter the US market. So, we can help facilitate and help build a team around that. Now, our law practice focuses on three service areas. The first is uh, international corporate structuring. And what I mean by that is, you know, you can have a subsidiary or or a principal office in Italy, but you're now ready to expand into the US market. So how do we get you there? What are the things that we need to consider? Is it opening a subsidiary? And even if we open a subsidiary, are we, what kind of, what kind of sophistication does the client need? Uh are we looking at holding companies, looking at operating companies, intellectual property companies, things of that nature. All depending on the sophistication of the client and meeting them where they're at. Some don't need that. Well, there's steps, right? There are levels to all that. Now our se- second service area is business immigration. And I'm an advocate for talking about that at the beginning when when uh, talking about US market entry, much of the time is talked about as an afterthought. But the reason why I'm talking about it at the beginning is because we work with a lot of government agencies such as CBP, Customs and Border Patrol, uh US CIS, State Department and they're on their own timeline. So, I like to get ahead of the game or ahead of the game and start talking about and talking to the client asking them, you know, do you see yourself, Mr. owner or founder coming to the United States? Okay, what types of visas should we consider? Is it an investor's visa? Is it a a founder's visa, like an O1? Are you going to bring over people who are uh engineers or quality control managers? That would be like an L1 type visa. So these are the these are this is where the business immigration comes into play. And then we also our third and last area is intellectual property. Our main focus there is uh, at least from Amell Law's side Amell Law's side is uh, trademarks. We also can handle copyright. For patents, we don't handle that, but we have lawyers that we refer and that we work with to handle the patent side. So that's a general, uh, a general picture of Amell Law and how we assist uh, Medtech companies with US market entry.
Trevor: How different do you think it is coming towards the US market as opposed to doing the inverse, starting in the US and moving towards a European market. I know it's a popular model for a lot of companies to, since it's a lot easier to raise funds and get that initial market access here, but what does that inverse look like?
JJ: I know FDA compliance is a major issue, and we we always try to work and find out where our client is in that stage because if we can't, if they can't get FDA compliance, then there is no US market entry. So we always try to find out with whom they're working with, and uh, where they're at in that stage. Now, we have we we we also assist with uh, global mobility, helping clients uh go abroad. So, we do have that aspect as well, Trevor. It is very different. The way I, and let me, and let me share it more from the perspective of what I'm hearing from my clients. Uh, the main challenge is getting into the US. Once we get into the US, everything else seems to be uh, much easier, whether going abroad. Now Europe is a little more challenging from my understanding. I don't and I don't work with the regulation side of of Europe, but I understand there are a lot of restrictions, so, but you can't really get too far on on on, well, let me put this way, having credibility in the US, having access to the US, having gone through been vetted in the US goes a long way abroad. Now, as I was sharing earlier, we do have a global mobility aspect so we do help US or even other citizens of different parts of the world, go to other markets. And we have a team for that as well. So, uh, that that's our global mobility side of our practice.
Christian: It sounds like if I'm coming from uh Europe to the US, there's a lot of things I needed to think about like you mentioned like an owner, 01 visa, uh, and if I bring a team over, it sounds like from a legal entity and visa and structure perspective, you know, they they definitely would need someone's guidance because it's not something you can easily navigate it sounds like.
JJ: Yeah. Yeah, uh, you definitely want to, a trusted team to work with you on your US market entry. There's so many hoops and hurdles to US market entry. Um, and there's so things that we're learning, that, um, you know, we're we're we're doing our due diligence, but there are things that we're still learning, Christian, on how best to prepare clients. Now, what I try to do is, understand the immediate needs, mid-term needs, so just to say, uh, out three years, and then five and beyond, long-term needs. And I try to not have any surprises. Now, the area where I see surprises mostly coming up is on the uh tax and fiscal side. And I didn't really touch on this before, but when we onboard clients, we always have uh an international tax consultant with us. And um, the uh, the service provider that we tend to like and work closely with is uh, Russell Bedford International, and they have offices all over uh, the world. Uh, they're headquartered in City of London, uh, but we've worked with several of their offices from Dubai, Qatar, here in The Woodlands, and we like that they're accessible everywhere. And our clients, if you're in Dubai, you can reach out to the Dubai office, and, you know, we've already got some kind of working rapport, and so we're all talking the same language. But the thing about US market entry is that if I were just starting out and I'm I'm exploring the US market entry, I want to be exploring the legal side as well as the the fiscal and tax side because there are severe repercussions for not addressing the fiscal and the tax side. And many times, some people are very, like, lawyers are very quick to say, oh, we can sell you this, but it's not the complete package, right? Like I I can sell someone on a visa, but that doesn't complete the whole picture. And that goes back to your point, yes, there are a lot of issues when entering the US market from someone who has never been in the market, you know, and protecting them uh, appropriately.
Christian: Is there a specific state, like, people when they enter the US market, I know there's like the federal rules, there's state governance. Is there a particular state that's typically easier to like enter the market in? Because Trevor's in California and I know California has a lot of red tape. New York does, Illinois does. Texas maybe a little more friendly for building a business. I'm just curious, like what it's like from, you know, in the United States, we notice like a little bit, but from someone in Europe trying to come to United States, should they pick a specific state one or the other to to establish themselves?
JJ: Yeah, a great question. And, uh, let me first state that when you think about or when a company from abroad is thinking about entering the US market, they're not looking at one market, really. You're really looking at 50 plus different markets because each state is a separate jurisdiction. Um, in the MedTech world, what's most popular is Delaware. And mostly because of venture capitalists. All right? And that's perfectly fine. Delaware is a is a gold standard for sure. Now, what I'm seeing uh, coming about right now is uh and what I'm liking more and more where I like to form more corporations is Texas. I think Texas is moving very aggressively to be very competitive to Delaware. And I think there is some case law in uh, that are making it more attractive to setting up shop here. One, uh, well, the Delaware system has a special court for all business disputes. Now, recent case law has it where minority shareholders can trump majority shareholder decisions. All right? And this is something that's becoming dis-attractive for setting up shop in Delaware. On the other hand in Texas that rule does not exist. So, majority shareholders maintain control of the corporations and and decisions. And so, that is one of the reasons why I like Texas.
Christian: Well that's the whole nature of the term "majority", right?
JJ: Yeah, yeah. Yeah, you're exactly right. You're exactly right. Um, but we're starting to see more, I'm starting to see a bit of a shift of uh, Texas becoming more attractive. Um, I think still though that that California has so much just history, tech history and uh, there's so much of a footprint there that it's still, it's still very viable. The what's killing California are are the high taxes and that's why we're seeing the the exodus. Um, but, you know, Newport, Orange County, they're still developing, uh, they have very a great number of facilities out there. So, California is still, still the hub for innovation. But I think as California becomes uh, hindering doing business, we're starting to see alternative hubs develop, and we're starting to see that grow a lot in Texas and Florida. I mean the cost of living is extremely expensive in California, but I think, So you're starting, so you're starting to see people migrate to other states, Florida and Texas, but the foundation of innovation is just so strong in California that I don't see it leaving anytime soon. In fact, I I think it's even getting stronger.
Trevor: I think it's kind of a, it's this ebb and flow pattern. You know, obviously during COVID, so I'm up in San Francisco, which is famously talked about as the city that got hit really hard by COVID, and everybody left. You know, massive, massive amounts of the population just left. Everybody was going to Phoenix, Nashville, Austin, Miami. And then the whole AI boom happened, and now, I mean, you know, there were lines down the block just to go see an apartment in the city. It's everybody wants to come back. And then, you know, who's to say what'll happen with AI? Maybe this is a bubble and it'll pop and then everybody flees again, and they'll come back for the next big thing.
Christian: Why did everybody leave during COVID just to get out of like a an urban area?
Trevor: Well, I think it was because the rent is so outrageous here. And you know, makes sense when you're working in office and downtown, but then it when it went to work from home, and people are going, why am I paying $4500 a month for an apartment?
Christian: I might as well move to Alabama or Arkansas and pay like 1/10th the price and make 10 times more money, basically.
Trevor: For some big old mansion and, you know, a big yard when everybody's working at home and spending most of the day there anyways, instead of being cooped up in your tiny little broom closet apartment here.
Christian: I guess all the history is what you were saying, JJ, and the established infrastructure that even though there is the Texadus, as you said, uh it's a slow migration before that infrastructure gets built up and that history somewhere else. So because I know Houston is is a hub for Medtech, starting to be a hub. I've also heard Miami is kind of a hub and and Florida, and then recently Salt Lake City. So before it was just Boston and the Bay Area. But now we're we seem other areas starting to pop up from a Medtech perspective.
JJ: Yes. And, you know, Texas you mentioned Texas and uh, Houston, Texas is certainly developing uh as an innovation hub. Um, I I meet with a number of individuals with the Texas Medical Center, and they're doing a a quite a number of work and right now they have a new initiative with the Netherlands to uh bridge innovation with them. So I think Texas or in Houston is certainly on the rise, and definitely worth keeping, if you're in the Medtech industry, definitely keep an eye on on the developments here because uh yeah, we're on the rise. And people are looking to alternative, you know, these facilities are expensive, Medtech innovation is expensive, and there's a price to all of that. Uh the cost of doing business in Texas and Florida is is very different. But again, the way uh what I have seen is there's such a strong history in California that I don't, I don't think it's ever going to, it may not ever leave. You know, the footprint is so strong.
Christian: I have a lot of conservative friends that always talk, they've never been to California. Uh, but they have a strong opinions about California. They tell me everybody's leaving California. It's like a ghost town there. And then I go to California and like the cars are crawling on the freeways. It's like, you know, car to car to car. It's like fully traffic jam. There's people all over the place. I'm like, I thought everyone left California. It seems like it's more crowded today than it was like last year when I was here.
Trevor: I wish they would. The traffic here sucks.
Christian: You said like even to get an apartment, people are, you know, waiting in line to, to just to get an apartment and people are paying over like the asking price. So it's definitely like the demand is out, outpacing the supply there, which which is the contra, the converse of what a lot of people say. It's the inverse, what a lot of people say that have these high opinions about California and the Exodus.
Trevor: I think it's also that the supply is just really constrained. Like everybody's trying to move to San Francisco, but it's not a big city. It's 49 square miles. And it's an extremely, extremely dense city, but there's under a million people that live here. And so given that this is the tech and AI capital of the world, people want to be here or nearby here. And so even seeing places an hour and a half away from San Francisco, they are exploding with popularity while everyone's trying to get here. If you compare it to, you know, even New York, another place that is a tech scene, a big city, there's a lot of startup culture there. There are almost 10 million people in New York. There's a lot more space to fit everybody. And it's not to say that it's not extremely competitive to find a place to stay in New York, but I think San Francisco has a really unique problem and they're not trying, they're not the city's not growing fast enough. And there's no way, nowhere for it to go. And so there's only so many people that can be here and way more people want to be here than can.
JJ: And California is so beautiful. And the, the venture capital, and let's not forget about the venture capital that's out there in California, so much is still right there. So people want to be close to their investors.
Christian: That's a good point.
JJ: And you can work it either way. I guess investors want to be close to their, their clients, and and clients want to be close to their investors.
Christian: It sounds like we both have a from a business perspective, a similar challenge where clients or prospects often come to us uh, after they've made seven steps when they ideally, they'd come to us before they make the first step or right around the first step. And then we have to make some course correction. Is that typically what happens uh with you, JJ? Because I know you're advocating like to reverse engineer the strategy. If you want to come to, go to the US market, they should be talking to you earlier on, but I get the feeling from what you're saying that they often try to make a few steps and then it sounds like there are some pretty severe consequences if they choose the wrong structure, the wrong, you know, a lot of, a lot of things, uh, that they could do without the right advice. Same thing from a cybersecurity perspective, people always, not always, typically come to us pretty late down the road after they've made a bunch of design decisions and it can be very costly to do to reverse all that.
JJ: And and and thank you for bringing that up. Uh what you say is true. And it's true from a perspective of corporate formation, also from branding. And I'll touch on corporate formation first. Many times, someone will just open up an LLC, thinking, oh, now I have market entry. And that's not really enough. Uh and as an attorney, what my job is to do is to protect my client from liability, and that structure may not be enough. Just going into something like a LegalZoom and setting up an LLC, um, it just doesn't give the adequate protections that the client needs. And we're talking about companies, even in the startups, you know, on multimillion dollar companies. So how do, you know, my question is, how do we protect the, the client's interest? So, yes, we have to sometimes reverse engineer and and restructure from an international corporate structuring perspective. Now, secondly, one of the issues that we deal with is rebranding. And as you know and as I know in the MedTech industry, branding is extremely important. and entering and making sure that those brand names are available to us in the United States. So, one of the things that uh we we do is if we're going to go with the route of, okay, we're going to set up some new entities, what, what particular names are affiliated with those entities? The brand names, and let's make sure that that we can clear the brand, and then as soon as possible, if we can clear the brand, then let's go ahead and file with the USPTO and and secure that. And there are some things that we do until we get the registered mark registered, uh, to to give notice to the public that, hey, our client is claiming this name exclusively as their own here in the United States.
Christian: We have a similar challenge cuz you mentioned Legal Zoom. Uh, a lot of, not a lot, but quite a few prospects of ours can find like an automated pen testing service, like the the LegalZoom equivalent but in cybersecurity to do some testing against their device for super cheap. It's super inadequate, it's super risky and it's not going to give them the outcome they need to get cleared by the FDA, but they're still enticed to do that because it just, I don't know, it's like an educational challenge, like consumer education challenge that we have to say like, you could spend the money on this, but ultimately, you're not going to get the outcome you want and you're going to have to come to someone like us anyway, so you're going to pay twice. I imagine that's kind of what you're seeing. Someone went pretty far down the LegalZoom route and they hit a roadblock and then they come to you. So all that time and effort they spent, really amounted to uh a a loss, really. Correct. Yeah, and there are severe repercussions for not addressing the fiscal and the tax side. And many times, people are very, like, lawyers are very quick to say, oh, we could sell you this, but it's not the complete package, right? Like I I can sell someone on a visa. But that doesn't complete the whole picture.
JJ: You can use these easy solutions, but you don't get the legal guidance or proper guidance that you need.
Trevor: You mentioned the venture capital part and I think that's that's a really really important one, and I was kind of hoping you would touch on that is, you know, from our perspective, when you you go through this automated penetration test, you go out and you pay, you know, $8,000 to get it done. And you get a report and you submit it to the FDA, and they say, no, it's unacceptable. You can't get cleared with an automated penetration test. Nobody accepts these. You have to do this manually so that you have quality coverage. Immediately, you're put into an interactive review with the FDA. Great. You've got a hold up to 180 days. 180 days that you did not expect to be burning your runway. Furthermore, now you have to go and do an actual real penetration test with real penetration testers who, guess what, are going to be better than this automated tool and they're going to find more problems. The amount of times we've had a company come to us with a deficiency from the FDA, and they say, well, you know, we used a, we just did a quick scan with an automated tool and we thought that was enough. And we do the penetration test and we say, look, there are significant product redesigns that need to be done. Likely going to have to add another three months onto this project because the device is fundamentally built in a way that the FDA would not consider secure as opposed to starting this process while you're going through development going, pause, before we freeze anything and make any big decisions, let's do this test while we still have some time left to go, and then they have a clean bill of health by the time the FDA comes up. So, not even just from the risk to the product and the risk to the security and safety, which is of course a massive problem, patients can get hurt, people can die when things go wrong here, but from the financial perspective, these startups are usually pretty thin with their budgets, especially in the MedTech space and how expensive everything is. They calculate their runway pretty tight and adding six months onto that is not something that anybody wants to have to deal with, and that can make this ship sink or swim pretty fast.
JJ: Yeah, absolutely. And you, you made me think of something, uh, Trevor that you could delay, you could delay your market entry even more without an understanding of how business immigration works. Now I'm going to share, I'm going to add to this what you just, okay? So imagine you have a company, someone sets up the, well, uses like an easy fix. LLC, no legal guidance. Then that there they have an entity that's operating here. Now, someone tries to come over, a founder tries to come over into the US with a B1B2 visa and they're denied entry. Why? Because the B1B2 visa is a tourist visa and with limited restrictions on how uh, it can be used for, for business, very limited use, maybe for signing a contract, that's it. But if that, if that founder or uh, employee is is receiving money in in the sense of of salary, then the intent is completely wrong. They have to get the an appropriate visa. So what happens, USCIS or this Customs from Border Patrol says, sorry, you're going to be deported. And so, that can delay, not having not being able to negotiate with your strategic partners, uh, coming, you know, coming to the United States and working with your strategic partners to build out your brand, to build out your company, to talk to venture capitalists can severely delay uh your market entry. And like I said, we're on government agency time, uh when we're working with with immigration. Remember I I like to talk about it at the beginning because I don't like because I know everyone has a time clock or a timeline and um I don't like it to be interrupted for for not having thought of business immigration at the beginning.
Christian: For not factoring in the the government bureaucracy timeline.
JJ: Exactly right. Yeah, Christian.
Trevor: And that's a long timeline to factor in sometimes. Uh, the government's pace is not known to be snappy.
JJ: Yeah.
Christian: Well hopefully we've educated the audience a little bit more so they avoid some of these common mistakes. Well, thanks so much JJ for being a guest and thanks everyone for tuning in.
JJ: Thanks guys, appreciate it.