High-stakes decisions rarely present as a clear choice between moving forward and holding back. More often, both paths carry visible downside.
Acting introduces financial exposure, execution risk, and the possibility of being wrong in public. Waiting preserves optionality, but it also consumes time, weakens momentum, and delays learning. The tension is not between risk and safety. It is between two different forms of risk.
Yi-Kai Lo faced that tension while leading Aneuvo through a critical clinical trial. The company chose to launch before receiving full FDA clarity. Months later, it chose to pause that same trial when product quality issues surfaced.
Those decisions move in opposite directions. One accelerates under uncertainty. The other halts progress under pressure. Taken together, they clarify a more demanding standard for CEO judgment: the ability to determine when delay has become more damaging than action—and when action has become more damaging than delay.
The context matters. Aneuvo is developing a bioelectronic medical device in an environment where regulatory approval, clinical validation, and product performance are tightly linked. Decisions are not easily reversible, and mistakes are measured in years and millions of dollars.
The company spent 11 months in discussion with the FDA to refine its clinical trial design. That duration reflects the novelty of the work. It also creates a structural problem for a small company. Extended waiting affects capital efficiency, team focus, and the ability to maintain forward motion.
The cost of the trial itself made the stakes explicit. Yi-Kai described it directly: “This study cost us like seven to eight million dollars.” The timeline was equally significant. A misstep could “easily waste two years and waste lot of money.”
Those are the risks of acting. They are concrete, measurable, and easy for a team to focus on. The harder task is identifying what continued waiting is costing in parallel.
The turning point in Aneuvo’s decision came from reframing the discussion. The team already understood the risks and potential benefits of launching. What had not been fully surfaced was the cost of waiting.
Yi-Kai described the alignment point: “After analyzing the risk and benefit, right, and also the cost of keep delaying the study,” the team moved forward.
That additional variable changes the decision. Without it, waiting appears disciplined. With it, waiting becomes a tradeoff that can be compared directly against action.
In this case, further delay was no longer producing enough additional clarity to justify the time it consumed. The company had already engaged extensively with the FDA. It understood the design well enough to proceed, even without final confirmation.
Aneuvo launched the study. Two weeks later, the FDA approval followed. The outcome reinforces the decision, but it does not define it. The reasoning was already complete before certainty arrived.
For a scaling CEO, this is the practical standard: act when additional information is unlikely to change the decision enough to justify the delay required to obtain it.
The team was not immediately aligned. Some members wanted more certainty before committing. Their position was grounded in real risk: capital, time, and regulatory uncertainty.
Alignment did not come from asserting urgency. It came from expanding the frame of the decision.
When both the cost of action and the cost of delay are visible, the team can evaluate the tradeoff rather than argue from different assumptions. The decision becomes a comparison, not a debate over posture.
This is especially important in technical and regulated environments where expertise is distributed. Engineers, clinicians, and regulatory advisors each see different aspects of the risk. The CEO’s role is to integrate those perspectives into a complete picture.
Once the decision is made, alignment must extend beyond the internal team. Aneuvo coordinated with clinical principal investigators across multiple research centers. The decision created commitments that others had to plan around. Execution depended on turning internal alignment into external coordination.
The second decision tested a different dimension of leadership.
After six months of execution, Aneuvo began receiving repeated complaints from clinical sites about electrode quality. The issue affected the delivery of stimulation, which meant the treatment could fail to produce meaningful results.
Yi-Kai described the moment: “all of a sudden, we got product issues.”
At this stage, the pressure favors continuation. The trial is underway. Time has been invested. Pausing disrupts progress and introduces delay after the company has already worked to avoid it.
Yet continuing with a known flaw would have compromised the outcome. In Yi-Kai’s words, it would be “throwing the money into the water.”
The company chose to pause recruitment for approximately six months while it addressed the issue. Patients already in the trial continued, but new enrollment stopped.
This decision applies the same logic as the first, but in reverse. The company again compared two costs: the cost of delay versus the cost of continuing flawed execution. In this case, continuing had become the more damaging path.
This is where decisiveness becomes more demanding. Moving forward under uncertainty is one form of commitment. Stopping after momentum exists requires a different kind of discipline.
Pausing the study created immediate implications for clinical partners. Investigators needed to understand what had changed, how the company would respond, and when the study would resume.
Yi-Kai’s approach was direct: “we have to be transparent.”
Transparency in this context is operational. It involves explaining the issue, outlining the response, and providing a timeline that others can plan against. It is not about framing the situation favorably. It is about maintaining coordination and trust.
Aneuvo had to ensure that clinical partners could continue to engage with the study once it resumed. That required clarity, not reassurance.
For a CEO, the decision does not end with the internal conclusion. It extends into how the decision is communicated to those who must act on it. Poor communication can undermine a sound decision. Clear communication reinforces it.
The electrode problem led to a broader set of insights. Yi-Kai noted that the issue was not isolated. It involved multiple contributing factors, including vendor selection, design considerations, and process decisions.
Addressing the problem required changes across hardware, software, and manufacturing. It also informed how the company approached vendor relationships going forward.
This pattern is common in scaling companies. A product failure often reveals weaknesses in the broader system: how vendors are selected, how quality is monitored, how teams are structured, and how decisions are escalated.
Yi-Kai connected this to a leadership principle that guided his thinking: “I have to build the right team at the right stage.”
In this context, team composition is directly tied to decision quality. The ability to identify risk early, evaluate tradeoffs accurately, and execute corrective action depends on having the right capabilities in place. The team shapes what the CEO can see and how effectively the company can respond.
Across both decisions, a consistent pattern emerges. The CEO is not choosing between speed and caution as fixed positions. The CEO is continually repricing the decision as new information appears.
Before launch, the question was whether additional FDA clarity justified further delay. After extended engagement, the answer was no. The cost of waiting had overtaken the remaining uncertainty.
After launch, the question shifted. Once product quality issues emerged, the cost of continuing outweighed the cost of pausing. The company adjusted accordingly.
In both cases, the decision was made without full certainty. In both cases, the company accepted a form of cost. What changed was the relative weight of each option as conditions evolved.
This is the core discipline. The CEO must:
Yi-Kai’s experience shows that these are not abstract principles. They are applied in moments where the consequences are immediate and material.
A scaling CEO is often caught between two incomplete views. One emphasizes caution and the avoidance of visible mistakes. The other emphasizes speed and the need to maintain momentum.
Neither is sufficient on its own.
The more useful approach is to treat delay and action as competing costs that must be evaluated explicitly. Waiting is not neutral. Acting is not inherently aggressive. Each has consequences that can be compared.
Yi-Kai Lo’s decisions illustrate how that comparison evolves over time. He moved forward when delay became the larger risk. He paused when continuation threatened the validity of the outcome. He maintained alignment by making the tradeoffs visible. He sustained execution by communicating clearly with stakeholders. He improved future decisions by addressing the underlying causes revealed by the problem.
For CEOs facing similar moments, the question is not whether to move or wait. The question is whether the cost of each path has been defined clearly enough to decide with discipline—and whether that evaluation is being updated as the situation changes.
Yi-Kai Lo is the CEO of Aneuvo, a bioelectronic medicine company developing medical products that use electrical stimulation to treat injuries and diseases not addressed by conventional approaches. He has led the company through FDA approval, clinical trials, product quality challenges, and commercialization planning.
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Jeff Holman is a CEO advisor, legal strategist, and founder of Intellectual Strategies. With years of experience guiding leaders through complex business and legal challenges, Jeff equips CEOs to scale with confidence by blending legal expertise with strategic foresight. Connect with him on LinkedIn.
Intellectual Strategies provides innovative legal solutions for CEOs and founders through its fractional legal team model. By offering proactive, integrated legal support at predictable costs, the firm helps leaders protect their businesses, manage risk, and focus on growth with confidence.
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The Breakout CEO podcast brings you inside the pivotal moments of scaling leaders. Each week, host Jeff Holman spotlights breakout stories of scaling CEOs—showing how resilience, insight, and strategy create pivotal inflection points and lasting growth.
Listen and subscribe on your favorite podcast platform:
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Want to be a guest—or know a scaling CEO with a breakout story to share? Apply directly at go.intellectualstrategies.com.
TRANSCRIPT SUMMARY
00:00 – High Stakes Medical Decisions
00:18 – Introducing Inuvo And Mission
02:05 – Founding UCLA Spinout Company
03:25 – Using Electricity For Healing
06:38 – Restoring Hand Mobility
10:13 – Seeing Immediate Patient Results
12:42 – Growing Beyond Engineering Leadership
14:04 – Learning To Lead Teams
17:42 – Launching Groundbreaking Clinical Trial
22:18 – Pausing Trial For Product Issues
29:11 – Turning Crisis Into Innovation
31:29 – Building The Right Team
FULL TRANSCRIPT:
Yi-Kai Lo (00:00)
After analyzing the risk and benefit, right, and also the cost of keep delaying the study, this study costed us like seven to eight million dollars. And there was a very hard decision because we have a limited timeline. All of a sudden, we got product issues. I have to build the right team at the right stage.
Jeff Holman (00:18)
Welcome back everyone to the breakout CEO podcast. I'm Jeff Holman. I'm your host. I'm an attorney with intellectual strategies and I get the opportunity to ⁓ fortunately work with a lot of people who are making big decisions. get to see what happens behind closed doors. And I like to bring some of that, some of these similar types of ⁓ situations and insights to the audience by speaking with really smart and successful people like Yikai Lo that we have on today. Yikai, thank you for coming on.
Yi-Kai Lo (00:46)
Yeah, thank you, Jeff, for inviting me. It's my pleasure to join your podcast and to share some of my experiences.
Jeff Holman (00:52)
fantastic. I've been excited to talk to you since I first heard, since we first interacted, you were talking about being in the middle of doing a product. Well, you'll be able to explain it better than me, but my take on it was Yika is really busy. His team has gotten some certifications on their medical device product in Europe. They're trying to get it in the US. And then when we were
when we started scheduling, I think we actually might've had to reschedule once because you in fact got the certification, you got the FDA approvals and had to do some meetings and things around that. So congratulations on that, that's very exciting.
Yi-Kai Lo (01:31)
Thank you, yeah. Thank you, Jeff. I think this is a hard work of our team, We spent almost eight years. We finally were able to not only have our product launched in the EU, but also bring it back to the US.
Jeff Holman (01:41)
Yeah, that's, mean, ⁓ medical devices are, that's not a, that's not usually a very fast development process. So, congratulations on that. And your company is Inuvo, right? Okay. Why don't you, why don't you give us just a little bit of a background about what Inuvo does. And you probably have all the background because I think you started Inuvo from the beginning, right?
Yi-Kai Lo (02:05)
Yes. So, a new role is a company that I founded, with my PhD advisor around eight years ago. Okay. So it's a spin off company from UCLA. So at that time, what I was trying to do is either find a faculty job or found a company by myself. Okay. And then I try and after now,
after seeing how my advisor now needs to spend years training students, after four years, still didn't graduated and need to return again another batch of people. I kind of feel like this is now something I will enjoy. And then I make a decision to found this company. So at Anuvo, we are developing bio-electronic medicine. So instead of using drug or pharmaceutical approach to treat patients,
We are developing medical products that use electricity to treat injuries or diseases that cannot be cured by conventional medical approaches.
Jeff Holman (03:09)
Yeah. How does that, at a really high level, I have ⁓ a little bit of an engineering background, but not a PhD level. At a high level, for those of us who aren't in that field, how does that work? How do you use electricity to, you know, fix injuries?
Yi-Kai Lo (03:25)
Right. So, I can use no spinal cord injury, the indication we're working on right now as example. Okay. So, ⁓ for, you for individuals with spinal cord injury, right? So, ⁓ they might lose because of, because of the legion, right? Spinal cord injury, you the legion, the signal from the brain probably can, you know, cannot effectively just be transmitted to the spinal cord below the legion.
Jeff Holman (03:52)
⁓ okay. So it's almost like where you've got the nervous system. It has a, has a disconnect or is severed or something. Okay.
Yi-Kai Lo (03:59)
But although clinically, these individuals with ACI might have a complete spinal cord injury, anatomically, they are still connected below and above the legion. So what we are doing is we are using electricity to stimulate or activate the neurons to help the brain signal to facilitate the communication below and above the legion.
so the users or the patients can regain or improve their voluntary motor control.
Jeff Holman (04:31)
That's fascinating. Would this, you're talking about lesions, would this work with something that was similar to like a pinched nerve too, where you could ⁓ bridge that pinch or is it more just lesions?
Yi-Kai Lo (04:48)
So for pinched nerve, I got pinched nerve a couple of times per year because I work for long hours, then I develop pinched nerve probably at least one or two times per year. So to my understanding, pinched nerve is more like some mechanical stress applied to your nerve. It's different from the legion. So for spinal cord injury, it's more like due to, especially for traumatic spinal cord injury, that is due to
likely due to a accident, balance, something like that right, it's a physical damage to the core or the nerves.
Jeff Holman (05:23)
something more dramatic. Well, I asked and this is not the purpose of our conversation today, but as you're describing that, I asked because a year ago, I was playing soccer and I had a weird experience where apparently between like T9 and T10 in my spine, you've got your radial nerves that come out of your spine and wrap around your body to about the lower rib cage.
I had a some, I guess I have a pinched nerve there that has resulted in the left side of my abdomen being numb for the last year. And so, which is you're describing this, I'm thinking, you know, I'm waiting for this to get better. I've seen some doctors and it just like, there's a real application for this. My, my situation is very trivial because I can live with it. It doesn't impede anything I do. doesn't, you know, it doesn't impact my.
the movement or sensations in my limbs, like it's really not that big of a deal. But I could see for somebody who's been in a ⁓ larger accident, had a very serious spinal injury, that this could really transform how they live, right?
Yi-Kai Lo (06:38)
Of course. ⁓ Now from our clinical data, so we run a clinical trial in the US and we just wrapped it up last year. So from the data we've seen, we saw some of our users, all the participants of our clinical trial, they were able to open the door, eat or pour water by themselves before they receive the treatment that we delivered.
Jeff Holman (07:08)
So wait, they regained, not only sensation, but they regained mobility. Is that what you're saying? Wow. So somebody whose arm was not working, they could potentially have regained some movement in the arm.
Yi-Kai Lo (07:13)
Yes. Yes.
Yeah, for patients with a spinal injury. So, um, kind of remember, remember that, uh, this year, right? When we got our C mark, we have one of the prestigious hospital in Germany to try our product. Okay. So they got a patient from Ukraine. Okay. And that patient has C3 complete spinal cord injury. And, um, yeah. And then he just, and he.
⁓ went to the hospital to receive treatment two or three weeks after his injury. based on the video or the data we've seen, after three weeks, he was able to use a fork to eat cake by himself.
Jeff Holman (08:04)
What a way to celebrate with a little bit of cake. Boy, what do the... Are there other treatments that have this type of impact where you can restore sensation and mobility? This sounds pretty unique.
Yi-Kai Lo (08:08)
Yeah, right, right.
This question kind of related to the regulatory indication as well. So in the Europe, I think our product is the only system or device that can be used to ⁓ restore the upper extremity functions for patients with complete incomplete traumatic, non-traumatic, chronic acute, subacute, all subtypes or stage of ACI patients in Europe. But in the US, there's
We are only allowed to treat patients with incomplete spinal cord injuries and only got indication to focus on hand sensation and strength.
Jeff Holman (09:05)
Okay, narrower, there are more constraints and narrower, you know, scope of what you can do in the US for now, but I that might expand as you keep going. Right. Well, that's really impressive from a technological standpoint. It has to be kind of exciting to be able to take something like this from your mind into reality and see doctors, you know, helping patients like...
measurably, like visibly improve their quality of life. That's got to be a very rewarding part of the job. Just a quick note about our guests. I host the Breakout CEO podcast to share behind the scenes insights from scaling businesses. As an attorney, I see the real challenges leaders face long before success becomes public. But client stories have to stay confidential. So we invite guest CEOs to share their own moments.
of struggle and success. I'm so grateful to our guests and my team at Intellectual Strategies for making this show possible. Now, let's get back to the show.
Yi-Kai Lo (10:13)
Of course it is. and Jeff, I forget to mention to you that actually the reason why we need to kind of move our podcast one day is because I was in one of our clinic yesterday. So I went there to see how our clinician use our product to treat five patients. So starting from 10 o'clock to 5.30 or 5 o'clock PM.
So many of them were the first time users. So some of the family members were with us yesterday. So I saw that one or two of the patients, when we use our product, we call SST to deliver stimulation, many of them are able to increase their hand strength immediately and they're able to pinch like this, much way better than... ⁓
just two or 20 minutes before they receive the treatment.
Jeff Holman (11:14)
Wait, it's that fast?
Yi-Kai Lo (11:16)
⁓ Yes, so we know that the product has both the opioid effect and also prosthetic effect. So if we continue to use the product or receive the stimulation, we know that the patient improved. But we also discovered that while the stimulation is on, the patient can actually perform better.
Jeff Holman (11:40)
So it continues to approve the longer that they're using the device. But in 20 minutes, you can go from limited or no mobility to some mobility that quickly.
Yi-Kai Lo (11:55)
We saw that when the estimation is on, the patient can perform better. So I wouldn't say that from no mobility to some mobility. I would say if the patient got some improvement already, and he continued to receive stimulation, and then when the treatment is delivered in real time, we see obvious change or improvement.
Jeff Holman (12:16)
Yeah. I guess I should be careful. I'm not trying to overstate what you've been regulatorially approved for here in the United States. I'm simply trying to understand and I'm impressed with what you're doing. So I really appreciate you sharing that. Clearly you and your team are very technologically capable. How big is your team, by the way?
Yi-Kai Lo (12:21)
Thank you, you, Jack.
I think we have around 18 people.
Jeff Holman (12:42)
Okay, all very smart, I'm sure, ⁓ at the technology and doing stuff. What has it been like for you as you've, because you probably started on this as a, you probably defined and started to solve the problem, brought team members on, but as you've grown with 18 people, a team of 18 people is, you know, it's more than just one person working on a problem. You now have a team, you have to start.
thinking about managing the culture of the team or bringing money in to pay the team. what is the evolution been like for you as you go from maybe strictly engineering and research and technology into more of a leadership?
Yi-Kai Lo (13:31)
I'm kind of thinking about what I did in the past from the beginning.
Jeff Holman (13:36)
How long do you think it took for you to get to the point where you said to yourself, I think I need to, well, you mentioned at one point you got a coach, right? And so at what point did you say to yourself, the team has been working fine. We're making progress on the technology, but I think I could do some more business side of things. think I could be more of a CEO or a mentor. When did that happen?
Yi-Kai Lo (14:04)
I, so that happened probably after eight or nine months when I started the company. And now I do remember the trigger point for that is at that time we got a very talented engineer who was ⁓ with Intel at that time. Okay, very smart guy and he can solve a lot of changing problems. And then all of a sudden after eight or nine months, he told me that he's going to quit and he was going to quit.
and he was going to start his own company, a different application, now ready to medical device. At that time, I started to think about what did I do wrong? How can I improve? And then I started to try to get advice here, how do I continue to improve around the company? It's kind of a triggering point for us to get this CEO coach at that time.
Jeff Holman (14:57)
Yeah, that makes sense. mean, it's, it's, it's sometimes we have to get a little bit surprised by the situation or to, to, to realize, ⁓ I probably need to spend more time on, you know, the strategy or the team or the culture or the numbers. ⁓ So I think a lot of CEOs go through that.
Yi-Kai Lo (15:16)
If I may, this one point I want to make. So in the beginning, as an engineer or researcher for PhD, first PhD, so we are good at defined problems, solved problems, but those are all probably non-human related problems. So I was really bad at handling human issues at that time. And that's why I have the urgent need to find someone to teach me how to handle this.
Jeff Holman (15:40)
Well, I think, you know, as an engineer, I say this with love because I think a lot of engineers, have a, we have a kind of a stereotype that people look at us and they say, you're really smart. You're really good with numbers, but people not as much. so, and, and while I think that's fair to a degree, I also think in my experience, having worked with a lot of different CEOs, ⁓ there are a lot of people who might be really good with people, but maybe they're not very good with numbers and numbers are
are also equally important when you're talking about financial projections in the company. And so you really need to have a balance. of course, it's not just people and numbers. There's much more to it than those two factors. But we've all got our skills and talents, and there's always room to improve in other areas. I think it's actually commendable that you saw so early on, hey, nine months in after starting a company to say, I need some help.
I need to get some coaching or mentoring. I think a lot of people don't do it that quickly. you know, it's commendable that you moved on that thought so quickly.
Yi-Kai Lo (16:49)
Thank you.
Jeff Holman (16:51)
So as you in the last eight years, as you've grown the company, ⁓ I'm curious, know that there are some big milestones like getting your, getting your approvals in Europe and the, the United States. But I'm curious from, as you look back, like, are there a couple of moments where you ran into some really big obstacles and you said, well, we might've, we might not be, we might not be able to get past this one. You know, some of those times, is there one or two that stand out where you.
we're able to approach the problem, maybe re-re-evaluate it, reflect on it, step back and get a new perspective and then be able to come tackle the problem ⁓ more effectively.
Yi-Kai Lo (17:35)
and they are probably more than fine.
Jeff Holman (17:38)
One
a year then, ⁓ huh?
Yi-Kai Lo (17:42)
Yeah, yeah, yeah. It looks like we know I've been taken on a roller coaster, right? Up and down, and And many times, sometimes just take the roller coaster, you know, ride in one or two times per month. But, but yeah, but I think there are a few, know, moments or events, right? I do know, very remember until now. So I would say one of the interesting one is ⁓ our KENCO trial. Okay. So
No, we did a gold standard clinical trial. So that people has not done before. Okay. And then in order to reduce the regulatory risk, right. So we talked to the FDA, the U.S. FDA to get their opinion regarding our clinical trial design. Okay. And it turns out that this conversation lasted 11 months.
Jeff Holman (18:38)
wow. Is this because the clinical trial design was so new, nobody had done it before?
Yi-Kai Lo (18:46)
Yeah, so because we are treating spinal cord injuries, right? There was no solution before. So basically even we, we don't know how we don't know. I think probably it's the same for FDA. So the conversation lasted for 11 months, but no, it's a small stop, right? So we have no way to move fast. And after a few rounds of conversation or going back ⁓ and forth communication, then we decided to launch our study.
even though we might not get their green light. we were lucky. After we decided to launch the study, probably two weeks after, we got the green light from the FDA. So we took the risk. We did not have a further delay. And then we get what we need. I think that's one.
Jeff Holman (19:35)
Yeah, how did that work with your team? Who was on your team at that point and were they all, like did it cause stress for the team that you're all just kind of waiting for the clinical trial proposal to be approved or was everybody busy? Like how did the team manage that?
Yi-Kai Lo (19:53)
So ⁓ they were very stressed because I told them we will have to long to the study. We cannot keep waiting. they are bit more conservative. They want to get more information before we go ahead to do the study. Because this is not a cheap study. This study cost us like $7 to $8 million. So this is a big decision. ⁓
two years time frame, right? So if we make it wrong, it might easily waste two years and waste lot of money.
Jeff Holman (20:29)
And so if you had done the study, I mean, that is a lot of money for a start to put towards something. If you had done the study and then ⁓ the FDA approval process took longer or maybe even didn't come through for some reason, would that have just been wasted money in the end?
Yi-Kai Lo (20:47)
No, we just want to get more clarity regarding our study design. So even if we didn't get it, I think we can still go ahead and do our submission.
Jeff Holman (20:58)
Okay. So it so it was still useful. wasn't, it wasn't like a huge gamble, but it was a big commitment at that point in time. Did you get your team on board with that?
Yi-Kai Lo (21:05)
Right, right.
After analyzing the risk and benefit, right, and also the cost of keep delaying the study, I think kind of got everyone aligned. So we went ahead to launch the study and have a clear communication with our clinical PIs. At that time, I we were running our clinical study at 14 prestigious research centers across the US from East Coast to West Coast. So we got everyone aligned and then went ahead to launch the study.
Jeff Holman (21:33)
I like that framing because I think for a lot of people they would just see the first half of that where you say eight or nine million dollars, that's a lot of money. That's huge expense if we launch this study. the way you just framed it added kind of the counterweight or the counterbalance to that, is, yeah, but what is the cost if we don't launch it? There's also a really big cost if we don't launch the study, sort of an opportunity cost type of scenario. That might be backwards from opportunity cost.
But you know, like, like you're actually, you're adding the, the, the, the other half of the analysis that isn't always, you know, not everyone's necessarily thinking about the cost if we don't do it versus it's easy to see the cost if we do it. Yeah. I like that. What's another time that you ran into kind of a, one of these moments.
Yi-Kai Lo (22:18)
Right.
Yeah, this one was even more challenging. So after we launched the study and executed the study for around six months, okay, so in the beginning, know, everything's fine, product's fine, but all of a sudden, we got product issues, okay? So we got continue reporting or complaint from all our clinical sites, right? ⁓ Now our electrode, you know, there's some issue or quality issue with our electrodes, okay?
Jeff Holman (22:55)
How does that present itself? Cause these are, this is, are you saying these are problems with the product that people are using?
Yi-Kai Lo (23:02)
⁓ So it's like the quality of the electrodes. So we rely on the external electrodes to deliver stimulation, right? But we continue to receive a complaint from our kanko sites.
Jeff Holman (23:17)
So the electrode, we're degrading in quality or something.
Yi-Kai Lo (23:21)
Yeah, so the lecture didn't work well, right? And then the patients could not receive effective estimation. So basically, what the treatment will receive is useless. ⁓ And at that time, we got our team to propose to post the study. ⁓ And it was a very hard decision because we have a limited timeline to finish the trial. But in the meantime,
⁓ If we continue the trial and using these electrodes with quality issues, basically we are throwing the money into the water. So after debating with our team and do a lot of evaluation and think about the contingent plan, I think we eventually decided to post a study for around six months.
Jeff Holman (24:13)
⁓ okay.
Yi-Kai Lo (24:14)
then need to inform all the KENCO-PI, tell them what we doing now, and also give them a date as to when we are going to restore the study. This kind of changed in that time because there were already some patients, they already arranged the time to join our trial.
Jeff Holman (24:32)
They were ready, but then you had to say, no, hold on. Is that common to pause a study like that? Does that happen often?
Yi-Kai Lo (24:38)
I don't have too much experiences. I don't know what others did, but I think this is not even for us. I don't think this is common.
Jeff Holman (24:47)
Okay, but it sounds like it was necessary because if you didn't pause it, then the results were not going to be what you needed.
Yi-Kai Lo (24:55)
Yeah,
yeah. Especially this also good for us, right? I think good for us because eventually we still need to do commercialization, right? So it's better to know the problem earlier. For that's a process, design, vendors, or whatever, right? So it's good to discover each root cause in the beginning.
Jeff Holman (25:16)
Yeah, that makes sense for sure. I'm curious, how did you, when you noticed this problem as a team and you debated, what do we do? Should we pause the study or not? ⁓ It seems to me like maybe one of the more critical parts of this story is how you guys decided to communicate pausing the study to the clinics that were participating and the actual participants themselves. How did you navigate that?
conversation and that type of communication.
Yi-Kai Lo (25:49)
Thinking about this again, this was not ever easy. ⁓ So I think one thing that we always keep in mind is we have to be transparent to let this clinical PI know what was going on at that time. And then make it very clear that this is how we are going to handle that, solution, and also give them an expected timeline so they know what is going to happen and then so that they can plan on their side too.
That's why this is how we measure that.
Jeff Holman (26:21)
Did that, ⁓ and I don't know the details here, but I'm curious, when you pushed pause on the study and you communicated it, I assume they all said, if that's what it has to be, then we understand. But did that leave ⁓ patients that were in the middle of the study? Did they have to discontinue the study and then pick it back up later?
Yi-Kai Lo (26:45)
No, for those patients who were already in their studies, I think we have them to continue the trial. just stop recruiting patients, post-recruiting new patients.
Jeff Holman (26:59)
Okay, okay. was going to say it would be really difficult for somebody who's seen that type of improvement in their quality of life, ⁓ even during the study have to be paused. that makes a lot more sense now that you've explained it that way. ⁓ So in the end, what did, you know, do you feel like pausing the study ⁓ helped you come out better than if you hadn't paused? I mean, I'm sure that's why you did.
That's why you made the decision to do it, but what was the result of pausing it? How did it, how did it change what you were able to achieve?
Yi-Kai Lo (27:33)
I think we figure out the root cause, okay, we fix a problem. Okay. And we also might do this process, right? We also learn a lot as to, you know, what kind of vendor that we should work with. this is not a single problem. It's it's a mix, it's a problem, ⁓ mixed with multiple issues. So we're able to identify, you know, different issues and try to work on that and improve it.
Jeff Holman (28:00)
That makes sense. Yeah, it sounds like maybe the quality of vendors or something might've been an issue. know, one of the things I love when I've worked with inventors and people innovating new things and creating new business around them is that these types of problems, and they're real problems, right? You see this and someone says to you, hey, we got a problem with the electrodes. And you're like, this is a big deal. While nobody wants to deal with the problem.
The fact that the problem exists oftentimes is also the ⁓ reason that some new inventions are created, right? Because they say, what do we do? And I don't know in your case if you just had to find a new vendor or if you had to, you know, redesign the electrodes or if you, you know, created software programming to control it. Like, I love that engineers and innovators can take these problems.
⁓ perhaps in a slightly less emotional way sometimes and look at them as the problem and then start to find solutions. Did you guys find that this created other innovation opportunities for you too?
Yi-Kai Lo (29:11)
huh. So the short answer is of course, I would say every crisis is opportunity, right? So we not only identify the root cause. think that lead us to our next generation of electric power, right? That result the issues for the fundamental issues, but also can reduce the manufacturing cost. Okay. then the also, that also know kind of
forces to improve the solution not only from hardware side, we also try to improve the solution from the software firmware. So we always solve the problem from multiple aspects instead of just one single brute-force solution.
Jeff Holman (29:57)
I like that. Well, this is fascinating, Ikai. I'm really glad you're sharing this with us. And it makes me wonder, you've been doing a lot of stuff for eight years now. You're starting to get, we'll call it traction, right, with approvals and things like that. Where do you see this going in the next three to five to eight more years?
Yi-Kai Lo (30:16)
So now we got our after the currents. And then just before the after the currents, I think in February, we also are close our seriously financing. Okay. Nice. So, the next three to five years, I think our goal is very clear. Right. So we have to focus on commercialization to, and to, you know, to sell our product in EU and us market.
as much and as fast as we can, but we also have to make sure that we are delivering quality product and the service to those patients in need, right? We're not just trying to scale in a very unreasonable way. want to make sure that we will provide quality to those users too. And then the second one is we are not just building a simple product, we are building a platform. So during the following few years, we are expecting that
Now we can expand our platform to cover other indications to treat a wide array of patients instead of limited to a spinal cord injuries. But spinal cord injury itself is already a tough and challenging problem to solve.
Jeff Holman (31:29)
That sounds like there's a lot of green field ahead of you, a lot of ability to go and continue to innovate. I love that. ⁓ And my last question for you before we end here, as a leader, what do you think is the quality that you'll take with you and continue to develop and apply during these coming years?
Yi-Kai Lo (31:51)
I'm not sure about the quality, but I think what I learned through this process that I will for sure bring with me is I have to build the right team at the right stage, at the right timing, and get the right people. I think by keeping this in mind, many of these people issues, technical issues, can be resolved by having the right team at the right time in the right structure.
I will keep doing this in the future.
Jeff Holman (32:23)
I love that. I love that. Well, thank you for sharing that because I know a lot of a lot of other CEOs who are building businesses are doing they see similar issues. They might be different fields of technology, but they see similar issues and even maybe in different orders. by by hearing, you know, experiences like yours and insights like you've like you've gained, it helps other CEOs know that they maybe they can tackle a problem and maybe even know how to tackle a problem. So thank you for for sharing that experience with us.
Yi-Kai Lo (32:50)
My pleasure. Thank you, Jeff.
Jeff Holman (32:52)
That's been a pleasure having you on, Yikai. And to our audience who's joined us today, thanks again for listening to The Breakout CEO. Be sure to follow or subscribe on your favorite podcast platform. And if you enjoy the show, a rating or a review goes a long way. Our mission is to promote the stories of breakout CEOs in scaling SaaS, e-commerce, and tech companies to equip peer CEOs with valuable perspectives and confidence.
Thanks again for joining us on this episode of The Breakout CEO. I'm Jeff Holman and I'll see you next time.
