How to Get Users to Fall in Love with Your Product

Sahil Diwan, CEO of SafKan Health, is an ambitious entrepreneur who was part of the youngest team to ever receive 510(k) clearance for a medical device. Funding his first business at the age of 16, he’s now at the helm of SafKan Health, bringing relief to impacted earwax with their automated ear cleaning device - OtoSet.

As a first-generation immigrant, Sahil grew up acutely aware of the sacrifices made for his opportunities in life. He says, “You really have this concept of return on investment just hardwired into you.” Motivated to do something big, Sahil taught himself to code at sixteen. Successively, he launched his first startup, Lunch Money, building websites and apps for small businesses. Even then, his goal was to use technology to create value and self-sufficiency, "Our goal was to make enough money to be able to go out and have cool lunches with our friends." 

Working part-time at Hollister as a teenager, Sahil quickly realized the limitations of a traditional job. He was earning about $30 a day, limited by the number of hours he could work as a minor. Meanwhile, he was also dabbling in web development on the side, which was proving far more lucrative, with clients paying thousands of dollars for his services. This is when it dawned on him that if he wanted to go big, it had to be with his own company.

His college years in computer science at the University of Oregon further sharpened both his technical skills and business savvy. He co-launched a SaaS startup, a platform for matching actors with auditions. He recalls with a chuckle, “It failed miserably, but I learned a ton. I called that my MBA.”

Upon graduation, as Sahil pursued a post-college career, his brother Aadil — studying biomedical engineering at the time — suffered from impacted earwax since childhood. The family thought Aadil was just producing too much earwax, which was correct, to some extent, but they later realized that he needed regular medical attention to remove the wax from his ear canal every month or so.

Impacted earwax, or cerumen impaction, is a condition where too much earwax builds up in the ear canal, causing hearing loss and other complications like pain, infection, tinnitus, and vertigo. Sahil shares the prevalence of this issue, “It affects one in 10 children, one in 20 healthy adults, and one in three people over the age of 65. That translates to about 35 million people in the US and over 800 million people around the world.” Ear wax also damages hearing aids, which people spend thousands of dollars to repair every year. Although the condition affects millions of people, it is surprisingly underserved. This sparked the brothers' entrepreneurial spirit to develop OtoSet, the first FDA-cleared automated ear-cleaning device.

The initial days of the device were humble. The brothers did not have a sophisticated R&D lab. They started in a dorm where Sahil would sleep on a cot in the closet, making prototypes with a 3D printer. Their dedication paid off when SafKan Health secured a spot in the Dreamit HealthTech accelerator, leading to seed funding and eventual FDA clearance. 

OtoSet combines irrigation and micro-suction technology to remove earwax. For now, it’s designed to be used by medical assistants. By automating what has traditionally been a manual and sometimes uncomfortable process, OtoSet takes a significant burden off of primary care providers. Sahil says, “Our customers are now able to significantly reduce referrals out to specialists.” 

Sahil's story is not just one of technological triumph but also of a mission to democratize healthcare. "Starting this company has given me the focus on creating greater access to healthcare," he shares. His vision for the consumerization of healthcare is inspiring as the company aims to empower individuals to proactively manage their health. In Sahil’s words, “We're really interested in advancing clinical care, but also making healthcare more consumer-friendly. We want to help people manage their health at home, especially now that the COVID-19 pandemic has changed how we all think about healthcare.” 

SafKan Health is dedicated, energetic, and focused on making an impact. With a nod to giants in dental care, Sahil ambitiously states, "Our goal is to do for ears what companies like Sonicare and Oral B did for teeth." With an eye on the future, the team is not only developing a home-use version of OtoSet but also exploring a pediatric version to broaden their impact and make ear care accessible to all.

Key Learnings From Sahil’s Experience

• Design is about so much more than just looks; it shapes how people see your product, how they use it, and even how they feel about it. Aim to craft something that’s not just easy on the eyes, but also easy to use, avoiding complex features that could overwhelm your users. 
• Facing FDA's rigorous guidelines shouldn’t be considered a regulatory hoop to jump through. Getting actively involved in the process, with a top-notch consultant by your side, can lead to some key learnings you may not have otherwise anticipated.
• Building a solid business foundation is often more challenging than raising capital. Managing a medtech startup involves juggling market demand, product refinement, and team-building, all the while balancing day-to-day operations. When you zero in on the fundamentals, funding gets a lot easier.

Design is Everything, and it’s Never-Ending

In the world of medtech, and most other industries, design is more than aesthetics: It's about how end users interact with the product and how they perceive it. And ultimately, user experience carries a lot of weight in the adoption rate of any given product.

In the early days of OtoSet, Sahil and his brother undertook the design side of the mission from a practical standpoint. They needed to translate medical needs into a user-friendly device. 

The foundational design of a medical device means understanding clinician and patient needs without putting the regulatory requirements aside. Sahil says, “We brought a totally novel ear-cleaning device to market. But the real learning is this: How to continuously iterate on a device that clinicians will use every single day on patients.”

The team at SafKan Health recognized early on that, given clinicians' demanding schedules, introducing a new tool can be challenging. Therefore, medical technology shouldn’t come with a steep learning curve. "If your medical device isn't intuitive or easy to use, your training has to be hands-on or hours long," Sahil emphasizes. Such a lengthy process is unfeasible, especially in a busy clinical setting.

So how do you successfully, and efficiently, refine the design of your product? Sahil’s first answer is real-world testing. "We bring in patients all day, every day to our office and offer free ear cleaning. We're learning a lot about how small tweaks can make a big difference in a product's workflow and usage,” Sahil comments.

Once you’ve set the foundation in place, the next step is creating an emotional connection. Packaging, for example, is something Sahil places importance on. The unboxing experience has to be special, for example. "You want them (physicians) to be excited that they have a new product in their office and you want them to be excited to use it,” Sahil mentions.

OtoSet boasts a sleek and intuitive design, resembling a pair of stylish headphones. The transparent compartments on each side allow you to visibly track the clean water as it flows into each ear and then emerges with earwax debris in a separate container. Thanks to the device’s stylish design, and partly thanks to the oddly satisfying visuals of the whole process, OtoSet became a viral sensation online, hitting 150 million views without a cent spent on consumer marketing. The viral fame led to a surge of patient interest on their website, offering Sahil valuable insights into managing growth effectively.

On that note, SafKan Health experienced the immense potential of social media. He advises other entrepreneurs not to shy away from, or underestimate, the power of social channels. Far from just being used for entertainment, platforms like Facebook, Instagram, and TikTok can be powerful tools for education, marketing, and brand-building, reaching audiences far and wide.

Use Regulatory Guardrails as a Forcing Function

Although there are other medical devices to clean earwax on the market, FDA's requirements for OtoSet were still stringent, necessitating a full 510(k) submission. 

Sahil says, “We are one of the youngest teams ever to receive 510(k) clearance for a medical device”. There are a few lessons Sahil gleaned through this experience. The first one was simple enough: bring in top talent. He praises his consultant Alison Komiyama for her crucial role in navigating FDA's requirements and ensuring compliance.

Yet, Sahil and his team weren't just bystanders. They were actively involved in the process, absorbing every detail. Sahil's advice to aspiring medtech entrepreneurs is straightforward: “Find a great regulatory consultant and don't be afraid to learn and do a lot of the work yourself.”

Their proactive approach didn't stop at addressing regulatory hurdles. They were hands-on at clinical trial sites as well, partnering up with both a Contract Research Organization (CRO) and experienced clinical advisors. When it comes to studies, Sahil keeps two pillars in mind: meticulous data collection and insights from real-world experience. “We used our clinical trial sites as a way to collect data for our 510(k), but then also to start getting real-world experience,” says Sahil. For example, he was there when the device's head strap broke on a trial. It was a simple snag, but it could have been a trickier setback — a reminder of the unpredictability in product development.

For Sahil, collaboration with clinicians who are keen on using and improving the product is crucial. "I don't really care if they have the biggest name in their space, I care if they're going to actually take the thing and put it on their patients and use it and tell me how to make it better," he notes.

Reflecting on the journey, Sahil concludes, “Honestly, I think going through that 510(k) process and all the effort and time it takes was well worth it. It helped us develop a much better product.” He also advises other founders in the medtech space to build a strong foundation in clinical affairs and establish market demand before seeking substantial funding. “You have to have significant momentum to raise a meaningful round,” he says.

Build Up a Business Before Raising Funds

Sahil, a first-time entrepreneur, quickly realized that laying the foundation of a solid business was a mightier challenge than fundraising. He says, "To me, raising money was actually easier than everything that comes with building an actual business."

Before you attempt to raise a serious round, you have to find ways to be capital-efficient. During the early stages, Sahil and his brother were quite prudent with their budget — a critical skill in the time and resource-intensive process of launching a medical device. He recalls, “When we did the Dreamit program, we were sleeping in $35 hotel rooms, my brother and I both. That's how we scraped by.” 

Another lesson Sahil had to learn the hard way was managing market demand. "We had so much demand that we ended up selling too many too fast," he shares. Having so much demand sounds like the dream for an emerging startup. However, failing to manage it risks your company’s reliability and trust, which is far more important than hitting short-term milestones. Therefore, thoughtful scaling and controlled growth are important.

Post-launch, the team needed to develop a playbook for broader adoption. For that, Sahil collaborated with early adopters to refine OtoSet, tailoring it to fit workflows and market needs before scaling up. This allowed them to enhance the product while strengthening relationships with key stakeholders. 

And when it finally came to capital raising, Sahil shares, “I have to mention how much I learned from all the rejection.” Every ‘no’ comes with some sort of feedback, and the team was on point in addressing those gaps. Do not take rejection as definitive and maintain communication with your potential investors. Sahil recounts how some initial skeptics returned, impressed by their progress and willing to invest.

Sahil’s overarching advice is to balance fundraising with day-to-day business operations. Maintaining focus on the business is critical, even while raising funds. Contrary to what you might be thinking, challenges in raising capital do not diminish with each successive round. In early fundraising, ”You're trying to sell a story or a world that doesn't really exist yet,” Sahil explains. However, he cautions that subsequent funding is equally challenging, each situation presenting unique obstacles that must be navigated in tandem with the business's evolving needs.