Hi Nikki,
Great to have you! You are one of the Top 40 under 40 (years), honored by the “The Ophthalmologist Powerlist”, you are a founder of different companies that inventor realize and commercialize several ophthalmic medical devices. How did you get involved with ophthalmology and what gives you so much power, to transform and improve ophthalmology?
Thank you, Sebastian, for your kind words! To be completely honest, my career grew organically, and I developed my skills based on what the market needs and trends were.
After finishing my bachelor’s degree from UCLA, I could not afford my post-graduate education, so I had to work to save enough money to continue my education in law. So, I started working for a non-profit organization that needed support fundraising. Combining my love to tell a story, to engage with people, and the desire to win arguments, I discovered a hidden talent, fundraising, which is the basis for my career.
After some time in public health and hospitals, I ended up working as the industrial liaison officer of a biomedical engineering research center funded by the US National Science Foundation. This position was my transition into the field of ophthalmology. My experience raising unrestricted funds aided my transition to working with industrial partners. Despite the source of funds (e.g. unrestricted versus restricted), understanding the motivation of both parties and enhancing the communication channel between partners were the secrets to successful projects.
Within one year at this research center, I saved enough money to continue with my postgraduate education in Los Angeles. However, my life took an unexpected turn at ARVO 2006 in Fort Lauderdale. I met my future husband, and together we decided to move to his home country of Switzerland…
Regarding my motivation, I think that growing up with limited resources, I could not take anything for granted. I had to take advantage of every opportunity that I was given. I knew that I did not have a backup plan in terms of a financial security net, so I had to get “it” right the first time… I also knew that I had to fight my own battles, so I always needed to be prepared for everything. So, these principles have been translated to the concepts, ideas, and later start-up companies, which I lead. I know that there is no promise for success, but my partners and collaborators know that I am a fighter who will exhaust every option before I concede.
Your latest project is to develop a Smartphone-based Corneal Keratographer. Tell us something about this project. How does this device work?
The Smartphone-based Corneal Keratographer (SBK) Project is a prime example of realizing a concept into a working model. The concept is to develop a simple, portable, and affordable screening tool to detect irregular corneas at an early stage. Funded and supported by two Swiss foundations, this project has been designed and managed with the commercialization goal in mind.
Although there is highly sophisticated technology available on the market, the reality is that only an elite group of ophthalmologists have access mainly because of the cost. To make a global impact, a product that is robust and only requires minimal infrastructure, limited training, and is affordable would democratize access to a means to conduct basic screening. The SBK has the possibility of improving global vision care.
While the SBK project is still in development, the concept is to use a commercially available camera and smartphone as the basis of the processing power. The data could be transferred to a cloud that would be transmitted to reading centers in the context of telemedicine. It will be a portable device that is lightweight and is easy to use.
The smartphone-based corneal keratographer is a smart device that enables cost-effective keratography even in areas where full-scope imaging (e.g. Scheimpflug Tomography, Optical Coherence Tomography) is unavailable. The hardware of a smartphone is used (Image courtesy of Nikki Hafezi).
Where do you see the main areas of application for such a portable device (e.g. home diagnosis, telemedicine etc.)?
Using the SBK as an example, I am focusing on democratizing access to technology from a global perspective. While there are highly sophisticated devices on the market, as stated previously, the majority of ophthalmologists do not have access.
The greatest impact will be the increase in the number of users from a global perspective. While telemedicine will serve as a critical component at the onset of the SBK into the commercialized market, the end goal is to empower more ophthalmologists and vision care specialists with a device that will improve the level of daily care for their patients.
Additionally, the SBK is focused to be used as a screening tool in the first stage. So, this device is not limited to the examination room of an ophthalmologist. In fact, the SBK has been designed with screening in schools and with different environmental conditions in mind. For this reason, the learning curve should be relatively shallow and designed for non-clinicians to increase the usage and accuracy of the measurements.
Should the device be able to compete with conventional topography or tomography devices in terms of resolution and accuracy, or is this not the intention at all?
It is a good question. The goal of the SBK project is to enable a simple, portable and affordable screening medical device for the global market. The concept is not to replace the existing technology available but rather to attempt to close the gap between clinicians who have access with those clinicians who do not. Access to reliable screening methods will enable the early detection of corneal diseases. In the end, it is an overall public health matter so the competition is not between the selection of devices but rather addressing unmet medical needs.
Do you think that due to the possibility that everybody can do such an examination himself and as often as he wants, we will also get more scientific knowledge about the development and progression of e.g. keratoconus?
The goal of the SBK project is not to do a self-examination but rather provide a screening tool to the masses who do not have access to a more sophisticated means.
Back to the beginning. You are now experienced in developing ideas into mature products and devices that are in clinical use. What advice would you give to young founders and especially start-ups who are planning to do something similar?
A common misconception is that commercial success is based solely on the idea. While a novel idea may generate intellectual property to provide a strong market entry barrier for competitors, there are so many steps along the way to commercialization. This pathway is long and unforgiving, and therefore, one must be willing to accept help along the way. Involving specialists in their area of expertise can determine the fate of your company, so choose wisely and be prepared to invest in them.
Managing expectations is also a critical skill that entrepreneurs must-have. You are dealing with people with different vested interests, so you must be able to balance what is expected of both you and the company. You are the heart and face of the company – for the good and the bad, and you must stand by what you are bringing to the market. In other words, do not cut corners or try to cheat. Although you may temporarily save time and/or money, the long-term effect is that it will just reduce the value of you and your company.
Last but certainly not least, building a successful start-up is highly competitive and very risky. There will be people who support you but also people who want to destroy you… so, celebrate every goal that you and your company make, learn from the goals that you miss, and above all keep playing.
What are important steps and key factors from the idea in your mind to the product in your hands (e.g. business plan, industry partners etc.)?
Being organized and staying alert to new trends in the field are essential to clear the pathway for your future product.
You will be asked routinely for a business plan that is arduous and boring to write, but the act of writing it forces you to consider aspects that are critical for the future of the company. This business plan will not be the road map but rather the framework that you can adapt along the way.
Financially speaking, it is important to understand what you are willing to sacrifice to build the company. The sacrifice includes little to no salary, free-time, shares, decision-making power, etc. Also, be realistic with your timeline. How long are you willing to wait until commercial success of your product?
When you think about what makes a new device or an increasingly "smart gadget" like the Keratographer successful, what do you think are the success factors of placing such a product on the market?
The goal of the SBK project is to provide a screening tool for clinicians that is affordable, portable, and simple to use. The success of the project in terms of market acceptance will most likely rely on price and precision.
Currently, the engineers are focused on balancing “good-enough” measurements that can be performed in the simplest manner. In other words, the feedback of the clinician is important at this stage of development because we need to understand what is the minimal quality of measurement that would be acceptable for a preliminary assessment. Knowing this level will help in designing based on the stability requirements and light access limitations.
In parallel, prevalence studies are needed to demonstrate to the governmental health authorities that keratoconus is not a rare disease and national screening methods are ultimately required. I believe that once peer-reviewed publications are made available, it will just be a matter of time until governmental support is provided for public hospitals for these types of devices and screening guidelines.
Nikki, what has been your experience asserting yourself in such a "male-dominated" environment as the ophthalmic medical industry and what should happen to motivate more women, to do the same as you?
In my experience, I find that obstacles are in place not because I am a woman but because of the preconceived notions that I should be at home raising my children instead of working at full capacity. Both men and women are guilty of placing women in this role, but it has gone a bit too far in some ways. Many women, including myself, feel the need to defend their decisions to work as opposed to challenging the stereotype of the roles. This defensive state of mind needs to stop because men do not feel this societal challenge, so why should women?
In Switzerland, the social infrastructure does not support or embrace a full-time working mother as evident with the school hours, vacation schedule, and the overall cost for childcare. Unless you have the privilege to have family members who can care for your children, or have the financial resources to hire full-time care, women, despite their desire, tend to work part-time, if at all. So, from a local perspective, the challenge is not because of men but rather society as a whole. Where I live, my friends lend support to each other in similar situations. So, two pieces of advice are to not be afraid to ask for help and to try to be available to help someone else.
On the international front, I have not experienced a barrier to career advancement or opportunities because I am a woman. Additionally, I am not typically asked about whether or not I have children as it does not pertain to the discussion or meeting topics. I find that if I can perform and deliver as needed, the fact that I am married with children is not a concern. I hope that this experience remains.
In summary, I want to challenge our young female colleagues that they should not consider themselves “lucky” to be able to exercise their profession once they become mothers. It is not a matter of being lucky because luck is based on chance. Whether you work full-time, part-time, or at all, should be a choice or rather mutual decision between the two partners. In other words, I recommend discussing expectations of parenting between the partners as soon as the possibility of a raising child becomes evident. I believe that it will take time to make the change, but we have to start somewhere.
Nikki has formed a network of companies that enable her to bring disruptive ideas in ophthalmology, directly to market, creating immediate benefits for patients and improving their care. The image was provided by Nikki Hafezi and taken at the Rio Congress 2020. Copyright is held by RM Events (https://www.rm-events.org).
The title image was provided by Nikki Hafezi and taken from an Touch Ophthalmology interview. Copyright is held by Touch Ophthalmology (https://www.touchophthalmology.com).
Thank you very much for your time Nikki!
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