We love startups! To show our love, we are interviewing our partners to hear their stories and share their experiences in starting a healthcare-related company.

This week, we spoke with Edward Allegra, CEO of BioLum Sciences, a current resident of Johnson & Johnson Innovation’s, JLABS@TMC (Texas Medical Center) in Houston, TX and the developer of the BioSense AMD (pending FDA clearance) - a point-of-care, low cost device that works with a proprietary biomarker technology to analyze airway inflammation in real-time.

Edward studied economics with a pre-med focus at Southern Methodist University. By majoring in economics, he developed skills important for the business side of launching a startup, while his pre-med focus brought him to the lab and introduced him to biomedical science. He and Jack Reynolds met early in college and joined the entrepreneurship club where they met Miguel Quimbar and Alexander Lippert, PhD, their co-founders. Together, they worked in the lab to develop the technology that would eventually become their product. The team co-founded BioLum Sciences in April of 2015.

The idea for BioSense AMD came after the co-founders, some of which are asthmatics, realized their research had potential to provide objective respiratory analysis of lung function and possibly improve patient outcomes. The team took their plan to business competitions and used this experience to advance the idea with incremental progress from feedback each time they presented, until finally deciding to start the company.

Around 25.7 million people suffer from asthma in the US, and 47% of these patients reported an asthma attack in 2016. The BioSense AMD streamlines management of chronic respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD), by analyzing disease biomarkers found in breath and providing a real-time reading of airway inflammation. It provides physicians and patients with another means of assessing lung function at point-of-care. This reliable, repeatable test can be used by even the most severe patients, bridging the gap between physician and patient, to optimize and personalize the overall treatment process.

We asked Edward to share some insight with our readers on what he has learned through the process of starting and developing a medical device company:

1. How would you describe the experience of creating a medical device startup? ‍

Lots of ups and downs, with very high highs and very low lows. The greatest learning experience of my life. You have the opportunity to meet awesome people and are never bored.

2. How did you transition from idea, to research, to company? How did BioLum come to be?

There is no one size fits all solution, look at your network and find guidance and help. The process is slow and steady, focus on mitigating high-risk challenges first. Business competitions gave us a 360° perspective; we learned something new every time we presented to a different audience.

3. What tips do you have for new startups looking to secure funding for their research?

Get out there and speak with people in the field. You will be surprised with how helpful people can be and willing to help out. Business competitions are great for getting started and building your network.

4. What is the main challenge you have encountered in developing your device/company?

Being a young, first timer. The people that you present to look for pedigree and history. You have to show traction – get involved in networks, build personal connections, and keep people updated on your progress.

5. How has working with a CRO helped you with preparing for your first FDA meeting?

They helped by walking through the FDA process, using their network of expertise (both internally and externally), contributing experience that our startup team didn’t have as first timers in the healthcare space especially, and by always being available to talk or help.

6. What did you look for when choosing a clinical research organization (CRO)?

It was really a gut feeling, but we looked at how the CRO business was set up: what experience the CRO had in the field, references from other people in startups at JLabs, and competitive pricing. When hiring someone I recommend meeting with people from three different companies and comparing.

7. What is something you wish you knew when starting your company?

There are a lot of legal fees. I wish we had known about the opportunities and healthcare resources available in Houston earlier. Expect things to take longer than planned. The NSF I-Corps program has been very helpful. Start with three questions: how is the science, what do the experts say, and is there a market?

8. What is something that you have learned in the process of building your company?

On a personal level, you need to find a middle ground between excited and frustrated, between the high highs and the low lows. Don’t be afraid to ask for help. People respond well to that and it can go a long way.

9. Is there a significant factor that you feel has influenced the success of your company?

Hard work and determination - nothing worth doing is easy. A great team. Everyone played into  their skillset to contribute to the success. No one person can carry the weight.

10. What advice do you have for others with a dream device looking to start development?

Get involved with the NSF I-corps as soon as possible to learn about the process of creating a device startup. Come to Houston and JLabs for an excellent, growing startup environment. Plug into the environment, network, and ask for help (feel free to reach out to me). You really have to want it in order to persevere and be successful.

We would like to thank Edward for sharing his experience with us and providing valuable insight for new startups. Keep an eye out for future conversations in our Meet the Innovator blog series where we will continue sharing wisdom from startups we love.

Proxima Clinical Research, Inc. offers services to help at every stage in biologic, drug, and device development including regulatory strategy, clinical trial services and beyond. If you have a question, reach out to our help desk to chat with a specialist or leave a message. We love startups like BioLum Sciences and we’d love to help you with your drug or device development!