Team members of the smartphone-based semen analysis system developed at Brigham and Women’s Hospital and Massachusetts General Hospital. The system is capable of performing semen analysis for less than $5. From left: Manoj Kumar Kanakasabapathy, Charles Bormann, Hadi Shafiee, John Petrozza, Prudhvi Thirumalaraju

The idea came to Hadi Shafiee, PhD: what if you could use a cell phone to test for male infertility from the comfort of your own home? Shafiee’s lab at BWH focuses on developing technologies that use micro and nano-fabrication – devices with dimensions less than a millionth of a millimeter. The team has developed tools with applications in medicine and biology including point-of-care diagnostics for global health. But they had never developed something to test for infertility. To bring his inspiration from idea to reality, Shafiee would need the help of many experts outside of his lab.

“My job is to try to understand some of the problems patients and physicians face in the clinic and try to come up with solutions for them,” said Shafiee, of the Division of Engineering in Medicine and Renal Division. “I was excited about the potential of using the advancements in consumer electronics and microfabrication techniques to make it possible to test for male infertility at home, but I wasn’t sure if this idea could be commercialized or how to refine it. The Brigham Innovation Hub team listened to my idea. They connected me to the right people at the right time and gave me pilot funding to develop a proof of concept. They were instrumental.”

In March, Shafiee and his colleagues published a paper in Science Translational Medicine (STM) describing the new smartphone platform, which can analyze semen samples with 98 percent accuracy. Their work, which made the cover of STM, was also featured in The New York Times, CNN, Boston Globe, NPR and elsewhere. Shafiee credits not only Brigham iHub, but also Partners Innovation, which integrated closely with iHub to advise him, as well as entrepreneurs, potential investors and clinicians, all of whom gave feedback on the device and its potential.

From Prototype to Publication – and Beyond

A technician operating the smartphone-based semen analyzer to test a semen sample for male infertility. The system can process most semen samples in under five seconds.

One of the ways that iHub can help investigators determine the commercial potential of a product is by connecting them to people with years of experience in hearing about and immediately assessing the potential impact of product ideas: “angel investors.” In the early days of his project, instead of asking for a financial investment from these experts, Shafiee asked them for their guidance. Did his idea have commercial potential? What could he do to refine his idea and create the best possible product?

After these initial conversations, Shafiee went back to the iHub team and told them he knew what step he could take next: he wanted to make a prototype. But he would need seed funding to make it happen.

“For projects with high potential, we can offer small amounts of funding through a grants program,” said Lesley Solomon, MBA, executive director of Brigham iHub. In less than a year, the lab had created their prototype.

The analyzer his lab developed consists of an optical attachment that connects to a smartphone and a disposable device onto which a semen sample is placed. The team designed a user-friendly smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count.

To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center, and evaluated how well both trained and untrained users performed the test. Overall, the smartphone-based device was able to detect abnormal semen samples based on World Health Organization thresholds on sperm concentration and motility (sperm concentration < 15million sperm/ml and/or sperm motility < 40%) with an accuracy of 98 percent.

Research Accelerated

The analyzer is easy for both trained and untrained users to operate.

Shafiee’s project was the first to go through the iHub team’s Accelerator – a term reserved for projects that are close to patient impact. For these ideas, iHub takes an all-hands-on-deck approach to help work on multiple elements of the project at once, including advising on product development, market research, business strategy and legal/administrative next steps.

“Our team rallied around this project,” said Brian Mullen, PhD, innovation strategy manager. “But Hadi was always our leader. Where we’ve seen the most success is when we are helping an investigator but they are taking the lead. Hadi knew that he owned this process, but had our support at each step along the way.”

As the project continued to evolve, the iHub team began to hand it off to Partners Innovation for further support and refinement. Carl Berke, PhD, of the Partners Innovation Fund, became increasingly involved in helping Shafiee and the team. He also introduced Shafiee to Eamonn Hobbs, who is now the entrepreneur-in-residence at the Brigham.

“I met Hadi a while back and thought his concept of a digital, at-home fertility test for men was intriguing,” said Hobbs. “I thought that it was very clever in how it was designed and could have tremendous appeal since it changes a lab test into a point of care diagnostic and is relatively instant.”

Hobbs, who calls himself a serial entrepreneur, advised Shafiee on quantifying the opportunity and developing a business plan. He also recommended performing competitor analysis.

“Most of the current at-home tests on the market are for sperm count only,” he said. “Hadi’s technology is much broader and can quantify more of the underlying issues and empower clinicians.”

Shafiee also worked directly with clinicians to solicit their feedback and input. One of those clinicians is BWH urologist Martin Kathrins, MD.

“When compared with other emerging technologies for home semen testing, Hadi has produced a testing platform that has clear advantages in ease of use, accuracy, and affordability,” said Kathrins. “The most promising application of this technology is for men who have undergone vasectomy, who are notoriously non-compliant with post-operative semen testing to confirm sterility. Of course, the process of coming to a lab and providing a sample is anxiety provoking for many patients and represents a significant barrier to male fertility testing. Hadi’s technology should help offset some of that anxiety.”

The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval. Shafiee and his colleagues are, as usual, focused on the future, thinking about other ways to apply to apply the technology and the next steps toward clinical impact.

“We are always thinking about what’s next and how to develop something new,” said Shafiee.