The Project

Focal Healthcare develops medical devices and technology for the purpose of fusion biopsy used for the diagnosis of prostate cancer. As part of their commitment to develop a state of the art solution, Focal Healthcare engaged White Rock Technology to help guide the development of the software that would operate their medical devices and assist them through the process of bringing their first product to FDA approval.

The Challenges

Focal Healthcare is empowered by a bright, young product development team with passion and technical skills but their small team had limited experience in developing a commercial medical device under an aggressive timeline.

Additionally, their product road map had three products being developed and released within three years. The first product was scheduled for release within 18 months and they needed to meticulously document the process in preparation for regulatory approval. It was crucial to their long-term viability that they retain the intellectual property.

The Solution

James O’Reilly and White Rock Technology were engaged very early in the process to work as a development partner with Focal Healthcare. By understanding their hardware configuration, software requirements, business structure and organizational culture, White Rock Technology customized solutions specific to Focal Healthcare’s short-term needs and long-term goals.

---

We work with James O’Reilly because he is intelligent and reliable. He is flexible and can respond to changes quickly. James has a wealth of experience we can draw on to help us navigate. We couldn’t have met our FDA timelines without him.  – Chicuong La, CEO

---

Leaning on White Rock Technology as a trusted development partner enabled Focal Healthcare to obtain FDA clearance within 18 months.

White Rock Technology built a foundational framework that would support Focal Healthcare’s entire product line and allow them to quickly leverage the components from each product to accelerate the development cycle for each of the upcoming releases. With this extensible software architecture, present requirements and future product needs were addressed.

James O’Reilly of White Rock Technology provided project management leadership to Focal Healthcare’s internal software team providing them with the scaffolding to build up their internal expertise.

---

Through the training and mentoring provided by White Rock to our team, we have been able to build up strong internal development capabilities. White Rock’s experience and knowledge of best practices has helped lay the proper framework for both our software development and strategy.  – Lauren Killip, Vice President, Business Development

---

Focal Healthcare retains full ownership and control of the intellectual property and continues to work with White Rock Technology to leverage this technology into their upcoming products.

The Client

Focal Healthcare is a medical technology company that was founded in 2014. Focal Healthcare’s vision is to improve the lives of prostate cancer patients by developing imaging technology that is accurate, efficient and accessible to enable better diagnosis and treatment.