Bringing Complex Medical Imaging Devices to Market

Read this interview of Dan Gray, the founder of FISBA, on bringing complex medical imaging devices to market.

An interview with dan gray


Dan Gray is the founder of FISBA based in Portland Maine. He is an accomplished Principal Optical Engineer with over 12 years of industry experience developing medical devices. Dan holds a Bachelors, Masters, and Ph.D. from the University of Rochester in Optics, a Six Sigma Black Belt obtained while working at General Electric, and an APMP Project Management Certificate from the ILX Group in London. Applying his background in optical engineering and product development, Dan is passionate about helping medical companies develop and advance their imaging technology.


JD.  What are some of the product development challenges companies face when designing medical imaging products?

DG.  We encounter many people trying to develop complex optical devices for the first time. What they quickly learn is designing an optical system for use in a medical device is non-trivial. The first critical challenge is developing a detailed specification that reflects the user requirements. This ensures the right technology is developed the first time. Balancing the optical design trade off’s during the development process with application know-how minimizes challenges when transitioning to manufacturing.  Depending on internal resources, expected commercial volumes, and cost targets; we view developing a trusted supply chain and a suitable manufacturing partner as part of the development process. Managing these challenges for our clients at FISBA allows them to focus on what they know best – their customer’s needs.

JD.  Why is following a design process so critical and how can working with a development partner accelerate this process?

DG.  The most valuable aspect of a design process is documentation and traceability. For example, we collaborated with a customer who was in the later stages of their product development process. Facing performance and manufacturing challenges, we asked them to help us understand the justification for some of the product features. With poorly understood user needs, many of the design decisions that had already been made could not be fully justified. A design process helps by defining the critical aspects of a product and ultimately saves significant time and cost.

JD.  Can you provide an example of emerging technology which is impacting the high-end medical imaging market?

DG.  We continue to see applications of CMOS image sensor technology in the medical space. Miniaturization of pixels, and integration of advanced image processing capabilities on a CMOS device, have enabled greater functionality in medical cameras. With smaller and smaller pixel sizes, matching optical performance to that of the image sensor and achieving tight tolerances on the lens components is becoming more critical.  Artificial Intelligence (AI) is being heavily explored for applications in medical imaging, not only related to robotic surgical applications, but also for conventional manual surgeries.

JD.  At what stage of the development process does FISBA become involved?

 DG.  Based on our team’s background in medical device product development, the majority of our work with customers spans the concept development phase through commercialization phase. Companies choose to work with us based on our agility, creativity in developing unique solutions, and optical domain know-how. We are motivated by our customers and the desire to advance their medical imaging projects thru a successful design process and to market.

JD.  What should companies know about FISBA and how can they reach you?

DG.  We are passionate about developing medical imaging products. Optics is in our DNA and our clients depend on us to design and deliver the best imaging products – because their customers, surgeons, doctors and healthcare clinicians worldwide, depend on them. Please learn more at or you can reach me directly on LinkedIn.

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