Table of Contents
The problem definition review PowerPoint can be viewed here.
Project SummaryA fundus camera is a device used in photography of the retina, the neurosensory tissue within the human eye. Such photography is useful in determining the state of the eye, including the detection of defects like diabetic retinopathy which is a major contributor to blindness. Current fundus cameras are a common tool used in optometrist offices, but are rarely used elsewhere.
The implementation of a more compact, inexpensive, and intuitive fundus camera would allow this tool to be implemented in more General Practitioner offices. This would allow more Diabetics to get their fundus photographed during regular check-ups with their local healthcare professional, such that diabetic retinopathy could be detected and treated before it caused permanent damage. Because the camera would be used by more general practitioners and nurses, they would have to have a very intuitive interface and be completely unintrusive to the patient. This means they would be able to participate with little notice, and no induced pupil dilation.
The goal of this project is to develop a prototype of a low-cost fundus camera using off-the-shelf optical components. The device will be simple enough that non-specialized medical personnel will be able to use it. It will provide high quality images in a package that would not be obtrusive in a general practitioner's office. The desired outcome is to increase patient compliance with regular screenings to decrease risk of permanent blindness due to diabetic retinopathy. The design and prototype may generate significant IP potential, with several companies already investigating this type of technology due to the market potential.
For more information read the project summary.
Project Goals and Key Deliverables
The end goal of this project is to produce an operational prototype that meets most or all of the customer requirements. The process must be adequately detailed and documented to facilitate future iterations of this project.
Customer Interview Questions and Answers
Q. What is the number one requirement for this new design of a Fundus Camera?
A. It needs to be used.
Q. Who is the most important stakeholder? Why and what are the key points for improvement that will benefit this stakeholder?
A. The most important stakeholder is the Diabetic patient. The key point for improvement to benefit the patient is the easy of access, this product needs to be used more than the current ones.
Q. Who is the intended primary user of the fundus camera?
A. A general practitioner or nurse in a typical doctor’s office.
Q. Who are the target patients? Will this be marketed only Diabetes patients?
A. The target patient is middle age adults, they are the majority of diabetic patients that are at risk of diabetic retinopathy.
Q. What is the end goal of the ‘low-cost’, what is an estimate of less than how much money. What is the defined MSRP of the camera?
A. Between $5,000 and $10,000 for the overall price of the new design. Current Fundus Photography Cameras are anywhere from $20,000 up to $100,000.
Q. Is there already specs defined for the camera? image quality?
A. The ‘guts’ of fundus cameras are fairly standard.
Q. What is the difference between an image of sufficient quality and a bad image?
A. Needs to be able to see clearly retina and cornea.
Q. We envision this system could be covered by insurance. What are the associated costs of Diabetic retinopathy? How common is this in diabetics?
A. It is recommended that all diabetic patients have an eye exam once per year.
Q. Is a UI expected to be on the device? What are the needs based around the user interface?
A. There does not need to be a UI on the device, but a UI could be valuable to input meta-data and have assisted alignment.
Q. What is the expected from the software abilities
A. At minimum the ability to package the meta-data and the fundus photograph together to transfer over to a PACS (Picture Archiving and Communication System). Also, beneficial functionality would be alignment assistance for the user.
Q. What is the scale of the market? Internationally?
A. Yes, this could be used internationally, but currently focused on the US due to high amount of adults with diabetes.
Q. How should the camera scan the retina, one eye or both eyes at once?
A. Photographing one eye or two eyes at once would both work. Eye one photographs lead to mislabeled pictures, the right eye labeled as the left. Two eye pictures would fix that problem but can make alignment harder because everyones eyes are not in the same place on the face.
Q. How important is the alignment of the device?
A. Very important, this is a key component to photographing.
Q. What are the main advantages you want to have over the current apparatus?
A. Portability, easy setup, and affordable (comparatively.)
Q. When is the best time to meet you and what type of communication do you prefer when we aren’t meeting face to face?
A. Can do online skype meetings and email.
Customer Requirements (Needs)
Engineering Requirements (Metrics & Specifications)
- A budget of $800 was allotted for this project.
- The device must be non-mydriatic, which means it should not require pupil dilation.
- The device must cost less than current low-cost Fundus cameras, which are around $10,000.
- The device must be easy to use. The device should be operable by non-specialized medical personnel.
- The device must comply with federal regulations.
- The device must not cause discomfort to the patient.
- The device must be portable. It should weigh no more than 40 lbs or be able to be wheeled around.