Having been part of several in vitro diagnostic device (IVD) development projects over the last 15 years, I’ve learned a thing or two about the the software effort. IVD’s are unique in that they ultimately have to orchestrate electronics, mechanical systems, fluidics, and chemistries together. And like an orchestra, if any one piece is not perfectly synchronized, the outcome is not pretty. Software is a huge part of making sure everything is playing well together, during the entire lifecycle of the instrument.
Getting the basics working for an instrument is straight-forward enough from the software perspective. System functionality is defined, requirements written, and components implemented. No big deal - easy to estimate and deliver. Or so I thought the first time around. But that is just the tip of the iceberg. Lurking underneath are the real requirements of the software development.
Integration Test Support - How is this integration effort going to be tested and problems sourced? Plug and Pray is not a sound, recommended approach. Software needs to support the effort in a way that components can be verified before attempting to combine them in a run.
Error Handling Support - How will you verify that if a sensor goes bad, pressures go out of range, or a motor encoder fails that the system will respond and handle correctly. Software that can simulate these conditions help verify the system
Manufacturing Support - How will subsystems be verified in manufacturing? How will instruments be calibrated,
Field Service Diagnostics - Where is the source of the issue that crops up?
These systems need a lot of experimentation and tuning. How will the scientist change parameters, mixing speeds, fluid movement without making a software engineer sit by his/her side?
Can the sequence of events be modified, tuned, and adjusted easily? Can tests be scripted to run repeatedly?
"Data is the new oil” . What can you do with the knowledge of your device's use in the field. Can you make it easy for you client to order disposables. Is the anonymous clinical data valuable? What can you do with the information known to your device in the field.
Field diagnostics and upgrades. Can you diagnose an instrument problem without sending out field service. And if they do need to go out, will they have the right parts? Will a newly discovered cyber-security vulnerability be quickly patched?
Many of these elements are not considered when projects are estimated, causing budgets to get completely destroyed. But with foresight and upfront investment in a solid software framework, these software efforts can be significantly reduced. This is why we at Promenade made our Parlay system - to address the massive development effort lurking under the visible surface.
Frances Cohen is President of Promenade Software Inc., a leading software services firm specializing in medical device and safety-critical system software. Frances has
more than 20 years of experience leading software teams for medical
device software. Starting with heart defibrillators for Cardiac Science and following with Source Scientific LLC and BIT
Analytical Instruments Inc., Frances has overseen dozens of projects
through development and the FDA, including IDEs, 510(k)s, and PMAs. Frances has a B.S. in computer engineering from the Technion, Israel Institute of Technology.
About Promenade Software
Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications. Promenade is ISO 13485 and 9001 certified.