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 software effort. IVD’s are unique in that they ultimately must 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 my 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 problem sources identified? 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. And software should be able to easily identify the source of the problems.
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 proves very useful in helping verify the system
Manufacturing Support - How will subsystems be verified in DV and manufacturing? Custom test rigs have been known to cost as much as your system. Having a built-in readymade solution can save a lot of money and time for this critical component.
Field Service Diagnostics - What tools will help find the source of the issue causing the malfunction?
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”. - How useful is the knowledge that can be gained and studied while your device is in the field? Can you make it easy for you client to order disposables? Is the anonymous clinical data valuable?
Field diagnostics and upgrades - Can you diagnose why an instrument isn't functioning properly without dispatching a service tech? And if a service tech does need to go out, will they have the right parts to repair the device? Can a newly discovered cyber-security vulnerability be quickly patched?
Many of these elements are not considered when projects are estimated causing huge budget overruns. But, with foresight and upfront investment in a solid design-for-test software framework, these efforts can be significantly reduced. At Promenade Software we created our Parlay framework and tool set to efficiently address this massive obstruction 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.