FPGA, CPLD, ASIC, and ASM Design

Key Points

  • If you don't have an audit trail for your medical design, you may as well not bother doing it. Inadequate documentation is reason enough for the FDA to make you go back and do everything over.
  • Biological signals are usually low frequency and low amplitude. Knowing how to trade bandwidth for accuracy is often critical to making medical devices work.
  • If your medical system requires any kind of feedback control, "hacking code" to make a control loop work is a cardinal sin. You have to have modeled device behavior thoroughly or you will have set yourself up for FDA rejection at best and a class-action lawsuit or mass tort at worst.

Medical Design

There are any number of medical product development companies out there.  And there are similarly plenty of engineering consulting companies offering electronic design services.  But if you’re planning on eventually making any money in the medical devices market, you’re going to have to jump through the hoops that say you’re compliant with HIPAA regulations and that you can pass the scrutiny of the FDA for acceptance into clinical trials or the issuing of a 501(k) clearance. And your product design company is going to have to make those jumps with you.
Here is where unless you’re planning on taking a few small steps forward followed immediately by a few more giant ones in a backwards direction, you’d better be partnering with medical device design consultants who have strict audit trails for every piece of work they do – be it for medical equipment or assistive technology design, or be it for simply a consumer or entertainment product.  And we at Focus Embedded figured out a long time ago that the best way to design things (for all markets, medical or otherwise) is to be able to document the design process at every step and quickly ferret out any potential mistakes before they propagate.
Mind you, this discipline helps you at both ends of the medical design cycle, since not only do you not have to face the problem where the FDA makes you redo much of your work to correct the lack of auditable process, you also don’t have nearly as much trouble convincing your own suppliers to certify their components for use in medical markets.  (Because of liability issues, many of them won’t do this – particularly if the end product is used for life support – unless they’re very sure that the people buying their stuff aren’t throwing it together haphazardly.)
Engineers at Focus Embedded have been doing design of analog instrumentation amplifiers for medical/biological systems since back in the days when A-to-D converter offerings were few, far between, and very expensive.  So we’ve mastered analog circuit design to a degree few others have (at least in the last 30 years, anyway).  At the same time, we have on staff several designers whose work over the years has been on the cutting edge of the kind of DSP-based compression techniques used in medical imaging.  Two of our engineers are noted experts on the Mallat transform that underlies the JPEG2000 video compression algorithm, and we’ve done our share of wavelet engine design for medical systems.
Even in technology areas as seemingly mundane as low-power switching power supply design, when you’re working with anything that might touch a patient, even indirectly, it pays to work with people who are building in safety and an audit trail from the beginning.
It pays to work with Focus Embedded.