Archive for April, 2010

Meeting CDRH/FDA Guidelines for Medical Device Companies

You Better Design Right, You Better Not Fail, if You Don’t Follow These Guidelines Your CEO’s going to Jail; The FDA/CDRH is Watching You Now

(Sung to Santa Claus is coming to town)

BP Cuff


Yes indeed – and it’s about time.

The FDA’s Center for Devices and Radiological Health (CDRH) reported that in 2006, 21% of all medical device recalls were for software defects – it is also estimated that one-in-three software-based products is recalled. They haven’t updated this data since, but one can assume that it might have gotten worse.

Medical device developers and company CEOs should be aware that this is an unacceptable situation and that it is going to rapidly change. Those that don’t get it straight won’t be around when the dust settles.

Is there enough aspirin to relieve the headaches that our government is giving medical device manufacturers? Moreover, is it deserved? The answer – depending on the specific question – is yes and no.

The Obama administration under pressure from Congress has combined the medical device industry with the drug industry as one, and has proposed taxing both industries to pay for universal health insurance (Obama Care). Hopefully thoughtful senators and representatives will see that these taxes will be passed down to patients and other users and will also impact the elderly who most require such devices and can ill afford them – then again it is more realistic to depend on the Easter bunny. But logic is no relief for the headache – particularly when it comes to Washington politicians. It’s no fun being a medical device executive today.

On July 31, 2008 a Senate Bill cosponsored by Senators Edward Kennedy (D – MA) and Chuck Grassley (R– IA) was filed that  would require senior officers or directors of drug and medical device companies to certify under penalty of perjury that all information submitted for a product’s approval is accurate and in compliance with federal regulations.

The Drug and Medical Device Accountability Act Bill expired at the end of the two year Senate session on December 31, 2008, but was refiled in the Senate (2009) with the hope of amending the current legislation by the end of October 2009. This is an important piece of legislation, and medical device executives should get their house in order to accommodate the provisions.

The Bill provided that product applications later found to have contained false or misleading information would be subject to stiff fines (up to $5,000,000), assessed both to companies and their senior officers, who, in addition, could face jail sentences of up to 20 years. These are serious issues. Currently the CDRH has a forensic group that looks at device software only after a device has been recalled.

This is a bad time, and a very costly time (regardless of the Act) for a medical device manufacturer – particularly if software development hadn’t been given the detailed oversight of using best practices. The new Obama tax on medical devices – used to pay for Obama Care – is allready a blow to the industry and to smaller medical device manufacturers.

The “Drug and Medical Device Accountability Act” will change the medical devices industry similarly to how the Sarbanes-Oxley bill impacted corporate accountability. Laws being what they are, we should expect overkill from its enactment. This is why medical device company’s senior management should take time to rethink their strategic approach to the delivery of their products.

EMF has available a report presenting alternative paths for developers to produce quality software for medical devices, minimize product recalls, and affordably provide comprehensive audit trails for CDRH inspectors (Critical Issues Confronting Medical Device Manufacturers). Keeping the company alive and your CEO out of jail are bonuses.

2010 Embedded Systems Conference – Silicon Valley (ESC)

Fearless and no longer loathing in San Jose (with apologies to the late Hunter Thompson)



Dolores and I made our annual trip to the Left Coast to attend the annual Embedded Systems Conference last week. It was the best ESC West in many years – more booths; larger booths; good floor traffic; interesting announcements and new to embedded players.


I’m not sure how Rich Nass does it – but the keynote speaker was again excellent. This time Michio Kaku, the co-founder of string theory and TV science presenter was the speaker and was charming, funny (but Seinfeld can breathe easy), informative and delightful. We joined the mass exodus to avoid the obligatory hour dedicated for the Microsoft Embedded Group (aka MS Purgatory – otherwise known as We B Arrogant). Granted that Microsoft contributes a lot of $$ to these very important events – for which I am grateful – but give me a friggin break MS, Windows 7 is not the promised land for the embedded world.


This was the year that the chip companies made confessions of love to many OS companies. Freescale made announcements with such stalwarts as Green Hills, while Intel teamed with LynuxWorks for an ill chosen medical product. ARM was very impressive as was Microchip, while Xilinx ran away with the FPGA application announcements. Xilinx for the 7th consecutive year (by EMF survey data) was the most used FPGA in the embedded space (and had the best ROI).


Green Hills also made a networking arrangement with Cavium (who recently acquired MontaVista and MV Linux) which caused us to ask if Dan O’Dowd (who has publicly claimed that anyone who used Linux was brain dead – or worse) had to be drugged or restrained to cut a deal with a Linux company. We checked the stock market for Prozac manufacturers to see if consumption was up in Santa Barbara. All chuckles aside – it was an excellent deal for Green Hills.


It surprised and impressed us that Green Hills made behind the scenes moves that portend for significant growth and positioning against Wind River by hiring two individuals that bring another dimension to the competitive marketplace that will be to their advantage. Although I’m not obliged to keep such under wraps, I do respect the Green Hills folks and will keep these details to ourselves – other than to mention that they are the first of the usual suspects to clearly see the light.

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