For the last 25 years I have been involved in medical device development. My specialty is pulse oximeters, devices that noninvasively measure blood oxygen saturation. There are many applications both in and out of the hospital. In recent years, low cost versions of these devices have become commonly available online and in local pharmacies. They are commonly used by patients with respiratory issues who depend on oxygen at home or other support means. The problem is that many of these devices are horribly inaccurate and can actually pose a danger by reassuring the patient, when they are actually at severe risk. This class of devices is not controlled by FDA and is typically not even tested for accuracy.
Initially my colleagues and I tried to push FDA to do something. We realized after a while, that it would be better to solve the problem in a more positive manner than to wait for government action. Our solution was to set up a pulse oximetry test lab in China. Working with colleagues at UCSF and Shenzhen Medical University, we established a nonprofit test lab open to industry and researchers. This lab has significant advantages to Chinese companies. It is local, it is low cost but most important the staff speak Mandarin so we are able to provide direct guidance and help the test sponsors improve their accuracy. The response has been tremendous and in the last 3 years we have averaged 40 tests per year, about what all the test labs in the west do combined.
Three years ago, there was a device sold by Walgreens and CVS. It was made by Beijing Choice and it was terrible. They came to us. We worked with them, and now it meets the ISO requirements for accuracy. So we can see that we have had an impact right at home, and had a part in making low cost accurate pulse oximeters available to anyone who needs one.
I have had a long, satisfying and lucrative career in medical devices. To be able to give back some of the knowledge and expertise I have gained feels better to me than I had expected.