what a nice presentation, now, i have learned about medical electronics, which is out of my sight or don't have any ideas all about. but because of this lecture, another learning i have comprehend in medical industries.
excellent, much appreciated for the lesson today...
Great intro to medical electronics, thanks Charles. To answer some of your questions I currently work with ARM A core devices communicating to sensors via Zigbee (Continua) and Bluetooth interfaces. Looking forward to the rest of the week.
Simon: Given the progress in chemical sensors being developed for everything from environmental monitoring to bio-terrism, I believe a basic sensor platform could be a marketable device. The sensor suite would be taylored to the needs of the patient. For example, creatine in urine. I saw the same discovery program, BTW. Also came across this concept in a science fiction novel by Greg Bear.
sorry to be late attending the lecture, as I made a mistake calculating the time zone:I thought it might be 3:00 early in the morning locally in China, however is there a 13 hour time difference between US EST time and Beijing time.
The problem with cellular service is that AT&T (for example) will not guarantee that IP service will be available at all, 100% of the time. The device can verify but can do nothing if cellular service is completely unavailable.
AH - missed the cellular service question! The way to assure it is to wrap a layer around the packets that get sent via the service - much like UDP gets used for some critical TCP/IP functions, but with a handshake OUTSIDE of the protocol (as opposed to TCP which is guaranteed). These are actually in the 11073 and Continua protocols and could be applied to something that uses cell service as the level 1-3 of the OSI model
THANKS everyone for all the great feedback!!! I will work on tweaking the rest of the week to address as many of the areas etc that you have asked or commented on. This is YOUR class and we love to make the class meet YOUR needs!
in a Discovery Channel programme last week, i saw a Japanese toilet with built-in urine monitor, blood pressure gauge, etc. do you think that such toilet devices will take off in North America? i have seen no sign at all so far...
The post from jcline about the need for fall monitoring is a huge case of deva vu. I invented one ca 1986 - no eldercare center would do the clinical trials!!! Their lawyers would not allow them to have documented proof (including the g-force vectors etc) that a patient ever FELL!!! I kid you not. Product never made it past prototype...
Fitbit is in the class of telehealth but it is not part of any formal telehealth protocol. But it may...
The reports of devices failing are scary and indicative of the need for new devices!!! I heard about the CBG meter recall - that BP monitor with the bad segment goes to prove that segment fail is a BIG issue!
@SIMON ... what is your background / experience in Patent Research ...
@ DESIGN NEWS ... it would be nice to have a separate area for pre and post class discussions that may get lengthy and detailed or that may be slightly off topic or only peripherally related to the class discussion ...
Hi Charles, could you provide a list of the specific regulatory and safety issues that you will be covering tomorrow? I think it would be beneficial to have our quality people sit in for your presentation tomorrow, but I'd like to give them some incentive to do so ;)
Thanks ... good presentation ... again, would like to see more on MEDICAL application, approaches, algorithms, architecture and communications (less so) ... will be interested in particulars of communications, but you had a good class on Zigbee, there was a good class on USB and Industrial, Medical, Scientific band in general ...
Problem with USB, Bluetooth etc is the lack of visualization capabilities. This protocols are design to transmit all kind of data but they are not aware of the Data Visualization capabilities of your system and require software engineers to manipulated the data too hard.
communications is and has been a good topic for its own class ... I would like to see more on the medical process and processing issues as well as application approach examples ... will still look forward to any particulars of communications you have to share
Most of my products were microprocessor-based. Many were simple PIC devices, although some were complex SOC, FPGA, and ARM-based systems. The sensor inputs spanned pressure, ultrasonic, strain, accelerometer, myoelectric, etc.
Interested in developing medical electronics in the distant future. Intested in immediately buying/developing simple medical electronic monitoring for 92 year old father, as well as myself, my wife, and my children.
For those of you developing or preparing to develop products, are you looking at a device for monitoring or treating of disease or illness - or are you developing a device for the wellness market - or BOTH?
Charles, I am a CTO in a medical device company that is bringing Substitotional Sensory Device to assist blind people to navigate and to identify objects around them. It uses IR detection, patern recognition and translation to provide the patient with the information that they need to generate a mental image of their environment
Mainly the Safety, Reliability, Reg Issues. We specialize in developing Human-Machine interfaces for medical devices, but are being called on to produce more of the system, requiring more knowledge of these areas. We are always working on new projects.
Electrical engineering PhD student, focusing on low power medical instrumentation and portable device design. Currently, I am working on cardiac devices, but am interested in startup companies in the future.
Jack Ganssle once told a story about .. A DOCTOR, LAWYER and ENGINEER, all sentenced to the guillotine. If any malfunction were to occur however, it resulted in an automatic pardon.
The Doctor is called first to the platform, head positioned in place ... the guilotine is set, and then released, the blade comes flying down ... and just an inch or so short of the doctors throat it stops - stuck ... the doctor is pardoned ....
next up the Lawyer is called to the platform, head positioned in place ... the guilotine is set, and then released, the blade comes flying down ... and just an inch or so short of the doctors throat it stops - stuck ... the lawyer is pardoned ....
lastly the engineer is led to the platform, and as they are about to set him in position .. he looks up and ponders .. then yells out .. WAIT ... I THINK I SEE THE PROBLEM ....
A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls, are met. The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials.
Class I: General controls - General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury
What are the goals ... e.g. close ten percent of the hospitals, cut 40 percent of Federal Research funding ... etc ... for example ...
Take the top ten chronic and infectious diseases and look at their etiology/epidemiology and what some might call the behavioral and/or 'social determinants of health' ... what apps can assist, plan, warn, notify, monitor such behaviors ... to take the power of the Big Pharms and transfer it to the people ...
@Dimitar Iron -- RE: but for my surprize most solutions for e-health was either doctor to doctor (hospital to hospital, hospital to insurance companies, etc.) or quite specific (like Iphone glucose measurement). Not much about general or personal e-health hardware and software, nor any interest when I was asking the exhibitors.
Perhaps a lot of opportunity for a multitude of preventive and monitoring and scheduling health apps still available out there -- do you have a take on it?
damenelwahidi: I didn't see a response to your question, and you may have already figured it out, but there is no charge for the course. Thanks to Design News and Digi-Key, all of the on-training is available for free.
Good afternoon from West Coast, Sweden. Thanks for the slides - seems it will be interesting. E-health is exactly what I am currently interested in. And with 1.5 year boy in my hands, I can tell, e-health is important not only for older, but for infants, too.
Before two weeks, I visit a local exhibition for advanced medical technologies - but for my surprize most solutions for e-health was either doctor to doctor (hospital to hospital, hospital to insurance companies, etc.) or quite specific (like Iphone glucose measurement). Not much about general or personal e-health hardware and software, nor any interest when I was asking the exhibitors.
Wal-Mart will hold its second Made in the USA Open Call July 7-8, at its headquarters in Bentonville, Ark. The event will be a repeat effort by the world’s biggest seller of consumer goods to increase the amount of US-made products it sells in Wal-Mart stores, in Sam’s Club members-only wholesale outlets, and on walmart.com.
From design feasibility, to development, to production, having the right information to make good decisions can ultimately keep a product from failing validation. The key is highly focused information that doesn’t come from conventional, statistics-based tests but from accelerated stress testing.
There’s a good chance that a few of the things mentioned here won't fully come to fruition in 2015 but rather much later down the line. However, as Malcolm X once said, "The future belongs to those who prepare for it today."
Focus on Fundamentals consists of 45-minute on-line classes that cover a host of technologies. You learn without leaving the comfort of your desk. All classes are taught by subject-matter experts and all are archived. So if you can't attend live, attend at your convenience.