IEEE Consumer Electronics Magazine - July 2018 - 83

associated with biomedical devices in general, through his
open comments in a Gizmodo article in 2017 [1]. Dr. Olhoeft
has also delivered numerous presentations to the EMR Policy
Institute on "Electromagnetic Interference and Medical
Implants," dating back to 2009 [2].
Katina Michael: Gary, as more people come on board with
various brain implants, heart pacemakers, and internal diagnostic devices, I think that the U.S. Federal Communications
Commission [FCC], the U.S. Food and Drug Administration
[FDA], and the health insurance industry more generally will
have to engage with at least some of the issues that you and
other biomedical device recipients have identified from your
experience. So many people who are designing biomedical
devices do not actually realize that patients are awake during
some of the DBS procedure. I found, on the engineering side
of the design, that many engineers have never witnessed a DBS
going into someone's brain or at least understood the actual
process of implantation. I do find it bewildering that some
engineers have never spoken to patients or are so withdrawn
from the practical side of biomedical device deployment. Engineers tasked with some complex problems sometimes look at
only solving a single part of the end-to-end design without
understanding how all the componentry works together.
Gary Olhoeft: I was also amazed to talk to the chief engineer at Medtronic about the DBS once. He told me the whole
thing was entirely built out of discrete components with no
integrated circuits because the FDA has not approved any
integrated circuits yet.
Michael: What do you make of this-that the regulations
and the regulatory body responsible are holding things up?
What is your personal position?
Olhoeft: Well, I definitely think that the regulatory body is
holding things up. Just look at when the first DBS was
installed in France in 1987. It was something like 14 years
before it was made available in the United States, in about
2001, with FDA approval. I got mine in 2009, and they had
already sold hundreds of them at that point in America.
Michael: And for you at that time, there was no other
alternative? I assume that if you had not adopted, that your
quality of life was going to diminish quickly?
Olhoeft: That's right. I would have continued shaking and
not been able to write, or I would have avoided reading or
walking or talking. Something I think I haven't told you yet
is that my device is also an interleaved device that has two
settings that alternate; one is set for me to walk, and the other
is set for me to talk. You used to have to choose between the
two, but now they can alternate because they are interleaved,
so that I can do both at the same time.
Michael: For me, Gary, it is nothing short of a miracle
what these biomedical engineers are doing. Was the FDA
correct in waiting those 15 years or so before they gave
their approval, or they should have approved earlier so other
people might have had an improved quality of life in the
United States?
Olhoeft: It depends on what they are talking about. Some
of the things they are talking about with genetic modification

Of particular interest is the
participant's qualifications in
the field of electromagnetics with
respect to his direct experience of
the benefits, risks, and challenges
surrounding the device that has
been implanted in his body.

implants-with viral-inducing genetic modifications and
stem cells-these things are going too fast. A doctor once
told me, when they go to the FDA for approval, they have to
go through trials. The first trial involves a few people. The
next involves a few tens of people. And then, at the approval
point, there are hundreds of people. But then, when it is
approved, possibly hundreds or thousands or millions of people will get it, and next all kinds of things can go wrong that
they did not anticipate. So you have to be very careful about
this stuff. However, the FDA seems to reinvent the wheel,
requiring their own testing when adequate testing has already
been done in other countries.
Michael: I agree with you. It is the brain we are talking
about after all.
Olhoeft: The thing that bothers me most is that Apple
footage you sent me [https://www.youtube.com/watch?v=
h6cIeZmFdPs]. You know, that clip with Steve Jobs and the
Wi-Fi problem? I would not have liked to have been in that
room with a DBS.
Michael: Yes. And, if he could not run an iPhone demo
with that EMC [electromagnetic compatibility] interference
problem when we know Jobs would do exhaustive user testing at launches, then what are we going to do, Gary, when we
have more and more people getting implants and even more
potential electromagnetic interference? I am trying to figure
out what kind of design solution could tackle this.
Olhoeft: And there's a whole bunch of other things that
bother me, like the electromagnetic pulse to stop cars on
freeways and the devices they have to shock people. What
about all those people who have implants like me or other
kinds of implants? In one of those fictitious mystery shows,
someone was depicted as being killed in a bank robbery, and
he was killed by an electromagnetic pulse. So we can see
these kinds of scenarios are making it into the public eye
through the visual press.
Michael: And that was a fictional account, right?
Olhoeft: It was a fictional scenario, but it is certainly possible. Do an Internet search on "nonlethal electric shock
devices" like stun guns, and you'll find people have been
killed by them. In Arizona, last month, a woman was run over
and killed by an Uber in autonomous mode. Earlier in the
year, a Tesla in autonomous mode killed its driver.
july 2018

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https://www.youtube.com/watch?v=h6cIeZmFdPs https://www.youtube.com/watch?v=h6cIeZmFdPs

Table of Contents for the Digital Edition of IEEE Consumer Electronics Magazine - July 2018