Patient Feedback in Product Lifecycle Management of Brain Pacemakers

The Need for Patient Feedback in the Product Lifecycle Management of Deep Brain Stimulation Devices

Katina Michael interviews Gary Olhoeft

Background

 Professor Emeritus Gary Olhoeft of the Colorado School of Mines

Professor Emeritus Gary Olhoeft of the Colorado School of Mines

This interview was conducted by Katina Michael with Gary Olhoeft, a deep brain stimulation (DBS) device recipient on September 8, 2017. Katina is a Professor at the University of Wollongong who has been researching the social implications of implantable devices for the last 20 years and Gary is a retired Emeritus Professor of Geophysics at the Colorado School of Mines. Gary has previously taught a number of subjects related to Advanced Electrical and Electromagnetic Methods, Antennas, Near Surface Field Methods, Ground Penetrating Radar, and Complex Resistivity. Gary had a deep brain stimulator  installed in 2009 to help him combat his Parkinson’s Disease. This interview is a participant observer’s first-hand journey into a life dependent on a deep brain stimulator. Of particular interest is the qualified nature of the participant in the field of electromagnetics with respect to his first-hand experience of the benefits, risks and challenges surrounding the device that has been implanted in his body. Katina first came to know of Gary’s work through his open comments in a Gizmodo article in 2017 [i] while looking into the risks associated with biomedical devices in general. Gary has also delivered numerous presentations to the EMR Policy Institute on “Electromagnetic Interference and Medical Implants”, dating back to 2009 [ii]. The interview is broken into two parts.

KATINA MICHAEL: Gary, thank you for your time. We have previously corresponded on two full-length written questionnaires, and now this structured Skype interview. I think within my capacity in the Society for the Social Implications of Technology in the IEEE, we might be able to take some of the issues you raise forward. I think as more people come on board with various brain implants, heart pacemakers and internal diagnostic devices that the Federal Communications Commission (FCC), the 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.

GARY OLHOEFT: Thank you for the opportunity.

KATINA MICHAEL: So many people who are designing biomedical devices do not actually realise 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 have spoken to biomedical engineers in key academic institutions that have major funded brain implant projects who have challenged me about whether or not the patient is actually awake during the process. I do find it bewildering at times 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: That’s amazing.

KATINA MICHAEL: Yes.

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.

KATINA MICHAEL: What do you make of this? That the regulations and the regulatory body responsible is holding things up? What is your personal position?

GARY 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 [iii]. It was something like 14 years before it was made available in the USA in about 2001 with FDA approval. I got mine in 2009, and they had already sold hundreds of them at that point in America.

KATINA 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?

GARY 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.

KATINA MICHAEL: For me Gary, it is nothing short of miracles what they are doing.

GARY OLHOEFT: Yes.

KATINA MICHAEL: And I marvel at these things. Was the FDA correct in waiting those 15 years or so before they approved or they should have approved earlier so other people may have had an improved quality of life in the United States? What do you think about the length of time it took to get approval? Are you critical of it?

GARY OLHOEFT: It depends on what they are talking about. Some of the things they are talking about with genetic modification 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 trial 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.

KATINA MICHAEL: I agree with you. It is the brain we are talking about after all.

GARY OLHOEFT: The thing that bothers me most is that Apple footage you sent me. You know that clip with Steve Jobs and the Wi-Fi problem?

KATINA MICHAEL: Yes [iv].

GARY OLHOEFT: I would not have liked to have been in that room with a DBS.

KATINA MICHAEL: Yes. Interestingly I was researching that for a talk on business ethics and AI and the future and then we had this correspondence, and I just connected the two things together [v]. And if he could not run an iPod demo with that EMC (electromagnetic compatibility) interference problem when we know he would do exhaustive user testing at launches [vi], 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?

GARY 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.

KATINA MICHAEL: The tasers?

GARY OLHOEFT: What about all those people that 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.

KATINA MICHAEL: And that is a fictional account, right?

GARY OLHOEFT: It’s a fictional scenario but it is certainly possible [vii].

KATINA MICHAEL: Yes, it sure is. Exactly. I am talking at the annual conference for the Australian Communications Media Authority (ACMA) next month, and I will be using our discussion today as a single case study to raise awareness here. I am talking on implantables for non-medical applications, and there is presently a great deal of pressure from the biohacking community [viii]. A lot of these guys are my friends given my research area, but are doing some very strange things. Presently some of them are talking about hacking the brain and I am telling them you really should not be doing that without medical expertise even if it is in the name of “citizen science”. Some of them are amateur engineers and others are fully-fledged qualified engineers but not medical people. And I personally feel the brain is not to be experimented with like this. It is reminiscent of what I would call ‘backyard lobotomies’. 

GARY OLHOEFT: It is like DARPA. They have a call up at the moment to have a million electrodes inside the brain so they can communicate, not for therapeutic value like I have [ix],[x].

KATINA MICHAEL: You are likely familiar with the DARPA project from 2012, for a brain implantable device that could be used to aid former service men and women suffering from post-traumatic stress disorder, depression and anxiety [xi]. We did a special issue on this in the IEEE Technology and Society Magazine last year [xii]. They have also claimed this device solution could be used for memory enhancement. It sounds like the cyborgisation of our forces.

GARY OLHOEFT: That’s like what I have. The latest one is more like when you want to remote control a vehicle or something. The September 2017 IEEE Spectrum had an article about Brain Racers using brain controlled avatars to compete in a cyborg Olympics [xiii].

KATINA MICHAEL: Exactly. And we did raise issues in that special which I will send to you. I held a national security workshop on brain implants in the military in 2016 [xiv], at the University of Melbourne where they are doing research on stentrodes. The University of Melbourne is considered to have some leading academics in this space, receiving some partial funding I believe from DARPA [xv]. I then invited some biomedical engineers in the DBS space from the University of Melbourne to participate in the workshop, like Thomas Oxley, but all were unavailable to make it. Thomas incidentally was undergoing training in the USA related to DBS and stentrodes [xvi].

GARY OLHOEFT: Okay.

KATINA MICHAEL: There are so many things going on at present like implantables in your jaw that are so close to the ear that they can allow you to communicate wirelessly so you can hear via your teeth [xvii]. We were looking at these kinds of implants and implications at various workshops including at the University of Wollongong where we have a Centre of Excellence [xviii].

GARY OLHOEFT: It’s not surprising. In the old days, when we had the silver amalgam fillings in teeth, there were people that used to go listening to the radio through their teeth.

KATINA MICHAEL: Yes. There’s a well-known episode of the Partridge Family where Laurie gets braces and her boyfriend’s Walkman is interfering with her ability to sing songs when a film crew comes to record music in the family home [xix]. So yes, teeth are amazing, the auditory links there have been well-known for decades are just being rediscovered by the younger generation.

GARY OLHOEFT: Yes.

KATINA MICHAEL: And the communications for autonomous weapons or over-ride. Can a human be autonomous for instance? Last week we were discussing some of the ethics behind overriding someone's decision not to fire or strike at a target [xx]. Or imagine the ability to remotely control a drone just by using your thoughts, versus someone in a remote location executing the fire or strike commands without being in-situ by intercepting that communication stream. Imagine the potential to intercept a person’s thoughts and to make them physically do something. This is where for me the waters get muddied. I do not mind the advancements in the Cochlear space for instance, where deaf persons have the ability to hear music and entertainment through an embedded technological device [xxi]. I think that is another marvel, really. But I’d be interested to hear your opinion about the crossover between the medical and non-medical spaces? Do you think that is just life- that is just how innovation is? That we need to get used to this or do you believe prosthetics are the only reason we should be implanting people in the brain?

GARY OLHOEFT: I think the only reason we should be implanting people is for therapeutic reasons. For instance, I have a deep brain stimulator for a specific disease, others might have a particular problem or maybe it is to replace a part of the brain that has been damaged physically. Because the question becomes, when are we no longer human anymore if we go beyond prosthetics purposes?

KATINA MICHAEL: Yes.

GARY OLHOEFT: We have problems with driverless cars and people are talking about mirrored systems and all sorts of electronics in them that interfere with DBS. There was a paper that was published where researchers took about 10 cars at different times, and they discovered the ones that were diesel powered did not interfere because they didn’t have any ignition system [xxii]. Conventionally powered cars which had an electronic ignition system pad caused some interference. But electrics and hybrid engines had problems with people with implants [xxiii], [xxiv], [xxv], [xxvi].

KATINA MICHAEL: So do you fear getting in a vehicle at any time? Or is that not the issue, rather it is if you are driving or physically touching parts of the car?

GARY OLHOEFT: No, it’s probably if you are just in the vehicle itself because of the way they have the wiring in some vehicles. A Prius has 8 computers inside it, Wi-Fi and Bluetooth, and the way they run the wiring from the batteries to the front, it is not twisted wiring it is just a straight pair of wiring. If it was twisted pair there would be a lot less magnetic noise inside the car body.

KATINA MICHAEL: So that’s the car company trying to save money, right?

GARY OLHOEFT: I really don’t know. We have a Prius as well. I’ve tested our car. We have two sets of batteries. The front and right passenger seat are okay but the driver’s position is very noisy. There’s a woman we know, when she drives her Prius, her deep brain stimulator turns off when the car goes into charging mode (while braking) [xxvii].

KATINA MICHAEL: Oh dear, this is a major problem.

GARY OLHOEFT: That’s why I don’t drive.

KATINA MICHAEL: These issues must get more visibility. They can no longer be ignored. This is where consumer electronics come head-to-head with biomedical devices.

GARY OLHOEFT: I’ve also sent you documents that I’ve sent to the FCC and FDA.

KATINA MICHAEL: I read these.

GARY OLHOEFT: I’ve not received any response to these.

KATINA MICHAEL: This is truly an important research area. This topic crosses over engineering, policy and society. It is really about the importance of including the end-user (or patient in this case) in the product lifecycle management (PLM) process.

GARY OLHOEFT: Agreed.

KATINA MICHAEL: You are the first person I have engaged with who has convinced me to go further with this particular research endeavour. Save for some very sporadic papers in the press, and random articles in journal publications about electromagnetic interference issues, it was the Gizmodo article [xxviii] that my husband stumbled across citing you, that has validated our present conversation. It is time to take this very seriously now. We now have so many pacemakers, it is not just heart, it is brain as well. And I cannot even get a good figure for how many there are out there and I keep being asked but different sources state different things.

GARY OLHOEFT: They don’t know because they don’t track them [see introduction in [xxix].

KATINA MICHAEL: That is right but somewhat shocking to me because surely these numbers exist somewhere. And we have to track them. And I do not mean track the names of people. I do not really want people to be in a database of some sort because they bear an implant. I worry about potential hackers getting access to that, not from the privacy perspective alone but the fact that I do not wish to tip off potential predatory hackers “switching people off” so to speak, in the future.

GARY OLHOEFT: Sure.

KATINA MICHAEL: My concern is that the more of us who bear these implantables for non-medical reasons in the future, the greater the risks.

GARY OLHOEFT: There is a well-known story of someone who has had an internal insulin pump hacked, and an insulin dose was changed so that it killed them [xxx], [xxxi].

KATINA MICHAEL: I do wonder Gary if this all has to do with liability issues [xxxii]. There is simply no reason that companies like Medtronic should not be engaging the public on these matters. In fact, it is in their best interest to receive customer feedback.

GARY OLHOEFT: It’s definitely a problem and I don’t know what to do about that….

KATINA MICHAEL: So we need some hard core evidence that someone’s implantable has previously been tampered with?

GARY OLHOEFT: I’ve already raised the issue several times and Medtronic, my brain implant manufacturer just sent me the programmer’s manual for the patient. The original one I got was just a couple of pages that had to do with interference. The latest version is 16-18 pages in length on interference. And that is because of the questions I raised about interference and the evidence I showed them.

KATINA MICHAEL: Right.

GARY OLHOEFT: They still won’t admit that their device was defective in one case where I could prove it. My doctor believed me because I showed him the evidence, so he had them replace it at no charge.

KATINA MICHAEL: Okay. I have a question about this. Thank you for the information you sent me regarding your EEG as being logged by your DBS implant.

GARY OLHOEFT: It is not the EEG that I sent you, it is the measurement of the magnetic field from induced DBS current.

KATINA MICHAEL: It is the pulse?

GARY OLHOEFT: Right. The pulse height and the pulse frequency.

KATINA MICHAEL: Ok. So I saw the graph which indicated that every second pulse was being skipped.

GARY OLHOEFT: Right.

KATINA MICHAEL: So the question I have, is whether you have access to your EEG information? There was a well-known case of Hugo Campos who wanted access to his ECG information and last I heard he had taken to court the manufacturer who claimed they had the right to withhold this data [xxxiii]. He is more interested in data advocacy than anything else [xxxiv]. He was claiming it was “his” heart rate, and his personal biometrics, and that he had every right to have access to that information [xxxv].

GARY OLHOEFT: There are devices on the web that show you how to build something to get an ECG [xxxvi].

KATINA MICHAEL: Exactly. Hugo, even enrolled himself in courses meant for biomedical engineers to do this himself, that is hack into his own heart beat information, with the pacemaker device residing in his own body [xxxvii]. So he has been at the forefront of that. But the manufacturer is claiming that “they” own the data [xxxviii]. And my question to you is: Is your DBS data uploaded through some mechanism, like the heart pacemaker data is uploaded on a nightly basis and sent back to base [xxxix]?

GARY OLHOEFT: No, only when I visit the doctor’s office, is the only time they have access to it. Only when I go to the doctor.

KATINA MICHAEL: You mean to download information or to check its operation?

GARY OLHOEFT: Download information from the pack in my chest. Actually, they store it in there. They print it out in hardcopy because they are afraid of people hacking their computers.

KATINA MICHAEL: Yes.

GARY OLHOEFT: And this is the University of Colorado Hospital.

KATINA MICHAEL: Yes, I totally understand this from my background reading. I’ve seen similar evidence where hardcopies are provided to the patient but a lot of the patients like Hugo Campos are saying hardcopies are not enough. I should be able to have access at any time, and I should be able to tell someone my device is playing up, or look something is wrong [xl].

GARY OLHOEFT: Right. Remember how I told you about the interleave function. Well when they set it to the interleave setting for the first time, they didn’t do it right. And I woke up the next morning feeling like I had had 40 cups of coffee. It turns out it was running at twice the frequency it should have been and I could show that. So I called them up and said you’ve got a problem here and they fixed it right away. I figured I could measure it independently of the Medtronic device. That’s why I built my own AC wirewound ferrite core magnetometer to monitor my own DBS.

KATINA MICHAEL: Okay.

GARY OLHOEFT: But all the Doctor had was a program that told him whatever Medtronic wanted to tell him. I wanted more information than that, I wanted to actually see it so I built my own.

KATINA MICHAEL: So I saw your information that you would have had a product out on the market to help others but the iPhone keeps upgrading so I get that.

GARY OLHOEFT: It keeps changing faster than I can keep up with it.

KATINA MICHAEL: So I am going to argue that it is their responsibility, the manufacturer’s responsibility to provide this capability.

GARY OLHOEFT: I see no reason why they couldn’t, but I like the idea of a third party providing an independent measurement of whether the implant is working and measuring the parameters directly (pulse height, pulse width, pulse repetition frequency, etc.).

KATINA MICHAEL: So I am concerned on a number of fronts, and have been for some time. This in particular is not a huge ask if they are cooperative in the process of an incremental innovation. E.g. imagine if Apple collaborated with Medtronic or the other providers from Stryker and so forth, like Cochlear have collaborated with Apple. I think biomedical device manufacturers have to offer this as a service and in layman’s understanding for non-engineers. And it must be free and not cost the recipient anything. It is the only way to empower recipients of the pacemakers and for them to feel at ease, without having to go for a visit to a cardiac specialist.

GARY OLHOEFT: I told you about the experience of walking into a Best Buy and having their automated inventory control system turn off my DBS?

KATINA MICHAEL: Yes.

GARY OLHOEFT: Then I used my device to see what frequency it was operating at and then asked my doctor to change my DBS to a different frequency so that I could walk in and out of Best Buy. So the frequency range means the operator needs to have such things in mind. These inventory control devices are built  into walls in stores and malls, so you no longer know that they are even there or have any warning. But they are there.

KATINA MICHAEL: I know, they are unobtrusive.

GARY OLHOEFT: So there needs to be warning signs or other things like that. They seem to begin appearing in hospitals and imaging centres where they say “MRI in use” if you have a cardiac pacemaker or brain pacemaker device do not enter this room. But it is a rare thing still. I remember 20 years ago or so when they had “danger microwave oven in use”.

KATINA MICHAEL: Yes, I remember that.

GARY OLHOEFT: It is like we need a more generic reason than that.

KATINA MICHAEL: What is your feeling with respect to radio frequency identification (RFID)? Or the new payment systems using near field communications? Are they affecting pacemakers? Or is it way too low in terms of emissions?

GARY OLHOEFT: Well, no. There are wireless devices that are low-level that don’t bother me. For example, I have a computer with Wi-Fi, and that doesn’t bother me. That is because I’ve measured it and I know what it is. It is a dosage thing. If I stay nearby it the dosage begins to build up, and eventually it can get to a point where it could be a problem. Not necessarily for my DBS but for other things. Heart pacemakers are much closer to the heart so there is less of a problem. And the length of wiring is much shorter in heart pacemakers. I have a piece of wire that runs from my chest, up my neck, up over the top of my head, and back behind my eyes, and it is almost 18 inches long. That is part of the problem. They could have made that a twisted pair with shielding like CAT6 wiring but they didn’t and the Medtronic people need to fix that one.

KATINA MICHAEL: And Gary I spoke to some researchers last year in June who were talking about not having the battery packs so low, having it closer to the brain and smaller in size. Do you think the problem would dissipate somewhat if the battery pack was closer to the brain?

GARY OLHOEFT: Yes. But then the battery won’t last as long because it’s smaller.

KATINA MICHAEL: Yes, I know that is the issue.

GARY OLHOEFT: They are already trying rechargeable batteries but you spend all day at the charger- you get 9 hours of charging for only 1 hour of use.

KATINA MICHAEL: No, that is definitely not feasible.

GARY OLHOEFT: So my doctor told me that, and he recommended against that for me.

KATINA MICHAEL: Now here is another question that is a difficult one for you, I think. Do you find a conflict in your heart sometimes? You are trying to help the manufacturer make a better product and you are trying to raise awareness of the important issues that patients face, and yet you are relying on the very product that you are trying to get some response to. Have you ever written to Medtronic and said “This is my name and this is my story- would you allow me to advise you, that is, provide feedback to your design team?” [xli]

GARY OLHOEFT: There is a Vice President that is responsible for R&D who is both a medical doctor and an engineer… I wrote to him several times and never got an answer.

KATINA MICHAEL: Right.

GARY OLHOEFT: But I have spoken to Medtronic’s Chief Engineer that my device is misbehaving, you know with all those missing pulses. He was quite open about it. I also told him about the interleave problem at that time that it felt like I had had 40 cups of coffee and he said that was outside his area of expertise because he built the hardware but someone else programmed it. And you can find there are books out there that might tell you how to program these things. I’ve looked at them but I don’t agree with the approach they take. They never talk about interference. The default programming for this is 180 repetitions … it’s still the wrong place to start because in the US, 180 is a multiple (harmonic) of the powerline and close to the frequency used by many security systems and inventory control systems. See my talks on YouTube [xlii], [xliii].

KATINA MICHAEL: I am so concerned about what I am hearing. Concerned that the company is not taking any action. Concerned that we are not teaching our up and coming engineers about these problems because they have to know if they are not going to fall into the same pitfalls down the track as devices get even more sophisticated. I am also concerned that recipients of these brain pacemakers are not given the opportunity to provide proper feedback to design teams directly and that there is no indirect path in which to do this. A web page does not cut it. There are people like yourself Gary, who are willing and have relevant research expertise, whom these companies should be even welcoming onto their payroll to improve the robustness of their technologies. And I’ve already raised issues like those you are stating, with collaborators at the Consortium for Science, Policy & Outcomes at Arizona State University.

GARY OLHOEFT: Well, I’ve tried writing to various organisations and agencies and when possible, giving testimony to FDA, FCC and other agency requests for information.

KATINA MICHAEL: I think it is important to create a safe space where manufacturers, medical practitioners, patients, and policymakers come together to discuss these matters openly. I know there are user groups where patients go to discuss issues but that serves quite a different function, more of a support group. But until there is some level of openness then it will be likely that these issues will continue to cloud future developments. Gary, we need more people like yourself who have real stories to share, that are documented, together with peer-reviewed published research in the domain of interference and DBS. We should continue to write to them and also invite them to workshops and roundtable meetings, invite representatives from the FDA and FCC. What do you think about this approach?

GARY OLHOEFT: Yes, you can put me down for that. I’ll be involved.

KATINA MICHAEL: Great!

GARY OLHOEFT: Part of the problem is that the FCC authorisation says 9KHertz up to 300 GigaHertz. And these devices operate at below 200 Hertz. So the FCC has no regulatory authority over them, except as Part 15 devices. The FDA has no limit. From lasers down to direct current (DC). The FCC has nothing to do with it, so we need to get involved with the FDA. We need them to get to document things at any rate.

KATINA MICHAEL: I have a question also about the length of time that battery packs last in biomedical implantable devices? Could they last longer? One researcher who is known as a Cyborg Anthropologist was speaking to someone on a plane from one of these biomedical companies who said to her that the devices are replaced in 4-5 year periods so that the companies can make more money, like 40,000 dollars for each new device. What do you make of this?

GARY OLHOEFT: Possibly the case. But really, you don’t want to be making bigger battery packs, right? You just want to be able to make better battery technology. For example, do you really want a Lithium ion battery in your body because it lasts longer?

KATINA MICHAEL: Yes, you have a point there. What kind of battery do you have?

GARY OLHOEFT: I don’t know what kind it is. I do have the dimensions for how big it is.

KATINA MICHAEL: Yes, I saw the information you sent, 6x6x2 cm.

GARY OLHOEFT: It’s already presentable “looks-wise”, so I wouldn’t risk it.

KATINA MICHAEL: Ok, I agree with your concerns here. I was just worried about this remark because I have heard it before, replacement biomedical devices being a money generator for the industry [xliv].

GARY OLHOEFT: He must’ve been a marketing type.

KATINA MICHAEL: Yes, he was in sales engineering.

GARY OLHOEFT: Do you know how they have those wireless power transmitters now? The Qi system is the only one I have been able to test because I’ve been able to get through to them as there is a potential there for interference [xlv]. So they have given me a device with which to actually play with.

KATINA MICHAEL: That is great. And a very good example of what we are talking about should be happening.

GARY OLHOEFT: There is a Wireless Power Consortium of other people who work at different frequencies [xlvi]. They are the only ones that give me no response to my letters. So the wireless power transmission people need to be brought into the scope of this somehow.

KATINA MICHAEL: Could you elaborate?

GARY OLHOEFT: These are the people who create devices to recharge batteries for devices that require power transmission.

KATINA MICHAEL: Yes, mobility types of technology devices. And there are lots of those coming and most of them with little testing in the security space. I mean the Internet of Things is promising so much in this market space. I think the last statistic I read that the media caught wind of was 20 billion devices by 2020 [xlvii].

GARY OLHOEFT: You are looking at a house that could have every lightbulb, every appliance, every device in it on the Internet.

KATINA MICHAEL: Yes indeed, we just have to look at the advent of NEST.

GARY OLHOEFT: And yet they are wirelessly transmitting. It would be much better if they were hooked up using fibre optics.

KATINA MICHAEL: Agreed… I mean for me it is also a privacy concern with everything hooked up in the house to the Internet [xlviii]. Last year somebody demonstrated they could set a toaster alight in the IOT scenario [xlix].

GARY OLHOEFT: You know how Google has these cars driving around taking pictures everywhere?

KATINA MICHAEL: Yes, that is part of my research [l].

GARY OLHOEFT: And they also record whatever wireless systems they can get into that is not subject to a password, and then they can record anything that is in it. They lost a lawsuit over that.

KATINA MICHAEL: Yes. There is one that was handed down into the billions in Europe recently. But over the last several years they have been fined very different amounts in different markets. It was very ridiculous that they were fined only a few thousand US dollars in for example, South Korea! [li]

GARY OLHOEFT: That is a joke.

KATINA MICHAEL: At the IEEE Sections Congress last month I spoke to several young people involved with driverless cars. And I don’t know, they were very much discounting the privacy and security issues that will arise. One delegate told me: “it’s all under control”. But I do not think they quite get it Gary. I said to one of them: “but what about the security issues” and he replied: “what issues, we’ve got them all under control, I am not in the slightest concerned about this because we are going to have protocols.” And I pointed to the Jeep Cherokee case that some hackers got to stop in its tracks on a highway in the United States [lii], [liii]. One of my concerns with these driverless cars is that people will die, sizzling in a hot vehicle, where they have been accidentally locked inside by the “car”. And they don’t even have to have pacemakers, it is an issue of simply having a vehicle unlock its doors for a client to exit.

GARY OLHOEFT: There was the case of the hybrid vehicle that was successfully stopped and demonstrated on TV.

KATINA MICHAEL: Yes. And there was also someone wearing an Emotiv device that was steering their vehicle with their thoughts [liv]. I was giving a talk at Wollongong’s innovation hub called iAccelerate last week and I told them this very scenario. What if I hacked into the driver’s thoughts, and steered the car off a cliff?

GARY OLHOEFT: So what will they do between vehicles when the devices start to interfere with one another? 

KATINA MICHAEL: Yes, exactly! And when devices begin interfering with one another more frequently for who knows what reason?

GARY OLHOEFT: We have had situations in which cell phones have stopped working because the network is simply overloaded on highways, or blocked by landslides or just traffic congestion. The Broncos Football Stadium here is undergoing a six million dollar upgrade, just so they can get the Wi-Fi working, and now they are building it in to every seat. So they now have security systems like Airports do, and so I cannot go into the Stadium anymore because of my DBS. I couldn’t sit in a  light rail train either.

KATINA MICHAEL: So here is a more metaphysical and existential question. I am so fortunate to be speaking to you! You are alive, you are well in terms of being able to talk and communicate, and yet somehow this sophisticated tech also means that you have had to dull down your accessibility to certain places, almost living off the grid to some degree. So all of this complex tech actually means you are living more simply perhaps. What does that feel like? It really is a paradox. You are being careful, testing your devices, testing the Wi-Fi, and learning by trial and error on-the-fly it seems.

GARY OLHOEFT: Well I have a landline phone against my head right now because I know it doesn’t bother me. I cannot hold a cellular phone within 20 inches of my head.

KATINA MICHAEL: Hmm…

GARY OLHOEFT: So you are right. I mean there are a lot of places I cannot go to, like the School Library or the Public Library because of their system for keeping track of books. It has a very powerful electromagnetic pulse. So when I go to the Library, I go remotely via Virtual Private Network (VPN) on the Internet and fortunately I have access to that. I can also call the librarian who lets me in via the back door.

KATINA MICHAEL: So for me, in one case you are very free, and in the other case, somewhat not free at all. I really do not know how to express that in any other way.

GARY OLHOEFT: I see what you are trying to say but I would be less free without the device because it dramatically improves my functionality and quality of life, but also limits where I can go.

KATINA MICHAEL: I know. I know. I am ever so thankful that you have it and that we are able to talk so freely. I am not one to slow down progress but I am looking at future social implications. One of the things I have been pondering on is the potential to use these brain stimulators in a jail-like way. I am not referring here to torturous uses of brain stimulators, but for example, the possibility of using brain stimulators for repeat offenders in paedophilia for instance, or extreme crimes, whether we would ever get to the point where an implantable would be used for boundary control. Perhaps I am referring here to electronic jails of the future.

GARY OLHOEFT: That gets to be worrisome in a different way. How far are you away from that from controlling people. 1984 and all that [lv]. These DBS are being used now to help with obsessive compulsive disorder (OCD) and neural pain management.

KATINA MICHAEL: Yes, that is what we have pondered in the research we have conducted on uberveillance with MG Michael. So if we can fix the brain with an implantable then we can also do damage to it [lvi]. It is a bit like the internal insulin pump- if we can help someone receive the right amount of insulin, we can also reverse this process and give an individual the wrong amount to worsen the problem. Predatory hacking is something that will happen, if it is not happening already. That’s just the human condition that people would be dabbling with that kind of stuff. It is very difficult to talk about this in public because you do not wish to scare or alarm brain pacemaker or any pacemaker recipient, but we do need to raise awareness about this.

GARY OLHOEFT: That would be good because we don’t have enough people talking about these issues.

KATINA MICHAEL: I know. According to the NIH, there are 25 million people who have pacemakers and are vulnerable to cybersecurity hacks [lvii], [lviii]. That is a huge number. And it was you who also told me that 8% of Americans have some form of implant.

GARY OLHOEFT: Well it was 25 million in the year 2000.

KATINA MICHAEL: And the biggest thing? They must never ever link biomedical devices to the Internet of Things. Never. That is probably my biggest worry for the pacemaker community, that the companies will not think about this properly and they are going to be thinking of the ease of firmware updates and monitoring rather than safety of the individual. I envisage it will require a community of people and I am not short-sighted, it will mean a five-year engagement to make a difference to policy internal to organisations, and government agencies to listen to the growing needs of biomedical patients. But this too is an educational process and highly iterative. This is not like going down to your local mechanic and getting your car serviced, this is about the potential for things to go wrong, minimising exposure, and ensuring they stay right.

GARY OLHOEFT: I agree.

KATINA MICHAEL: Thank you Gary for your time.

 

Key Terms

Biomedical device: is the integration of a medical device and information system that facilitates life-sustaining care to a patient in need of a prosthetic function. Biomedical devices monitor physiological characteristics through mechanical parts small enough to embed in the human body. Popular biomedical devices include heart pacemakers and defibrillators, brain stimulator and vagus nerve stimulator devices, cochlear and retinal implants, among others. The biomedical device takes what was once a manual function in the human body, and replaces it with an automatic function, for example, helping to pump blood through the heart to sustain circulation.

Biomedical Co-creation: co-creation is a term popularised in the Harvard Business Review in 2000. Biomedical co-creation is a management design strategy, bringing together a company the manufactures a biomedical device and recipients of that device (i.e. patients) in order to jointly produce a mutually valued outcome. Customer perspectives, experiences and views in this instance, are vital for the long-term success of biomedical devices.

Deep Brain Stimulation: also known as DBS, is a neurosurgical procedure involving the implantation of a biomedical device called a neurostimulator (also known as a brain pacemaker), which sends electrical impulses, through implanted electrodes, to specific targets in the brain for the treatment of movement and neuropsychiatric disorders. DBS has provided therapeutic uses in otherwise treatment-resistant illnesses like Parkinson's disease, Tourette’s Syndrome, dystonia, chronic pain, major depressive disorder (MDD), and obsessive compulsive disorder (OCD). It is also being considered in the fields of autism and even anxiety-related disorders. The technique is still in its infancy and at the experimental stages with inconclusive evidence in treating MDD or OCD.

Federal Communications Commission: The Federal Communications Commission is an independent agency of the United States government created by statute to regulate interstate communications by radio, television, wire, satellite, and cable. Biomedical devices are not under the regulation of the FCC.

Food and Drug Administration: The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of a number of domains, among them those relevant to the biomedical device industry including electromagnetic radiation emitting devices (ERED).

Cybersecurity issues: are those that affect biomedical device recipients and place patients at risk of an unauthorised intervention. Hackers can attempt to hi-jack and administer incorrect levels of dosage to a recipient by penetrating proprietary code. These hackers are known as predatory hackers, given the harm they can cause persons who rely on life-sustaining technology.

Implantables: are technologies that sense parameters of various diseases and can either transfer data to a remote center, direct the patient to take a specific action, or automatically perform a function based on what the sensors are reading. There are implantables that have sensors that monitor, and those that facilitate direct drug delivery, or those that do both.

Participatory Design: is synonymous with a co-design strategy of development of biomedical devices. It is an approach that tries to incorporate various stakeholders in the process of design, such as engineers, medical practitioners, partners, manufacturers, surgeons, patients, ethics and privacy-related NGOs, end-users, to ensure that resultant needs are met.

Product Lifecycle Management: is the process of managing the entire lifecycle of a biomedical device from inception, through engineering design and manufacture, to service and disposal of manufactured products. Importantly, PLM is being extended to the ongoing monitoring of the embedded biomedical device in the patient, remotely using wireless capabilities.

 

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Citation: Excerpt from Gary Olhoeft and Katina Michael (2018), Product Lifecycle Management for Brain Pacemakers: Risks, Issues and Challenges Technology and Society (Vol. 2), University of Wollongong (Faculty of Engineering and Information Services), ISBN: 978-1-74128-270-2.