Interview with a medical device engineer

As health workers we do all kinds of jobs and many of us don’t know what the other one is actually doing. This is a problem in at least two senses. Firstly, our struggles for better conditions for ourselves and our patients often remain divided into professional groups, trusts or departments. We therefore feature reports about health workers talking about their work, e.g. these reports by an NHS IT worker or by a clinical research nurse. Secondly, in the current system industries are structured in the interest of those in power and according to the rules of markets and money relations. That turns them into often fragmented and hierarchical systems that are not very conducive for a free and effective cooperation of everyone involved. As health workers, we therefore have to start understanding how our industry actually works in order to be able to take it over and run it in the interest of everyone in the future. We have to understand various aspects, from the supply of material, to research and production of pharmaceuticals or medical machinery, to the wider management of hospitals and services. For that purpose we spoke to a friend who works in medical device engineering.

Could you introduce yourself and your job?

I’m trained as a mechanical engineer, which has enabled me to work in several different industries. I’ve most recently found myself working in biomedical device engineering. There’s many different kinds of medical devices. In some ways they’re like separate industries with different supply chains, capital ecosystems, business models, regulatory regimes, etc. Most of my time in this industry has been spent working on disposable medical devices, particularly those used in diagnostics. Sometimes these devices are used by healthcare staff, sometimes it’s at home testing. Examples of this sort of device include at-home antigen tests for COVID-19 or other respiratory illnesses. Other examples include PCR systems, which have to be processed in a lab. There’s definitely a big difference in designing a disposable medical device that an untrained patient is supposed to self-administer versus something that a trained nurse or a laboratory technician is going to use. 

For work I have to go into the office and into our laboratory. I don’t usually have to travel to mass manufacturing sites myself, but I’ve worked with plenty of engineers who either visit them often or simply work in them daily. I am doing the design work, meaning, I’m taking abstract requirements and inventing a product, often from scratch, that is capable of satisfying those technical requirements. This means I have to be able to not only come up with original ideas, but also make iterative prototypes and prove that the design not just works, but will work reliably when manufactured in high quantities. Of course part of this is making sure the biological, fluidic, chemical, etc. processes happening in the device perform well consistently. But an understated part of this is ensuring this product is profitable to produce and sell. Per-unit production costs are often quite low, sometimes just a few cents. This can be achieved through smart design that leverages existing supply chains that depend on massive economies of scale and are flexible enough for this product to be made in high volumes. Since these are disposables, I don’t usually have to consider ways to economise on the product life cycle. People who design medical instrumentation that you use over and over again, by contrast, have to consider whether it is easy to repair and how durable it is. Or alternatively, they can design it to have just enough lifetime so that the company can then sell a maintenance plan, so that the client winds up paying more money on top of the initial sale of the unit. All technical considerations are just concrete manifestations of different layers of a single abstraction: of money and profit, unsurprisingly.

I basically never worked with plastics before entering the single-use medical device industry. Specific grades of plastics are ubiquitous in these sorts of devices because they’re easy to sterilise, cheap to fabricate at high volumes, and do not react chemically with various biological substances. It is very common to rely on the same handful of plastic grades that have already been certified for medical use rather than attempting to qualify new materials, which require a lot of effort to prove the safety of. The actual physical forms of these devices are always a compromise between functionality, user experience, and manufacturability. It is very tricky to get the balance right!

You already mentioned the importance of supply-chains for the manufacturing of medical devices, could you expand on that?

The supply chains for medical devices are really interesting. Disposables are produced in very high volume. There tends to be a lot of money to be either gained or saved by manufacturers, or rather by the companies that own the product, through extending the supply-chain globally, e.g. the plastics industry in the Pearl River Delta region in China is huge. A lot of the injection moulding is done there for world manufacturers across a large variety of industries. This includes all the necessary machine shops to fabricate the moulds. But you can also find production locations in places like Malaysia and other parts of Southeast Asia. There’s also a good amount of medical device manufacturing in Latin America. The distribution of manufacturing has a lot to do with exploiting wage differentials of course, not just for basic labour but also for educated labour. But geopolitics and state economic policy play large roles too, such as governments offering subsidies to foreign companies who want to open a manufacturing site and hire local workers, such as in Costa Rica. The effect compounds: it becomes more attractive to open a manufacturing site where there is already an “ecosystem” that can more readily provide the right type of supply inputs, public infrastructure, technical expertise, and cheap labour-power.

I’ve seen medical devices where certain parts are manufactured in a couple different cities in South China – and then they’re all shipped to Malaysia for additional work steps. This is not because Malaysian labour is significantly cheaper than Chinese labour, they’re pretty comparable. Instead it’s to get around trade restrictions on China. Goods that are finished outside of China can often avoid restrictions on Chinese goods, even if all the components of those goods were made in China. But in either case, the supply chains are truly global, with raw material often circling the planet several times before it finally congeals into a medical device that you use once and then throw into a landfill or incinerate for biohazard safety reasons. I would say that the medical device manufacturing supply chain has a comparable level of breadth and complexity as the one for consumer electronics. Things are different with low volume and expensive devices, such as MRI scanners or surgical instruments, which are more likely to have more of their manufacturing performed in the global North. But even for these, the various components and many subassemblies will have a significant international dimension to their origins. 

You talked about the fact that supply-chains don’t primarily exist for ‘natural reasons, e.g. because certain raw materials are only available in certain regions, but because of profits and politics. Could we go into more detail?

When we talk about profit incentives and the logic of capital, it’s easiest to think about it in terms of considerations like whether or not this material is cheaper than that material, or the fact that these wages are lower in one country versus another. These things play a determining role in the practical character of not just medical devices, but any product. Factors like trade restrictions, tariffs, and geopolitics are just another layer of this inscription of capitalist imperatives on the practicalities of production. The reality is that the influence of capitalism on technical design considerations is deeper than just picking the cheapest option. The global system of industrial production and supply logistics is at every single node a business being run for profit. So capitalism is inscribed in your medical device not just when the shape of a plastic component is optimised for per-unit price, but because the capacity to even design, develop, and manufacture this component is made up of material flows and machine systems, from the extraction of the oil that becomes plastic to the construction of an injection moulding machine, that must be profitable for somebody at every step of the way. There’s a certain insanity to it all. Engineers aren’t really setting out to make products that are good or useful. Instead we make products that are profitable, which means they only need to be just good or useful enough to sell. The usefulness and quality of a product is subordinated to its economic dimension as an object produced specifically to be sold, rather than the other way around.

The complexity of your work consists not just in the global dimension of the industry, but also because it bridges the gap between industry and science. Could you tell us more about that?

There’s definitely a division of labour amongst engineers and scientists as well. For designing a medical device, you need to have visibility into the whole manufacturing process and the whole product life cycle. But companies hardly ever have one engineer who’s in charge for everything, from straight initial design all the way through to manufacturing. They are different skill sets.

Most biotechnology companies that own a product line have a research and development department of some kind, with their own scientists and engineers. Small companies like startups hire perhaps just a few engineers, or even just one, and then they oversee the work of an engineering consultancy or engineering contractors. But whoever is designing this product has to collaborate with the scientists who developed the original biochemical process being productized. There’s a cross-functional kind of difficulty, as scientists and engineers speak two different languages. It’s the design engineer’s responsibility to balance the requirements from the scientists with the manufacturability and usability of other stakeholders, such as the people who actually use the device. Often the company who is responsible for designing the product will be the same one who’s responsible for the final manufacturing steps. But comprehensive vertical integration of manufacturing is quite rare. There’s usually all sorts of different types of subcontracted manufacturers that provide fabrication services for custom components and subassemblies, not to mention vendors that sell ready-made parts “off the shelf.” Medical devices, even simple ones, are typically the end result of many inputs from many different firms.

Does this complexity and do these contradictions ever lead to problems and if so, how do you solve them?

Manufacturing never really goes the way you plan. It’s incredibly rare for an engineer to design something and then it goes straight to mass production without any problems. It’s very normal to have to run around with your hair on fire saying: “Oh my God, this isn’t working!”. When it comes to manufacturing of high volume things you need to invest a lot of money in machinery and the specific tooling for those machines. If you haven’t really verified your process before getting to that point, you may invest money in tooling just to find out the tooling doesn’t work the way you expect. The manufacturing process for that product also needs to be prototyped. This usually looks like a small manufacturing line with technicians being closely watched by engineers. Volumes are continually increased as the process is increasingly developed. The higher the volume, the more likely statistically anomalous problems will crop up. You iron out those bugs before you scale up further. The prototype manufacturing line grows, and new ones are opened, sometimes at other sites or at entirely different companies. Depending on the nature of the product, you may even split certain fabrication sequences apart and have the different portions performed by entirely separate organisational entities, including outsourcing some of it. A common supply chain management tactic is to move from having one dedicated supplier for a certain part to having two or even three suppliers. Dealing with the variabilities from multiple vendors for the same parts is a small price to pay for supply chain redundancy. During the COVID-19 pandemic we have seen that supply chain disruptions can be catastrophic for profit margins. 

In the medical field there’s all sorts of legislation and rules about things such as cross-contamination. Engineers have to be aware of the relevant protocols for the specific device being designed.  But apart from that, when it comes to the production of medical devices you would assume that there is a close connection between the engineers designing these things and the actual medical users – but actually it’s very rare that engineers get to talk to a bunch of lab technicians or nurses. Usually there are layers of intermediary business functions between engineers and these users. From a profit perspective it’s not the nurses and lab techs whose views you really care about. You don’t really care about what makes their job nicer or easier. If you’re a company, you care about what makes their job cheaper to do. In any kind of industry the people on the lower level of the qualification hierarchy have a lot more things imposed on them by those higher in the hierarchy. So the feedback will not come from the users, but from hospital managers or lead scientists, with a very business-oriented perspective. By the time the representation of the work of a lab tech or a nurse makes its way to me, it has been so abstracted and filtered through monetary considerations that it’s not even easy for me to really remember that it’s someone else’s labour that we’re talking about. This is a really good example of what Marx called the “commodity fetish:” when relationships between people, like engineers and the people who will use the product they design, are obscured and instead appear as a relationship between inhuman things like commodities or money. As engineers, we have this direct connection with something that might actually improve the working life of another person. But again, it’s always instrumentalized for profit rather than being an end unto itself.

It seems that a lot of capital is necessary in order to set up such a complex productive network. People have coined the term ‘medical-industrial complex’ in order to describe the increasing concentration of capital in the medical field. Could you relate to this from your experience?

The landscape of capital and financing is a bit weird in the medical device world. On one hand there’s a lot of venture capital involved, in particular in biotech. On the other hand there are definitely these old legacy companies that are very big and very powerful with outsized profits. They just have a ton of market share. They are surrounded by this massive foaming sea of startups and loads of venture capital money that is constantly cycling through these startups. A lot of this venture capital comes from the same capitalists that invest in all your fancy big Silicon Valley tech stuff, all the stupid generative AI and blockchain crap that always ends up being a big bubble and bursts. Their goal is to create a product that lets them generate revenue from healthcare. Sometimes this involves creating a novel treatment to some illness or developing a miracle cure. But more often than not it’s really about productizing some existing medical or laboratory process in a way that either gives more control to managers and shareholders, or gets people to pay for medical services they would not have normally sought out or paid for. In order for this latter strategy to work, the product has to offer some tangible benefit, or at least a perceived benefit. It’s all very complicated because it’s people’s health on the line here, but our health is instrumentalized for the sake of profit. Investors are not incentivized to actually make people as healthy as possible, but rather to find ways to use people’s desire for health and wellness to generate revenue. A particularly egregious example is Theranos. They were a start-up that became a mega share market success by claiming that with a drop of blood everyone could diagnose themselves about everything with their smart-phone. The whole thing was impossible, a big fraud. But they got insane funding and media buzz. Of course they eventually could not deliver and it all came crashing down. Most of these startups are not like Theranos though, they actually have something that could at least plausibly work. But this is the type of financial environment they have to navigate: one that rewards a prioritisation of profit and hype over patient health or scientific due-diligence.  

So far we primarily talked about the ‘objective’ side of the process, e.g. about supply-chains, work organisation and financial flows. What about you and your colleagues? Does the experience of working within such a contradictory industry express itself politically – or at least in some form of discontent?

Engineering is a pretty conservative field for a number of reasons. Here in the US, engineering is deeply intertwined with the defence industry. Many industries here historically evolved out of private military contracts, whether it be for developing equipment or bolstering critical manufacturing capacity. Huge sectors of manufacturing today receive a lot of business from defence industry work, which keeps them profitable enough to maintain an ecosystem of vendors for other sectors that are not immediately defence-related. So engineers, even those working in sectors with no immediate connection to the military, are kept employed to some degree or another by the U.S. war machine. On top of this, engineers are paid far better than the average worker, which has predictable aggregate effects on their political outlooks. This is only exacerbated by the fact that engineering, as a profession, revolves around using technology to systematise and control lower-wage labour on behalf of managers. Unsurprisingly, many engineers more closely identify with the managers and owners at their place of employment rather than the rest of the workers. 

But what’s interesting is how many engineers are still starting to realise that something is fundamentally untenable about this system. For the longest time there was this narrative that if you work as an engineer (or other “respectable” professional), you’ll be able to afford a 2.4 child nuclear family, you’ll have your white picket fence, you’ll get your golden retriever, you’ll have your nice house in the suburbs and two vacations a year. And that’s very quickly becoming not the case. There’s a broken promise of middle class prosperity and a very palpable sense of downward mobility that a lot of highly educated technical professionals are experiencing. Historically, middle class anxieties about downward mobility tend to create a lot of nasty downward-punching rightist nonsense, rather than a commitment to any sort of emancipatory politics. For some of them it very much is conducive to a straight out fascist worldview, whether they call it that or not. But if you focus more on younger engineers whose careers are not as secure as those of older engineers, it’s not as universally bleak. There is obviously a generational divide in political orientations, with younger people currently skewing further left, including a resurgence of interest in communism, anarchism, socialism, etc. Younger engineers are less likely to have achieved the level of wealth and stability that older engineers have, and are more likely to attribute this broken middle class promise to a fundamentally broken system rather than adopting the crude “fuck you, I’ve got mine” mentality that is common among the comfortably wealthy. But of course engineers genuinely critical of capitalism are a very tiny minority currently, and will very likely remain a minority for the foreseeable future.

I actually run a study group in my city with scientists and engineers who are interested in communism. These are largely people that I’ve met in my workplace and that were politicised outside of the subcultural milieus that currently make up the far left. I’ve met a lot of scientists and engineers, who are very aware that there’s something wrong about capitalism, and know that some guy named Karl Marx wrote something about it once, or that there’s something called socialism that sounds intriguing. But for most that are curious about this sort of thing there’s not much to plug into. Engineers and private-sector scientists are virtually never unionised in the US. There’s nothing remotely resembling any kind of even vaguely left-wing organisation they can join that is immediately relevant to their daily experience as technical professionals. The closest I can think of are some of these professional societies that women or certain minorities can join (the field is predictably male dominated and can be quite toxic for women), but these tend to be oriented around career development and managerial aspirations rather than anything remotely related to worker solidarity. There’s nothing constructive for those with far-left proclivities.  Well, almost nothing, there’s this group I run! We read various political texts and discuss the relevance to our professions and life in general. Once people are in the group for a while they can talk about what labour rationalisation is. They can tell you how that works in their job and where they sit in that international division of labour and stuff. There’s a deep desire to actually understand how this fucked up world works and how our jobs fit into the technical systems that keep it running. So there’s a big educational component to it, but sometimes I think the biggest benefit it offers is for the members to have like-minded individuals to talk to, a biweekly reminder that we’re not crazy for hating capitalism. More and more members are expressing a desire to do something with all the theory they’ve learned, to find novel ways to organise in ways that can bring a culture of solidarity and anti-capitalism to the engineering stratum of the workforce. Time will tell how this shapes out.   

I should make a distinction here between scientists and engineers in the medical device industry. Biologists, even with equivalent levels of formal education, tend to be paid significantly less than engineers. For an engineer it’s easy to take your skill set from one industry to another, the process of product development and manufacturing is, on an abstract level, very similar between medical devices to electronics to industrial equipment or anything else. The technical knowledge unique to that domain of course takes time to learn, but the skillset overall is highly portable and there is wide demand for it. Whereas if you’re a microbiologist or a biochemist, then you are specialised and there’s not a lot of places that will hire you outside of the biomedical and biotechnological sectors, or academia. In some places you could work in agricultural biology maybe, but overall the labour market for bioscientists is dwarfed by the market for engineers. As a result, if you’re a scientist and you want to have a well-paying career, you usually need a PhD because there’s so much competition. Whereas if you’re an engineer you can have a great career with just a bachelor’s degree, as long as you’re staying on top of your professional/technical development. I think engineering managers understand that the skills one learns in engineering academia are often not at all the same skills required to succeed in private industry, unless it’s a very specialised (and not very common) research-oriented role. For biologists, by contrast, life as a working scientist more closely (but definitely not entirely) resembles the day-to-day of academic research. Academic credentials are a better heuristic for managers to evaluate a biologist’s capacities as an industrial scientist than for an engineer’s capacity to design profitable products or scale up a manufacturing line. There is a much tighter relationship between academic research and industrial applications for biologists than there is for engineers.  

Let’s talk a bit about the labour politics of engineering here in the US. There have been a number of notable unionisation efforts in the last few years involving software engineers and non-engineering tech workers at companies like Google (Alphabet Workers Union), New York Times (New York Times Tech Guild), NPR (Digital Media United), and more. These exemplify a very interesting trajectory in the organised labour landscape here in the US, and I am excited to see the novel strategies and tactics coming out of it, especially from the CODE-CWA campaigns. While there are in fact software engineers involved in these campaigns, I am quite sceptical about the notion that this will be spreading to engineers of other disciplines and/or those in other industries though. There’s a number of reasons for this, but chief among them is the fact that if you actually look at these campaigns closely, engineers are not really the workers being organised, let alone winning fights against their bosses. It’s mostly technical staff that occupy lower positions in the company hierarchy than engineers. Think QA testers and technical support personnel. It is people with undeniably worse pay and working conditions than software engineers. I’d love to be proven wrong, but I have not seen evidence that software engineers are notably more organisable than engineers in traditional disciplines in the US, which is to say hardly at all. The software engineers at Google (AWU) are a noteworthy exception, however I am not confident that minority unions such as theirs are a viable strategy outside of very high-profile companies such as Google. Despite that, it’s obviously great to see people building capacity for confrontation with capital in whatever ways they can. 

Speaking of organising the intelligentsia, another noteworthy group of people experiencing a growth in labour organising lately is grad students. What’s really unique about grad students is that they have no mobility. They’re stuck there until they finish their program. By contrast, if engineers have bad workplace conditions,it is much easier to simply get a new job than to go through the gruelling process of unionising. It’s an open secret that once you’ve been working in a place for a couple of years, if you want to get a raise that’s actually going to reflect your “real market worth,” you typically have to leave. If this wave of grad student organising is able to spread to university science and engineering departments, then there’s a chance it could spill over into private industry in 5 or 10 years once these people get increasingly established in jobs outside of academia and find themselves among coworkers who also have tangible experience unionising. Because bioscientists have far less job mobility than engineers, and the links between  academia and biotech/biomed are tighter, I think such a spillover of labour organising into the private sector from academia is far more likely to happen with biologists than engineers. Time will tell. 

Vital Signs wants to go beyond debating about the struggle of how to defend our conditions as workers, although this is still central. For us the challenge would be to relate the daily experience of work and struggle to debates about a radical transformation of the sector in the interest of workers, patients and society at large. What do you reckon?

I think a big task of communism is to rectify this really demeaning division of labour, this stratification that has been imposed upon the global proletariat. A lot of people have fewer skills and knowledge and technical expertise, not because they’re stupid, but because they’ve been robbed of a meaningful opportunity to learn. People are purposely kept in a position where their labour is made simpler and more repetitive so it can be more easily controlled by management and more easily replaced by a wider labour pool. This is great for profits, but it is a horrific thing to do to human beings capable of being more than just a dumbed down cog in a machine that exploits them. A big task of communism would be to rectify this polarisation of technical and productive expertise across the human population. The construction of communist society would need to involve the cultivation of an entirely new way of socialising people with respect to the systems of production upon which everybody’s life depends. Most immediately, this means ensuring that the knowledge required to produce all manner of goods would need to be widely distributed rather than concentrated among a minority of technical experts who carry out the whims of the ruling class (like how it is now in capitalism). But more generally, this means cultivating an improved capacity in people to continually learn and use this knowledge throughout their lives in ways that are not only important for keeping society running, but for the fulfilment of the very basic human need to perform activity that is meaningful, interesting, and that makes us grow as people rather than hobbles us mentally and physically. Because everybody is different, people would naturally gravitate towards different domains of expertise. But by eliminating the brutal capitalist division of labour and making subsistence no longer tied to the wage, people would assuredly develop competencies in numerous fields rather than the narrow purview of specialised “careers” many of us find ourselves in today. Rather than having microbiologists and electrical engineers, communism would have a higher average baseline amount of microbiological or electrical engineering expertise embedded in the population, with some people choosing to pursue this competency at a higher level than the average. 

So what does this mean for technical machines or for infrastructure? For medical devices, a big part of why they’re disposable is because of sterility concerns. I think that it would be pretty hard to really excise plastic usage entirely from this industry. I think that the medical field is one of the few fields where plastics are very necessary. But in a communist future I think that there would be a lot more modularisation of objects produced. Currently there are all sorts of different competing diagnostic devices. Instead of a million different systems you would probably have a smaller, more unified set of instruments and then disposables that go into them that are meant to be capable of casting a wider net for diagnostics. You also wouldn’t have to rely on a small handful of technicians to be running a lab all the time. It’s very possible that under a particular proliferation of technical expertise among the population, more and more people would be equipped to operate this equipment themselves or to be quickly trained to do so. Standardising and modularising these machines and instruments in an open source type of way would facilitate this general knowledge. You would have a lot of standards that people adhere to, not because there’s some kind of imposition from above on how to do things, but because it makes it easier for you to manufacture things that other people have already designed and that they know works and has proven data. This makes much more sense than having to constantly reinvent the wheel for proprietary reasons. That’s not the primary task of communism, but one of the things that would make it actually work properly. By making all productive information (including designs, data, schematics, and everything else that is today considered “intellectual property”) freely accessible to all, and therefore reducing the amount of redundant labour performed, there would be much more free time for everybody. If people are socialised as people free to pursue the infinite passions of the human experience rather than the narrow tyranny of wage labour, and the rift between mental and manual labour is rendered meaningless, it is basically guaranteed that our combined species-level intellect will yield new forms of materials or design paradigms that far surpass those used by engineers today. Unconstrained by the imperatives of profit-making, one can only imagine the revolutionary transformations that would be unleashed in medical devices specifically and healthcare overall. 

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