They Know How to Work It,That’s Their Focus in Life: The Complex Role of Industry Representatives in Surgical Innovation

Nonfinancial and Within-Role Conflicts

We found some evidence in our interviews of nonfinancial conflicts for surgeons that were both external and within role. The desire for peer recognition, prestige, and standing can drive surgical innovation, as noted by this participant: “there is an egotistical component to it [surgery is] a highly competitive environment, so being perceived as a leader in your profession is an important thing” (Participant 14). Instances were also cited of within role conflicts where the pursuit of innovation had the capacity to cause patient harm. For instance, one participant acknowledged the downside of surgeons pursuing innovation: “people want to be pushing the frontiers of medical knowledge and science, but sometimes in doing so, you lose sight of, you know, the human being” (Participant 1).

Health care Professionals Deny the Sway of Conflicts of Interest

Our study suggests that, on the whole, professionals discount or fail to recognize the importance of the role played by conflicts of interest in decision making. In fact, few participants spontaneously identified conflicts of interest as an ethical issue associated with surgical innovation at all. Instead, comments pertinent to conflicts of interest often arose incidentally when participants were describing their participation in the implementation of innovations at various hospitals where they had worked. However, for some participants there was an explicit, unprompted acknowledgment of conflicts of interests and the tension they generate:

[E]verybody knows that if the company is training someone to be proficient in their [product], that they, in the long run, want them to use that [product]. (Participant 15)

Yet this same individual expressed optimism that the conflict would not impact decision making, as did a number of other participants:

[Y]ou would hope that, in the long run, that the practicing physician opts for the device that best fits the patient, as opposed to [deciding] “well that company that flew me to all the way across to Perth and I stayed in a really nice apartment and I am going to pay them back by giving them loyalty” (Participant 15).

One interviewee made a distinction between sales representatives, and industry representatives with specialist knowledge and expertise. The former was characterized as “the one that’s coming in, sort of pedalling, you know, their own brand of equipment or device, can be problematic” (Participant 2), while the latter was viewed favorably “machine wise, they know how to work it, that’s their focus in life is to learn how to use this machine. They can trouble shoot for this machine, you know, any problem—if they are there, it’s fantastic!” (Participant 2). The same distinction was implicit in other comments, comparing the current role of industry representative as experts with the past when they were focused on sales: “these days, a medical specialist is not a . . . she doesn’t sell . . . she is somebody employed by the company who is expert in that equipment” (Participant 18). The implication here is that only relations with the former—the sales person—would be problematic. However, even if a medical specialist is not overtly engaged in selling a product, by virtue of the relationships they cultivate with surgical professionals, their actions can still be potent in securing brand loyalty.

Provision of Support From Industry for Research and Development

Participants talked about the role of industry in funding research and product development. It was noted that this might be driven by surgeons who would go to companies with a view to having a product developed or altered: “some of the more innovative surgeons will say ‘well, I am not really happy with this’ and will approach companies” (Participant 15). Interviewees discussed industry funded research in both a negative and positive light. In the case of the former it was noted that industry funding could lead to publications of spurious quality. “I mean, there is people publishing stuff which they don’t really believe, but because it’s company sponsored” (Participant 17). But the same interviewee stated that some industry funding came without such apparent strings attached “it’s an unconditional grant, which means that if we get a negative result—showing that it doesn’t work—they can’t stop us publishing it. They have no influence over how we publish it” (Participant 17).

Provision of Training, Technical/Clinical Support and Credentialing

Participants revealed a significant role played by industry in new product training, technical support in the techniques required to implant innovative devices in operating theaters and (in some cases) the credentialing of clinicians to perform new types of procedures.

According to participants, the role of industry in education and support around new products and the associated surgical implantation extended beyond training settings and included actual clinical advice and assistance in theater. A number of interviewees made the point that the services of the rep for theater were available around the clock in case of emergencies. The following quotes illustrate the extent of this support:

There’s always reps—in the hospital, in the operating theatres, helping to support your use of the product. (Participant 12)

when I was the manager I insisted that there was a rep from the company—like, they are on call 24/7—and that they would attend all surgeries, especially out of hours, when the people are not used to using the stuff. (Participant 16)

This support could be quite direct and tangible as this nurse manager revealed:

with the more technical stuff, we always get one of the company reps to come and they have laser pointers and they point you through—especially in orthopaedics, when things can get quite—you have to put bits together and pull them apart afterwards to do it—they are there with their little laser pointers saying “this slot A goes in to slot B,” you know what I mean? (Participant 16)

Participants noted that industry could even be involved in credentialing with respect to new products:

the manufacturers came to an arrangement with the institutions, that they would have some credentialing features, so this was a manufacturer led—and they said “if you want to be a [device name] surgeon, you have to go to our courses.” (Participant 14)

In addition to providing technical support in the operating theater and their involvement in credentialing, participants also discussed industry involvement in training. Those interviewed as part of our study nominated three main benefits associated with industry involvement in the provision of training for use of innovative devices. Industry was important to ensuring those involved in surgery had the appropriate knowledge and skills regarding particular products, that training was properly structured, and that training was in fact provided in the absence of funding for this from other sources.

According to some participants, industry provides important opportunities for surgeons and operating theater nurses to gain knowledge and skills on new devices and equipment. A number cited the value of “hands on practice,” whether on a simulator or a nonhuman animal. Talking about a new surgical stapler, one participant said,

the company also have, like, a session—we talk about it and they will probably buy some, like, meat, or whatever, and then you can like hands on practice. (Participant 10)

However important such sessions are in terms of improving the skills of nurses and clinicians, they can also include a marketing agenda. The same participant described sessions that promoted a new product over a previous or rival version by encouraging participants to compare the experience of using both:

they have a model of a vessel and ask you to using that wire to go through that vessel and probably, like, you have difficulty to trying to get through. And then they will giving to you, like a new product to saying “Look, try this one” and you say “Ah, yeah, it does go through with this, this wiring.” (Participant 10)

One participant acknowledged that although the College of Surgeons was officially “responsible for training” and that they offer “workshops and that sort of stuff” a major shortcoming is that, unlike industry, the College “doesn’t really have the . . . the opportunity to provide the clinical work, apart from through its fellows” (Participant 14).

Participants noted that industry thereby plays a significant role in setting the standards surgeons are required to meet. This was generally expressed in positive terms, for example,

The company is actually quite good. They have a process themselves, so that’s—there’s some theory, there’s some simulation, and there’s a practical course and I went to America in September, too. There’s [an] animal lab and also they have some observation. And then when we’re introduced and do it in [the hospital] there is a proctoring process too. (Participant 11)

And, Participant 14 commented that the manufacturers of a particular product, rather than the profession, led the credentialing on their device:

so I went to the USA and I spent 3 days playing games, operating on pigs and then I had to come back here and I had to be mentored. So I had to have 5 cases and then you have a supporting structure [. . .] and by and large this has been a very successful way of introducing [product name]. (Participant 14)

It is possible, then, that the involvement of industry helps structure and formalize training, which otherwise might be quite disorganized and ad hoc. For instance, describing attempts to introduce proctorships to assist in training, one participant stated “it’s difficult, it’s not well organized, the profession really has not got to grips with how you train middle aged surgeons in innovative technology” (Participant 14).

Some company training sessions seem fairly comprehensive and inclusive, involving not just surgeons but other theater staff. For example,

[the company] actually have even courses for the nursing staff, and the, you know—I guess they are doing their type of the proctoring and things like that—and for anaesthetists. (Participant 11)

the medical representative will come and give [operating theatre nurses] like in service workshop. (Participant 18)

It appears hospitals rely on industry provided training, particularly in the case of nonsurgical personnel, to ensure that staff can use new products. Surgeons have a level of independence to identify and undertake training, but this is not the case, for instance, with nursing staff. Rather, our interview data suggest that provision of training for nurses by industry is generally expected by institutions, with managers contacting device companies to arrange training for new products:

what our managers do is, first, to have in service. (Participant 21)

sometimes I’ll get a rep to come in, organise for a rep to come in and set them up in the anaesthetic store room to give the in-services on the devices or products we have. (Participant 19)

However, these training sessions did not always meet the training requirements, with some participants describing situations in which they could not operate a new piece of equipment when it came time to use it on a patient, despite having attended a training session:

Even minor situations such as the unfamiliarity of staff with a new stapler can be problematic. In addition to delaying the surgery, they potentially disrupt the work of staff in other operating theaters. In a case such as this, the participant said she might call in a nurse from another operating theater (module) to demonstrate the equipment during the surgery:

usually I’ll ring up somebody else that I think will know [. . .] from her module, I’ll ring up someone asking “could you come and show me?” [. . .] and so they will come and show you. (Participant 22)

And these disruptions can distract staff from their primary patient-focused roles in the operating theater. “You spend less time, you know, attending to the patient. Or the scouting nurse has less time attending to her scrub [. . .] You have your backs turned” (Participant 22).

Our interviews provide evidence of how industry representatives have come to be involved not only in training, but also in actually attending surgical procedures and offering instruction and technical support to surgeons and nurses in the operating theater. In this capacity they frequently bring a superior and detailed knowledge of the working of their equipment, a capacity to troubleshoot on that equipment, and an ability to offer support and guidance to surgeons, nurses and other members of the surgical team. Not only do they have the requisite knowledge of the equipment, but they have an interest in ensuring it is used safely and effectively.

As one nurse manager put it:

as a clinician the rep can be your best friend, you know, um, they can help you sort of make—. . . particularly more equipment wise, like cameras and you know, any new sort of new gadgetry that comes in, I mean like, machine wise—they know how to work it, that’s their focus in life is to learn how to use this machine. They can trouble shoot for this machine, you know, any problem. If they are there, it’s fantastic! (Participant 2)

This capacity on the part of reps to trouble shoot adds to their value in the sometimes high pressure environment of theater, especially when an innovative procedure is being done for the first time. A nurse manager highlights this point below:

they could actually trouble shoot [if someone says] “how come I haven’t got this, I need it now!” They can, they can get, and like it’s their job on the line [. . .] that’s the attitude they have. So, if you need something, and if the surgeon says “this instrument doesn’t seem to be working, the torque screwdriver is not right” or something, they can troubleshoot that as well. They say “well, you haven’t got it quite, you know” [. . .] Obviously, as time goes on, there’s less of that and they know how to put it exactly right straight away, so. But I think, you know, I think with people’s lives they do actually. I mean, it’s a person they are operating on, so they want to do it right the first time. (Participant 16)

Another crucial dimension to the role of the rep in theater is as someone who can provide support and guidance to surgeons and nurses, as this nurse indicates:

When we handle the graft itself, the—we can tell the rep that we are not familiar with this, would you mind helping us. They will guide us how to do things, and other than that, if they also want help, the surgeons, with the positioning. (Participant 21)

A nurse participant reiterates this support role,

the rep from the company normally turn up to assist with the surgeon during the surgery [. . .] they talking to the surgeon about the orientation of the graft. [. . .] To the nursing staff as well, how are we dealing with the package and once we open the package what will we gonna flush with and where we gonna flush. (Participant 10)

In training, credentialing and in the surgical suite, the role of industry in surgical innovation is significant. Although the role of industry may appear to deliver clear benefits for surgical teams and patients, as we outline below in the discussion, these come at a cost.

Putting the Findings in Context

The results from this study offer insight into device industry involvement in surgical innovation. Insofar as they can be compared to theoretical work on the types of conflicts of interest encountered by surgeons, and existing studies on interactions between clinicians and the pharmaceutical and medical device industry, they are in broad alignment. For instance, our finding that surgeons are affected by nonfinancial conflicts of interest is consistent with the literature where nonfinancial conflicts have been identified and discussed (Rogers & Johnson, 2013). Sade (2006), for instance, has canvassed the particular motivations of the surgical innovator in some depth (p. 1958):

Surgeons who wish to be innovative [. . .] may have additional interests of their own to pursue ahead of those of their patients: the intangible reward of emotional excitement from breaking new ground and making new discoveries, the possibility of enhanced reputation and of academic advancement through discovery of new information and its publication; the possibility of obtaining grants, awards, or contracts to create a formal clinical trial if an innovation is successful, and perhaps the satisfaction of very strong personal dedication to advancing the science of medicine.

Likewise, our finding that on the whole clinicians underestimate the impact of conflicts of interest on their decision making bears out a previously identified concern (Morgan, Dana & Loewenstein, 2006; Schwarze, 2009; Zipkin & Steinman, 2005). Participants in our study were confident that the conflicts of interest generated by training would not impact decision making. But such confidence does not appear to be borne out in the evidence collected from social science research (Dana, 2009) according to which judgments are often subconsciously impacted by what Pronin, Lin, and Ross (2002) have described as a “bias blind spot.”

The literature on surgical innovation led us to anticipate strong relationships between industry and surgeons around products, with suggestions that these relations are actually essential to facilitating surgical innovation (Camp et al., 2013; Jacobs et al., 2006; McKneally, 2007) and ensuring good patient support and outcomes (Camp et al., 2013; DiPaola et al., 2014; Jacobs et al., 2006). Commenting on orthopaedic clinical practice, Jacobs et al. (2006) suggest industry represents “an intrinsic partner with medicine in providing the tools that the practitioner needs to serve the needs of his patients” (p. 1651). This relationship is multifaceted. The input of surgeons has been deemed essential “in refining and standardizing surgical techniques and indications and in anticipating and avoiding potential problems” (Jacobs et al., 2006, p. 1652), while surgical skills are clearly required in the implantation of new devices, with early attempts at implantation (whether in animals or humans) requiring the involvement of surgeons with developers, before devices go to market.

Despite differences regarding who drives research and development (see, for instance, Mirza, 2004 who suggests contemporary innovation tends to be driven by industry, who seek out support from prominent surgeons), there is clear recognition in the literature that industry funds surgical research aimed at product development.

What we did not expect, was that industry representatives played such a significant and widely accepted role in training, credentialing, and providing technical support with new products during surgery. Although there is evidence of concern about the involvement of pharmaceutical companies in training (particularly the formally recognized continuing medical education schemes; Relman, 2001; Rodwin, 2010; Rothman et al., 2009; Steinbrook, 2008), there is no parallel and well developed literature on the involvement of the device industry in surgical training. Unlike prescribing, performing surgery requires the surgeon to master relevant hands-on techniques. Although sometimes lamented as inadequate “see one, do one, teach one” has long been regarded a minimum requirement for surgical training (Schwaitzberg et al., 2009). The involvement of industry representatives as instructors in the operating theater, walking surgeons through implantations of new devices with a laser pointer, suggests abandonment of this expectation. This is despite the occasional scandal or legal case that links bad outcomes to substandard industry-provided training (Langreth, 2013; Rabin, 2013). A few studies are starting to emerge, however, which (while not focused specifically on innovative surgery) support our findings regarding the role of industry representatives in theater. For example, the qualitative ethnographic study by O’Connor, Pollner, and Fugh-Berman (2016) examining relationships between surgeons and medical device representatives in the United States and Grundy’s (2016) qualitative ethnographic research with nurses, also focusing on the United States. O’Connor’s study demonstrates how device representatives work to make themselves indispensable to surgeons to secure influence and loyalty to the representatives and the companies for which they work, while Grundy shows how crucial sales representatives are to purchasing decisions in health care through creating product interest and supplying product information. Neither of these studies comments on the nexus between surgical innovation, device development, and dependence of health professionals on industry expertise, which is a focus in our study.

Why Worry About the Role of Industry in Training, Credentialing, and Theater?

Although there are advantages that attach to having industry and its representatives involved in training and in theater when innovative devices are used, there are also a variety of reasons to be concerned about industry’s role in this domain. There are the standard concerns around conflicts of interest; as well as worries about potentially less-than-ideal practices associated with industry-led and industry-provided training, including with respect to credentialing. Concerns also arise from the involvement of industry employees in patient care, the possibility of role ambiguities for industry employees, as well as the possibility of inadequate informed consent.

In the context of training and clinical support, conflicts of interest bring the worry that surgeons and surgical teams may fail to fulfill their primary obligation to make decisions and act based on the best interests of patients. Instead, relations with industry representatives may foster feelings of obligation and reciprocity, favorably predisposing surgical professionals toward the products of that particular company in ways that may impact adversely on decision making and patient care.

There are also shortcomings to industry-provided training as it tends to focus on specific products, whereas training programs overseen by professional bodies are likely to take a broader approach. In the context of formally recognized continuing medical education, surgical colleges have explicitly stated that it is important for them to retain control over the design and content of training when these courses involve collaboration with industry (American College of Surgeons, 2009). However, much of the training in how to use innovative devices is more informal than continuing medical education, and there are no guidelines or policies on such informal training.

Furthermore, as the results above indicate, the quality of industry-provided training may vary. For example, the standard of training for nurses is apparently lower than that for surgeons, and is dominated by “in-services”—meetings on the ward attended by industry representatives, at which they demonstrate the functioning of the new product at the front of the room but often do not facilitate proctored clinical experience. Our participants described situations in which this led to reduced attention on patients while the staff tried to master new equipment quickly during a procedure. Such examples suggest that the there is a mismatch between the training provided by industry and the training needs of health professionals. In the context of innovative surgery, the associated risks are compounded because the surgeon is likely to be on a learning curve at the same time (McCulloch et al., 2009).

There are also questions about the appropriateness of manufacturer involvement in setting appropriate training, supervision, and practice requirements to achieve competency on innovative equipment. These questions have come to the fore in recent legal proceedings in the United States testing whether Intuitive Surgical, manufacturer of the Da Vinci surgical robot, is legally accountable for bad outcomes associated with surgeons who are not adequately trained. A New York Times investigation revealed that sales representatives from Intuitive Surgical encouraged hospitals to reduce their requirements for the number of proctored (or supervised) procedures a surgeon should complete before being deemed competent to perform robotic surgery unassisted (Langreth, 2013; Rabin, 2013), while at the same time the manufacturer was the main provider of training and had de facto responsibility for guidance to hospitals about appropriate credentialing requirements, given their intimate knowledge of the product.

This tension is deeper than it may appear, because the companies that develop new products generally are best placed to provide training (and make recommendations about training requirements) while the device is new. At first, all the experts on the device are either internal to these companies, or are direct collaborators. As such, although independent bodies such as hospitals are expected to evaluate the appropriateness of training when there are credentialing implications, in practice determining appropriate training requires an understanding of the product and its risk profile. The more innovative the product is, the more difficult it is to verify the appropriateness of training recommendations because appropriate comparators may be difficult to identify. Thus companies are both best placed to make recommendations about and provide adequate training, and at the same time they cannot be relied on to do so in an impartial way due to their interest in maximizing sales and lack of liability for bad outcomes, even when these are the result of poor training or standards. This dilemma is reflected in the statements of professional groups such as the Royal Australasian College of Surgeons (RACS, 2017), whose position paper on surgeons’ and trainees’ interactions with the medical industry states both that “[m]eetings with medical industry representatives are encouraged for the purposes of education and obtaining information” (p. 3) while at the same time acknowledging that “interactions between qualified Surgeons, Trainees or International Medical Graduates (IMGs) and the medical industry have the potential to become a conflict of interest” (p. 1) and also that “[e]ducation development should, wherever possible, be through third parties such as specialist groups/training boards that are accountable to the profession” (p. 3). The potential harms associated with this tension feature in the recent case of Taylor versus Intuitive Surgical which turns on the relative responsibilities of surgeon, hospital, and device manufacturer for negligent surgery resulting in severe harm to a patient. County and local appellate courts in Washington State initially ruled that the surgeon and hospital were liable for negligent surgery and inadequate credentialing, but the device company was not, despite developing the training program and providing the training (Pradarelli et al., 2015). However, this decision has recently been overturned on appeal in the Supreme Court (Taylor v. Intuitive Surgical, 2013, 2015, 2017).

Despite widespread acceptance that many industry-provided educational activities represent an alignment of interests between industry, the surgeon, and patients, these contexts also provide an opportunity for influence. The problem is that none of the parties may be aware of when a line has been crossed between aligned and conflicted interests. Brody (2011) has argued that it may be impossible to tell whether or when influence has occurred as a result of relationships with industry, and that this suggests that the “critical threat to public trust” occurs when a relationship is struck rather than when influence occurs.

The presence of industry representatives in the operating suite providing assistance to surgeons using devices, as well as in clinical care such as in follow-up with patients, can blur roles and responsibilities, potentially compromising patient care. Surgeons, other health professionals, and patients can all suffer the illusion that reps are first and foremost part of the health care team rather than a sales professional. A RACS (2017) position paper on interactions with industry notes the potential benefits of industry employees “proctoring the introduction of new technology” (p. 1) but advises caution, particularly around over-reliance on the advice of industry representatives during surgery: “Although the attendance of medical industry representatives during procedures can be useful, the overall responsibility for the treatment of the patient resides with the clinician” (RACS, 2017, p. 2). With industry reps playing such a significant role in theater, clinicians need to ensure they do not cede decision making to reps. Surgeons must also remain critically reflective regarding what reps are advising.

Although industry reps might have an excellent knowledge of the equipment they support, they are unlikely to have comparable knowledge of their competitor’s products or of standard treatments that do not involve their product. For example, representatives for the da Vinci robot may have a good understanding of the robot in the context of robotic prostatectomy, but may be unfamiliar with standard prostatectomy. So although they can speak to the advantages and use of their products in theater, they lack a capacity to give a fuller account of the relative merits of their equipment in its broader context.

Questions also arise over informed consent in situations where a patient is unaware of the presence and involvement of industry representatives in procedures. For instance, in Australia, there is no requirement to declare the potential presence of representatives in the consent process. This means there is the risk of a loss of trust on the part of the patient if they discover the rep has been involved in theater without their knowledge.

From a terminological perspective, it is not clear whether the potential for industry representatives to exert influence through providing training and support is best described as generating “conflicts of interest” for the clinicians, teams, or hospitals who receive the support. It may be more appropriate to adopt different terminology for these types of interactions. Whatever terminology is adopted, however, the key point is to recognize that industry can influence purchasing patterns and equipment choice by their involvement in these training and support capacities. The positive terms in which participants in the study described such support, as quoted in the results above, (e.g., fantastic [Participant 2]; helping to support your use of the product [Participant 12]; supporting structure [Participant 14]; they can troubleshoot [Participant 16]; and guide us [Participant 21]) indicate that alongside support and training the interactions also cultivate positive feelings, dependence, and trust, which is open to exploitation by device companies.

How has the Role of Industry Reps Become so Pervasive?

We have developed a model of how features of surgery and surgical innovation support and normalize the involvement of industry, as well as create particular risks, in the provision of innovative surgical care. The components of this model will be explained below and then the model itself is shown (Figure 1).

OPEN IN VIEWER

Figure 1.

A visual representation of interrelationships between surgery and industry.

In the first instance, there are features of surgery that have the potential to create particular difficulties around industry interactions. For instance, the decision making of surgeons is a highly valued commodity and their decisions generally go unchallenged. As Mastroianni (2006) argues, decisions occur “within a culture of deference to surgeon decision-making” (p. 362). Because surgery by its very nature involves uncertainty and subjective judgments, there is an increased possibility that unconscious bias (e.g., in favor of a particular product) can slip into and affect decision making in a manner that goes unquestioned.

Research suggests that surgeons are less troubled by conflicts of interest than, for instance, medical physicians (de Gara, Rennick, & Hanson, 2013) and our findings are consistent with this. Such a situation is particularly problematic in the context of relations with industry, since any tensions and potential for harm generated by industry relations cannot be remedied if there is no acknowledgment that there may be a problem in the first place.

Particular features of surgical innovation normalize, enable, and support the pervasive role of industry representatives in surgery. Historically, industry has been seen as an important partner in the development of new devices and equipment. As Mirza (2004) explains, “[t]raditionally, well-intentioned and clinically adept surgeons coaxed device manufacturers to create new tools for them at a nominal cost; the same surgeons then applied these innovations in their clinical practice and wrote about results” (p. 492). There is a long pedigree to relations between commercial interests and surgical innovators that establishes these as the norm.

Another feature of surgical innovation that facilitates an important role for industry is epistemological. Frequently surgical innovations are not well supported by evidence regarding safety and efficacy. In spite of this there is often a rapid uptake of new equipment (Johnson & Rogers, 2012), bolstered by the technological misconception and an optimism bias on the part of surgeons. Industry and its representatives play an important part in filling this evidence vacuum through in-house research and technical knowledge. Industry reps have intimate and detailed know-how about the functioning of the products they sell. This practical knowledge makes them indispensable in the context of modern surgery.

Strengths and Limitations of the Study

The study involved in-depth interviews with health professions from a range of roles, all involved in surgical innovation, and all offering insight into the role of industry representatives in theater from their perspective. The study was conducted with 22 participants at a single site. As such, there is a risk that some findings of the research emphasize local features of that site rather than broader issues. To some extent this risk is mitigated by the fact that all the health professionals interviewed had experiences at other sites within the Australian health care system (this is required in training), and were invited to draw upon these experiences as well as current local practices in the interview discussion. Nevertheless, health systems differ significantly between countries, and the study does inevitably reflect rules, regulations, and norms within the Australian health care system. This is both a strength and limitation of the study. It is a strength insofar as the study identifies and describes the specific features of this ethical challenge as it arises in Australia. It is a limitation insofar as some of the challenges in the Australian context do not arise or have already been addressed in some other regions. In the discussion above, we compare our findings with those of other studies on industry involvement in surgery and medical care. While our focus on surgical innovation differs from other literature on the topic, there are a set of ethical challenges identified both in our study and in other studies from outside of Australia that suggest the findings and suggestions in this article will apply more widely.