John Watson, CMPP, The Manuscript Agent; Anna Boyum, PhD, CMPP, The Manuscript Agent; Tatiana E. Salazar, PhD, CMPP, Cook Research Incorporated
Email your questions and comments on this article to TheMAP@ismpp.org.
For nearly two decades, ISMPP has helped identify and refine what goes into a successful, ethical, and transparent publication plan, most recently in the form of the Good Publication Practice (GPP 2022) guidelines. That these publication planning practices have been embraced by pharmaceutical companies should not come as a surprise; not only do they represent the most effective means of disseminating data, but they were also largely shaped to fit this industry’s unique considerations.
But how applicable are these recommended practices to the medical device industry, whose technologies represent a crucial but oft-overlooked sector of contemporary healthcare? Discussions with ISMPP members who work within this industry indicate that publication planning models have often been poorly suited to their needs and, as a result, have been rarely used as recommended in GPP 2022.
However, the time when medical device companies could afford not to implement publication planning may be ending. Recent regulatory shifts have pushed the medical device industry to adopt more rigorous standards of reporting data. To adjust to this new reality, the industry will need to adapt traditional publication planning models to meet its own needs. ISMPP members are uniquely suited to help the medical device industry in these efforts.
… the time when medical device companies could afford not to implement publication planning may be ending. Recent regulatory shifts have pushed the medical device industry to adopt more rigorous standards of reporting data. To adjust to this new reality, the industry will need to adapt traditional publication planning models to meet its own needs.
Why Medical Device Publications Often Do Not Fit in the Pharma Mold
Several differences between the medical device and pharmaceutical industries make it nearly impossible to adopt the same approach to publication planning. Complex devices that include a drug-delivery component are outside of the scope of this article. The drug itself is often, if not always, developed separately from the device, and hence requires its own publication plan.
Product Pipeline: What constitutes a “medical device” varies tremendously, encompassing everything from latex surgical gloves to implantable cardiac and neurological devices or even computer-navigation technologies. As a result, the number of medical technology products marketed globally greatly exceeds medicinal products.1 The World Health Organization estimates that there are 2 million medical devices on the global market.2 Most medical device companies simply cannot invest in creating publication plans for all their products, nor do all devices require them.
Development: The development of a medical device is a relatively fast process, often taking 3-7 years compared with the more than a decade needed to bring a pharmaceutical to market.3 Faster development means less opportunity for publishing data that would be considered essential with pharmaceuticals (e.g., preclinical studies).
Conversely, although pharmaceutical products may reveal their safety and efficacy with relatively brief follow-up periods, certain medical devices (e.g., orthopedic repair systems) require more than a decade of post-market surveillance to provide compelling evidence in this regard. Medical device congresses and journals are therefore less interested in data at earlier time points.
Budget Considerations: In terms of revenue, the medical device industry lags behind pharmaceutical and biotech industries. The approximate 2023 revenue of the top 5 pharmaceutical companies ranged from $54 to $85 billion,4 compared with $23 to $31 billion for the top 5 medical device companies.5 Such figures do not capture the perspective of small-to medium-sized medical device companies, which may have relatively limited resources to support the products they design and develop.
As such, medical device companies may choose to direct their resources to supporting novel products. Although this is sensible as a short-term strategic goal – one that happens to also be the goal of journals and congresses looking for novelty in submissions – it can leave gaps in published data for other devices in their portfolio, a decision that can come back to haunt these companies (more on that later).
Company Structure: It is estimated that most US-based medical technology companies have fewer than 100 employees.6 They often rely on small in-house medical writing teams with wide-ranging remits. In addition to traditional publications, these teams may handle regulatory submissions, marketing communications, and other types of writing. This significantly limits their ability to develop and oversee the implementation of long-term publication plans.
Specialist Knowledge: Relatively few publication professionals specialize (or even have experience) in medical devices. For example, of active ISMPP members, 2% reported a medical device/diagnostics company as their employer, compared with the 25% and 6% who work in the pharmaceutical and biotech industries, respectively. This presents an ongoing challenge for agencies and companies looking to staff their publication teams.
Healthcare Practitioner (HCP) Involvement: Unlike HCPs prescribing pharmaceuticals, surgeons and other providers using medical devices require hands-on training, the extent of which directly correlates with device complexity.
Additionally, HCPs are often very involved in the development of medical devices. Their feedback to company representatives during training and implementation often lays the groundwork for new device iterations. This means that budgets – already relatively limited – are skewed toward training and device innovation rather than publishing and communicating clinical data.
A recent analysis of Open Payments data found that the average payment for physician royalties from medical device companies is about twice that paid out by pharmaceutical companies in the same category. Furthermore, this report showed that medical device companies spend approximately 24 times more than pharmaceutical companies on per-physician education budgets, a necessary expenditure to appropriately train physicians on the use of new devices.7
The Cost of Reactive Publication Practices
Although there are valid reasons why the medical device industry does not widely adopt strategic publication planning, this does carry several risks.
- Medical device companies may settle for reactive publication activities focused on positive late-stage clinical trial results at the expense of other publications (negative, early-stage, or post-market studies). This might adversely impact public perception, garnering accusations of selective publishing.
- Failure to design an effective publication plan will lead to missed opportunities to present at relevant congresses followed by simultaneous publication in a journal, limiting dissemination of the results among HCPs.
- Selective support of novel, priority products can hurt medical device manufacturers in the intermediate-to-long term when they find themselves lacking sufficient data to conduct robust meta-analyses, healthcare economic analyses, and other studies that can strengthen their product claims, secure market access, and build confidence amongst HCPs and patients.
- Lack of publications to support the safety and performance of some products can also leave companies ill-equipped to meet increasingly stringent regulatory requirements. The recent implementation of the European Medical Devices Regulation (EU MDR)8 necessitates a greater reliance on clinical evidence specific to each medical device than in years past when companies could argue on their products’ behalf by claiming similarities with established devices. Companies lacking such published data may be forced to conduct expensive clinical trials or retrospective data collections and analyses to continue to meet these requirements.
However, the introduction of EU MDR required many companies to take a long, hard look at their product portfolios, pick winners to continue supporting, and phase out legacy products. As a result, medical device companies find themselves with leaner product portfolios and more clinical data than they had in the past. This means now is an ideal opportunity for convincing these companies to adopt more traditional publication planning.
… medical device companies find themselves with leaner product portfolios and more clinical data than they had in the past. This means now is an ideal opportunity for convincing these companies to adopt more traditional publication planning.
Finding the Opportunity: Six Tips for Partnering with Medical Device Companies
With that in mind, here are six tips for partnering with medical device companies to create a comprehensive, long-term publication strategy firmly rooted in current best practices, yet tailored to their needs:
- Understand the Company’s Publication Model: Medical device companies vary tremendously in terms of which function is responsible for driving publication activities. You cannot take it for granted that publications are their focus and or that they have a strong baseline knowledge of publication practices. Understanding the backgrounds of those who make the decisions, and tailoring your message to them, is a crucial first step.
- Lead with the Value Proposition: Emphasize to the relevant stakeholders why investing in comprehensive publication planning will have long-term benefits, but start small. Given their level of resources, these companies are more likely to be convinced by leaner plans foregrounding publications that can markedly enhance HCP understanding and adoption, with metrics to measure engagement. Highlight how such publications can improve HCP comfort with using new technologies, with the goals of increasing adoption and sharing best practices. This approach would organically benefit the company’s long-term financial prospects.
- Educate on Publication Opportunities: Given HCP preference for hands-on training, highlight the possibilities in emerging and alternative publication formats (e.g., publication extenders). This will build upon formats that HCPs are comfortable with, but with the added authority of peer review.
- Seek Out Writers Versed in Industry Nuances: Publication professionals versed in the medical device field are relatively rare and therefore in high demand. Consider expanding your search to those with experience in other types of device writing, such as regulatory submissions.
- Leverage EU MDR Data: Do not overlook data generated from the EU MDR process, including real-world evidence and systematic literature reviews conducted for regulatory submissions. These companies may well have recently amassed droves of quality data, yet haven’t considered the added value of getting it to congresses and journals.
- Engage with ISMPP: Connect through ISMPP to stay informed and engaged with industry best practices. ISMPP members are eager to hear about unmet needs and work collaboratively to offer solutions, including those for medical device companies.
Understanding what makes the medical device industry unique, as well as ISMPP guidance and tools, such as training to be offered at the forthcoming ISMPP Academy meeting, will prepare publication professionals to lead this change for the ultimate benefit of HCPs and patients.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the opinions of Cook Medical or any of its subsidiaries.
References
- MedTech Europe. Medical devices and pharmaceuticals: Two different worlds in one health setting. Available at: https://www.medtecheurope.org/news-and-events/news/medical-devices-and-pharmaceuticals-two-different-worlds-in-one-health-setting/
- World Health Organization. Medical devices. Available at: https://www.who.int/health-topics/medical-devices
- Van Norman GA. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC Basic Transl Sci. 2016 Jun 27;1(4):277-287. doi: 10.1016/j.jacbts.2016.03.009.
- Dunleavy K. The top 20 pharma companies by 2023 revenue. Fierce Pharma. April 15, 2024. Available at: https://www.fiercepharma.com/pharma/top-20-pharma-companies-2023-revenue
- Medical Device and Diagnostic Industry. Top 40 Medical Device Companies. February 29, 2024. Available at: https://www.mddionline.com/business/top-40-medical-device-companies
- Advanced Medical Technology Association. Medical device industry facts. Available at: https://www.advamed.org/medical-device-industry-facts/
- Bergman A, Grennan M, Swanson A. Medical Device Firm Payments To Physicians Exceed What Drug Companies Pay Physicians, Target Surgical Specialists. Health Aff (Millwood). 2021 Apr;40(4):603-612. doi: 10.1377/hlthaff.2020.01785.
- Fink M. How To navigate clinical data per EU MDR. Med Device Online. April 7, 2021. Available at: https://www.meddeviceonline.com/doc/how-to-navigate-clinical-data-per-eu-mdr-0001