- \n
- Structured publication planning is no longer optional in MedTech\u2014it’s a regulatory, clinical, and commercial imperative.<\/li>\n
- Pharma-derived models need to be adapted to suit the realities of device, diagnostic, and software-based innovations.<\/li>\n
- ISMPP offers cost-effective, flexible tools to upskill teams and foster peer learning\u2014especially where internal capacity is limited.<\/li>\n
- \u00a0Companies that commit to educating their staff on the foundations of publication planning can gain visibility, credibility, and strategic advantage.<\/li>\n
- Partnering with publication professionals and\/or agencies allows companies to implement strong publication practices now, while building internal knowledge and capacity for the future.<\/li>\n<\/ul>\n
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<\/p>\nIntroduction: MedTech at a crossroads<\/strong><\/p>\n
The medical technology (MedTech) sector is evolving rapidly, the result of both design innovations and increasing regulatory requirements. These dual trends have transformed nearly all areas of the industry, which spans surgical devices, diagnostics, digital health platforms, and increasingly, software and artificial intelligence (AI)-powered tools.<\/p>\n
Yet there\u2019s one area where MedTech appears to remain more static: publication practices. This isn\u2019t due to any inherent limitations within the industry, but rather because most MedTech companies\u2014especially small to mid-sized ones\u2014simply lack the internal infrastructure to support strategic, consistent publication planning and execution.<\/p>\n
As outlined in a previous article<\/a> focused on small pharma and biotech companies, the International Society for Medical Publication Professionals (ISMPP<\/a>) plays an essential role in equipping publication professionals with the tools and community they need to stay ahead. That same opportunity\u2014and urgency\u2014now applies to MedTech.<\/p>\n
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<\/strong>\u201cThere is growing recognition that MedTech products bring enormous value to healthcare, and with that has come increasing scrutiny. To keep pace, companies must apply the same innovative spirit to publication practices as they do to product development. Those that invest in building publication planning knowledge and resources now can set the standard for the field going forward.\u201d
\n<\/strong>\u2013 John Watson, The Manuscript Agent<\/em><\/p>\n<\/blockquote>\nThe publication planning gap in MedTech<\/strong><\/p>\n
Unlike the pharmaceutical sector, many MedTech companies don\u2019t have dedicated publication teams. Instead, evidence dissemination responsibilities often fall to medical affairs or regulatory staff juggling multiple roles. Although at odds with good publication practice, and because of the unique MedTech environment, commercial roles are sometimes involved as well. As a result, publication efforts may be reactive\u2014tied solely to product launches or regulatory milestones\u2014and lack long-term strategic vision. When publication plans exist, they are often developed without input from all relevant stakeholders, potentially resulting in redundancies or even conflicting messages.<\/p>\n
Adding to the complexity, traditional pharma-derived publication models don\u2019t map neatly onto MedTech lifecycles. MedTech products tend to iterate faster, making it harder to generate long-term evidence. Whereas pharma hinges on large randomized controlled trials, MedTech evidence generation more often depends on an array of smaller studies, retrospective analyses, registries, and other pragmatic data sources that balance scientific rigor with cost constraints. These differences can be especially challenging for smaller companies with limited bandwidth for structured publication planning.<\/p>\n
\n
A <\/em>survey<\/em><\/a> conducted by the ISMPP Small Companies Education Committee found that professionals in small and device-focused companies cite lack of time, training, and structured guidance as top barriers to publication planning<\/em>. (1)<\/p>\n<\/blockquote>\n
Regulatory and market pressures are rising<\/strong><\/p>\n
Regulatory requirements facing the industry have intensified, particularly with the implementation of the European Medical Devices Regulation (EU MDR). Where companies were once able to rely on data with comparable devices, they now must provide robust clinical evidence with their own technologies. This shift has also increased scrutiny of post-market surveillance, safety reporting, and health economic data from regulators, payers, and clinicians.<\/p>\n
Meanwhile, the MedTech industry is innovating at an accelerated pace. The number of FDA-cleared AI and machine learning-enabled devices surpassed 1,000 in 2024<\/a>, with software-based tools leading the charge. These novel products raise complex new questions around algorithm transparency and evidence generation, placing further emphasis on the need for timely, well-structured publications.<\/p>\n
In short, MedTech companies face an unprecedented imperative to generate and communicate high-quality data on their products. Just as they have innovated with their products, so too must they adopt strategies for successful evidence dissemination.<\/p>\n
Whether launching a Class III implant or a Class I digital tool, companies must demonstrate credibility\u2014and transparent, peer-reviewed publications remain the most effective way to do so. By strengthening their foundational knowledge around publication planning now, MedTech teams can do more than keep pace with change\u2014they can lead it.<\/p>\n
What MedTech can gain from stronger publication planning<\/strong><\/p>\n
Publication planning is not just about compliance; it\u2019s a strategic investment in building credibility, commercial success, and trust. With even modest investments, MedTech companies can:<\/p>\n
- \n
- ensure clinical evidence is disseminated through credible, peer-reviewed channels<\/li>\n
- boost HCP confidence and product adoption<\/li>\n
- build long-term visibility for products and platforms<\/li>\n
- support regulatory and reimbursement submissions.<\/li>\n<\/ul>\n
Better publication planning strengthens the story around a product and helps ensure that story is heard.<\/p>\n
Building skills and capacity: how ISMPP can help<\/strong><\/p>\n
ISMPP offers education and training especially relevant to those navigating the complexity of MedTech communications. For companies without formal training programmes or clear internal publication processes, ISMPP serves as a practical partner and knowledge hub.<\/p>\n
Members benefit from:<\/p>\n
- \n
- training on Good Publications Practice (GPP 2022)<\/strong><\/a><\/li>\n
- guidance on authorship, transparency, and AI use in writing<\/a><\/strong><\/li>\n
- access to ISMPP U webinars<\/strong><\/a>, podcasts<\/strong><\/a>,<\/strong> and the CMPP\u2122 certification<\/strong><\/a><\/li>\n
- peer connection via ISMPP Connect<\/strong><\/a>, which includes professionals working in diagnostics, devices, and software settings.<\/li>\n<\/ul>\n
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ISMPP\u2019s Certified Medical Publication Professional\u2122 (CMPP\u2122) credential is recognized globally and is increasingly valued by employers and partners in the MedTech sector.<\/em><\/p>\n<\/blockquote>\nPartnering<\/strong> with experts: agency support for publications<\/strong><\/p>\n
MedTech companies aren\u2019t on this journey alone: many choose to partner with medical communications agencies who bring expertise, familiarity with compliant publication processes, and therapeutic area knowledge\u2014without requiring additional internal hires.<\/p>\n
This hybrid model works especially well when:<\/p>\n
- \n
- teams are stretched thin<\/li>\n
- publication needs must scale quickly<\/li>\n
- expertise in regulatory-driven publication formats is lacking.<\/li>\n<\/ul>\n
Strategic partnerships allow even smaller companies to produce high-quality, compliant publications that support key business objectives.<\/p>\n
This article was developed on behalf of the ISMPP Small Companies Outreach Committee by John Watson (The Manuscript Agent), Tony Ferrar (Porterhouse Medical), and Anne-Clare Wadsworth (Amica Scientific). Please note, the authors used ChatGPT-4o (OpenAI) to support the collation of resources and to generate an initial outline and draft of the manuscript. The authors reviewed, edited, and take full responsibility for all subsequent content and the final submitted version.<\/p>\n
References<\/p>\n
(1) Carroll L, Duggan S, Sweetlove M, Gor V, Kelley D, Pinkham L, Piano CA. Identifying processes and challenges in medical publication planning and execution for small biopharmaceutical companies. Presented at: International Society for Medical Publication Professionals (ISMPP) Annual Meeting; 12\u201314 May 2025; Washington, DC<\/p>\n
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- guidance on authorship, transparency, and AI use in writing<\/a><\/strong><\/li>\n
- training on Good Publications Practice (GPP 2022)<\/strong><\/a><\/li>\n