Life sciences Archives - sa国际传媒 /category/life-sciences/ Nordic translation specialists Tue, 31 Mar 2026 08:23:32 +0000 en-GB hourly 1 Pharmaceutical regulatory translation: The hidden bottlenecks slowing your global submissions /pharmaceutical-regulatory-translation/ Tue, 31 Mar 2026 08:18:52 +0000 /?p=54382 Most regulatory submission delays attributed to translation are avoidable. Not because the scientific content was wrong or the regulatory strategy was flawed, but because language was treated as a procurement task and planned for accordingly. The consequence of that framing shows up at the worst possible moment: the submission window opens, the timeline has no ...

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Most regulatory submission delays attributed to translation are avoidable. Not because the scientific content was wrong or the regulatory strategy was flawed, but because language was treated as a procurement task and planned for accordingly. The consequence of that framing shows up at the worst possible moment: the submission window opens, the timeline has no flexibility and the bottleneck has been sitting undetected in the documentation workflow for months.

Pharmaceutical regulatory translation covers dossier documentation 鈥 CTD modules, SmPCs, patient information leaflets, pharmacovigilance reports, clinical study reports 鈥 across every market where you intend to seek approval. This article covers where it fails, why those failures are so often invisible until they hit a regulatory deadline and what separates the programmes that manage it well from those that don’t.

The planning assumption that creates the problem

Drug development teams plan meticulously for scientific risk. Clinical endpoints, safety signals, manufacturing scale-up, regulatory feedback 鈥 all modelled, sequenced and resourced well in advance. Translation tends to appear on the project plan late, scoped narrowly and briefed once the scientific content is finalised.

That assumption made more sense before the regulatory environment tightened around it. The gives sponsors a fixed window to submit translated product information in final form during the centralised procedure. Miss that window or submit content that generates questions, and the programme risks being pushed to the next clock-stop cycle.

For teams coordinating submissions across multiple competent authorities simultaneously, the compounding effect is significant. A query from one agency, triggering a document revision, means every translated version across every other market needs updating in parallel. Without structured workflows to manage that, the revision cycle becomes a coordination problem as much as a language problem, and it lands on the desks of regulatory and medical writing teams who were not expecting it.

Clinical trials: where language risk starts

Translation obligations begin well before a dossier is assembled. For patient-reported outcomes, informed consent forms and other patient-facing content, regulators and sponsors frequently require evidence that translated materials convey the original meaning accurately 鈥 not only linguistically, but conceptually. This means back-translation and, for clinical outcome assessments, full linguistic validation, including cognitive debriefing, a step in which a small group of target patients reviews the translated content to confirm it is understood as intended. For a closer look at how these processes work in a clinical trial context, see our clinical trial translation services page.

These processes are time-consuming. Sponsors who discover the requirement during study start-up, with ethics submission timelines already fixed, face a difficult choice between compressing the validation process and delaying the submission. Guidance on patient-reported outcomes is clear that if your programme includes patient-facing content, linguistic validation is expected, and it needs time built around it from the outset of study design.

Marketing authorisation: where pharmaceutical regulatory translation fails

The transition from clinical development to marketing authorisation brings a different set of language challenges. These tend to be structural rather than process-driven, and scale with the complexity of the submission.

Terminology drift across the dossier

A global dossier is dozens of documents, produced by different teams at different stages, often with different reference materials. All of it requires the same controlled terminology across every language: the same compound name, the same indication wording, the same adverse event terminology aligned with .

Without a validated, product-specific termbase maintained throughout the programme, terminology drifts. Not through error 鈥 through the perfectly reasonable independent judgements of translators working without adequate reference materials. Those variations are invisible in any single document. They become visible when a regulator cross-references Module 2 against Module 5, or compares the SmPC against the labelling, and finds them inconsistent.

The resulting clarification requests rarely present as translation problems. They come in as scientific or regulatory queries. The root cause only becomes clear in retrospect, usually after a significant amount of time has been lost.

Version control failures during amendments

Amendment cycles are where multi-market programmes are most vulnerable. Whether it’s a labelling change, a protocol update or a safety amendment, any revision to source content triggers a translation requirement across every active market. In a programme spanning 15 or 20 languages, that’s a significant coordination task.

Without structured version control, markets fall out of sync. The scenario that causes the most disruption is submitting updated content in some markets before others, or submitting content where the translated version reflects an earlier source draft than the one under review. Regulators who catch this do not limit their queries to the translation. They question the integrity of the submission process.

Providers without genuine regulatory depth

There is a practical difference between a translator who is medically qualified and one who understands the regulatory context in which pharmaceutical documents are reviewed. , on summary of product characteristics and FDA regulatory submission standards 鈥 for a pharmaceutical regulatory translator, these are the frameworks that should guide every linguistic decision, not just background knowledge.

A provider without that depth produces translations that are linguistically accurate but regulatorily inconsistent. The compound is named correctly, but the indication is phrased in a way that does not map cleanly to the approved therapeutic area wording. The safety section reads fluently, but uses terminology that diverges from what the agency’s own guidance documents use. These issues typically surface in agency review, at the point where the timeline is least able to absorb them.

Post-approval: the audit trail most teams are unprepared for

Once a product reaches market, pharmacovigilance obligations generate a sustained volume of multilingual documentation, such as PSURs, RMPs, DSURs, individual case safety reports and literature monitoring outputs, that must meet the same standards of accuracy and traceability as submission documentation. The difference is that post-approval documentation is subject to inspection rather than prospective review, which means gaps in process documentation surface during audits rather than at submission.

Regulatory inspections of translation processes are more common than many sponsors anticipate, particularly in post-approval pharmacovigilance audits and GCP inspections of clinical trial documentation. Inspectors ask for documented evidence of how translations were produced: who translated, who reviewed, what reference materials were used, how versions were controlled and how the process was applied consistently across the programme.

ISO 17100-aligned workflows provide that documentation as standard. Many sponsors only discover what their provider’s process documentation actually looks like when an inspector asks for it. Gaps at that point become findings, with the corrective action requirements and re-inspection timelines that follow from them.

Building traceability into translation workflows from the outset 鈥 version records, translator qualifications, review documentation, delivery sign-off 鈥 is far less burdensome to establish at programme start than to reconstruct during an inspection.

Selecting a pharmaceutical translation partner: what to look for

If you’re evaluating providers, whether reconsidering an existing relationship or assessing new ones, these are the areas where the difference between a capable generalist and a genuine pharmaceutical specialist becomes visible.

Termbase and terminology management: Can they build and maintain a product-specific validated termbase? Do they apply it consistently across document types and update it as your programme evolves? Ask to see what that looks like in practice, not just in theory.

Process documentation and ISO alignment: Do they work to ISO 17100? Can they provide documentation of translator qualifications, review stages and version control processes in a format that would satisfy a GCP or pharmacovigilance inspector? Ask for an example before you need it under pressure.

Regulatory familiarity: Ask specific questions: how do they handle MedDRA terminology alignment? What is their approach when the source text is ambiguous and the linguistic choice has regulatory implications? How do they manage EMA linguistic review timelines within the centralised procedure? The answers will tell you quickly whether you are talking to people who truly understand the regulatory environment.

Technology transparency: AI translation has a legitimate role in pharmaceutical programmes for high-volume, lower-risk content with stable phrasing, such as internal training materials or market monitoring. It has no role without significant human review in regulatory submissions, patient-facing materials or safety documentation. A credible provider will be unambiguous about where technology is applied to your content before work begins.

Account management and escalation: In a tight timeline, your language partner needs to be reachable, accountable and able to make decisions quickly. A large provider with rigid workflow hierarchies can be slower in a crisis than a mid-sized specialist, where the person managing your account has the authority to escalate and resolve issues directly.

The internal coordination problem vendors rarely mention

One aspect of pharmaceutical regulatory translation that rarely appears in vendor capability documents is the internal alignment challenge it creates. Regulatory affairs teams, medical writers, localisation managers, QA and procurement all have a stake in how translation is managed, and they frequently disagree on what good looks like and who owns the decision.

That misalignment affects how translation partners get selected and how they’re managed day to day. A QA manager evaluating vendor qualifications is asking different questions than a localisation manager evaluating workflow integration, or a regulatory affairs lead evaluating scientific accuracy. When those perspectives are not reconciled before a vendor relationship begins, selection tends to default to cost and existing relationships rather than regulatory fit, and the gaps only become apparent under submission pressure.

The programmes that manage pharmaceutical regulatory translation most effectively tend to have resolved that internal question first: who is accountable for translation quality, and by what criteria is quality being measured?

What effective planning looks like

The companies that consistently avoid language bottlenecks in their regulatory submissions share a few characteristics. They involve their language partner during study start-up planning, well before submission preparation begins. They maintain validated termbases from early development and update them as the programme progresses. They have structured version control workflows that keep all markets aligned through amendment cycles. And they select providers on the basis of regulatory depth and process transparency, then hold them accountable to it.

Most language-related submission delays come from planning gaps, not from problems that were impossible to anticipate. The documentation volume, the amendment pressure, the audit trail requirements 鈥 none of these are surprises. They are predictable features of global pharmaceutical programmes, and managing them well starts with treating language as a programme-critical function from the outset.

To find out how Sandberg supports regulatory affairs, medical writing and localisation teams from early-phase development through to post-approval obligations, visit our pharmaceutical translation services page.

Frequently asked questions:

Pharmaceutical translation requirements are shaped by several overlapping frameworks. ICH E6 Good Clinical Practice covers clinical trial documentation. EMA procedural guidance sets out linguistic review requirements within the centralised procedure, including timelines for translated product information. FDA guidance addresses translation expectations for IND, NDA and BLA submissions. At the national level, individual EU member states set language requirements for locally authorised products.

Evaluate ISO 17100 certification and what their process documentation looks like in practice; translator qualifications and subject-matter expertise in pharmaceutical regulatory content; terminology management, including termbase build and maintenance; version control processes across multi-market programmes; and where machine translation is and is not applied. Ask how they handle source text ambiguity when the linguistic choice has regulatory implications.

Linguistic validation confirms that translated patient-facing documents, particularly patient-reported outcomes and clinical outcome assessments, are understood by target populations as intended. It typically includes forward translation, back-translation, reconciliation and cognitive debriefing.

ISO 17100 is the international standard for translation service providers, covering translator qualifications, review processes, project management and quality assurance. For pharmaceutical regulatory submissions, an ISO 17100-aligned provider produces the process documentation regulators and inspectors require, such as translator credentials, review records, version control and delivery sign-off, as standard, providing an auditable framework that satisfies inspection requirements.

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]]> Clinical trial language requirements: Why studies get delayed before they even start /clinical-trial-language-requirements/ Thu, 26 Feb 2026 15:55:08 +0000 /?p=53584 Clinical trial language requirements are regulatory and ethical standards that ensure all participant-facing and submission documents are translated accurately, clearly and in a way that participants and authorities can fully understand. These requirements focus on informed consent clarity, terminology consistency, cultural adaptation and documented translation workflows. Clinical trials are becoming increasingly global, with sponsors recruiting ...

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Clinical trial language requirements are regulatory and ethical standards that ensure all participant-facing and submission documents are translated accurately, clearly and in a way that participants and authorities can fully understand. These requirements focus on informed consent clarity, terminology consistency, cultural adaptation and documented translation workflows.

Clinical trials are becoming increasingly global, with sponsors recruiting participants across multiple countries, languages and healthcare systems. While this diversity strengthens research outcomes, it also introduces a significant challenge: ensuring that every participant, investigator and regulator fully understands trial documentation.

Clinical trial language requirements exist to protect patient safety, preserve data integrity and ensure regulatory compliance. Poor or inconsistent translations can result in participants misunderstanding consent, dosing instructions or safety reporting procedures. In the worst cases, this can compromise both participant welfare and the validity of trial results.

As a result, regulators have placed growing emphasis on language accessibility, traceability and documentation transparency. As clinical trials become more decentralised and patient-centric, translation quality has become a core compliance issue rather than a secondary operational task.

The regulatory foundations behind clinical trial language requirements

Across global markets, regulatory frameworks consistently emphasise one core principle: participants must be able to understand all trial information clearly and in their own language.

require that consent and patient-facing materials be written in non-technical, understandable language. allow member states to determine which languages clinical trial content must be made available in, while strengthening transparency obligations through public reporting systems.

In the UK, recent regulatory reforms have reinforced this focus on accessibility. now places stronger expectations on clarity, plain language communication and timely publication of participant-friendly summaries. These changes reflect a broader shift toward patient-centric research design, where transparency and inclusivity are considered essential to ethical trial conduct.

As a result, translation is no longer treated as a final administrative step. It must now be integrated early into trial planning to meet tighter approval timelines and ensure compliance from the outset.

Where language issues cause delays

1. Ethics committee rejections

Informed consent documentation must meet strict local standards for clarity, readability and terminology. Even small inconsistencies can prompt questions from ethics committees.

When this happens, teams must revise, retranslate and resubmit documents, which can add weeks to approval timelines.

2. Version control complexity

Global trials generate multiple document versions across stakeholders and countries. Without structured workflows, teams may work from outdated files, duplicate efforts or introduce inconsistencies between markets.

Amendments can be particularly disruptive, forcing last-minute updates across multiple languages.

3. Terminology inconsistencies

Clinical terminology must remain consistent across protocols, patient materials and regulatory submissions.

Inconsistent wording can slow regulatory review, increase clarification requests and create risks around participant comprehension.

The ripple effect of language delays

Documentation issues rarely remain isolated, often creating broader operational challenges across the trial ecosystem.

These can include:

  • Delayed site activation and recruitment timelines
  • Increased workload for regulatory and clinical teams
  • Strained sponsor鈥揅RO relationships
  • Reduced internal confidence in study readiness

Because language challenges typically emerge late in the process, they can disrupt even well-planned timelines. Preventing these issues therefore requires proactive planning rather than reactive corrections.

Understanding common clinical trial language requirements

Clinical trial language requirements vary by country but typically focus on ensuring participant understanding and regulatory clarity.

Key requirements often include:

  • Clear, plain-language informed consent documentation
  • Alignment with local ethics committee terminology expectations
  • Consistency across protocols, patient materials and submissions
  • Back-translation or linguistic validation processes
  • Strict version control during amendments

Understanding these requirements early helps prevent avoidable delays later in the study lifecycle and reduces the likelihood of regulatory queries later on.

Which clinical trial documents require translation?

While requirements vary by region, the most commonly translated materials include patient-facing materials, like informed consent forms, participant information sheets, recruitment materials, protocols, regulatory submissions and safety reporting documentation.

Why Quality Assurance and validation are essential

Meeting clinical trial language requirements demands more than accurate translation alone. Structured QA workflows are essential to ensure conceptual consistency and regulatory readiness.

Clinical translation processes often involve multiple review stages designed to confirm accuracy, consistency and clarity. For participant-facing materials, additional validation steps may be used to ensure that translated content is interpreted as intended across different cultural contexts.

Equally important is maintaining a clear audit trail. Regulators expect sponsors to demonstrate how translations were produced, reviewed and approved, reinforcing the need for documented workflows and controlled processes.

The role of cultural adaptation

Imagine a global clinical trial preparing informed consent materials for participants across several countries. The English version explains possible side effects using familiar phrases like 鈥渇lu-like symptoms鈥, advises patients to contact their primary care doctor if needed and suggests common over-the-counter medicines for relief.

When these materials are translated word-for-word into other languages, they might remain technically correct, but problems quickly appear. In one country, 鈥渇lu-like symptoms鈥 could be interpreted as a serious infectious disease rather than mild discomfort. In another, the idea of contacting a personal doctor causes confusion because patients typically access care directly through hospitals. Some participants also struggle with highly formal medical phrasing that feels dense and difficult to understand.

As ethics committees review the documents, they raise concerns about whether participants would truly comprehend the information. The sponsor must then revise wording, simplify explanations and adapt references to reflect local healthcare realities, which adds extra review cycles and delays study approval.

This is why language requirements extend beyond literal translation. Cultural adaptation plays a vital role in ensuring that clinical information is not only accurate, but meaningful within different social and healthcare contexts.

What effective language planning looks like

Avoiding language-related delays does not typically require complex solutions. In most cases, problems arise from planning gaps rather than technical challenges.

Strong multilingual workflows typically include:

Early integration into study planning: Language requirements are identified during start-up rather than shortly before submission.

Regulatory-aware processes: Local expectations for informed consent and patient materials are considered from the outset.

Structured version control: Clear workflows prevent duplication and confusion across stakeholders.

Consistent terminology management: Approved glossaries ensure alignment across documents and languages.

When these elements are in place, multilingual documentation supports trial timelines rather than disrupting them.

Language as a strategic enabler in clinical trials

Clinical trials are complex, tightly regulated and highly time-sensitive. Every operational element has the potential to either accelerate or delay progress, and multilingual documentation is no exception.

Although translation often operates behind the scenes, its impact on approvals, compliance and participant safety is substantial. When managed effectively, it supports a much smoother process overall.

Many sponsors therefore choose to work with partners providing specialist clinical trial translation services to ensure documentation meets regulatory expectations across all markets. By combining subject-matter expertise with structured workflows, these partners help reduce risk while supporting efficient trial start-up.

Recognising language as an operational factor, rather than simply a procurement task, is often the first step toward fewer delays and more successful global trials.

The future of clinical trial language requirements

As clinical research continues to globalise, clinical trial language requirements are likely to grow in importance. Regulators are placing increasing emphasis on transparency, diversity in participant populations and accessibility of trial information.

Digital technologies and decentralised trial models also introduce new language considerations, including multilingual patient interfaces and remote consent processes.

These trends suggest that high-quality translation will continue evolving from a compliance requirement into a strategic component of ethical and effective clinical research.

Frequently asked questions:

Language requirements ensure participants fully understand study information and help regulators verify compliance, supporting both patient safety and reliable data.

Common materials include informed consent forms, patient information sheets, recruitment content, protocols and regulatory submission documents.

Delays often occur when translations are inconsistent, require revision after ethics review or when version control problems create discrepancies across markets. Building robust and professional clinical translation workflows is crucial.

Translation should be integrated early during study start-up planning to avoid last-minute revisions and regulatory approval delays.

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]]> EU MDR translation requirements: What medical device manufacturers need to know in 2026 /eu-mdr-translation-requirements/ Mon, 02 Feb 2026 09:00:44 +0000 /?p=39836 EU MDR translation requirements determine which medical device documents must be translated, into which languages, and when those translations must be available. Under the regulation, manufacturers are responsible for ensuring that instructions for use (IFUs), labels, safety information and clinical documentation are provided in the official language or languages required by each EU member state ...

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EU MDR translation requirements determine which medical device documents must be translated, into which languages, and when those translations must be available. Under the regulation, manufacturers are responsible for ensuring that instructions for use (IFUs), labels, safety information and clinical documentation are provided in the official language or languages required by each EU member state where the device is sold.

The global medical devices market was valued at around and is expected to exceed USD 1000 billion by 2034. Europe remains central to that growth, accounting for more than and ranking as the second-largest market worldwide after the United States.

Since the EU Medical Device Regulation (MDR) became fully applicable in May 2021, language requirements have become clearer, stricter and more closely enforced. By 2026, with the progressive rollout of EUDAMED and increased scrutiny from notified bodies, translation is no longer an administrative afterthought, but a compliance requirement.

If you manufacture or distribute medical devices in Europe, this guide explains what the EU MDR translation requirements mean in practice, and how to stay compliant without slowing down your market entry.

Europe remains a high-value medical device market

Europe鈥檚 medical technology market was estimated at around and has shown steady long-term growth despite economic uncertainty. Healthcare spending across Europe averages around , with close to 8% of this healthcare spending allocated to medical technology, including medical devices.

Innovation remains strong. Of the more than 15,700 medical-related patents filed with the , over 40% originate from EU and EEA countries, with the US and other regions making up the rest.

Germany and the Netherlands consistently rank among the world鈥檚 largest importers of medical devices, making Europe both a centre of innovation and a highly attractive destination for global manufacturers.

The opportunity is clear, but so are the regulatory expectations.

What the EU MDR covers

The governs 鈥渢he placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices鈥 within the European Union.

The most notable difference between this regulation and the directives it replaces is the scope. The MDR now covers:

  • Medical devices and accessories
  • Certain products without an intended medical purpose but with similar risk profiles
  • Software used for medical purposes
  • Clinical investigations conducted in the EU

It also covers 鈥淒evices with both a medical and a non-medical intended purpose鈥, but excludes 鈥渋n vitro diagnostic medical devices covered by Regulation (EU) 2017/746鈥 as well as certain medicinal products such as blood, tissue or anything of animal or human origin.

The practical result is more documentation, more oversight and more content that must be translated correctly.

EU MDR language requirements: Clarity, not choice

One of the most important changes introduced by the MDR is how explicitly it addresses language. The previous regulation says that member states 鈥渕ay require鈥 translations to be made into the various languages of the member states, but in MDR, Chapter IV, Article 41, under the heading 鈥淟anguage requirements鈥, it says:

鈥淎ll documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.鈥

Note the subtle but distinct evolution from 鈥渕ay require鈥 to 鈥渟hall be鈥. In other words, this is not optional, and producers and resellers should not wait for a request to be made.

Article 41 states that all required documentation must be drawn up in the language or languages determined by the member state concerned. In addition, Annex II requires that labels, packaging and instructions for use (IFUs) be provided in the languages accepted in the member states where the device is sold.

For clinical investigations, Annex XV specifies that summaries must be available in an official EU language determined by the relevant member state.

In short, the responsibility now sits firmly with you to:

  • Identify language requirements per country
  • Prepare compliant translations in advance
  • Maintain consistency across all markets

from the European Commission is useful, as it includes tables you can consult to determine which languages you must cover.

Which documents need to be translated under the MDR?

Depending on your device and its classification, the MDR typically requires translation of:

  • Labels and packaging (including transport packaging where relevant)
  • Instructions for use (IFUs)
  • Safety information, warnings and notices
  • Declarations of conformity
  • Summaries of Safety and Clinical Performance (SSCPs), where applicable
  • Clinical investigation documentation and summaries

There is no single EU language rule. Some countries accept English for certain documents, others do not. Multilingual countries may require translations into all official languages.

EUDAMED and terminology consistency in 2026

The has moved from delayed implementation to progressive operational use across its core modules. By May 28, 2026, the first four modules will be mandatory for new devices, and the deadline for legacy devices is November 28.

These modules are:

  • Actor registration
  • UDI/Devices registration
  • Notified Bodies & certificates
  • Market surveillance

From a language perspective, this increases the importance of standardised terminology. MDR requires alignment with internationally recognised medical device nomenclature, and inconsistencies between IFUs, labels, technical documentation and database entries are easier to spot.

This makes terminology management, approved glossaries and reusable translation assets essential for long-term compliance.

MDR, Brexit and selling into the EU

The EU MDR does not apply in Great Britain, where medical devices are regulated under the UK MDR 2002 and overseen by the MHRA. However, the EU MDR continues to apply in Northern Ireland.

If you sell into both the UK and EU:

  • UK documentation must be in English
  • EU documentation must meet member-state-specific language requirements

For UK-based manufacturers exporting to the EU, MDR-compliant translation workflows remain a business necessity.

Why speed and accuracy matter equally

MDR documentation must be available at the point of market entry, which means that translations need to be ready when you submit technical documentation, not afterwards.

At the same time, accuracy is critical. A showed how an incorrect translation of 鈥渘on-modular cemented鈥 as 鈥渨ithout cement鈥 led to dozens of knee implants being applied incorrectly. The issue was not regulation 鈥 it was translation quality.

Poor translation can:

  • Delay CE marking
  • Trigger regulatory questions
  • Increase liability risk
  • Compromise patient safety

This is why many manufacturers work with specialist medical device translation services that understand MDR, clinical terminology and regulatory expectations.

Consistency supports compliance and efficiency

As MDR enforcement matures and EUDAMED use increases, consistency across languages becomes easier to audit and harder to overlook.

Using controlled terminology, validated glossaries and translation memory tools helps you:

  • Maintain consistency across documents and markets
  • Reduce review cycles
  • Improve turnaround times
  • Lower long-term translation costs

These resources can then be reapplied to subsequent translations, thus saving turnaround time without sacrificing accuracy or introducing inconsistencies. When managed correctly, quality and speed do not have to compete.

Supporting compliance and a healthy bottom line

Europe remains a high-value market for medical devices, but access depends on meeting clear regulatory and linguistic requirements. The MDR aims to reduce ambiguity, protect patients and improve transparency 鈥 and language plays a central role in that goal.

By ensuring your documentation is translated accurately, consistently and in line with member-state requirements, you protect patients, support compliance and keep your products moving to market.

Working with an experienced language partner helps you do all three without unnecessary friction. Read more about our medical translation services here.

Frequently asked questions:

Each EU member state determines which official language or languages must be used. There is no single EU-wide language rule, and requirements vary by country. can help you.

Typically, labels, IFUs, safety information and certain clinical and regulatory documents must be translated, depending on the device and the target market. Consult for the specific guidance from the EU for each country and various documents.

No. Translations must be kept up to date throughout the device鈥檚 lifecycle, including updates to labels, IFUs and regulatory documentation.

Part of this article was initially published in 2023 by William Hagerup and has since been edited and revised with up-to-date information and new analysis.

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]]> 3 booming industries in the Nordics听 /3-booming-industries-in-the-nordics/ Thu, 25 Nov 2021 11:10:39 +0000 /?p=35220 The Nordic countries have a lot in common 鈥 they are all small and open economies that depend a great deal on foreign trade. Despite their swift economic development, these countries can鈥檛 necessarily be considered the typical model of efficiency, given that they adopted their own Nordic Model combining economic systems with social welfare.听听 Some ...

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]]> The Nordic countries have a lot in common 鈥 they are all small and open economies that depend a great deal on foreign trade. Despite their swift economic development, these countries can鈥檛 necessarily be considered the , given that they adopted their own combining economic systems with social welfare.听听

Some of the Nordic countries have achieved international acclaim across many different industries; from Norway鈥檚 Stavanger-based leveraging strong synergies between oil, gas renewables, carbon capture and hydrogen, to Denmark鈥檚 which has been a source of fun for people of all ages since 1932.听

In this article, however, we will take a look at three industries driven by technology that are making particularly big waves in the Nordics: fintech, life science and cleantech.听

The fintech industry听

The Nordics are already home to 300+ fintechs.

Several factors highlight the strengths of the Nordic region and explain why it is excelling within the fintech industry. Increased investment, new government initiatives, an openness to new technology and social welfare programmes, grants and tax breaks that stoke the flames of entrepreneurship mean the Nordics are already home to .听

The Nordic region is second only to Silicon Valley in terms of the number of , with 27 unicorns from a population of 26 million. Having brought in in the second half of 2021, the Nordics are bound to attract further investment which will surely increase the number of unicorns emerging from this region as the fintech sector matures.听

, currently fintech unicorn, and are two Stockholm-based fintech mobile payment companies that have opened the door to many more start-ups. The success of Nordic fintechs is seen across the entire industry landscape, including companies such as alternative lenders and , online payment providers and , and personal financial management companies and .听

Paving the way to a 鈥榗ashless society鈥听

As society evolves, so too must financial services and apps. has stated that it is unlikely that millennials will visit branches or use financial services in the same way as previous generations. According to , the Nordics are hoping that by moving away from using physical cash 鈥 thus turning society 鈥榗ashless鈥 鈥 they will be able to lower costs for merchants, offer better security and make it harder for criminals to launder money.听听

Localisation: the key to success in fintech听

The closer you get to a person鈥檚 wallet, the more important it is to speak their language.

Fintechs aim to make financial solutions more accessible and convenient for all. Those who secure investment will next be looking to scale up beyond the limits of the Nordics 鈥 something that requires a thorough understanding of the needs and norms of their new target market. To make a success of scaling up, it’s important to provide information in a transparent, trustworthy and comprehensible manner.

After all, as Nataly Kelly says, 鈥渢he closer you get to a person鈥檚 wallet, the more important it is to speak their language鈥. Simply put, this means communicating in the languages of your system鈥檚 users and offering services tailored to the needs of each locale you wish to provide for.听

The life science industry听

The life science industry is another in which the Nordics see a significant engagement. Built on a solid foundation of high-quality education and collaboration, the Nordics have already produced over life science companies. To name but a few of the biggest players from the industry, they can count and , both world leading pharmaceuticals, and from medtech , and . With Denmark as the second largest medical device market in Europe and Norway as a centre of excellence for medical imaging, the breadth of expertise demonstrated in the Nordics is really something to behold.听

This success in the life science industry wouldn鈥檛 have been possible without the support and commitment of a variety of institutions; from the Nordic life science consortium 鈥 a platform that enables the Nordic countries to collaborate and showcase the region and its achievements to the rest of the world 鈥 to universities, such as , focused on life science, to well-known researchers and research centres, such as in Denmark and in Sweden. All these players make significant contributions that enable the Nordics to remain a hotspot for pioneering R&D.听

Medicon Valley听

Medicon Valley is a prominent international life science cluster in Europe that spans the Greater Copenhagen region of eastern Denmark and southern Sweden. In recent years, Medicon Valley has grown to be the of the Nordic life science clusters thanks to a dynamic ecosystem and vibrant talent pool including 350+ biotech, medtech and pharma companies; 9 outstanding life science universities; 14,600 life science researchers; and world-class research facilities such as and .听

Rising stars in life science听

The Nordics share the same values: openness, trust, sustainability, equality and innovation.

from Sweden, from Norway and from Iceland were announced as the winners on the in the Biotech/Pharma, Medtech/Diagnostics and Digital/E-health categories. Other industry newcomers to keep an eye on include from Finland and from Sweden. LS CancerDiag hopes to save millions of lives by preventing cancer as well as enabling personalised care through early detection of Lynch syndrome, while Medvasc is looking to optimise the procedure of delivering anaesthetic in laser treatment of varicose veins, a significant medical conundrum that is yet to be solved.听

鈥淕iven their shared values of openness, trust, sustainability, equality and innovation鈥, summarises Helena Strig氓rd, Director General at SwedenBIO writing for , 鈥渢he Nordics are the perfect setting for partnership and investments鈥 in life science.听

The cleantech industry

Cleantech, or clean technology, is a term used to refer to companies and technologies that aim to improve environmental sustainability. The Nordics are rich in natural resources, which played a key role during the early industrialisation of the region. Rigorous environmental requirements have spurred both knowledge and technological development, which in turn stimulate environmental technology exports.听

Whether through public R&D, cleantech-friendly policies or other cleantech innovations, the Nordics attract and facilitate a lot of investment. For example, 鈥 the leading Nordic cleantech investor network 鈥 runs an internationally established network of different stakeholders with an interest in Nordic cleantech including investors, industrials and public actors. The aim of the 鈥 part of the Nordic Council of Ministers 鈥 is to turn the Nordic region into a pioneer for sustainable growth by promoting entrepreneurship, innovation and competitiveness among Nordic businesses.听

Global Cleantech Innovation Index

The explores which countries currently have the greatest potential to produce entrepreneurial cleantech start-ups that will commercialise clean technology innovations over the next 10 years. In 2017, Denmark, Finland and Sweden ranked in the top three places in the GCII, with Norway taking ninth spot. The index demonstrates how a country can get ahead by adapting to the growing demand of renewable energies, by building connections between start-ups and other channels to increase their rate of success, and by increasing international engagement with cleantechs to encourage the adoption of clean technologies.听

Cleantech start-ups to keep an eye on

Investors have been particularly present in the agriculture, transportation and logistics, recycling and waste, manufacturing and industrial, and energy sectors of the cleantech industry. Start-ups making a name for themselves within these sectors include Voi and Quantafuel.听

Providing for the transportation and logistics sector, Stokholm-based offers electric scooter and bike sharing to encourage the use of more sustainable transportation across many European cities.听

As part of the recycling and waste sector in Norway, provides a clean solution to plastic waste. All types of plastic waste are converted into environmentally friendly fuel and chemicals.听

Sweden leads the way in cleantech investment

In 2020, the top 5 investments in Sweden totalled 880 million euros.

Of the Nordics, Sweden is blazing a trail. In terms of the number of investments made and deals secured, Sweden comes out on top. In 2020, the top 5 investments in Sweden were secured by , , , and coming to a total of 880 million euros. Northvolt secured the with 532 million euros raised in equity from international investors.

While the Nordic region provides a good environment for the emergence of unicorns in general, Sweden in particular has the ideal conditions for cleantech companies to thrive, with an ecosystem tailored to start-ups in combination with ambitious climate goals.听

It is of course still unclear exactly what the future of the fintech, life science and cleantech industries has in store, but one thing is for sure 鈥 the Nordics will play a pivotal role in shaping their future.

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]]> It鈥檚 All About the Brand: Pharma Marketing Localisation /pharma-marketing-localisation/ Thu, 04 Nov 2021 15:00:01 +0000 /?p=34986 In a pharmaceutical organisation, Product Managers play a crucial role in establishing a product鈥檚 brand identity, in building awareness, and in maintaining credibility. They are uniquely positioned to understand and scope out market trends, to develop the product鈥檚 brand strategic direction and to coordinate and communicate marketing plans. As the gatekeepers of product brand marketing, ...

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]]> In a pharmaceutical organisation, Product Managers play a crucial role in establishing a product鈥檚 brand identity, in building awareness, and in maintaining credibility. They are uniquely positioned to understand and scope out market trends, to develop the product鈥檚 brand strategic direction and to coordinate and communicate marketing plans.

As the gatekeepers of product brand marketing, Product Managers manage existing product lines and build launch strategies for new products. Through their work with Key Opinion Leaders and their deep insight into brand building, Product Managers gain a keen sense of what the medical community wants and needs, and how the community views current healthcare priorities, challenges and opportunities.

A well-researched, engaging and timely marketing plan is the backbone of a successful pharma marketing campaign. When it comes to building a product鈥檚 brand presence in multiple international target markets, the key to success lies in marrying the campaign with skilled localisation, i.e. collaborating with the right localisation partner.

In international markets, a new product stands or falls on the merit of its local reach, credibility and engagement.

In this blog, we explore three key elements of pharma marketing through the eyes of a Product Manager running a successful localisation campaign: product brand credibility, brand engagement and brand reach.

Credibility

Healthcare professionals and their patients share one overarching concern 鈥 the drugs and medicines they use must be safe and effective. Trust plays a hugely important role in marketing a new drug and in maintaining a brand鈥檚 existing market presence.

As such, a product鈥檚 brand credibility is one of the cornerstones of successful pharmaceutical marketing. In international markets, that credibility is communicated through translation.

In pharmaceutical translation, credibility rests in the hands of professional, domain-expert translators. They understand the science behind the words and use the right medical or lay terminology, depending on the target audience.

This is the first key element of pharma marketing localisation 鈥 building product brand credibility through translation by expert pharmaceutical translators.

Engagement

Pharma marketing might focus on pharmaceutical products, but it鈥檚 still marketing. Its key aim is to build brand awareness and engagement, and to sell a product. Pharma marketing takes a sophisticated, rigorously tested product and introduces it to the world in an engaging, effective manner.

A clever pharmaceutical marketing plan identifies the need to review and, where necessary, adjust brand messaging for local markets. The witty punchline that works so well in English won’t necessarily translate into French, and might even be offensive if converted directly into Finnish.

Marketing translation is an art in itself. A marketing translator with flair doesn鈥檛 just translate the content, they transcreate it to convey the message behind the words. Their goal is to create engagement and match the impact of the source text 鈥 but in a completely different target culture and language.

This is the second key element of pharma marketing localisation: creating engagement using the right marketing touch and flair.

Reach

But credibility and engagement alone don鈥檛 make a successful pharma marketing campaign. The message also needs to reach its audience in the right place, at the right time, over and over again.

In building reach into the marketing campaign, the goal of a Product Manager is to create a versatile suite of marketing materials for a number of different purposes, in different formats. All these materials must then move into the localisation phase, of course, but by the time localisation happens in the lifecycle of a marketing campaign, it鈥檚 usually already urgent.

Within a pharma marketing campaign, the role of localisation is not just to deliver professional, engaging, high-quality marketing translation. It鈥檚 critical that localisation is delivered at speed, and in volume, using the right technology.

This is the third key element of pharma marketing localisation: choosing a professional team who can deliver in volume, at speed and using the right technology.

Building a Brand: What Good Localisation Looks Like

Product Managers at a pharmaceutical company have to keep lots of plates spinning at once. They build, develop and maintain brand awareness and engagement of multiple products across several digital and traditional touchpoints. The strategies and campaigns they design can make or break a product in a local market.

A good localisation service provider understands the challenges of pharma marketing and the need for combining pharmaceutical expertise with marketing flair.

In pharmaceutical translation, trust is built on credibility. Credibility in translated marketing content is built by a savvy Product Manager choosing the right localisation partner with the right expert resources.

Engagement is fostered through compelling marketing copy. In international markets, a switched-on Product Manager knows that the role of localised copy is to compel and engage, and ensures that localisation teams have the right marketing expertise.

Reach is about delivering your message to the target audience at the right time and place so that the brand鈥檚 credibility can shine through, thus equating to engagement. A Product Manager running an international marketing campaign ensures that their localisation partner has the right resources 鈥 both human and technological 鈥 to deliver in volume, at speed and with the right technology, without compromising quality.

For听your localisation service provider, this means that:听

  • Account Managers听build localisation for the听dual pharma-marketing听aspect.听
  • Project management workflows are agile听and responsive.听
  • Translators are vetted, tested,听subject-matter experts,听with听proven听marketing flair.听
  • Translation teams are sufficiently large to handle听content in听volume听and听at speed,听without compromising quality.听
  • Translation consistency听and terminology听is managed through sophisticated language technology solutions.听
  • Documentation is听double-checked and听formatted correctly at delivery.听
  • Deliveries are correct, timely and complete.听

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]]> Regulatory compliance in the life sciences localisation supply chain /regulatory-compliance-life-sciences-localisation-supply-chain/ Wed, 13 Oct 2021 10:00:54 +0000 /?p=34610 The life sciences industry faces unprecedented challenges in responding to an increasingly complex regulatory environment characterised by a faster pace of regulatory changes, shorter product life cycles, and an evolving set of global laws and regulations. At the same time, global life sciences supply chains are being stretched by a variety of internal factors and ...

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]]> The life sciences industry faces unprecedented challenges in responding to an increasingly complex regulatory environment characterised by a faster pace of regulatory changes, shorter product life cycles, and an evolving set of global laws and regulations.

At the same time, global life sciences supply chains are being stretched by a variety of internal factors and external influences. Failures of any kind in the supply chain can result in significant loss of revenue from delayed product launches.

In a complex, ever-shifting environment like this, a safe, transparent and reliable supply chain is critical in managing global compliance.

But where does the localisation supply chain fit into global compliance? How can a partnership with your localisation service provider help you to manage regulatory compliance more efficiently? What does good localisation look like?

In this blog, we explore the challenges around identifying, analysing and mitigating regulatory compliance risks in the localisation service process, in partnership with your service provider.

Identifying Compliance Risks: Quality at Speed, in Volume

Over the past years, life sciences companies have seen significant growth in the development of new product types with shorter lifecycles.

Covid-19 vaccines have broken the bank, of course, in the speed of regulatory implementation and time-to-market. But already two decades ago, researchers identified the need to drive rapidly to 鈥榢iller鈥 experiments that provide decision-critical information, focus limited resources to enhance speed, break down barriers between research and manufacturing, and manage product life cycles effectively, in the , a highly successful medicine for arthritis.

Complying with legislation and implementing changes at an increasing pace requires for the entire supply chain to work in a coordinated, transparent and timely manner.

In the localisation supply chain, the greatest risks to regulatory compliance arise firstly from the need to translate large volumes of data for the marketing authorisation application (MAA) at maximum accuracy, within a restricted timeline, and secondly from managing the subsequent frequent regulatory changes requiring further translation 鈥 whilst maintaining the same level of high quality and speed.

Another regulatory compliance risk centres around the challenge of managing compliance throughout the supply chain, including oversight of the localisation service provider鈥檚 workflows and processes.

Analysing Compliance Risks: What鈥檚 at Stake?

Preparing an MAA for a regulatory authority like the is even at its best a lengthy, involved process. Working with the regulatory authorities of another country adds a further layer of complexity, with .

In your MAA documentation, whether it鈥檚 the clinical trial summaries, instructions for use, or technical sheets, issues in document formatting or the accuracy and terminology of the translation may lead to significant delays in the application and approval stages, or in a worst-case scenario to the regulatory authority declining the application.

At the same time, efforts to maintain a very high quality of translation cannot compromise application submission timelines. For a first application, the volume of data for translation is significant, and unless the localisation process is built to accommodate it, delays in producing the translation can lead to just as severe consequences as issues within the translation itself.

Further down the line, the increasingly frequent regulatory changes also require for the localisation workflow to accommodate quick, efficient turnarounds, to ensure that the product鈥檚 validity is not compromised in any of the markets it鈥檚 available in.

Mitigating Compliance Risks: What Good Localisation Looks Like

Mitigating the above compliance risks in the localisation supply chain involves close communication and dialogue with your localisation service provider.

A good localisation service provider understands the challenges of the regulatory process, and your need for not just high translation quality, at speed, in volume, but for transparency, compliance and flexibility.

This converts to concrete actions and processes. Quality is everyone鈥檚 responsibility.

At your localisation service provider, this means that:

  • Account Managers understand the challenges of the marketing authorisation application process.
  • Project management workflows are agile but robust.
  • Translation quality management processes comply with industry standards.
  • Translators are vetted, tested subject matter experts.
  • Translation teams are sufficiently large to handle volume data at speed.
  • Translation consistency and terminology is managed through sophisticated language technology solutions.
  • Documentation is double-checked and formatted correctly at delivery.
  • Deliveries are correct, timely and complete.

At the Heart of it All: Patient Safety and Products That Deliver

Localisation is an integral part of life sciences supply chains today. It is an enabler of global regulatory compliance. As such, identifying, analysing and managing risks around the localisation supply chain helps you to ensure that the localisation cog does not fail.

Good localisation starts with partnering with a localisation service provider who understands the challenges of the global regulatory process, and offers not just quality, at speed, in volume, but transparency, compliance and flexibility.

The purpose of the localisation supply chain in the global regulatory process is to deliver correct, high-quality translations, submitted to the regulatory authority on time. At the end of the day, regulators, life sciences companies and their suppliers share the same passion 鈥 patient safety and products that deliver.

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]]> Exporting medical devices /exporting-medical-devices/ Wed, 01 Sep 2021 08:14:00 +0000 /?p=33796 No longer part of the European Union, the regulatory burden of exporting can be substantial for a UK company that produces medical devices for the EU market. The good news is that there are experts who can help 鈥 but how do you find them? Here are the key points to consider when choosing a ...

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]]> No longer part of the European Union, the regulatory burden of exporting can be substantial for a UK company that produces medical devices for the EU market. The good news is that there are experts who can help 鈥 but how do you find them? Here are the key points to consider when choosing a language solutions partner that will empower you at the different stages of your exporting journey.

How to appoint an authorised representative

The European Union is in the process of transitioning from the Medical Devices Directive (MDD) to the more onerous Medical Devices Regulation (MDR). The requirements for the documentation that accompanies your product will vary depending on your product鈥檚 classification.

The appointment of an authorised representative within the EU will be necessary in order to sell medical devices to the member states. They have to 鈥verify that the EU declaration of conformity and technical documentation have been drawn up [鈥” and they need to hold your documentation in readiness for requests from bodies within the member states. They will also act as your point of contact for regulatory, legal or product quality queries.

The first step, therefore, is to find and appoint an authorised representative within a member state. Depending on where your representative is based, this can be dealt with in English, so at this point, you don鈥檛 necessarily have a language barrier to overcome.

How to keep control of your content

Translations must be accurate, up to date and in an official Union language

Although you can deal with your authorised representative in English, once you are ready to take the product to the wholesalers, distributors and consumers, the new MDR regulation states that:

鈥Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up to date [鈥鈥, and then goes on to say, 鈥The EU declaration of conformity shall [鈥 be translated into an official Union language or languages required by the Member State(s) in which the device is made available.鈥

At this point, you need to decide whether you want to be in control of the translation process, translation partner selection and quality of your content. If you want to relinquish that control, your rep or business partners in the markets will take the task on. One alternative is that you control the localisation of the assets that are key to your brand, whilst they take care of content that has less visibility or more local flavour.

Some translated content may have to be attached to your product before it leaves the UK, whereas other content may be added to the packaging in the target country. But this need not dictate who is in control of producing the translations and making sure they are fit for purpose. How you choose to sell your medical device in the target country also has a bearing on these decisions.

There is much to be said for working with a trusted language services partner who ensures that your content is translated with a process that you have full control over and can audit, review, change and influence according to your evolving business needs.

How to impress distributors of medical devices

You can choose from a number of channels for selling your medical device to European markets: directly from your own website, through online marketplaces like Amazon, or through distributors and wholesalers in the European countries.

Networking with distributors is best done at exhibitions and shows where manufacturers and importers meet to seek out the new and interesting or the tried and tested. Marketing material in the local market鈥檚 language is not only a powerful way to communicate the key points of your product, it鈥檚 also a matter of courtesy and shows commitment from your side. From pop-up banners to brochures and hand-outs, impress your potential partners by bridging the language gap so that they don鈥檛 have to. 

How to engage consumers

Sales exhibitions and shows were of course put on hold during the recent pandemic, and the increased uptake of online shopping has most probably led to a permanent shift in consumer habits, according to a report by consultancy firm McKinsey, . Whether your distributors use online sales channels, or you sell your product directly to consumers, the value of a clear and culturally appropriate description of the product and sales pitch is of utmost importance.

Online marketplaces, such as Amazon, sometimes offer you automated translations on their platforms. The algorithms behind them may produce results out of context; laughter may be the best medicine, but not if you want your product to be taken seriously. A company selling suitcase and storage boxes that they called 鈥榯runks鈥 recently appeared on the Swedish Amazon page with a translation in Swedish for 鈥榰nderpants鈥 鈥 admittedly a correct translation, but not in that context.

A quality check performed by a human linguist is therefore not a luxury, but essential to ensuring that your product inspires confidence in buyers, retailers or consumers. A transparent quality control process is key in protecting the value of your brand.

How to support users of medical devices

Information needs to be written differently if the user is an ordinary consumer or a health professional

At some point, your product reaches the consumers 鈥 the end users of the medical device you manufacture. The EU regulations are likely to require product information to be displayed in the native language of the user. In addition, the information needs to be written differently if the user is an ordinary consumer or a health professional.

Whether you have a product of a less medical nature in the Class I category, or an implant to go into a patient鈥檚 body in Class III, the instructions must be written well. You may consider presenting everything in one multilingual booklet or package the materials individually for each market, adjusting to the local complexity.

How to select a language services partner

With more than 20 years in business, Sandberg has considerable expertise in medical translation, technical translation and marketing translation. As your language solutions partner, we help you take your product to new markets, or improve your penetration in existing markets with culturally appropriate translations that meet regulatory requirements.

When you work with Sandberg, you maintain control over your content and have a partner on your home soil. We help you create and maintain glossaries (term bases) and translation memories (TMs) that are reused whenever a new translation is needed or an update to an existing translation is necessary. With them, you ensure consistency, quality and speed, as well as compliance with regulatory requirements.

We offer a completely free assessment of your current needs and provisions. Contact us today to have a chat about where to start.

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]]> Is femtech the future? /is-femtech-the-future/ Wed, 14 Jul 2021 14:56:25 +0000 /?p=33171 Femtech: first coined in 2016, the term refers to a sector within the technology industry that has since seen a lot of growth. But what is it, and what is it used for? If you are someone who has periods, chances are you鈥檝e downloaded a period-tracking app, such as Clue, to keep an eye on ...

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]]> Femtech: first coined in 2016, the term refers to a sector within the technology industry that has since seen a lot of growth. But what is it, and what is it used for?

If you are someone who has periods, chances are you鈥檝e downloaded a period-tracking app, such as , to keep an eye on your symptoms throughout the month and to get an idea of when your period is due to start.

If you have children or are looking to conceive, maybe you have used or other fertility and ovulation trackers, pregnancy trackers like or a smart breast pump such as that developed by .

From apps allowing users to set up monthly tampon subscriptions to products such as period underwear 鈥 , and to name just a few 鈥 and health advice services, 鈥渇emtech鈥 is a catch-all term for products aimed towards women (and those with female anatomy).

Breaking taboos

Historically, the general public and investors alike have tended to shy away from discussing periods. Even adverts for feminine products often skirt around the very topic they are advertising for. Any talk of what actually happens during a period is avoided. These adverts will even go as far as using blue paint rather than red when demonstrating how products work.

Adverts for feminine products will often use blue paint rather than red

In the past, this has caused many of us to be ashamed of talking candidly about the symptoms we experience on a monthly basis. This in turn can lead to issues such as infertility and conditions like endometriosis to go undiagnosed.

However, the emergence of these apps in the femtech sector is changing things. We are being led to become more comfortable with our own bodies, helping us identify more easily when something is 鈥渨rong鈥.

Not only does this empower women to better track their health, but it also proves to them that there is nothing to be ashamed of. Especially when it comes to taking care of their bodies.

Empowering female-led startups

92% of femtech startups were founded and are led by women

reported that 92% of femtech startups were founded and are led by women. This demonstrates just how valuable the perspective of women for women is in the tech world.

And even more so if we鈥檙e going to tackle some of the biggest challenges impacting us.

Compared to other sectors, this is an astounding number of female-directed companies. It helps to diversify the gender makeup of those in power in the technology industry 鈥 where decision-making power most often lies in the hands of men.

With much of this technology being developed by women for women, this is not only a win for gender equality. It also means that the people who are providing solutions are those who truly understand the health issues that women face.

Put simply, it allows the concerns that women have to be seen and addressed by someone with similar experiences.

At the forefront of telehealth

In the throes of the Covid-19 pandemic, many people were sequestered in their houses, only leaving when absolutely necessary in order to help slow the spread of the virus.

During the lockdowns, this meant that many turned to subscription services to buy their period products or order medication rather than popping to the pharmacy. Not only was this invaluable during the pandemic, but it is also a useful service for those with reduced mobility who may find it hard to get to the shops regularly.

Often, disability issues are not accounted for when it comes to technology. So, it鈥檚 promising to hear that these innovations are making a positive impact in terms of telehealth. This technology may enable those with disabilities to access a similar level of care as their able-bodied counterparts.

Obviously, there is still a long way to go. But it is encouraging that certain forms of femtech have succeeded in improving the quality of life for many who have historically been marginalised by society.

The role of language in femtech

Femtech solutions should, by their nature, have universal applications. When a company plans to provide these products to new user groups across a wider range of markets, there are many aspects to consider.

Among the most important are the reasons for them to carefully vet and translate their content:

  • Women have the right to access health information in a language they understand and feel comfortable with.
  • In many countries, the level of education is still not the same for women as it is for men. Therefore, any products available only in a non-native language may be a barrier to women who wish to use them.
  • These are personal, often private, matters that you might only discuss with your closest circle or your doctor. So that these products are more relatable and confidence-inspiring, the right tone of voice needs to be translated.
  • These are important matters that concern your health. Consequently, terminology must be translated correctly so as not to be confusing or misleading.

Language service providers (LSP) have a natural affinity with femtech companies. Many LSPs are female-led and they have a great percentage of highly educated female staff who work competently with technology. Many of our linguists and project managers are fans of such tech solutions and are keen to make them accessible to a wider audience.

All in all, this is clearly just the start when it comes to the potential growth of femtech. The femtech sector has already made so much headway, with hundreds of millions of dollars invested in femtech within just the last decade. With this, it鈥檚 safe to say that there鈥檚 a lot more to come 鈥 and likely sooner rather than later.

It will certainly be interesting to see in what ways the industry continues to adapt and develop as it expands into new niches and international markets.

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