Siobhán Ní Chatháin explores the potential contribution of technical communicators to medtech documentation, and the usability pay-offs.
This article was published originally in Communicator (Winter 2016). Communicator is the authoritative, award winning, journal for UK technical communicators. It is home to high quality, objective, and peer-reviewed features – current, relevant, and in-depth.
Introduction
Usability is increasingly important across a range of industries, particularly the medical technology (medtech) field. Documentation is a crucial component of usability in medtech and, as this article elaborates, its significance is accentuated by the current emphasis on usability and human factors.
From the perspective of our own profession, it may be quite obvious that technical communicators have highly pertinent documentation expertise. However, many in the medtech industry are unaware of the extent to which documentation impacts usability, and the value that technical communicators can offer.
Documentation in medtech
In industry, documentation is a shorthand term referring to any kind of paper-based or electronic reports and records, from the beginning to the end of the supply chain. In medtech contexts, this includes documents prepared for the purposes of:
- Replicating and validating laboratory research and clinical trials
- Defining and standardising manufacturing processes
- Monitoring quality
- Conforming to regulatory requirements
- Informing commercialisation and marketing Improving patients’ user experience and quality of life.
Accordingly, medtech documentation can range from internal standard operating procedures (SOPs) to customer-facing user guides, and take on many other guises in-between Medtech organisations typically generate vast quantities of documentation to meet their wide-ranging information and communication requirements. Yet, professional technical communicators seem to be a rarity in the medtech industry.
Who produces, contributes to, and manages medtech documentation? Our understanding is that, in general, scientists and engineers create product and process documentation; quality or compliance people coordinate regulatory documentation; marketing departments handle user documentation.
Inadequate documentation practices
Many people across different departments contribute to documentation, often in the absence of a coherent process for managing the volume and standards of that documentation.
Scott Abel and Ann Rockley have produced a series of in-depth webinars exploring the practicalities of producing and managing documentation for medical device manufacturers (The Content Wrangler 2016a; 2016b; 2016c).
As they observe, the documentation processes traditionally employed in medtech companies are riddled with unnecessary, error-prone manual tasks. Common problems include:
- Insufficient version control
- Complex review and approval cycles
- Reliance on out-dated, labour-intensive methods
- Inappropriate use of tools
- Complications introduced by translation requirements and practices
- Lack of content modularisation and reuse
Such piecemeal approaches to documentation, without an overarching strategy or framework, have costly implications.
Implications of documentation inadequacies
People working in the medtech industry have anecdotally relayed the following scenarios, which arise from inadequate documentation practices:
- High-value subject matter expert (SME) time is overly occupied by documentation tasks.
- Ambiguous or unnecessarily complex SOPs lead to confusion and misinterpretation.
- Operators bypass instructions that aren’t user-friendly or readily accessible.
- Vast quantities of expert knowledge are stored in people’s heads and lost due to staff turnover.
- Inconsistent documentation practices, combined with a chaotic content infrastructure, makes regulatory applications and audits labour-intensive and stressful.
Such ineffective, inefficient documentation practices waste time and resources. Moreover, they have the potential to jeopardise the quality and compliance foundations of a successful medtech business.
Documentation jeopardy
We, as technical communicators, are acutely aware of the need for complete, accurate, and consistent documentation, managed according to a coherent and comprehensive content strategy.
Unfortunately, many medtech companies don’t see the value of investing in documentation up-front. All too often, they fail to recognise the importance of documentation until a crisis arises. Such crises may involve the failure to pass a regulatory application, or the failure of a product at the market stage.
Regulatory failure
The success or failure of regulatory applications is entirely dependent on the quality of the documentation provided. Regulatory authorities can only base their evaluations and decisions on the documentation made available to them by applicants.
Submission of inaccurate or incomplete documentation almost inevitably prolongs the review and clearance process, with a potential loss of market opportunity. Conversely, improving the completeness and accuracy of documentation increases the likelihood of timely review and clearance.
Inadequate documentation is one of the top reasons why the US regulatory authority, the Food and Drug Administration (FDA) issues Form 483 warning letters, indicating areas of noncompliance identified by an inspection (see Gaffney 2015).
Market failure
The failure of medtech products following their market launch is much more commonplace than you might expect. We recently learned from a human factors engineering (HFE) expert that over 30% of the world’s leading medtech providers have experienced device recalls due to human factor issues (Canavan 2016).
These are recalls of products that have made it through all of the hurdles of validity testing, funding applications, clinical trials, and regulatory applications, to make it to commercialisation. No product would reach the market unless it were proven to address a clinical or medical need.
Yet, while responding to specific medical needs, many product developers and manufacturers pay insufficient attention to the more holistic context of user requirements.
A recent example is HeartWare’s Ventricular Assist Device (HVAD), which was subject to Class I recall on five occasions last year. (See FDA product recalls panel for details.)
Aside from regulatory interventions, users themselves reject devices that give rise to discomfort or stigma, or that are simply too difficult to use. Products that fail to accommodate users’ emotional and social circumstances are unlikely to achieve commercial success (Vaes 2014).
Documentation failure
Poor documentation is a common denominator linking many medtech regulatory and market failures. Indeed, some such failures may be seen as symptomatic of underlying documentation failures. Since documentation is the first line of inspection to verify compliance, it should be the first line of defence (Kohli and Desai 2011).
Start-ups are particularly vulnerable to documentation inadequacies: ‘Paradoxically, the most critical stage of an entrepreneurial organization occurs when it has the least amount of expertise’ (Wehner 2010: 52). Nonetheless, documentation problems can affect companies of all sizes and stages of development.
Both early-stage and established medtech organisations outsource assembly or manufacture, often without giving adequate consideration to communication of specifications and change control.
Organisational change as a result of mergers or acquisitions can expose knowledge transfer shortfalls. High rates of employee turnover, a feature of the medtech industry, can lead to the loss of valuable information where there are insufficient knowledge transfer processes.
Documentation: problem or solution
Research carried out by the Harvard Business School found that up to 75% of venture capital-backed technology (including medtech) start-ups go bust (Nobel 2011). Complacency with regard to regulatory approval or user need is not an option in the current investment climate (see EY 2016).
In light of the crippling consequences of documentation failures, it is unsurprising that the term documentation evokes trepidation in the medtech world. Regrettably, documentation tends to be viewed simply as a problem, without recognising that it must also hold the solution.
This is where technical communicators can intervene and offer their expertise. But first, we need to convince the medtech industry that dealing with documentation appropriately and systematically can improve the chances of success at regulatory and market stages, and avoid unnecessary crises.
One way to start doing this is to elaborate on the role of documentation and technical communication in optimising usability.
Current trends: usability and human factors
When my colleague, Ruth Quinlan, presented a paper at the ‘Medtec Ireland 2016 conference’ recently, the theme of usability consistently came to the fore through the various speakers.
In the medtech industry, the terms usability and human factors are often used interchangeably. Human factors engineering (HFE) and usability engineering (UE) focus on creating user interfaces (UIs) conducive to rapid learning, efficient interaction, and user satisfaction (North 2015).
Medical device UIs are defined as incorporating all packaging and labelling, including operating instructions, and training materials (FDA 2016).
Human factors address the manner in which a person interacts with systems or technologies, and the context in which they do so. Contextual factors taken into account include the use environment (for example, ambulances, hospital wards, or home environment), potential distractions, and urgency of use.
Usability refers to the qualities of a system or product that facilitate appropriate and satisfactory use. Effectiveness and safety is paramount in the use of medical devices: ‘Simply put, if usability is lacking, the completion of user tasks may be slower and more error-prone. Therefore, delivery of therapy will suffer and patient safety may be compromised’ (North 2015: 2-3).
Advances in medical technologies bring increasing complexity. At the same time, the clinical environments in which such technology is used are growing ever busier. Furthermore, systemic pressures along with technological developments mean that remote healthcare is quickly becoming a reality for health service users. ‘As healthcare evolves, and patient care is transferred to the home environment, less skilled users, including patients and carers must learn how to use quite complex medical devices’ (MHRA 2016: 4).
Since human error and patient harm can result from unclear electronic interfaces or complicated procedures for use, the growth of home-based healthcare makes usability even more crucial.
The combination of these trends – growing technological complexity and greater emphasis on remote care – means that user information and training is more important than ever.
This speaks to the increasing significance of documentation as a component of usability.
Documentation and usability
In the US, the FDA has appealed to medtech companies to pay more attention to usability, and has issued guidelines on applying HFE and UE. Similarly, the international regulatory community has incorporated standards developed by the International Electrotechnical Commission (IEC 62366) for applying usability engineering to medical devices.
In its guidance, the FDA states that the primary focus for eliminating or reducing use-related hazards is through the design of the device itself. Supplementary to this, labelling, instructions, and training, ‘if designed adequately, can support users to use devices more safely and effectively and are important HFE/UE strategies to address device use hazards’ (FDA 2016: 19).
These regulatory developments are increasing awareness of the need to integrate usability as a key element of medical device design. Aside from the regulatory impetus, usability promotes user efficiency and user satisfaction, leading to reduced user support costs, and improved brand reputation.
Conclusion
While products and systems designed with usability in mind can reduce user reliance on documentation, design usability does not supersede the need for documentation. Despite growing awareness of usability, the role of documentation and technical communication in supporting, optimising, and demonstrating usability is not yet fully appreciated.
Technical communicators understand that user requirements are absolutely paramount. We are skilled in designing documentation solutions that address real users and meet their actual needs, while adhering to professional standards.
Every stage of the medtech product lifecycle demands detailed documentation (Kohli and Desai 2011). Those working in quality, regulatory and compliance roles are aware of the extent to which documentation permeates medtech organisations. They aren’t necessarily aware that technical communicators can help to avert documentation-related crises, support critical functions, and increase efficiency.
Technical communication expertise remains underutilised in the medtech organisations. We have to convince the medtech industry that quality documentation is a key component of usability, and that we are the profession to deliver it.
FDA product recalls
FDA (2009) defines three major classes of recall:
- Class I recall: there is a reasonable probability that the use of or exposure to a
violative product will cause serious adverse health consequences or death. - Class II recall: use of or exposure to a violative product may cause temporary or
medically reversible adverse health consequences or where the probability of
serious adverse health consequences is remote. - Class III recall: use of or exposure to a violative product is not likely to cause
adverse health consequences.
In June 2015 HeartWare voluntarily sent customers and physicians a letter about the proper use and potential problems associated with its HVAD product. The letter instructed users about how to avoid unsafe practices (FierceBiotech 2016). This incident resulted in a Class I recall notice from the FDA. Further problems and corrective actions associated with the device, also designated as Class I recalls, have been mechanical in nature.
For more examples of medical device usability failures, see Clark and Israelski (2012).
Linking documentation with usability and human factors
Recent FDA (2016: 29) guidance clearly links documentation with implementation of HFE and UE best practices, and compliance with regulatory expectations:
‘Documenting your risk management, HFE/UE testing, and design optimization processes… provides evidence that you considered the needs of the intended users in the design of your new device and determined that the device is safe and effective for the intended users, uses and use environments.’
‘When it is required, providing information about these processes as part of a premarket submission for a new device will reduce the need for requests for additional information and facilitate FDA’s review of all HFE/UE information contained in your submission.’
References
Canavan, E. (2016) ‘Baked in Usability Engineering in Medical Device Development’ presented at Medtec Ireland 2016 Conference, 4-5 October.
Clark, S. and Israelski, E. (2012) ‘Total Recall: The Consequence of Ignoring Medical Device Usability’, User Experience Magazine, 11 (1).
EY (2016) ‘Pulse of the Industry: Medical Technology Report 2015’ www.ey.com/gl/en/industries/life-sciences/ey-pulse-medical- technology-report-2015 [accessed October 2016].
FDA (2016) ‘Applying Human Factors and Usability Engineering
to Medical Devices: Guidance for Industry and Food and
Drug Administration Staff’ www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM259760 [accessed October 2016].
FDA (2009) ‘Background and Definitions’ www.fda.gov/Safety/Recalls/ ucm165546.htm [accessed October 2016].
Fierce Biotech (2016) ‘FDA Lists Difficult-to-Use Devices That Will Be Subject to Human Factors Validation Testing’ www.fiercebiotech. com/medical-devices/fda-lists-difficult-to-use-devices-will-be- subject-to-human-factors-validation [accessed October 2016].
Gaffney, A. (2014) ‘The Top 15 Medical Device Deficiencies
Cited by FDA in 2014’ www.raps.org/Regulatory-Focus/ News/2014/12/08/20926/The-Top-15-Medical-Device-Deficiencies- Cited-by-FDA-in-2014 [accessed October 2016].
IEC (2016) ‘IEC 62366-1:2015. Medical Devices – Part 1: Application of Usability Engineering to Medical Devices’, Geneva: IEC.
ISO (2015) ‘Guidance on the Requirements for Documented Information’ www.iso.org/iso/documented_information.pdf [accessed October 2016].
Kohli, A. and Desai, S. (2011) ‘How do you define regulatory compliance?’ Regulatory Focus, July.
MHRA (2016) ‘Human Factors and Usability Engineering
– Guidance for Medical Devices Including Drug-device Combination Products’ www.gov.uk/government/news/ human-factors-and-usability-engineering-guidance-for-medical- devices-including-drug-device-combination-products
[accessed October 2016].
Nobel, C. (2011) ‘Why Companies Fail and How Their Founders Can Bounce Back’, Harvard Business School Working Knowledge http://hbswk.hbs.edu/item/why-companies-failand-how-their- founders-can-bounce-back [accessed October 2016].
North, B. (2015) ‘The Growing Role of Human Factors and Usability Engineering for Medical Devices’ www.bsigroup.com/en-GB/ our-services/medical-device-services/BSI-Medical-Devices- Whitepapers [accessed October 2016].
Quinlan, R. (2016) ‘Case Study: Documentation and MedTech – The Untapped Value-Adds’ presented at Medtec Ireland 2016 Conference, 4-5 October.
The Content Wrangler (2016a) ‘Helping Teams to Adapt to Medical Device Content’ [webinar] 13 September, available: http://thecontentwrangler.com/webinars [accessed October 2016].
The Content Wrangler (2016b) ‘Manufacturing Medical Device Content’ [webinar] 14 June, available: http://thecontentwrangler.com/webinars [accessed October 2016].
The Content Wrangler (2016c) ‘Understanding Medical Device Content Challenges’ [webinar] 28 April, available: http://thecontentwrangler.com/webinars [accessed October 2016].
Vaes, K. (2014) ‘Product Stigmaticity: Understanding, Measuring and Managing Product-Related Stigma’ [online], unpublished thesis (PhD), University of Antwerp, available: www.researchgate.net/ publication/267075539_Product_Stigmaticity_Understanding_ Measuring_and_Managing_Product-Related_Stigma#pfb [accessed October 2016].
Siobhán Ní Chatháin PhD has a background in third-level education and research.
