The Challenging Endeavour to Ensure Usable Medical Devices and Conformity with Global Regulations
Thorsten Gruchmann, Use-Lab GmbH

Ergonomics and usability do not only pertain to computer work places.More and more they are becoming an important factor in the process of ensuring safety, efficacy, and return on investment. Especially in the medical field, the increasing life expectancy requires among other things continually new methods of therapy and diagnosis. Triggered by competition and higher functionality of the devices medical products becomes more and more complex.

The growing density of achievements in the public health care system such as DRG’s, as well as the larger number of various medical devices imply for physicians and nursing staff a heavy burden that can deteriorate therapy quality and safety. The rapidly changing requirements on medical products as a result of this alteration have a high pressure also on products’ development. The critical questions refer equally to an efficient development combined with reduced expenses for development time and costs, as to an optimized use of the products by the customer with reduced process costs and an increased user satisfaction and safety for the welfare of patients and users.

As a reaction several standards and directives have been adopted, stipulating that usability should be integrated into the medical device development process, in order to guarantee the safe use of medical devices.

This presentation describes challenges and possible solutions for medical devices’ or IVD manufacturers seeking to follow the new regulations.

Technical Writing in a Highly-Regulated Environment
Hans-Jörg Elsen, Varian Medical Systems Particle Therapy GmbH

Medical device companies work in a highly-regulated industry, which is strongly influenced by strict legislative and regulatory requirements. User instruction plays an important role as it contributes significantly to the safety of patients and personnel. In his presentation, Hans-Jörg Elsen gives insight into the daily work of the Technical Publications team in Varian’s Particle Therapy business, including:

  • How legislative and regulatory requirements affect the day-to-day routine of technical writers.
  • How a technical writing team integrates into a medical device manufacturer’s process landscape.        
  • A sample process for managing risk mitigations in user instructions.
  • Signification personal skills and qualifications that are important for working in a highly regulated environment.
Optimizing your Healthcare Documentation – Opt for the Right Methods and Techniques
André Vanderschueren, ASTeC

A recent survey showed your users ignore your 400-page manuals? Are you searching for a suitable, viable and economically-savvy solution?
 To provide a useful because usable documentation, documentation professionals should turn to:

  • Focusing on the user's needs, instead of describing your product features
  • Building on the user's prior knowledge (such as similar product knowledge, professional training…)
  • Considering the user's work environment (space, aseptic conditions, time pressure...)
  • Increasing searchability

User’s needs implies asking the essential question: what is the user looking for when he opens the manual? Certainly not « Introduction » or « General overview ».
User’s prior knowledge means skipping information about basics tasks the user performs on a daily basis. Explaining a nurse how to make an injection is profoundly redundant (and insulting): she learned it during her professional education!
User’s work environment requires considering the user’s tasks in situation. Providing a 300-page manual to be used in an aseptic environment is not the best choice (… or do you recommend to clean the manual with chlorhexidine after each treatment?).
Increased searchability is essential for healthcare staff. Because time is limited, medical staff is eager to find the required information immediately. Browsing a long manual without index is not a solution.
Applying the above recommendations, it is possible to reduce the amount of documentation and still optimize its usability, making it more efficient.
Further, because the documentation is based on stand-alone chunks, it easily adapts to any documentation format: paper, electronic, mobile-compliant, etc.

To provide a useful because usable documentation, documentation professionals should turn to:

  • Topic-based authoring instead of full document writing
  • Clear titles and structured organization instead of generic titles
  • Multiple formats publication
  • Enhanced search capabilities
Topic-based authoring means reusing content and increasing consistency over different similar manuals.
Clear titles and structured organization means easing and boosting the search of content for required information. Multiple format publication means access to information in the easiest and most adapted way for the user depending on his current needs (responsive HTML5 to adapt to his display size, HTML to dynamically search the content, pdf to print a specific section…).
Enhanced search capabilities, such as synonyms and index, means getting relevant search results even if the searched term is not used in the documentation.
Using the above techniques allows to reduce the writer’s work while optimizing the documentation usability and thus enhancing the different users’ experience.
Automating Content Layout Without Losing Flexibility
Sebastian Göttel, SCHEMA Group

The high cost for publishing print material in a globalized market is not only due to translation but also to costs for adapting layout for each translation. Manual tweaking in the source language is usually repeated in every target language. As a rule of thumb the DTP costs for translating technical documentation account for almost 50% of the total costs.

It comes as no surprise that the biggest advantage of DITA and XML lies in automating layout and not in reuse or other virtues. Unfortunately one of the major challenges of deploying DITA and XML lies in automating layout. Most XML-based documentation set-ups produce some kind of print output.

The XML standard proposes XSL-FO as a powerful mechanism to transform media-neutral XML content into professional looking PDF documents. Setting-up an XML / XSL-FO / PDF transformation chain is a tedious task usually performed by some technically gifted persons.

If there are just one or two layouts, this is just another hurdle in deploying XML-based documentation. But what if there are dozens, even hundreds of different layouts? Then automating layout becomes expensive and restricted to large-scale projects. Rolling out structured authoring to areas with such layout requirements is virtually impossible.

What if the required layout cannot be fully automated? Using open formats instead of PDF may pose other problems in regards of performance, security and time-consumption for fiddling layout. Since documents are to be re-generated when the content is updated, this fine-tuning has to be re-applied every time the document is updated. This might be a show stopper on an otherwise worthwhile move to DITA and XML content management.

In this presentation Sebastian Goettel explains an alternative approach to tackle the challenge by allowing for automating layout without scripting and reusing fine-tuning. Layout automation and flexibility do not have to be in contradiction!

'The Kaiser Wants Kaizen' - A Firm Grip on Customer Feedback in a Service Environment
Eef Blommaart, Yamagata Europe
Customer is king, we all know that. But in this modern day and age just treating them as royals is no longer enough to keep them loyal to you as a supplier. Modern patriarchs demand cold facts and exact figures that prove our worth and it is often what you do with these data that makes or breaks your royal ties. The Kaiser wants Kaizen these days.
With a large turnover of translated words, layout pages and printed items, customer feedback is the most desired method to objectively measure the quality of your services. Especially with customers active in the domain of medical equipment and automotive, where rules and regulations are strongly defined, you need facts and figures to guide you through the creation process.
In this presentation we give an in-depth explanation on how we carefully track and trace every part, be it word, page or printed item throughout the production process in our service factory. Then we map this against the objective customer claims in our Quality Management System (QMS). This allows us to calculate how we score on the six sigma scales. Six Sigma means you cannot deliver more than 3.4 defective parts per million items.
Following to that we elaborate on how we deal with these newly found data: we discuss it with both our suppliers and our clients in order to come to a “kaizen” where we improve services and goods.
Feedback often goes both ways. For instance, we tell our clients to take care with source data consistency and advise them that being consistent can help improve overall quality of the end product.
This does not take away the emotional aspect of customer feedback and we surely listen to them in person. We also organize a yearly survey in order to know how their satisfaction level maps to the figures.
All the above measurements and methods are then used to define the KPIs (Key Performance Indicators) per department for the following year. These KPIs in turn are used in the ISO 9001 certification renewal process.

Our Sponsor for all cities

Our Sponsors

Supported by