Resources / Blog

Cost-Effective Strategies for Updating Medical Device Documentation

Nov 30, 2016


By: Jack Fischer, Business Development Manager – Life Sciences division

 

The mantra of medical device development is ‘Design, Validate, Iterate – and Repeat’. Unlike large- and small- molecule therapies, the tangible nature of medical devices enables a more efficient path for innovations to reach the market.

For developers, this represents a double-edged sword—the average 510(k) device takes only $73 million to successfully traverse the path from concept to reimbursement[1]. On the other hand, most medical devices have an 18 to 24-month window before an improved substitute enters the market[2].

By steadily iterating your device – incorporating novel materials, more user-friendly designs, and feedback from physicians, patients, & regulatory bodies – your medical devices can remain competitive across several product cycles.

As devices are improved in order to stay competitive, documentation must be updated to remain applicable and relevant. With limited resources, this raises a key question – what is the best strategy for managing the costs of translation while ensuring high quality and consistency across all your medical device documentation?

As we know, design is all about making the most appealing trade-offs. Iteration is meant to address those compromises to create a better experience & outcome. Updating your translations with Morningside will allow for an iterative process, which is both cost-effective and increases consistency. In order to create value for our clients, Morningside utilizes a series of software tools to aid linguists, known collectively as Translation Memory. Translation Memory, or ‘TM’, increases quality & consistency, while reducing costs.

Morningside uses translation memory software to increase value for clients by reconciling the precise & repetitive nature of documentation with the human element of translation. At its most basic level, translation memory functions as a client-specific database of previously translated documents. During the quoting process, we use this interactive database to check your new files for repetitive and/or previously translated text. To avoid stylistic changes in translation of the same terms and phrases, our translation memory software flags the text in question and notes the previously used translation. During the translation process, linguists check the previous translation to make sure it fits in the context of your new documentation. Not having to re-translate the same text ensures high quality by protecting against stylistic changes and ensuring consistency across documents.

While translation memory increases consistency and quality, it also decreases cost and turnaround time. Just as you leverage your past experience to keep up with new market trends, leveraging translation memory allows linguists to produce high quality translations at a faster turnaround time. Repetitive phrases are also billed as a discount, allowing for significant cost savings.

Just as patients and physicians choose specific medical devices because they improve quality of life, you can choose an informed partner who provides a personal, professional experience with the benefits of customized translation memory that speeds up turnaround times and lowers costs. At Morningside, we put our best foot forward to understand your needs. By utilizing our tools, like TM, to create a professional experience, we ensure that we can meet and exceed them.

 

The Author

Jack Fischer

Jack Fischer is a Business Development Manager at Morningside’s Life Sciences division. After researching Tuberculosis genetics at Albert Einstein College of Medicine, and working with numerous biotechnology startups in New York, Jack moved to Morningside in order to apply his expertise to developing and implementing translation solutions for the life sciences industry. Jack has a dual B.A from Skidmore College in Integrative Biology & Business.

 

[1] Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Wizemann T, editor. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington (DC): National Academies Press (US); 2010. 4, The Medical Device Industry Innovation Ecosystem. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209786/
[2] Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Wizemann T, editor. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington (DC): National Academies Press (US); 2010. Appendix D, Impact of the Regulatory Framework on Medical Device Development and Innovation. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209794/
Resources / Blog

The Critical Role of Language in Global Clinical Trials

Nov 22, 2016

Life science companies – including critical-role-of-languagemedical device, biotech and pharma – are increasingly turning to countries outside the US and W. Europe for clinical trial sites. According to the statistics kept by the National Institutes of Health, almost half of the currently registered studies are being conducted entirely outside of the US and an additional 6% are being conducted both in and outside the US. A more detailed breakdown of the distribution of the non-US multi-regional clinical trial (MRCT) locations indicates that Europe accounts for slightly less than 50% of clinical trials, followed by Asia with 26%, Latin America with 8% and the Middle East with approximately 7%. [1]:

critical-role-of-lang-pic-2

Why are companies going abroad?

The two major benefits of MRCTs for the life science companies are: access to larger and more diverse patient populations that are often willing participants thus expediting enrollment; and the lower cost of conducting trials in developing countries. One publication estimates that, for a 60,000-subject study, $600 million per year can be saved by shifting half of the late-phase trials from the US and Western Europe to South America or India. [2]

The other benefits of the growing trend toward MRCTs are improvements to the healthcare and clinical research infrastructures in the target countries; opportunities for talented practitioners to be principal investigators; faster launches of innovative drugs and devices and improved global patient access to these products.

What are the challenges of going abroad?

At the clinical level, differences in medical practice and standards of care across multiple geographies can make it difficult to validate the results. At the clinical study design level, diverse and sometimes contradictory regulatory requirements have to be bridged regarding issues such as endpoint definitions and required levels of evidence.

There are also potentially troubling ethical issues such as adequate protection of research subjects, getting truly informed consent, levels of research conduct and transparency, the quality of the local reviews that authorize the research, etc. [3] In response to unease that is frequently expressed concerning how clinical trials are conducted in developing countries, the large pharma companies, such as Pfizer, have made clear and public commitments to ensuring that their research strictly conforms to international standards no matter where the trial is taking place.[4]

Translation can make or break an MRCT

Clinical trials are highly structured and meticulously documented processes. A partial list of the documents that have to be made available in all relevant languages for healthcare professionals, investigators and patients at every clinical trial site includes: Clinical Study Protocols, Case Report Forms, Investigator’s Brochures, Patient Information Leaflets, Patient Informed Consent Forms, Patient Questionnaires, Patient-Reported Outcomes.

Terminology has to be stringently controlled across all languages. Translations have to be done by qualified professionals under strict quality assurance processes, such as validation by experienced clinicians. Errors not only potentially endanger lives, they can undermine the very validity of the trial. To this end regulatory bodies such as the FDA, EMA and professional organizations such as ISPOR (International Society For Pharmacoeconomics and Outcomes Research) provide good practice guidelines on how to conduct and document MRCTs so that patients are protected, their reported outcomes – including Adverse Events — are unequivocally validated, and the clinical trial data can be used confidently to make a decision about whether or not a new medication or device should be allowed to enter the market.

References

[1] Based on data from ClinicalTrials.gov (NIH) as of September 1, 2016
[2] Rebecca Li et al, Global Clinical Trials: Ethics, Harmonization and Commitments to Transparency, Harvard Public Health Review Volume 5, May 2015
[3] Premnath Shenoy, Multi-regional clinical trials and global drug development, Perspectives in Clinical Research, 2016 Apr-Jun; 7(2): 62–67
[4] Joe Feczko et al, The Globalization of Clinical Trials, Pfizer, March 2009
Resources / Blog

Four Translation Mistakes that could harm your Law Firm’s Website

Nov 15, 2016

Websites in professional industries such as law rely on the trust, credibility and reputation built by the company in question. More often than not, a potential customer’s first impression of a law firm is the law firm’s website.

For this very reason, the way that the information is displayed and delivered on a law firm’s website is of paramount importance. Translation is key to getting the branded messaging across to the target audience effectively and an accurate and localized translation of the website’s content is a key part of this task.

There are countless examples of embarrassing website translation mistakes, some of which would leave the most stoic lawyer red in the face, but these mistakes are easily avoided by using the right tools and translation services. We’ve highlighted four of the most common website translation mistakes made by law firms and provided useful tips for avoiding these pitfalls

1. Using machine translation for multilingual versions of your law firm’s website or landing pages

Whilst it may be tempting to utilize the immediacy and low cost of machine translation to create your law firm’s multilingual website, the poor quality of these translations may be detrimental to your firm’s credibility and leave your potential overseas’ clients with a bad first impression.

Of course, translated landing pages will ensure the website is visible and targeted to a wider audience, but if that audience sees mistakes in grammar, syntax and word choice in the translation, then it would be difficult to convert them into a paying customer.

The solution to this really common mistake is a simple one, and it comes in the form of hiring a professional legal translation firm that employs legal translation experts who also have website translation experience and are able to understand the nuances of legal translation as well as how to effectively market legal services to the target audience.

2. Forgetting to translate email and contact us forms

So, your law firm’s website is ready to launch and contains perfectly translated copy for each of your target markets, but what about next steps in the conversion funnel?

Take this conversion path for example:

  • A potential client who only speaks Spanish is looking for legal assistance with divorce proceedings.
  • She visits the site and is impressed with the way the website is translated in a professional manner.
  • She clicks ‘contact us’ and sends a short message asking for more information from your specialist divorce lawyer.
  • The automated response she receives is in English and she cannot understand the next steps required of her.
  • She leaves the website to look for another legal firm to handle her case.

Particularly with sensitive legal matters, it is important to have the entire user journey translated properly to ensure that no potential client leads are lost.

3. Failing to translate lawyer profiles

The majority of website searches that lead visitors to your law firm’s website will be by potential clients searching for a lawyer to potentially work on their case.

These visitors have often been given a recommendation by a friend, family or work associate. In order not to waste this warm lead arriving at the website, ensuring that your lawyer’s profiles and descriptions are translated will improve both conversion and decrease bounce and exit rates on your site.

Monitoring Google Analytics is a simple way to see which lawyer profiles are generating inbound traffic and this information can be used as a benchmark to decide the order and priority in which these pages are translated, to have the maximum impact in the shortest time – a significant quick win for your law website.

4. Email Marketing and Newsletters – all important for getting your localized message across

If your law firm uses email marketing or newsletters as a channel to communicate with clients and prospects, then translation will be important to consider when spending time on these marketing assets.

Email marketing and newsletters are an example where audience-specific translated content should be considered. If, for example a market you’re looking to target is the Spanish-speaking community, then it makes sense to send out translated newsletters and email campaigns to coincide with national holidays like Cinco de Mayo, Día de Acción de Gracias and similar.

This will demonstrate a clear understanding of the audience you’re catering to, and this relates back to establishing trust, credibility and confidence in your law firm’s ability to tailor your services to your client’s background and specific needs.

Resources / Blog

MSDS Translation: An Essential Safety Tool

Nov 08, 2016

What is an MSDS and who is responsible for it?

A Material Safety Data Sheet (MSDS) is a document that provides information on the potential hazards (health, fire, reactivity, environmental) of a chemical product. It also contains instructions on how to use, store and handle chemical products safely, as well as potentially life-saving guidelines on what to do in the case of an emergency − spillage, overexposure, and so much more. The patient risk associated to these medical products means MSDS translation should be handled by subject matter experts who have been rigorously vetted.

Many workplaces use dangerous chemical products – from industrial plants to labs, to the cleaning supplies found in every office. Improper handling of chemical products can cause damage of staggering proportions through explosion, fire, and/or the release of lethal toxins into the atmosphere. When creating this piece of critical content, it is important to extend an agreement of partnership with a professional language services provider with ISO certifications. ISO certifications indicate an organization’s services and business processes have been independently audited to meet or exceed international best standards or practices. So, look for a language service provider certified to ISO standards – especially ISO 13485, which specifies QMS standards for medical device companies. Doing so ensures your technical MSDS translation is reliable and accurate.

With so much at stake, national and global regulators have established a clear chain of responsibility for educating users on how to safely handle hazardous products and how to respond to an emergency: the manufacturers are required to prepare a detailed MSDS that covers all the mandated topics and to update them regularly, typically every three or five years; suppliers are required to deliver, along with the product, the most updated material safety data sheets in all the languages relevant to the buyer; and employers are required to make the MSDSs readily available to their employees.

Basic MSDS requirements

There are a number of harmonized and national regulations that dictate the basic content and format of the MSDS [i]. Thus, for example, the European Union’s REACH (Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals), requires that the following 16 topics be covered [ii]:

1.       Product, manufacturer, supplier info

2.       Composition of ingredients

3.       Identification of hazards

4.       First-aid measures

5.       Fire-fighting measures

6.       Accidental release measures

7.       Recommended handling & storage conditions

8.       Exposure controls / Personal protection

9.     Physical and chemical properties

10.   Stability and reactivity data

11.   Toxicological information

12.   Ecological information

13.   Disposal considerations

14.   Transport information

15.   Regulatory classification

16.   Other information, disclaimer, etc.

Making MSDS Understandable

As noted in Canada’s Workplace Hazardous Materials Information System guidelines [iii], in the past the intended readers of MSDSs were occupational hygienists and safety professionals. Today, however, the audience also includes employers, workers, supervisors, nurses, doctors, and emergency responders. Thus, in order to ensure that MSDS users can quickly find the information that they need, the MSDS should be in an easy-to-read format and written in a clear, precise and understandable manner.

Not only must MSDSs be clearly written, but they must also be carefully localized[iv]. For one thing, they must be adapted to regional regulatory specificities such as the emergency call number in section 1, the occupational exposure limit values in section 8, and the list of the regulations that correspond to the substance in section 15. MSDS translations are a critical form of communication to safely inform your product users of patient risk, localizing the content ensures maximum comprehension.

MSDS Translation Challenges

In addition, they must be provided in the language of the user. REACH, for example, states explicitly (article 31, paragraph 5) “The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market unless the Member State(s) concerned provide otherwise.”

Translating MSDSs is a mission-critical responsibility that should only be undertaken by knowledgeable and experienced translators. Not only must they be chemistry subject matter experts, but they must also be well-versed in the MSDS requirements of the target audience. In addition, they must be working within a well-established quality system that ensures accurate, consistent deliverables. The well-being of people, the environment and valuable assets are dependent on always-accurate, always-understandable MSDS translations.

References

[i] Morningside Translations
[ii] Safety Data Sheet, Wikipedia
[iii] WHMIS 1988 – Material Safety Data Sheets (MSDSs): General
[iv] Sabine Ashfaq, I have to translate my MSDS! The least expensive solution: software, February 24, 2016