We introduce another guest blogger today, Beth Tripp, a technical writer for a medical device manufacturer. Beth will be posting monthly on the area of medical writing under the “MedDevDiva” title.
I am a technical writer for a medical device manufacturer. That hasn’t always been the case; I started in aerospace then moved to documenting software programs. During a period of under-employment in 2003 I interviewed with a medical device manufacturer. I did not have a background in medical devices, science, or life sciences, but had a degree in humanities. I was a good tech writer and I could market my skill set. I got the job.
What is discussed here is just a small part of technical writing in the biotechnology/medical device arena. We won’t be going into pharma (pharmaceuticals), posters, clinical reports, or journal articles; just manuals. Manuals in the medical device industry are referred to as Labeling or formally as Instructions for Use (IFU). There is also a DFU (Directions for Use). If you want to read up on the FDA guidelines for labeling do an internet search for “medical devices labeling” if the link below does not work.
Guidance on Medical Device Patient Labeling.
As tech writer for a medical device you need to think globally ,as most companies sell worldwide.
Your audience can be the:
- Surgeon and rotating nurse in the operating room
- Grandmother with her glucose meter
- Service representative on a service call (somewhere in Europe)
- Laboratory technician (lab tech) in a developing country
There are different classifications of medical devices, from a bandage to a pacemaker. Medical devices can be a combination of hardware and software, just hardware, or software alone.
Medical device documentation is an area that is ruled by many regulations and guidelines. Some of those regulatory organizations are list here but are not limited to:
- Food and Drug Administration (FDA),
- European Union (EU) Medical Device Directive (MDD)
- International Electrotechnical Commission (IEC)
Resources for current regulatory guidelines can be:
- Regulatory Affairs (RA)
- Quality Assurance (QA); QA uses FMEA (Failure Mode and Effects Analysis) and HRA (Hazard Risk Assessments)
- Electrical Engineers for IEC compliance
- Your translation service provider
There may also be unique requirements from within the company regarding trademarks and copyrights and requirements specific to other countries, such as Brazil and Japan.
Because the industry is so highly regulated, there are SOPs (Standard Operating Procedures), which are the rules that the company must follow. SOPs are constantly updated to reflect the current processes within the company.
This area of tech writing may not be for everyone. If you want to be creative, do things in a non-standard way, and rebel at doing tedious change orders and redlines, you may want to look for something else. But if you are driven by order and rules, put your portfolio together and go for it. All they can say is no.