Re: Technical Writing in the Medical Device Industry

Subject: Re: Technical Writing in the Medical Device Industry
From: Keith Mahoney <kamahoney1965 -at- gmail -dot- com>
To: Naomi L Burnett <burn1729 -at- fredonia -dot- edu>, List,Ã Techwriter <techwr-l -at- lists -dot- techwr-l -dot- com>, Keith Mahoney <kamahoney1965 -at- gmail -dot- com>
Date: Thu, 18 Feb 2016 10:32:44 -0800

Naomi -

Building on what others have said thus far (apart from the Regs
responses).... I worked a Med Device Pubs and Training Manager and here's
some of the things that I think might help.

1) If you have UX at your company - utilize them. I had a few of them on my
team and we did things such as field trials, in-house trails, and blind
studies to observe how our users would interact with our product. This
allowed us to tailor our documentation, software, and UI to our target
audience -- the elderly.

2.) Use a Fog Index to determine your readers level of understanding -
again, we had specific audiences and so we wanted to ensure that they were
able to understand the content - I had to fight regarding this one because
engineers *sometimes* think everyone understands their level of
communication.

3.) If you are going global, get a good translation service - Machine
translation is never as good or, do as I did and ask for native speakers to
review your materials - thus you save $$.

4.) If you are not a PM - become one quick. You'll have a lot to balance
and creating, driving, and maintaining schedules is key to any publication
project - IMHO. Also, partner with the PMs in your org. If you are a PM,
then I would adopt whatever style they are using to drive projects.

5.) Seriously, recognize the people you work with - far too often folks do
not take the time to recognize others work and it can be demoralizing. I
would encourage you to do offsites after a big push!

6.) If you can get end users to provide testimonials regarding your work,
that helps with end-year review. However, I also got our Nursing staff to
provide feedback to the team and let them know that what they were doing
made a big impact on peoples lives - this help during times of crazy
deliverables.

I could go on; every situation is different, right.... Hope these nuggets
help.

KAM

On Thu, Feb 18, 2016 at 5:49 AM, Naomi L Burnett <burn1729 -at- fredonia -dot- edu>
wrote:

> Hi everyone,
>
> Do you have any suggestions of books, blogs, or other resources that would
> help a beginning tech writer in the medical device industry?
>
> To give you a little background (if it will help), I began a job as a tech
> writer in the medical device industry a few months ago at a very small
> company. I'm new to everything about this job; I have my Master's Degree in
> English Literature, and this is my first tech writing experience.
>
> So far, on the job, I've written a draft of the quality manual (using
> general Internet research, a retracted FDA manual on quality systems that
> my boss saved, and of course 21 C.F.R. part 820). I'm now working on the
> standard operating procedures for the quality system and researching how to
> write a 510(k) for a new product.
>
> I would love any advice you experienced tech writers might have about tech
> writing in the medical device industry, and I would especially appreciate
> any titles of (or links to) research resources that might be of help for my
> research.
>
> Thank you so much!
>
> Naomi
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References:
Technical Writing in the Medical Device Industry: From: Naomi L Burnett

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