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FAQs:  How and Why to Budget for Medical Device Product Documentation

budget-faqsWhen launching a medical device product, providing easy-to-use, accurate instructions are critical  in order to operate, service, or sell the device. But developing highly professional product documentation requires a certain skill set that may extend beyond the manufacturer's internal resources. 

Here we'll answer the most frequently asked questions so you'll understand the true cost vs. benefit of outsourcing the documentation function, the potential ROI, and how to keep your project within budget.

1. Isn’t it expensive to hire a technical writer? I'll just have one of my engineers  write the product documentation.

Companies often assign technical documentation responsibility to the product engineers, given their in-depth knowledge of the product. Although engineers are considered the subject matter experts, they may not possess the professional writing skills necessary to produce clear, concise, easy-to-use documents. Consequently, the total cost of a finished technical manual is most often higher and the turnaround time is longer. 

Take a hard look at the cost-benefit analysis of outsourcing the documentation function. Consider the following:
 
  • Save compensation dollars. There's approximately $15,080 difference in annual salary between a technical writer and an engineer
  • Consider the opportunity cost. It takes between 40 - 400 hours to write the documentation. Do you really want an engineer spending their valuable time writing instead of the job they were hired to do?
  • Match skills with tasks. Useful documentation relies upon content organization strategies, document usability techniques, audience needs and gaps, and style guides. Without these skills, a final document can take 3x - 5x longer than outsourcing it to a technical writer who does this for a living.
  • Dedicate even more internal resources. You'll need another set of eyes to check for grammar, consistency, organization, formatting, and end-user understanding.
  • Risk reduced morale and job satisfaction.  It may frustrate your engineers to complete tasks outside of their strengths and responsibilities.
  • Uphold your product or company's reputation.  Your instructions need to be clearly written so that customers can understand how to operate or repair the product.

2. How do I justify the added investment?

The ROI for technical documentation depends on the benefits produced from the purpose of your document. For example, a complete service manual has different benefits than a quick-start guide. Either way, producing a thorough, accurate, user-friendly document can result in:

  • Reduced number of help desk calls and customer complaints.
  • Less field service engineer deployments and travel costs.
  • Faster installation time.
  • Increased customer satisfaction.
  • More time to focus on product launch. 
These benefits may be difficult to quantify in dollars, so it's important to start measuring early to get an accurate before-and-after picture.


3. How do we manage scope creep so we don't go over budget?

Typically, adding content, changing content, and switching directions all contribute to scope creep. The following conditions also pose risks to the budget and need to be addressed:

  • Lack of understanding. Stakeholders need to understand what is required to meet the project objectives to avoid inadvertently requesting deviations to the technical documentation process. Early deviations in the project schedule can have a “domino effect” on the overall timeline of the project.
  • Delays in Subject Matter Expert (SME) review. Unresponsive SMEs can bottleneck the project timeline, which may require additional resources or overtime hours to meet the deadline. 
  • Late changes to content. Edits received after the review period may require rework to changes that have already been made. This cost of rework can grow if the documentation has already been sent to translation or production. 
  • Poor communication. When working with your documentation team, it's vitally important to explicitly state expectations upfront. Lack of clear communication can lead to multiple, costly revisions.
  • Changes in stakeholders. Getting a new SME, project manager, or decision maker up to speed can add unnecessary costs to the project. Changing content, requesting more review cycles, and revisiting overall objectives not only adds costs, but can also delay the project.

Have a question about your project's budget?  Just ask! 

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Topics: outsourcing, controlling cost, product launch, Frequently Asked Questions, medical device launch, documentation, product documentation

 EU MDR