Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Planning for Outsourced Technical Documentation Services in Medical Device Companies

product_manager_internal_commAll product managers have carefully designed plans and well thought out strategies to achieving objectives. For medical device manufacturers, technical documentation should be one of those carefully planned strategies needed to achieve product success and regulatory compliance. And a technical writing team is a key player in achieving that goal.

Outsourcing these technical documentation projects is a decision many medical device companies make in order to stay on budget and on schedule. Project planning becomes even more important when manufacturers decide to outsource because it ensures both organizations are on the same page and understand what need the final documentation is serving. The more the technical writing team knows what is expected of them, the fewer problems arise.

Below are a few key phases to successfully planning your outsourced documentation project:

1. Prior to meeting with your outsourced team, outline project details.

Before bringing choosing an outsourcing partner, it's important to develop the initial plan for your project. Having these details in order will help you and a technical writing team determine how collaboration will best work:

  • Objectives
  • Scope
  • Schedule
  • Key expectations
  • Deliverables
  • Costs involved

2. Make sure your in-house team and your outsourced professionals can answer the key questions.

Both your in-house development team and the outsourced technical writing team you've hired should be able to answer the following questions about the project:

  • What needs to be accomplished?
  • What are the deliverables, and what is their expected delivery timeline?
  • What tasks must be completed to achieve the desired result?
  • What resources are required and who will perform each task (for example, the project manager, subject matter expert, writer, graphic designer, and technical editor)?
  • Are there any standards and/or regulations that must be followed?
  • What is the process for overseeing the work?

3. Create a Statement of Work (SOW) for better project execution.

For outsourced technical writing projects, an SOW is one of the most important project components.It defines and identifies the project’s expectations and objectives in writing for both the client and the vendor. To create an effective Statement of Work:

  • Choose a template and start creating the SOW before you need it to give yourself time to customize the agreement and reduce the chance of leaving out critical information.
  • Use simple direct language and be consistent with terminology. Avoid words with multiple interpretations that could cause misunderstandings. Do not use different terms for the same item.
  • Outline individual responsibilities for each team member carefully and specifically. Use the term shall to identify mandated actions, rather than inferring responsibilities.
  • Spell out all standards and regulations to be followed. This is especially critical for clients that operate in a regulated environment such as medical devices and manufacturing.
  • Identify all style guides to be followed, such as corporate or commercial style guides with version control.
  • Include Standards of Measurements to make performance measurements and acceptance possible and meaningful.
  • Do not over specify or over state. Depending upon the nature of the work to be completed, and the type of contract, the ideal situation may be to specify the deliverables or results required and let the vendor propose the best method.
  • Obtain proper sign-offs from authorized client and vendor representatives to verify that the terms of the SOW are acceptable and each are acting with proper authority from their respective company.
Use our Statement of Work template to get started. Download the template.

 4. Add a technical editor to your documentation team.

It is important to incorporate an editing phase into all of your documentation projects. A technical editor increases the credibility and professionalism of the entire process. As an independent member of the documentation team, the technical editor provides value-added support to guard against publishing that could compromise your products, embarrass your company, and lose customers. To effectively bring a technical editor on to the team:
  • Define the editor’s responsibilities and explain how errors caught by the editor early in the development stage, when they are less expensive to correct, can significantly impact the company’s bottom line.
  • Remember that saving the other writer's time will also impact the company's bottom line.
  • Determine how the editor's time can be easily and best leveraged projects.
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Topics: outsourcing, technical writing