Human Factors Review

1. The Unmet Need

Clearly define the clinical problem both qualitatively and quantitatively. Consider:

  • What customer need(s) does this product address?
  • What product family does it fall into?
  • What is the general workflow in which the product would be involved?

2. Stakeholder map

Medical devices typically have a complex stakeholder map. When you go to a store, you make a decision to purchase a product, you buy the product and then you use it. For medical devices, however, there are often three different people who do each of these tasks. A hospital executive may make a purchasing decision, a procurement person may do the buying, and then a nurse may be the actual end user. Understanding all the stakeholders involved in your commercial product is critical.

stakeholderDiagram.png

First consider:

  • Who uses this product family today?
  • Who are we targeting? 
  • Who are the clinical champions and who are the other key decision makers in the purchasing process?

Now fill out this table. Document a key stakeholder in each row:

Stakeholder
Role
Obstacles to Adoption
Current Practices/Motivators
e.g. Surgeon
e.g. Person using the tool
e.g. Quick learning curve, efficient usage
e.g. Manually complete task, which takes a lot of time

Finally, for each row build a target customer persona. Make each of your personas come alive by selecting a name, representative picture and developing an appropriate history for each persona. Describe each person's pain points and motivations. You'll return to these personas often since you'll be developing your product for them.

3. Completed User Research

Throughout your development process it is critical that you work closely with your future customers to ensure that your product works for them. Please document the learnings from the conversations you've had so far with future customers. Consider:

  • What has resonated? What hasn't?
  • What design decisions have you made as a result of your conversations?
  • What have you learned about the dynamics amongst your projected stakeholders?

Please use this table to communicate your learnings:

Date
Research Type
Findings
Participants
e.g. March 2016
e.g. In-person 1:1 conversations
e.g. Surgeons rely heavily on assistants to get tools ready
e.g. 5 surgeons

4. Planned User Research 

Since research should never end, please document what you plan to do in the near future. Here is a table to help:

Projected Date
Research Type
Purpose
Esimated Costs
e.g. December 2016
e.g. Online Survey with 100 surgeons
e.g. To inform design details of our commercial product
e.g. $2500 ($25/surgeon)
 

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