Postmarket Surveillance - Medical Device Design: Innovation from Concept to Market - page 294

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Figure 12.8
Example measles chart: (a) at the start; (b) after a few months.

Table 12.2: Example Pareto Analysis

Device (Ranked) No. of Complaints Cumulative Complaints Proportion

1 55 55 0.37

2 50 105 0.7

3 25 130 0.87

4 12 142 0.95

5 5 147 0.99

6 2 149 1

Total 149

12.3.5 Pareto Analysis
The Pareto rule is the 80/20 rule. It states that 80% of your complaints will arise from 20%
of your devices (or in the case of one device - 80% of the issues arise from 20% of the
components). To perform this analysis, collect the data as individual complaints and build a
table as illustrated by Table 12.2 .

Figure 12.9 illustrates the data in Table 12.2 plotted on a Pareto plot. Using the 80% as a
threshold demonstrates that the devices ranked as No. 1 and No. 2 require examination; this
will reduce complaints significantly.

12.4 Using Your Existing Contacts
12.4.1 Early Adopters and Key Opinion Leaders
Key opinion leaders 3 (KOLs) and early adopters (EAs) are essential allies in your battle to
achieve perfection. While it is ideal to produce a device that is 100% perfect at its first
edition, this is often unlikely. If you have a team of KOLs and EAs available to you they can
often provide excellent feedback on a potential device before it even reaches an end-user.

3 A key opinion leader is someone that all other clinicians in said field would look up to. Someone who if you said
“B has got one” they would be impressed.