Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 97

7 Packaging and Transportation:

7.1 Supplied to end-user as single items Initial focus group

7.2 Packaging to protect stab point

7.3 Packaging to protect sharp cutting

edges

7.4 Standard tube 200 × 10 mm

7.5 Label to state nonsterile 93/42/EC

CFR 21

7.6 Label to state manufacturer's

name, date of packaging, CE
mark, lot number

93/42/EC
CFR 21
BS ISO 15223-2:2010

8 Environmental:

8.1 Packaging to be recyclable (if

possible)

8.2 Invasive device, disposed as

clinical sharp

Approved/Not Approved
Signed
Date
PDS.doc

version 1.0 Approved by:

Date: 17.5.2010

Case Study 5.4
Using the information gathered for Case Study 5.3, repeat the exercise but ignore the fact that
they have asked for a drill bit - imagine that they have requested an item to produce a hole of
4.8 mm dia. but do not stipulate a method. How does this change the PDS?
Notice that this case study removes the “sacred cow” of a drill bit. There are many other ways to
produce a hole … and this PDS does not limit the solution.

Table 5.10: Example PDS for a Device to Produce a 4.8 mm dia. Hole

MedicalDeviceCo Inc.
Product Design Specification Originator PJO Date 21/8/11
Project Number/Part Number 04801 Version: 1.0
Product Title: Device to produce a 4.8 mm hole
Summary
This specification is for a reusable device for producing 4.8 mm dia. holes in human bone.
It is estimated that this device is a transient, invasive device but is one that is reusable ; hence it is a reusable
surgical instrument class I .