Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 96

4 Performance:

4.1 Drill time in bone to be no worse

than existing 4.8 mm drills

4.2 Drill to perform consistently for 25

individual uses

4.3 Breaking torque to be no worse

than existing 4.8 drills

4.4 Bending strength to be no worse

than existing 4.8 drills

4.5 “Point” to locate hole securely to

within ± 1 mm

5 Sales:

5.1 Sales cost c £40 (gross margin

60%)

Sales report

5.2 Estimate 100 sold per month Sales report

5.3 Should fit in std Jacob's Chuck Sales report/follow-up

focus group

5.4 Packaging to be minimal Sales report

5.5 Would be good to have a mark

every 5 mm between 60-90 mm to
estimate drill depth (UPS against
other drills)

Sales report

5.6 Can the flutes be gold in color to

match market leader?

Sales report

6 Manufacturing:

6.1 Invasive hence restricted to ISO

13485 subcontractors

Company policy

6.2 Device to be supplied clean in

batches

Standards review

6.3 Sharp edges to be protected

6.4 Finish to be to standard Standards review

ASTM F86-04
ISO 9714-1:1991
BS 3531-5.5:1990
BS 7254-2:1990

6.5 No animal products to be used in

manufacturing

6.6 Device to be laser marked with CE

mark, dia., company logo, part
number, and lot number.

Standards review
93/42/EC
ASTM F86-04
ASTM F983-86

6.7 Materials restricted by standards ISO 7153

ASTM F899-09