This presentation was originally conducted by Pete Davis of 

Neomend at the MD&M West Conference, Feb 11 2013.  

VISIT HERE for the full presentation.

1

To err is human

Pete Davis

VP of Research & Development

Neomend a subsidiary of Bard Davol

2

Really – an R&D guy

presenting risk

analyses??

Risks exist because perfection doesn’t!

3

Communicating to

Management the Value of

Risk Management

4

5

Risk Analysis Steps

• Why Risk Management

• Why ―Communicate‖

• Doing a Hazard Analysis...quickly

• How to ―Communicate‖ to ―Them‖

6

What is important

• It’s about the Specs!

• “A problem well defined is a

problem half solved.”

• John Dewey

7

What does Quality ―control‖?

8

Quality

• Does not Design.

• Does not Manufacture.

• Does not Distribute.

• Use? Possibly.

• Words – No.

• Control? Yes.

9

Again, what does quality

―control‖?

10

Think about these?

11

Any impact on

•Customers

•Patients

•Business

•Environment

12

Thoughts?

13

• ISO 11540:1993 - Caps for writing and marking instruments

intended for use by children up to 14 years of age -- Safety

requirements

• Specifies safety requirements for cap size, ventilated caps

(vent area, air flow) and marking. Annex A describes the

test for air flow. Caps which do not comply should have

the instrument or its packaging labelled with a warning as

to the dangers of asphyxiation from pen caps.

• ASTM D4236 - 94(2005) Standard Practice for Labeling Art

Materials for Chronic Health Hazards

• Scope 1, 1.1... chronic health hazards known to be

associated with a product or product component(s), when

the component(s) is present in a physical form, volume, or

concentration that in the opinion of a toxicologist (see

2.1.11) has the potential to produce a chronic adverse

health effect(s).

Writing Instrument Standards

H

i

g

h

l

i

g

h

t

e

r

14

Importance of Risk Management

• Prepare and respond to your Customers!

• Business strategy

• Business security

• Provide a Competitive advantage

• Communicate information

• Good news

• Bad news

• Not counting everything else

– Regulatory requirement

15

Evolving Process

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Feasiblity

and Research

Prototyping Development Clincal Trial Distribution Post-Market

Survellance

Known Unknown = Risk

Risk needs a multi-functional approach!

16

New requirements

• Medical Device Directive 93/42/EEC (M5)

• Add’s Usability - See Annex I, 1st paragraph

• Subset of Risk Management

• EC 62366 - Medical devices -- Application

of usability engineering to medical devices

17

Structure

Design (ISO

14971)

Process (ISO

14971)

Usability (EC

62366)

New Risks?

Risk Analysis

process

Mitigation & Control

This presentation was originally conducted by Pete Davis of 

Neomend at the MD&M West Conference, Feb 11 2013.  

VISIT HERE for the full presentation.