Device Development and Risk management

Question 1

What stages are involved in traditional product development ?

Answer 1

Conceptualisation
Research
Analysis
Development
Launch

Question 2

What stages might be relevant to medical devices ?

Answer 2

Concept
Feasibility
Design Validation and preclinical studies
Clinical studies
Market approval
Post market approval

Question 3

What might be involved at the concept stage ?

Answer 3

Market trends, competition analysis, regulations, patentability, product risk (to users and shareholders) and user acceptance.

Question 4

What might be involved in the feasibility stage ?

Answer 4

Determining a plan for scope and outcomes, determine product to risk ratio and plausibility of manufacturing. Several design concepts and test prototypes.

Question 5

What might be involved in design validation and preclinical stages ?

Answer 5

Product Materials selection (including packaging materials), manufacturing methods, study design for the study, biocompatibility testing and pre-planning of regulation submissions.

Question 6

What might be involved in the clinical studies phase ?

Answer 6

Development of a protocol and selection of a clinical site. Data collection and study monitoring

Question 7

What be involved at the market approval and post market approval stages ?

Answer 7

FDA regulatory submissions, monitoring safety of the device, planning of post market research

Question 8

What is TRL and how do agile scrum frameworks function ?

Answer 8

TRL is the technology readiness scale usually scored between 1 (basic principles) and 9 (actual system proved in operational environment). An agile scrum works using a product owner who takes information from the stakeholders, a scrum master who leads team meeting each day and workers who are exclusively focussed on small tasks set to them each week.

Question 9

What is risk ?

Answer 9

exposure to danger, injury or loss

Question 10

What may be the stages involved in a risk management framework for a medical device?

Answer 10

Specifying intended use of device
Identification of hazards
Estimate and evaluate risk and find ways to control / minimise risks
Determine if remaining risks are acceptable and produce a risk report.

Question 11

What is an FMEA ?

Answer 11

FMEA - Failure mode and effects analysis. What can go wrong weighted by its occurrence, severity and overall detectability.