Our initial efforts were to organize our team’s Design Inputs Requirement (DIR) documentation. This includes developing an Understanding of the needs of end users through interviews and literature reviews. It also includes initial performance specifications for the tactile display. This document is useful for the team as we can then reference it against the technical capabilities of design concepts and prototypes.

This document includes requirements for pin density, pin holding force, refresh rates, energy use, error rates per 500,000 pin presentations, maintenance requirements, likely use environmental accident scenarios, environmental durability requirements, pin head shapes, temperature requirements, Unit weight and dimension constraints, cost to manufacture, device to device interfaces, in use service life, software requirements, user interface requirements, and graphical output capacity analyses.

A Process Failure Mode and Effects Analysis process was performed. A PFMEA is one of several methods that can be used in evaluating processes as part of Risk Assessment. PFMEA is a tool used to systematically identify process characteristics that constitute risk to patient safety, product acceptance or product profitability. The objective of a PFMEA is to identify potential failure modes and establish a priority for allocating eff orts or resources to reduce the risk associated with those failures. A PFMEA may be used in conjunction with a Design Failure Mode and Effects Analysis (DFMEA).

REFERENCES

EN ISO 14971:2000; Medical Devices – Application of Risk Management to Medical Devices.

IEC 812; Analysis Technique for Reliability – Procedure for Failure Mode Effects Analysis

In parallel with development of the DIR the team invested resources to understand existing intellectual property universe around the device – both to inform us of what has been explored and to identify licensable innovation that can accelerate the development process.  Fifty-four relevant patents were identified, reviewed and analyzed. Through this process we identified IP at several companies and institutions that were of interest, entered negotiations with two entities, and licensing two patents that offered value and that could not be engineered around.