Product Definition Chapter 4

What is a Medical Device? FDA: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: - recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them - intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or in the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.”

1976: The Medical Device Amendments expansion: - devices intended for use in the diagnosis of conditions other than disease, such as pregnancy, and - in vitro diagnostic products, including those previously regulated as drugs. & “significant risk” device definition

Medical Device Directives: any instrument, appliance, apparatus, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease; - diagnosis, monitoring, alleviation of or compensation for an injury or handicap;

- investigation, replacement or modification of the anatomy or of a physiological process; - control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. These definitions are critical to this course and to the following definition & design text…

Product Definition Process Where are we in the market now? Where do we want to go? How big is the potential market? What does the customer really want? How feasible is technical development? How do we get where we want to go? What are the chances of success?

Surveying the Customer Very important! Match customer needs with product concept Quality product meets customer needs Identify segments of a population with similar needs Target marketing to that group

Defining Company Needs Increases scope of consumers Takes into account market analysis to take a broader look at potential customers Includes market sizes and trends Reviews competitive and regulatory environment

Company Competencies Determine how to get ahead of competitors Examine company using same level of objectivity used when viewing competitors Examine core competencies/weaknesses Capitalize on strengths

Outside Competencies Examine strengths/weaknesses of competition Identify resources of the competition Study market shares of industry players

Completing Product Definition Consider the marketing mix of products, distribution networks, pricing structure, and overall economics Examine company issues with potential product- technologies, company fit, life cycle, differentiation Customer Market Competition (Internal look) Competition (External look) Final Company Issues Definition Complete!

Quality Function Deployment Process in which ‘voice of the customer’ is heard and deployed Orderly, four-phase process:  Planning  Designing  Constructing  Consistently constructing Distinguishes between customer attributes and technical characteristics Yes, this guy again!

QFD Process The wants of the customer Companies Begins with….. Then it links……… and assists with the planning process -Matrix format is essential to this process with

Voice of the Customer Basic input required to begin QFD Relative importance of each voice is measured by importance rating Competitive evaluation of products or services permit company to observe how its products rate on a numerical scale Customer complaints serve as an indication of dissatisfaction

Technical Information Determine how company will respond to customer voice Technical or design requirements placed on top of the matrix Center of matrix records presence and strength of relationship between customer wants and technical requirements Goals can be established for technical requirements

Example House of Quality Matrix (Mountaineering Climbing Harness) © Dr. A. J. Lowe 2000

Best tutorial is at: Before embarking on the tutorial you are encouraged to print a hardcopy of an example completed matrix and the blank matrix template (MS Word doc).hardcopy of an example completed matrix and the blank matrix template (MS Word doc)

In short, QFD process…. 9 Easy Steps Determining voice of the customer Customer Surveys Customer portion of the matrix Technical portion of the matrix Matrix analysis and selection of priority items Proposed design comparison and synthesis of the best Part planning matrix development Process planning matrix development Manufacturing planning chart development

Some final notes: QFD should be used, especially in the layout phase, to assist in the verification and validation of the product and in the minimization of stated requirements for the product.

Product Specification (via QFD): The type of product The market it addresses The function of the product The product parameters necessary to function effectively Accuracy requirements Tolerances necessary for function

Product Specification, Continued The anticipated environment for the device Cautions for anticipated misuse Safety issues Human factors issues The anticipated life of the product The reliability goal Requirements from applicable domestic or international standards.