The document discusses the importance of product definition as the critical starting point for medical device manufacturing. It states that product definition involves developing a product strategy and plan to define target markets, customers, and competitive strengths. It also involves translating customer needs into a set of product requirements through techniques like Quality Function Deployment. The document emphasizes that properly defining requirements upfront and managing them throughout development is key to minimizing redesign iterations and ensuring medical devices can successfully navigate regulatory processes and certification.

1. StarFish Medical
www.starfishmedical.com
Product Definition Starting Point
for Medical Device Manufacturing

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Medical device manufacturing is a demanding task which begins with product definition.
This critical starting point is when the right questions are asked and answered to provide
the framework for not only manufacturing the device, but also taking it to a market where
it is positioned to fit the needs of the audience.
Product definition is a critical starting point in the development of any new product. Yet
for all its importance, there are a number of common shortcomings to the process of
product definition in many companies:
 No defined product strategy or product plan
 Lack of formal requirements as a basis for initiating product development
 Product requirements developed without true customer input
 A marketing requirement specification (MRS) that is completed late - after
development is underway
 Engineering having little or no involvement in development of MRS, thereby
lacking a true understanding of requirements
 An incomplete, ambiguous, or overly ambitious MRS
 A constantly evolving specification that requires increasing development scope
and redesign iteration
In the rush to achieve rapid time-to-market, short-cuts are often taken with the product
definition phase. The result is a product that is off target or unnecessary time is spent
with subsequent requirements definition and redesign iteration. To be successful, a
comprehensive, well-defined, continuous process is needed. The starting point is a
product strategy which defines markets so that proper customer needs can be captured.
Overall Product Strategy
The product strategy helps resolve issues related to markets, types of products and
opportunities the company will invest in, and resources required to support product
development.
More specifically, the product plan is used to:
 Define an overall strategy for products
 Define target markets, customers, competitive strengths, and a competition
strategy
 Position planned products relative to competitive products and identify what will
differentiate or distinguish these products from the competition
 Rationalize these competing development projects and establish priorities for
development projects
 Provide a high-level schedule of various development projects
 Estimate development resources and balance project resource requirements with
a budget in the overall business plan
The plan should be reviewed and updated quarterly, if not monthly, as market conditions
change and new product opportunities and technologies emerge. All opportunities need
to be evaluated and changes made to the product plan if necessary to optimize new
opportunities.
Product requirements
Product requirements are often expressed in the form of a product specification,
functional specification, or marketing requirements specification. In addition to
performance requirements and technical characteristics, a comprehensive specification

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would also address ease of use, ergonomics, styling and aesthetic, robustness, reliability
and servicing, the product operating environment or conditions of use, life cycle costs,
and packaging.
Product Plan
A business strategy which defines customers and markets to be served, competitors, and
competitive strengths provides a framework from which to evaluate potential
opportunities. Getting the device right the first time results from diligence in field studies,
interviews and competitive analysis of the user and their environment.
Traditionally, Marketing has had responsibility for defining customer needs and product
requirements but engineering should also be involved in this process to gain a first hand
understanding of needs. It is necessary to identify customer needs, environment and
product use to provide a better perspective for development decisions. Quite often, the
customer is more interested in ease of use and durability than the latest technology.
Customer needs are then translated into a set of product requirements that can be
acted upon by Engineering. Quality Function Deployment (QFD) is an excellent
methodology to support this objective while considering the competitive situation.
QFD is a structured planning and decision-making methodology for capturing
customer needs and translating those requirements into product requirements, part
characteristics, and process plans. QFD was developed to bring this personal
interface to modern manufacturing and business. In today's industrial society,
where the growing distance between producers and users is a concern, QFD links
the needs of the customer (end user) with design, development, engineering,
manufacturing, and service functions.
QFD provides a system of comprehensive development process for:
 Understanding 'true' customer needs from the customer's perspective
 What 'value' means to the customer, from the customer's perspective
 Understanding how customers or end users become interested, choose,
and are satisfied
 Analyzing how we know the needs of the customer
 Deciding what features to include
 Determining what level of performance to deliver
 Intelligently linking the needs of the customer with design, development,
engineering, manufacturing, and service functions
Designing to maximize intellectual property while identifying constraints
Several factors are considered when exploring the strength of any potential intellectual
property, such as differences between the current technology and other patented or
available technologies, the type and strength of patent claims that will likely be available,
how crowded the IP landscape is, and the ability to seek IP protection outside the U.S.
Market Analysis and Business Risk
A comprehensive review of the relevant market for potential products that could come out
of the intellectual property is conducted. This analysis estimates the size of the market,
the market impact of the product, the market growth rate, and the current market state.
Other associated potential market factors, such as market margins and current market
segmentation also play key determination roles in this process. The market analysis also
considers whether the market is ready for entry of this particular type of technology, i.e.

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whether there is existing infrastructure. The intention of the analysis is to determine the
market strength of an invention and whether IP protection would likely result in a
licensed, commercial product.
Successfully Navigate Regulatory Hurdles for High Quality, Safe and Certified
Medical Devices
The development, manufacturing, marketing and sale ofmedical devices are highly regulated.
This can be a complex area.
Best practice steps include:
 Defining your regulatory pathway in the jurisdictions of interest
 Developing a regulatory strategy
 Investigational testing and device license applications
 Creating and running all verification testing protocols
 Product validation
 Clinical trials
 Electrical safety certifications (e.g. IEC 60601)
 Preparing technical file and regulatory submissions
 ISO 13485 and FDA compliant processes and documentation for all stages of your
project, including:
 Policy and Procedures
 Forms
 Log Checklists
 Work Instructions
 An audit dry run by a quality control expert prior to ISO 13485 certification audit
Product definition management
Once requirements for a product are defined, they must be managed and kept stable.
When requirements are a moving target, the redesign iterations severely impact time-to-
market. To minimize the impact on time-to-market and more rigorously manage
requirements or specifications, establish realistic requirements at the start and make
necessary changes. Avoid a tendency to proceed with the design before requirements
are completely defined. Document requirements to communicate and develop a
consistent understanding. Carefully consider the need to change requirements after
development has started.
Product definition includes the proof of concept and renderings that make the value
stream clear and add impact to investor financing presentations. It's often surprising how
useful the results are in bringing your business plan alive.
StarFish Medical is registered with both Health Canada and the FDA. As an ISO 13485
certified manufacturing facility, you can count on a reliable, responsive and transparent
operation following exacting procedures that result in a consistent, quality product. Our
procedures, documentation and quality management systems will provide assurance to
your product launch team and medical device investors.
StarFish Medical www.starfishmedical.com