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Product definition starting point for medical device manufacturing


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Product definition starting point for medical device manufacturing

  1. 1. StarFish Medical Product Definition Starting Point for Medical Device Manufacturing
  2. 2. 2 | P a g e 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
  3. 3. 3 | P a g e 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.
  4. 4. 4 | P a g e 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