Medical Device Development Concept and Feasibility Part 1

Medical Device Development: Concept and Feasibility, Part 1

In MRO, Regulatory by Darci Diage and Therese Everson

Concept and feasibility stages in product design and development processes are not required by regulations or harmonized standards and are therefore not required. However, virtually every organization includes these phases in their design and development process. Why? The answer is, to minimize product risk during product development and to prevent unexpected failures during design verification and validation testing.

Concept and feasibility are performed in the early stages of the product design and development process. However, there is no requirement in ISO 13485 or 21 CFR 820 to perform concept or feasibility activities, yet most companies do it. You may be wondering “Should I be doing it? And if so, how much analysis and testing should I do?” Unfortunately, there is no easy cookie cutter answer. The best approach is to keep the end goal in mind: to mitigate risk to users and to prevent discovering unexpected failures during design verification and validation testing.

It’s a delicate balance between doing enough concept and feasibility activities and not doing it all. Concept and feasibility tasks do cost money and time but can add a lot of value. By implementing a risk based approach to the concept and feasibility phases, the value can pay off in time, money and potential lawsuits. Concept and feasibility can prevent the discovery of unexpected catastrophes during verification and validation testing, which would require developers to go back to the beginning of the design and development effort and start over. Unexpected failures can lead to stopping the project, a complete redesign of the product and worst of all, shelving the technology entirely.

The concept phase, sometimes referred to as ideation, typically comes first. It explores an idea for a new or modified product or a new use for an existing product to determine if the idea, or concept, is worth pursuing from company, business and market perspectives. Spending time and money on the concept phase can save companies time and money during later phases and can prevent future patent infringement lawsuits or placing a product on the market that is not medically reimbursable.

During the concept phase, a company explores the product idea from multiple perspectives, including market trends, user acceptance, competition, product risk, regulatory path, patentability and product reimbursement. The company also determines whether the product idea makes sense from a strategic standpoint (i.e., does the product fit in the company’s product portfolio).

The company explores if the product idea already has an existing patent(s). If a patent exists, are there ways to design around the patent to come up with a new patent? If a patent does not exist, can the idea be patented, and if so, in which geographies? The company also assesses if there is a market need for the product idea. If there is not a strong need for the product, the company should focus their efforts on a more acceptable product idea.

Analysis of the competition is also important during the concept phase. Is the company competing with large competitors who have a major share of the market? If so, the company will need to develop a market penetration strategy. The company should also determine if the product has an existing reimbursement code. If not, a reimbursement strategy is needed if they wish to pursue this product idea.

During the concept phase, the company evaluates the potential risks to the users of the product. If the product is considered high-risk, is the company willing to take on the risk of potential lawsuits from patient deaths and/or serious injuries?

Finally, the company assesses how the product will be regulated in various geographies. Is a clinical study needed to commercialize this product idea? Clinical studies can add 3 to 5 years to the product development timeline and often cost millions of dollars.

Be sure to look out for Part 2, where we will discuss best practices during the Feasibility Phase.

In case you missed it, you can view the first part in this series, Common Mistakes in the Medical Device Development Continuum (Infographic), here.

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Darci Diage, a Principal Medical Research Manager at NAMSA, holds a Masters of Biomedical Laboratory Science from San Francisco State University and a Bachelors of Science in Molecular Biology from Sonoma State University. Her primary expertise is in the areas of medical device quality and regulatory compliance with over 16 years of experience in the medical device industry focusing on manufacturing, design control, risk management and concept to commercial product development activities. Ms. Diage holds an ASQ Lead Auditor Certification and is currently a member of the American Society for Quality (ASQ).

Therese Everson, a Senior Principal Medical Research Manager at NAMSA, holds a Masters of Business Administration with an emphasis in Operations Management from the University of Minnesota and a Bachelor of Arts in Biology and Chemistry for the St. Thomas University. Her primary expertise is in the areas of medical device quality, regulatory compliance and clinical quality assurance, with over 28 years of experience in medical research and in the medical device industry. Ms. Everson holds the following ASQ Certifications: Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), and Certified Manager of Quality and Organization Excellence (CMQ/OE). She is currently a senior member of the American Society for Quality (ASQ).