Strategy 2 Market Introduces a Workshop to Help Medical Device Companies Address Confusion on Product Development Lean and Agile Techniques

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Strategy 2 Market developed a 2-day Workshop to assist with the confusion that many medical device companies still have about the integration of lean and agile techniques in their product development process.

Therese Graff, Partner. Strategy 2 Market

Therese Graff, Partner. Strategy 2 Market

After almost 20 years, many medical device companies are still confused on how to integrate lean and agile techniques in their product development process. Strategy 2 Market introduces a new offering to address this.

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Strategy 2 Market finds that medical device companies are confused on whether or not they can use lean and agile techniques when developing products because of design controls. Lean and agile techniques can help these companies get their products to market faster. Delay affects both the medical device company’s bottom-line and its strategic advantage in the marketplace.

FDA and ISO 13485 regulations do not prevent integration of lean and agile methods into medical devices processes. When design controls were implemented in 1997, the FDA released a guidance document that included a waterfall development process. Many medical device product developers believe the FDA expects them to use this waterfall process. Actually, the FDA doesn’t mandate any specific product development methodology.

This is what the FDA expects: Document how lean and agile will be used in the project, then follow it. Therefore, product development processes can integrate lean and agile techniques.

After almost 20 years, many medical device companies still don’t know how to integrate lean and agile techniques in their product development process.

Strategy 2 Market developed a new offering: a 2-day workshop that will clearly illustrate how to navigate FDA regulations and ISO requirements using lean and agile techniques for medical device companies. This workshop will led by medical device expert, Therese Graff, Partner at Strategy 2 Market.

Strategy 2 Market (http://www.strategy2market.com) is a product development consulting firm specializing in helping medical device and industrial companies decrease product development complexity and increase growth.

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Kathy Morrissey
@strategy2market
since: 04/2010
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