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Articles

Disruptive Events: How Medical Device Companies Can Deal with Them Head on and Learn for the Future

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

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Articles – Video

Driving Innovation Through Changes to FDA Medical Device Regulations

The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…

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Articles

10 Tips for Leading Successful Medical Device Development Projects

Overseeing the development of a new medical device is a challenging undertaking. There are many moving parts involved in the process and risks and pitfalls…

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Case Studies

Optimized PPM Process Helps Medical Device Company Deliver Strategic Projects

The R&D team of a global medical device company was experiencing project slippage, diluted resources, prioritization problems, and too many projects within its current portfolio.…

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Case Studies

Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…

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Case Studies

Effective Project Facilitation Enables Recovery of Device Development Alliance

Project Background A biotech company formed an alliance with a large medical device manufacturer to develop and commercialize three device and reagent combination products. Cost…

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Case Studies

Early Approval of Key Biologic Product Ensured Through Professional Project Leadership

Project Background A large medical company had salvaged a medical device system from a failing company and planned to commercialize this product for new medical…

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