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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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Articles

Common Regulatory Submission Pitfalls and Ways to Avoid Them

By Susan Carino, Principal Consultant, and Ruba Hadidi, Project Management Consultant Integrated Project Management Company, Inc. (IPM) No matter your company size or phase of…

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Articles

New Drug Commercialization

A Project Leadership Perspective on Approaching Market Access A new drug product launch is an exciting time for a pharmaceutical company. New product development is…

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Case Studies

Planning Helps Outdoor Power Equipment Manufacturer Launch New Product Line

A U.S.-based power tool manufacturer was becoming a victim of its own success. Known in the States and Latin America for professional power landscaping tools,…

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Case Studies

Sound Structure & Governance Prepares Start-Up for Product Manufacture

A renewable fuels start-up company had made significant advances in their research on the production of a renewable raw hydrocarbon material. They also had made…

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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

Tighter Research Processes Lead to $10 Million in New Funding for Biotech Start-Up

Project Background A start-up nanotechnology company needed to raise additional funding to continue development of its holographic optical trapping (HOT) technology. To capture investor attention,…

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Case Studies

Professional Plan and Execution Results in On-Time IND Submission and Clinical Program Initiation

Project Background A mid-size biotechnology company with multiple development candidates in their pipeline lacked an overarching strategy for moving a lead compound from selection to…

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Case Studies

Fledgling Biotech Speeds towards NDA Due to Intense Coordination Effort

Project Background A privately held, startup biopharmaceutical company had acquired a key compound for treating cancer, one of a new class of anti-cancer agents. The…

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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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