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Bay Bio: Medical Device and Therapeutic Breakfast Series
Submitted by Shannon Smith on Thu, 2009-11-05 13:02
November 10: Medical Device Breakfast Series | The Product Development Process Product development delays mean prolonged timelines and missed launch dates, which result in budget shortfalls, stunted fiscal growth, even potential company failure. At best, the impact of a delayed product launch is lost revenue and market share opportunity. As the economic climate has become more challenging, the need for a formal, flexible, and proactive development process has become key to a company’s success. Adherence to such a process maximizes efficiencies and facilitates speed-to-market while ensuring FDA and ISO compliance, but implementation and ongoing execution can be challenging. This panel will examine potential issues inherent in the creation of a robust and formal product development process (PDP) and the operational framework necessary for its success. Panelists from several medical device companies will share tips on anticipating and conquering challenges and common pitfalls, based on their own experiences. November 19: Therapeutic Breakfast Series | Running a Virtual Company All companies face daily decisions about what to activities should be contracted out. For many life sciences companies, the answer has been virtually everything, from discovery to manufacturing to clinical trials. Management in such virtual companies rely on a network of contractors to perform these key functions. This panel explores how best to balance cost vs. control and the benefits and challenges of relying on contractors and consultants. Bookmark/Search this post with: |
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Medical Device Breakfast - The Product Development Process
I am hoping that my notes and memory are going to serve me well so that I can share some of the highlights from this session with you. Regardless of which segment of the healthcare industry you work in, you'll find these project management principles helpful - or at least a good reminder.
1. Start with good data - There is always a trade off between time and cost but starting with bad data is a bad idea! Taking the time to get good data will help you make good decisions and develop a good product or deliver a good service.
2. Document what you do. - Documentation might seem like the necessary evil, but for some it can be a real advantage. Denise Zarins from Ardian shared how her team did a little extra documentation at the start and shortened their time to market when they were able to use the information for one of their trials. So long story short - regulations can be much more than a necessary evil.
3. Know your risk tolerance. - Make sure your team knows how much risk you are willing to tolerate so that your processes match your expectation. Everyone brings good ideas of how they did things other places but as the old adage goes - too many cooks in the kitchen is not necessarily a good thing.
4. Constantly look for ways to improve. Just because something worked once or it's how you've always done it doesn't make it the best way. Take time to sit down and think about what you're doing, why you're doing it and be open to change.
The ah-ha moment for me was the discussion about the size of the QSR handbook and the fact that it can fit in a coat pocket. The regulations tell you what you should achieve not how you should do it. It's up to each company to figure out how it should be done best! I'll tell you more later why this was such an ah-ha moment for me.