Why you should know your regulatory requirements before starting a medical device project
When you build(or buy!) a house, you make sure the foundations are in place before starting anything else. The same goes for starting a new medical device project. And one of the major foundational pieces for starting a new medical device project is to know your regulatory requirements. Ignoring or misunderstanding these requirements can lead to significant setbacks, financial penalties, and even project failure. Here’s why knowing your regulatory requirements at the beginning of a project is important Knowing your regulatory requirements helps you avoid market entry barriers Ignoring regulatory…
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How not to screw up getting your medical device to market on time.
Our clients have shared with us the most important questions they have regarding project management. The first one is, how do we make sure we get the medical device to market on time? That’s clearly our client’s number one priority, as medical device development (for products to sell) drives a medical device company’s top line in years to come. When a project is delayed, it can remove the product from the market completely as it may already be obsolete due to evolving market needs and advancements by competitors. When writing…
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Why is it better to have a project manager with experience in medical device development
When you have a GI tract issue, do you go to a gastroenterologist or a general practitioner? If you want to handle a property dispute, would you go to a real estate attorney or a general practice attorney? Now, think about your medical device project. If you want a project manager for it, would you prefer a typical project manager or a project manager with experience in the medical device industry? The math is simple. If you want the best service, you need to go to people who specialize in…
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Cost-Effective Strategies for Developing Medical Devices
Many companies make this mistake when it comes to cost-effective strategies for developing medical devices. The mistake; thinking cost-effective strategies equal cost-cutting. Or at least include cost-cutting. This is not necessarily the case. Sometimes, cost-cutting is the last thing you should do when it comes to medical device development. This article discusses some cost-effective development strategies that may seem counterintuitive. However, we have spent 20 years trying and testing these strategies in the medical device industry with great success. We can assure you they work. Cost-Effective Strategies for Developing Medical…
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