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…
Read More »
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…
Read More »
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…
Read More »
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…
Read More »
An Insider’s Approach to medical device vendor selection + Resources
The first step to selecting the right fit vendor for your medical device project is to determine exactly what you need from your vendor. The next step — gather information on potential medical device vendors from the market to select the best vendor from the lot. Doing this research will not only help you come up with a list of potential vendors that closely match your requirements but also help you: Recently we talked about establishing a networking tree to gather current industry feedback on medical device vendors. Here are…
Read More »
Vendor Evaluation Matrix for Your Medical Device Company: What You Need To Know
Choosing the best vendor for your medical device project requires you to do a thorough vendor evaluation and understand every vendor’s potential. How do they fit into your needs? How do they compare and contrast with each other? What are their key strengths? Will they complement your company, objectives, and culture? How about their impact on your profit margins? If you have more than one vendor or supplier that fits the bill, you need to select the best one for the job. For the rest, you can create a comprehensive…
Read More »
Essential Elements and Stages Of A Medical Device Development Project
There are a lot of complex moving parts in all the stages of a medical device development project. Plus, the exact process for development projects differs across companies, industries, and regions. Market and regulatory requirements that hold true for European companies may not be applicable for a company in the USA. A company located elsewhere but wanting to market to Europe would have different requirements. And so on. As a result, no two medical device development projects are the same. But there’s one thing they all share. Any medical device development…
Read More »
So you want to make a Medical Device . . .
We help inventors navigate the rigorous steps needed to get their medical device products to the market. We often meet people who have an idea for a medical device. They have identified a problem that they want to solve and have set about inventing a potential solution to that problem. But what then? How do you get that idea to market? Waddell Group is a part of the Medical Device Resources Group, a consortium of businesses that help inventors get their medical device through the many steps it takes to…
Read More »