Effective Guidelines to Launch a Medical Device Product

Developing and commercializing a new product is an exciting and dynamic process. Unfortunately, more products fail to launch than actually do launch and many times this is due to poor project management, rather than the product itself. Boyd Biomedical has helped customers effectively and efficiently navigate the hurdles to commercialization and in the process, we have developed some guidelines to help teams with this process.

Effectively managing these 3 hurdles will help your team stay on track to success during your next product launch.   

• Set a Realistic Timeline
• Choose Great Material Suppliers
• Follow Standard Operating Procedures

Practicing these steps over and over will help you refine these steps in the context of your own business and become more efficient with the process.

Set Realistic Timelines

To ensure success, make realistic goals that are communicated and updated regularly within the team. We all want to cross the finish line first, but setting an unrealistic timeline is a sure way to cause concern for your customer and frustration within your team. Being aggressive and setting stretch goals is important, however promising your customer results that you can’t realistically deliver will only undermine the project. It is always better to under-promise and over-deliver.

A typical timeline for receiving roll samples of advanced flexible materials tend to be in the 8 -12 week range, but can be a lot more than that for some materials that have higher demands. Our engineering team has seen lead times as long as 26 weeks for some specialized flexible materials. An equipment or tooling timeline can also vary greatly. Simple dies and other parts can often be delivered in as little as a few weeks, while more complex tools and modules can take 8 weeks or longer.

Developing a new product will take input from a team. Remember that every department and team member is dealing with their own sets of variables and corresponding timelines. Holding a project launch meeting will help with assigning the initial workload, but it doesn’t end there. Involve your quality and regulatory teams early so that they can listen for any details that might need extra attention, and support the team with good documentation practices.

Choose Great Material Suppliers

When sourcing advanced flexible materials it is critical that you know everything you can about the materials that will be in your product. We find it useful to keep these simple questions in mind:

• Where is the supplier located? Does that match your logistics requirements?
• Does the manufacturing facility and its controlled processes align with the regulatory and quality requirements of your company?
• How does the supplier handle quality and change controls with their own suppliers? (keep in mind, tertiary suppliers can cause long-term issues if they are not aligned with the requirements of the finished product).

Choosing a supplier that understands your application and has a comprehensive understanding of the quality and regulatory landscape is a critical success factor for commercialization projects that use advanced flexible materials.

The critical importance and difficult nature of choosing a great supplier is a point that cannot be overemphasized. Overcoming this challenge and reducing mismatches between suppliers and customers is one of the main reasons we developed our material sourcing library. 

Follow SOPs

When capturing and recording the information for a new product there is no detail too small. At first, you may feel like pressing a new customer for more details is going to annoy the customer, but if they are serious about developing the product, they will appreciate the attention to detail. This initial focus will show your commitment to being a focused and effective partner. The gathering of information will benefit customers and suppliers alike.

All the detail in the world will be useless if it’s not captured in some system, or systems, where every member of the team can review and act on the information relevant to their part in the project. Customer Relationship Management systems (CRM) are usually very effective - as are stand-alone project management systems. There are a number of very good systems available that will allow sales, engineering, material sourcing, and management teams to capture, view, and track projects. We recommend a system be used to facilitate the project from start to finish.

With an established system in place to manage your projects, you can then begin to focus your standardization on smaller tools that will help you gather and utilize information effectively and efficiently. Focus first on re-occurring elements of your projects. For instance, if you sterilize all of your products you know this is information you will be gathering all the time. Find an effective way to accurately and efficiently collect the information you know you will be gathering regularly. 

Conclusion

Developing and commercializing a new product is exciting. We've learned by doing this over and over with our clients at Boyd Biomedical and have developed some guidelines to help teams navigate this process. Effectively managing these 3 hurdles will help your team stay on track to success during your next product launch.  Remember to practice these steps so your team can become more efficient and effective.  

• Set a Realistic Timeline
• Choose Great Material Suppliers
• Follow Standard Operating Procedures