Launching a medical product is not the same as launching a widget. Your plastic parts company should have medical device-specific processes and knowledge to set your launch up for success. Medical device product development can be time-consuming and expensive, but a successful product launch can generate significant profits and gains in market share. Speed and accuracy are critical. When you work with a plastics parts company that understands the intricacies of launching a medical product, you will have increased success and will get to market faster with the potential to generate greater revenue.
A Gartner study showed that 45 percent of product launches are delayed by at least a month, with reasons that include a lack of a formal launch process and delays in product development. This can have a significant impact on revenue. Research has demonstrated that a product forecasted to reach peak sales of $100 million can expect a $17 million loss in revenue over the product’s life if the launch is delayed by two months. However, launching six months early could result in up to a nearly $50 million gain. Big money is at stake for getting the launch right and moving from low-volume production to high-volume.
Your product manager may have a formal launch plan with all the i’s dotted at t’s crossed. However, if your plastic injection molder doesn’t have experience with medical device manufacturing, has a poor on-time delivery track record, or struggles to meet quality requirements, all that planning means little. There are several reasons why delays can occur that deserve greater exploration.
Communication and coordination between your plastic parts company and the injection molder are, without debate, critical. But communication and coordination between the internal departments within the injection molder can also significantly impact your product’s launch success.
Transparency from your injection molder should be a given, but unfortunately, this is not always the case. Concerns and problems, as well as fresh ideas and potential improvement opportunities, should be communicated with you. You can’t help to come up with a solution if you don’t know there is an issue. It will also allow you to adjust your timeline and company expectations if required.
A successful product launch also requires cross-functional coordination and communication from the injection molder. Sales, engineering, tool designers, process development, operations, quality, purchasing, finance, and shipping & receiving all play a role, whether large or small, in ensuring your project stays on schedule. Coordination is required between departments from when you discuss your project with a salesperson until the final product ships. When there is a lack of coordination and communication, your project could be left in chaos. Having a single point person within the injection molding company who can coordinate the project is helpful.
Even injection molders with an excellent track record for product launches and ISO 9001 certification can face challenges if their expertise is not with medical devices. There is a steep learning curve for molders new to the industry that you probably don’t want to happen while they are manufacturing your product. A lack of understanding of regulatory requirements could delay filings and approvals. Some required elements that might not be understood are knowing what resins are acceptable for medical devices, ensuring proper equipment validation is performed, and following documentation requirements.
There are a few things you will notice immediately about injection molders that do have medical device experience. Injection molders with medical device experience will understand the importance of certifying to ISO 13485, an international quality standard for medical devices. They will also have clean rooms for manufacturing, and if they are doing assembly will have FDA registration so that they can be listed as the manufacturer of record.
It is easy to get caught up in what you need to do to launch your product immediately. Often when working with a low-volume injection molder at the beginning of your product journey, that is all that matters because getting to market fast will generate revenue quickly.
But fast forward, your product has taken off, and demand is increasing. While your injection molder was great for your low- and mid-volume production needs, they are nearing capacity. It’s time to move to a high-volume injection molder. Because if customers who have an immediate need are faced with waiting for a back-ordered product or finding a similar product, they will look for a similar product that will perform the same function. And you could start losing customers and revenue opportunities. However, when you move your project, you soon find out your new injection molder is running into some of the same issues your previous molder faced. Its dé jà vu, expect this time it is happening with thousands of parts. Your low-volume molder wasn’t transparent with program information, and now, when even more revenue is at stake, you are facing delays.
At Omega Plastics, we can help you launch products faster and more effectively than other injection molders because we have implemented processes to help our customers succeed. Speed is at the forefront of our minds; whether it’s engineering changes, capacity management for quick turn tooling, reporting, or any other component in our processes, we work to decrease your time to market.
We want you to see us as your recipe for success. Not every medical device manufacturer has the exact needs – some need full service some just need lab work and metrology reports. Therefore, we want you to use our services where we will work best for you, whether you are taking advantage of our “bridge to production” or a la carte services.
We know that collaboration and transparency are critical. Our development systems are designed to capture and share data, including design for manufacturability (DFM), MoldFlow analysis and tool designs, lessons learned, production opportunities and recommendations, and manufacturing and inspection data. The transition will be seamless when it is time to move to large-scale production.
We have so much more to offer medical device manufacturers launching injection molded products. Contact us to learn what we can do to make your launch successful.