No medical device startup will hear any argument from us that the development of your device is Job One—as it should be. It is what drives you and your team, and if it goes well, that device could provide new care for the patients you’re trying to reach, while elevating your corporate and individual roles in the global med tech community. Yet, for all the possibilities, many medical device startups fall prey to a single risk that, if not realized and addressed, can significantly (and negatively) change the trajectory of a successful market launch. That risk is the failure to prioritize packaging design as a key—and parallel—component of the medical device development process.
Picture a Google search, say, “key factors in medical device development,” or “top medical device startup mistakes.” We tried it and received “9,700,000,000 results in 0.59 seconds.” What we discovered on multiple click-throughs was this: not one of the industry resources we sampled even alluded to medical packaging design in its guidance to those embarking on the journey. While this might seem to corroborate a laissez faire approach, we maintain that the opposite is true.
At Oliver Healthcare Packaging, we see many instances of dismay, delay and higher costs suffered by underestimating the complexities of packaging and leading to challenging, sometimes disastrous, outcomes. Educating your team on exactly what packaging “does” is the first step to avoiding problems.
Medical packaging systems must do many things – and it is important to understand ISO11607 inside and out. The top performance requirements are:
- Compliance with (changing) FDA, MDR and other regulations
- Protecting the product from physical damage
- Maintaining sterility up to the point of use
- Ensuring aseptic presentation for patient safety
- Validation of the manufacturing process
Another major packaging consideration is also coming into view. Increasing calls for environmental stewardship and sustainability in medical packaging are gaining momentum. As global (and regulatory) attention to earth ethics grows, we are already seeing new and sometimes confusing carbon footprint and materials data emerging. As this guidance evolves, we should anticipate that it will impact medical device packaging design—and lead times.
The sooner the real risks of packaging procrastination are understood, the sooner the benefits become clear: Engaging a packaging expert early allows the design to be optimized for your product footprint—and can accommodate tweaks along the way. This kind of collaborative workflow realizes cost savings through the entire supply chain, from material to distribution.
Oliver Healthcare Packaging thrives on the excitement and inspiration of our client innovations. It’s a privilege to be trusted with major responsibilities and collaborative relationships where we can help you get to launch. For additional information and resources, please visit our website or contact Connie Anderson (canderson@oliverhcp.com) with your packaging needs.