Welcome back to MedTech Compliance Chronicles! Continuing our journey through the Quality Management System (QMS), we shift our focus towards a pivotal aspect: planning for product realization. Planning everything up-front is in general a good idea but in the medical device industry it is also a legal requirement. You must plan and document everything that you do when designing, testing and releasing your product.
Planning for product realization is crucial because it ensures that all aspects of a medical device's design, development, and manufacturing are thoughtfully considered and documented. This structured approach helps identify potential risks, resource needs, and regulatory requirements early on, enabling effective mitigation strategies and ensuring compliance. By meticulously planning each stage, manufacturers can improve efficiency, enhance product quality, and ultimately ensure the safety and efficacy of medical devices, aligning with both patient needs and regulatory expectations.
This is another situation where the FDA requirement is relatively short but ISO provides a much more in-depth set of requirements that better helps you meet regulatory expectations. From an FDA standpoint, the requirement is simply to establish and maintain plans for design and development activities which includes identifying ‘interfaces with different groups or activities that provide or result in input to the design and development process.’ That is a lot of unspecific language that probably seems really confusing if this is your first time reading it. ISO helps flush this out a little bit more by boiling it down to determining the requirements for your product, which will include documentation, processes and resources. A lot of the specific requirements around these have already been covered in previous posts so this post will focus on specific considerations for determining which and what kind of requirements are applicable to your product. In general, you must take at a minimum customer, product and regulatory requirements into consideration.
Customer Requirements
The first set of requirements for planning product realization are those related to customers. Determining customer requirements for a medical device involves collecting and analyzing input from end-users, healthcare professionals, and market research. Companies often use surveys, interviews, focus groups, and feedback from clinical trials to gather insights. Documented customer requirements can come from formal documentation provided by clients in business to business transactions or derived from market research and user feedback in business to customer scenarios. For example a hospital might provide a medical device manufacturer with a requirements document for a surgical instrument or parents of diabetic children might express a need for a more child-friendly glucose monitoring device that is less intimidating and easier for children to use on their own.
Now you may be wondering “what about if I don’t have a formal documented requirement from a customer yet?” No worries, there are ways to determine what customers need without necessarily hearing it directly from them. When explicit documentation from customers isn't available, companies validate requirements through prototypes, usability testing, and direct consultations, ensuring the product meets the anticipated needs and usage conditions of the end-users. You can also partner with healthcare providers, patient advocacy groups, or research institutions that already have IRB(independent review board)-approved studies or patient outreach programs. There are still many options but whatever path you take you must include and document customer requirements into product realization planning.
Product & Regulatory Requirements
The next set of requirements that you must take into account are the requirements of the product itself. The customer requirements should make up a lot of these, as the product is being made for the customer. Your technical specifications will make up much of the rest. One thing not to forget here though is that product requirements are not only requirements related to the physical product itself but also everything that is involved in producing, storing and transporting of the product and any documentation required for all of this. The specifics related to much of these requirements have already been discussed in prior posts about resource and document requirements.
Regulatory requirements are another major source of requirements that must be accounted for when planning for product realization. I will not go into depth on regulatory requirements as a whole here because the topic is far too vast, this entire blog series is about meeting regulatory requirements set forth by the US FDA. Just remember that if you are a manufacturer of a medical device, you must thoroughly research the laws of any nation you plan on marketing that device in to determine if they regulate medical devices and, if they do, what the requirements of those regulations are.
Conclusion
I hope you now have a better understanding of what you must do when planning to develop a new product. Always remember that the customer is first, if your product does not meet their needs you will not have a business. For product requirements the emphasis is thinking about it holistically, every aspect from the supply chain of the raw materials and components to calibrating the equipment you use to inspect it must be thought out. As with everything in the QMS, all of this must be documented, reviewed and approved.
One final requirement of planning for product realization that was not covered in this post is risk management. Risk management is quite a large topic so that will get a whole post for itself next week. See you then!
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