Process takes time and care.

Healthcare innovation is central to successful medical device companies. Premarket validation, product novelty, lifecycle management, and product iterations are segments of innovation. FDA guidance documents can guide new firms in the right direction — but they are not the end-all-be-all. Focusing too much on government buzzwords , safety and efficacy, ignores the most important part.

The latest medical device technologies need process. This term means written procedures, records, and trainings. Successful device firms must balance technology with process. While technology is exciting and gets the headlines, process is boring.

Innovation = Product x Process

Your medical device launch strategy can afford to ignore Process. For instance, a robust Quality Management System establishes a process of checks-and-balances between departments. User Requirements (a Marketing responsibility) should match the Design Outputs (a Engineering responsibility). The main reason is to mitigate risks and avoid device failures.

As The Wall Street Journal points out, unproven healthcare innovations that ignore process put people at risk.

Don’t forget this is a team sport — team meetings keep everyone informed. Regular Design Reviews ensure manufacturing best-practices, timelines are met, and product launch goes smoothly.

But back to product iterations — that is how to improve existing products. With a proper process in place complains and adverse events can be quickly analyzed and fixed. Next-generation products are able to reach the shelves faster. Effective Complaint Handling (a Quality responsibility) and adverse event trending analyses are processes that help identify weak points.

Process feedback loops trigger Change Management and Design Controls procedures, respectively. This will serve you well, for decades to come. Firms can, and should, combine impending standards and bug-fixes into a single remediation project. Combine errands today and pat yourself on the back tomorrow.

Avoiding jumbled processes — those that somehow always lead to recalls — should an objective. Without a concerted effort to write coherent procedures, organizations flounder. Employees come and go. Teams evolve. Understanding a procedure should not require legacy team members to explain them to new ones. Your Quality System must NOT make the situation worse.

Medical device regulatory strategy is easier than it sounds. With the new administration, medical equipment manufacturers could be affected as Modern Healthcare points out. Things like repealing the 2.3% Medical Device Tax would benefit start-up healthcare innovators.

Regardless of possible FDA policy changes, one thing is certain. The importance of process will remain.

Do your company a favor and start building your process ASAP. The road to innovation will not change. The sooner you realize this, the better your product will be.

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