Each sector of the research industry faces its own unique challenges. For instance, take clinical research involving drugs versus devices. While some aspects of the research process and clinical trial are the same, their differences require special attention to have a compliant and well-controlled study. Likewise, an article titled, “Combating the challenges of medical device development,” investigates how medical device development is similar to other product development- but still faces unique challenges.
The article lists the following challenges that are specific to the medical device industry:
- Strict regulatory regimes that demand proof of compliance and vary between markets
- Potentially significant damage if you fall foul of regulatory bodies
- Need to show traceability from user needs right through to delivered products
- Need to have systems in place to ensure customer requests/complaints are managed and, if necessary, changes made to products
- Everything needs to be documented and reported
The amount of regulation that is involved in device development definitely sets the industry apart. On top of this list, pile on another set of complications, including:
- Increased competition
- Need to sell into global markets
- Need to shorten development time and time to market
It’s obvious the pathway to approval isn’t exactly broad and easy. Then again, the patients on the other end of approval deserve something that is proven safe and effective. While they may seem like burdens or obstacles these challenges ultimately help the people who will receive them.
What are your thoughts on device development? Can you think of any other unique challenges to add to the list? Let us know below.
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