The Challenges Emerging for Combination Products

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The Challenges Emerging for Combination Products

 
Combination products represent a new challenge to the pharmaceutical industry in relation to how best to manage these exciting new biomechanical products.  Combination drugs, known as combination products, are biologically engineered products that represent a mixture of drug, device and in some cases other biological components, to form a single drug or product.  Combination products represent a relatively new therapeutic treatment approach, which is proving for some companies, to be a more effective way of delivering  their treatments..  Will combination products change the whole pharmaceutical and device industry as we know it, or are combination drug products just a pharmaceutical flash in the pan? This is a key question many industry analysts are asking.
 
Are combination products really this effective treatment approach of the future, as some pharmaceutical consultants and advisors are saying?  Some experts aren’t yet so sure, while others in the industry are already incorporating combination products into their primary marketing system.  In many cases, drug companies are finding combination products more appealing, for the simple fact that marketing a single combination product containing both drug and device components together, and can be significantly more cost- effective than offering either component on their own.
 
As collaboration between drug and device companies continues to grow, there would be no great surprise to some in the pharmaceutical industry, to see combination products as the primary drug delivery system of the future.  In fact, some combination products have already been in the market for years, and have already proven to be profitable.  And as more drug companies in the future begin reaching out to one another, the expectation is likely to bebetter and more cost-effective combination products on the market. 
 
Although there is little doubt that combination products may be an effective drug delivery system, it is not without its own challenges and hurdles.  And one of the biggest challenges is the difficulty between drug-device companies working together to offer the best product possible.  This can be challenging because companies need to work not only through the potential cultural differences between their two countries, but also their industries, different practices and mind-sets, as well as different business strategies. 
 
Another common challenge is appropriately recognizing target markets for which these combination products will be sold.  This can sometimes be difficult to assessas some device companies prefer to focus their marketing efforts on hospitals and different health care environments, while others typically look to focus their efforts primarily on direct consumer use. 
 
Besides problems with business strategy, the biggest challenge drug companies face are the obstacles involved with passing FDA inspections.  Regulations and FDA approval are probably the most daunting obstacles because combination products require approval from more than one FDA agency.  Also, it can be difficult to determine how certain combination products should be classified, and regulated as well as who they should primarily be marketed to, which can cause more confusion and delay production.  Regardless of all the challenges drug manufacturers need to overcome in the next few years regarding combination drug products, there is little doubt, even among skeptics, that combination drugs are a fascinating new trend in the pharmaceutical industry that is here to stay.
 
Nigel Smart
Nigel Smart is a pharmaceutical consultant and founder of the pharmaceutical consulting blog.