Product Creation – 4 Requirements of Product Creation

A few years ago, the idea of integrating Internet capability, a camera and a video and audio player into a single compact device based on a cell phone was very appealing but hard, if not impossible to imagine. Now, there’s Apple’s iPhone and any number of competing devices that made that possibility an affordable, common reality. Converging different technologies into one single product is not confined to consumer and entertainment products anymore, either. Various industries, and in particular the pharmaceutical and medical device segments, are finding innovative means to deliver multi-functional healthcare products. It is a trend that has been developing for a few years now, and the stage is set for solid growth.

Engineered from a mix of drug, device, or biologic components to form a single product, combination products represent a relatively new therapeutic and treatment approach, which is proving to be more effective for both pharmaceutical and device companies. Drug-device combinations are more appealing to both healthcare sectors simply because, in many cases, a single combination product containing both drug and device components can be more effective than either one of the components acting alone.

Drug-eluting stints are 레플리카쇼핑몰 prime examples of such combination products. Approved by the FDA in 2003, the Cypher Sirolimus-eluting stint was designed to prevent or minimize restenosis (recurrence of narrowing of blood vessels) and to hold open narrowed arteries in cardiovascular applications. In this device, a time-release drug component incorporated as a coating for bare metal stints is used to prevent and minimize the risks and complications associated with typical non-drug, stand-alone stints.

Inhalation devices, drug-delivery pumps, drug-impregnated films and some wound care products also provide examples of successful combination products. Today, in many orthopedic devices, it is becoming customary to infuse implants with special proteins to facilitate bone growth and tissue regeneration.

Collaboration between drug and device companies is multiplying. The combination products currently in the market have already proven to be profitable. In recent years, more device and drug companies are reaching out to one another to develop better products to remain competitive technologically. According to a Navigation Consulting Inc. study, the global market for combination products would reach an estimated value of $9.5 billion by 2009. The big question is why more companies are not investing in this area.

Perhaps the biggest challenges to collaboration between drug-device companies, are the fundamental cultural difference between the two industries-different mind-sets, practices, and business strategies. A second hurdle is identifying and recognizing target markets for combination products. For instance, device companies typically focus on hospitals and healthcare environments, whereas combination products are primarily intended for direct consumer uses.

Regulations and FDA approval are perhaps the most challenging obstacle for combination products because they require approval from more than one FDA medical agency. Furthermore, it becomes more challenging to figure out how combination products get classified, which ultimately results in more ambiguity and delay to market the product.

As a result of the Medical Device User Fee and Modernization Act of 2002, the Office of Combination Products (OCP) currently handles these products and regulates the jurisdictions of an alphabet soup of agencies that includes the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). The OCP determines a combination product’s primary mode of action and then assigns it to the appropriate FDA agency. In 2006, 231 original applications for combination products were submitted to FDA.

Establishing the OCP was a big step toward better handling of combination product assessments and approvals. However, ambiguity surrounding regulation and manufacturing protocols still exists. Companies manufacturing these combination products often have to deal with additional regulatory rules and compliance with more FDA agencies.

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