A few years ago the idea of integration of Internet capability, a camera and a video and audio player into a single compact device based on a mobile phone was very appealing, but difficult, if not impossible to imagine. Well, there are Apple's iPhone and any number of competing devices, the possibility that an affordable, common reality. Converging different technologies into a single product is not on the consumer and entertainment products more, either. Various industries, especially the pharmaceutical and medical device segments, find innovative ways to multi-functional health care products. There is a trend, since a few years, and the stage is set for solid growth.

Converging technologies yield efficiency gains

Designed by a mix of drug, device, or biological components into a single product, combination products are a relatively new therapeutic and treatment approach, which proves to be effective for the pharmaceutical and device companies. Drug-device combinations are attractive to both areas of health care, because in many cases a single product, the combination of both drug and device components can be more effective than either of the two components alone.

Drug-eluting stations are prime examples of such combination products. From 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 the cardio-vascular applications. In this device, a time-release drug component as a coating for bare metal stations to avoid and minimize the risks and complications associated with the typical non-drug, stand-alone stations.

Inhalation devices, drug delivery pumps, drug-impregnated films and some of Wound Care products are also examples of successful combination products. Today, in many orthopedic devices, it is increasingly common, infusion implants with special proteins to facilitate bone growth and tissue regeneration.

The cooperation between drug and device companies has multiplied. The combination products currently on the market have already proven successful, to be profitable. In recent years, more drug and device companies to reach to another to develop better products to remain competitive technologically. According to a study navigation Consulting Inc., the combined global market for products to reach an estimated value of $ 9.5 billion in 2009. The big question is, why do not more companies invest in this area.

Challenges and hurdles

Perhaps the greatest challenges for cooperation between drug-device, are the fundamental cultural difference between the two different industries Spirit sets, practices and business strategies. A second hurdle is the identification and recognition of target markets for composite products. For example, device companies typically focus on hospitals and healthcare environments, while the combination products are primarily for the direct consumer.

Laws and FDA approval are perhaps the most difficult obstacle for combined products, because they require the agreement of more than one FDA Medicines Agency. Moreover, it is increasingly difficult to find out how to classify products combination, leading to more confusion and delays to market the product.

As a result of the Medical Device User Fee and Modernization Act of 2002, the Office of Combination Products (OCP), which currently regulates these products and the competence of an alphabet soup of agencies, 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 provides a combination product in the first place the type of activities and assigns them to the appropriate FDA agency. In 2006, 231 original applications for combination products have been FDA.

Establishing the OCP was a big step towards a better handling of the combination product reviews and approvals. However, regulatory uncertainty and manufacturing protocols still exists. Companies producing these products are often combined with additional regulatory requirements and compliance with the FDA more agencies.

While the drugs have to comply with the FDA "" current Good Manufacturing Practices, "and medical devices must be" quality system "regulations, combination products must comply with both regimes. Therefore, businesses, the combination products need to understand each set of regulations, as well as the development and manufacture of quality systems protocols, including drug and device requirements. To speed up the process and last-minute surprises, the FDA recommends that manufacturers of combination products on the regulations with the agency to understand how they affect their products in very early stages of development.

In addition, FDA

Successful collaborations between drug and device companies also require adjustments. Complete evaluations, such as combination products for end users, are required, together with further in vivo studies. Companies need to understand the interactions between the drug and the device when used by patients. And they must estimate the possible side effects. All of these tasks, the product development, but it is crucial that companies understand that adding an additional component to a pharmaceutical product can adversely affect the device performance and potentially undesirable results. And when an already approved drug or device is for use in another part of the body, additional preclinical and clinical studies are needed to evaluate how it works in the new environment.

In addition, combination products, sterilization and packaging process differs from standard operations for individual drugs and devices. Companies, the combination requires the manufacturing protocols, and focus on internal requirements much earlier in the development process.

Looking to the future

The union of the drug and device companies can offer tremendous therapeutic and financial advantages and patients an effective and efficient medical treatments. Many experts predict that the healthcare industry will be further mergers and takeovers among drug and device in the near future with significant learning in the two sectors. The device has to learn how the drug works before it by the device, while the drug is required to deal with FDA medical device regulations, how the devices work, and what factors can affect performance.

The concept of convergent technology is more common in the healthcare industry than ever before. Company specializes in the drug or device segments evaluation options for multiple technologies to better products. And the convergence is not limited to drug and device manufacturers, as more electronics are interconnected into appliances. Orthopedic manufacturers are working with embedded chips in the human bone, to facilitate and support bone growth. Advanced pain management systems include implantable devices, the transceiver to facilitate communication and the transfer of data to improve ultimate patient outcomes. In many cases, open innovation is the key, where the development of products from the expertise of the various technologies that can serve different purposes. This immense promise in the healthcare industry, which simply too good to miss.

Nérac Inc. is a global research and consulting firm for companies developing innovative products and technologies. Nérac analysts provide their own assessment of the product and technology development offers, competitor intelligence, intellectual property strategies, and compliance requirements through a proven approach for their own blended analysis: review of technical knowledge, investigation of intellectual property, and the assess the business impact. Nérac requires analysts in various disciplines to help our customers new applications, which serve as a catalyst for new concepts and creative approaches to business problems or identifying strategic growth opportunities. On the Internet at http://www.nerac.com