| A few years ago, the idea of integrating Internet | | | | combination product's primary mode of action and |
| capability, a camera and a video and audio player into | | | | then assigns it to the appropriate FDA agency. In |
| a single compact device based on a cell phone was | | | | 2006, 231 original applications for combination |
| very appealing but hard, if not impossible to imagine. | | | | products were submitted to FDA. |
| Now, there's Apple's iPhone and any number of | | | | Establishing the OCP was a big step toward better |
| competing devices that made that possibility an | | | | handling of combination product assessments and |
| affordable, common reality. Converging different | | | | approvals. However, ambiguity surrounding regulation |
| technologies into one single product is not confined to | | | | and manufacturing protocols still exists. Companies |
| consumer and entertainment products anymore, | | | | manufacturing these combination products often |
| either. Various industries, and in particular the | | | | have to deal with additional regulatory rules and |
| pharmaceutical and medical device segments, are | | | | compliance with more FDA agencies. |
| finding innovative means to deliver multi-functional | | | | While drugs need to adhere to the FDA's "current |
| healthcare products. It is a trend that has been | | | | good manufacturing practices," and medical devices |
| developing for a few years now, and the stage is | | | | need to follow "quality system" regulations, |
| set for solid growth. | | | | combination products must comply with both sets of |
| Converging Technologies Yield Efficiencies | | | | regulations. Therefore, companies developing |
| Engineered from a mix of drug, device, or biologic | | | | combination products need to understand each set |
| components to form a single product, combination | | | | of regulations, as well as developing manufacturing |
| products represent a relatively new therapeutic and | | | | protocols and quality systems that meet both drug |
| treatment approach, which is proving to be more | | | | and device requirements. To speed up the process |
| effective for both pharmaceutical and device | | | | and avoid last-minute surprises, the FDA strongly |
| companies. Drug-device combinations are more | | | | recommends that manufacturers of combination |
| appealing to both healthcare sectors simply because, | | | | products discuss the regulations with the agency to |
| in many cases, a single combination product containing | | | | understand how they pertain to their products at |
| both drug and device components can be more | | | | very early development stages. |
| effective than either one of the components acting | | | | Beyond FDA Regulations |
| alone. | | | | Successful collaborations between drug and device |
| Drug-eluting stints are prime examples of such | | | | companies also require adjustments. Complete |
| combination products. Approved by the FDA in 2003, | | | | evaluations of how these combination products work |
| the Cypher Sirolimus-eluting stint was designed to | | | | for end users, are required, along with additional in |
| prevent or minimize restenosis (reoccurrence of | | | | vivo clinical studies. The companies must understand |
| narrowing of blood vessels) and to hold open | | | | the interactions between the drug and the device |
| narrowed arteries in cardiovascular applications. In this | | | | when used by patients. And they must estimate |
| device, a time-release drug component incorporated | | | | potential side effects. All these tasks can delay the |
| as a coating for bare metal stints is used to prevent | | | | product development process, but it is crucial that |
| and minimize the risks and complications associated | | | | companies understand that adding an additional |
| with typical non-drug, stand-alone stints. | | | | pharmaceutical component to a device can adversely |
| Inhalation devices, drug-delivery pumps, | | | | affect the device's performance and potentially cause |
| drug-impregnated films and some wound care | | | | unwanted results. And if an already-approved device |
| products also provide examples of successful | | | | or drug is to be used in another part of the body, |
| combination products. Today, in many orthopedic | | | | additional preclinical safety and clinical studies are |
| devices, it is becoming customary to infuse implants | | | | needed to evaluate how it functions in the new |
| with special proteins to facilitate bone growth and | | | | environment. |
| tissue regeneration. | | | | In addition, combination products typically need |
| Collaboration between drug and device companies is | | | | sterilization and packaging procedures different from |
| multiplying. The combination products currently in the | | | | standard operations for individual drugs and devices. |
| market have already proven to be profitable. In | | | | Companies developing combination products must |
| recent years, more device and drug companies are | | | | adopt appropriate manufacturing protocols, and focus |
| reaching out to one another to develop better | | | | on internal business requirements much earlier in the |
| products to remain competitive technologically. | | | | development process. |
| According to a Navigation Consulting Inc. study, the | | | | Looking Ahead |
| global market for combination products would reach | | | | The union of drug and device companies can offer |
| an estimated value of $9.5 billion by 2009. The big | | | | tremendous therapeutic and financial advantages and |
| question is why more companies are not investing in | | | | bring patients more effective and efficient medical |
| this area. | | | | treatments. Many experts predict that the healthcare |
| Challenges and Hurdles | | | | industry will see more mergers and acquisitions |
| Perhaps the biggest challenges to collaboration | | | | among drug and device companies in the near future, |
| between drug-device companies, are the fundamental | | | | requiring significant learning across the two industries. |
| cultural difference between the two | | | | The device company must learn how the drug works |
| industries-different mind-sets, practices, and business | | | | before delivering it through the device, while the drug |
| strategies. A second hurdle is identifying and | | | | company needs to become more familiar with FDA |
| recognizing target markets for combination products. | | | | medical device regulations, how the devices work, |
| For instance, device companies typically focus on | | | | and what factors may affect performance. |
| hospitals and healthcare environments, whereas | | | | The term convergent technology is being used more |
| combination products are primarily intended for direct | | | | frequently in the healthcare industry than ever |
| consumer uses. | | | | before. Companies specializing in drug or device |
| Regulations and FDA approval are perhaps the most | | | | segments are evaluating options to combine multiple |
| challenging obstacle for combination products because | | | | technologies to create better products. And the |
| they require approval from more than one FDA | | | | convergence is not limited to drug and device |
| medical agency. Furthermore, it becomes more | | | | manufacturers as more electronics are being |
| challenging to figure out how combination products | | | | interwoven into devices. Orthopedic manufacturers |
| get classified, which ultimately results in more | | | | are looking into using chips embedded in human bones |
| ambiguity and delay to market the product. | | | | to facilitate and support bone growth. Advanced pain |
| As a result of the Medical Device User Fee and | | | | management systems incorporate implantable devices |
| Modernization Act of 2002, the Office of Combination | | | | that use transceivers to facilitate communication and |
| Products (OCP) currently handles these products and | | | | data transfer to ultimately improve patient outcomes. |
| regulates the jurisdictions of an alphabet soup of | | | | In many cases, open innovation is the key, where |
| agencies that includes the Center for Drug Evaluation | | | | development of products drawn from the expertise |
| and Research (CDER), Center for Biologics Evaluation | | | | of different technologies, can serve various purposes. |
| and Research (CBER), and Center for Devices and | | | | This holds immeasurable promise in the healthcare |
| Radiological Health (CDRH). The OCP determines a | | | | industry, which is simply too good to overlook. |