Tuesday, June 5, 2012

The Challenges with Drug/Device Combination Products

Active medical devices are that device which interact with the body systems and is has been highly effective. Drug is a common active component of medical devices such as inhalations sprays, nebulizers, stents, some orthopedic implants etc. . When the devices are merging, there is always a look to how two industries can merge at least for common interest areas to have compact medical package. Although the concept primarily looks to be invaded by issues, still situation is practically manageable. Several large companies in other business segments and a few hospitals manage several disciplines already.

For this, we need to collate some factoids for comprehensive evaluation of the situation. As the interrogator has correctly put the three areas to bear the primary stress will be regulatory, engineering and Quality. One functional sect area that would bear a lot of stress will be training. The segments those will be eased by this merger will be clinical, marketing and finance. The functionality of merger is integral in most segments other than production. There can be two scenarios about production facility: First, production of Drugs and devices in the same facility, and Second, Production of Drugs and Devices in two distinct facilities. The second case looks to be more feasible model for regulatory and engineering reasons. There can be two units in one premise, but intersecting utility is practically less possible for execution.

The first and the major impact will be on the regulatory and QMS professionals who need to manage compliances for highly diverse set of regulation in one infrastructure. The first scenario is when there is complete merger including production units. Let us discuss the compliance factoids of Audits in both cases. Good Manufacturing practice applies to both, Medical Devices as well as Drugs, with some fine tuning required. In This case, meeting systemic requirements of ISO 9001 and to an extent GMP will be relatively easy. Contrarily, it would critically elevate challenge in compliances for ISO 13485 and US FDA CRF section 510k. Some parts of medical devices will interfere with drugs production and vice versa. Storage, recycling and disposal needs; water, ground clearance, environmental needs, Infrastructure and machinery needs are three sets of diverse requirements. Compliances of these three sets are commonly seen to be antagonists to each other and hence is an edge-walk for Quality managers. The Regulators would face several constrains in Audits and inspections for intersecting facility. When the facility is intersecting, for all practical reasons they need to operate as two different units. Otherwise, they will keep complicating each other’s regulatory requirements.

Similar load will be taken by engineers, responsible for maintenance of infrastructure and machinery. Medical devices require sterilization of the products and drugs do not. Some byproducts of medical devices such as ETO fumes are known to have adverse effects on composition of pharmaceutical agents, and a few raw materials of pharmaceutical agents may have corrosive or other chemical impacts on raw material or finished goods of medical devices. The Engineering section has to develop efficiency in handling the diversity and counterproductive nature of some components in merging systems. Requirements of Maintenance in terms of Air Hosing units, Backups, machinery etc. will rage very wide.

With the merger of production and other facility of medical device and drugs, certain unforeseen manageable issues may pop up as the progress in fields is seen, yet it will be highly optimistic step up in reducing healthcare cost and deliver even better quality. Costs of regulatory set up, human resources, clinical, Engineering, benchmarking, preclinical and quality check testing etc. will significantly reduce. Marketing strategies like product bundling, in-house production of active components like drugs, polymers and merging of logistics, transportation, storage and corporate requisites will help availing quality products in minimum costs. When weighing Risks and challenges vs. benefits the the homeostatis shifts towards the merger.

Dr. Ashish Indani
Head, Clinical Operations
29/243, Unnat Nagar II,
Off SV Road, Goregaon (W)
Mumbai 400063
Maharashtra, INDIA
Email: ashishi@genelifecr.com


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