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Medicine Dispersion Inhaler Design and Development
The concept of a pulmonary dry powder inhaler addresses multiple consumer needs. Everything from the ECO aspect of addressing the ban on CFCs used in metered dose inhalers (MDI's) to being able to deliver unique types of drugs such as proteins and peptides. The system principle uses a blended powder formulation of an active drug ingredient mixed with a non-active carrier. With slight inhalation from the patient, dispenser is automatically activated and an impeller mechanism separates the drug from the carrier by active agitation. Energy is imparted to the drug blend and smaller drug particles in the formulation are separated from the excipient. These lighter drug particles (micron size range) are subject to the momentum of the inhaled breath and are delivered to the deep lung where the dose can be absorbed. Thus eliminating the awkward coordination of a metered dose inhaler that makes most devices difficult for children, seniors and pulmonary compromised patients to use.
The development of the device presented a broad range of challenges for the group from coordinating the start of the impeller or de-agglomeration system to device life and patient convenience and system status. All of these challenges were met by the team in innovative and cost effective ways with quick to market solutions.
The challenge was divided into subsystems and each in turn addressed with a coordinated effort and an eye to the entire system delivering the correct efficacious drug dose. Vacuum triggers, impeller/de-agglomeration systems, battery life considerations, electrical control systems, aesthetic and user friendly device design and their interaction were all considered by the team.
The unique skills brought to this project by us can be applied to a variety of projects from simple consumer items to the more in depth medical device development. The research and development controls applied are tailored to the needs of the project. As with medical device projects all applicable stage gate development methods, documentation and design history are managed for proper approval submissions. Device manufacturing is offered with ISO 13485 approved manufacturing sites either in the US or offshore for cost advantages. All offshore operations are personally managed to provide on time product delivery combined with product safety and intellectual property protection.
Providing Medical Device Solutions for Unique Challenges
The Synthesis Labs team can provide expertise in system design in the medical device arena. We have experience with products from simple class I disposable devices to class II implantables. Areas of expertise and experience include:
• Plastics Disposables
• Catheter Development
• Cardiopulmonary
• Cardiovascular
• Pulmonary
• Implantables
• Medical Device Packaging
Providing Engineering Solutions for Unique Challenges
In support of the medical device development, the Synthesis Labs team has extensive experience in these technical areas:
• Injection Molding
• Extrusion
• Secondary Plastics Processing
• Mechanisms
• Mechanical Design
• Electrical Systems
• Battery Systems
• Documentation
• CAD Design
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