Ventilator-associated pneumonia (VAP) is one of most significant healthcare-associated infection (HCAI) risks for patients in long-term intensive care. Traditional endotracheal tube design can contribute to this since oropharyngeal secretions that would normally be swallowed can pool on the top of the cuff of the endotracheal tube and subsequently be passed into the lungs. A number of interventions and prevention strategies are used to minimize the incidence of VAP with varying degrees of success. A least two studies have found that the use of tracheal tubes with subglottic secretion drainage in patients expected to be ventilated for 72 hours or longer, significantly reduces VAP.
In 2013, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was selected by one of its existing clients to support the development of the single-use portion of new endotracheal tube designed to mitigate the incidence of VAP by maintaining constant pressure within the tube and providing a collection point for oropharyngeal secretions that could easily be drained and cleaned by the hospital’s nursing staff.
Forefront’s team worked with the customer to develop the single-use components for two models of endotracheal tubes. The complete product combines endotracheal tubes with tracheometry drain tubes made from silicone, along with a tracheal seal monitor which continuously measures the pressure between the cuff and the trachea, enabling it to generate maximum cuff pressure. The resultant optimal tracheal seal significantly helps reduce the risk of aspiration. Key product features included:
- Non-stick coating inside the tube to reduce the formation of biofilm
- An adjustable flange and safety system to prevent any unforeseen extubations
- A silicon spiral tube which can adapt flexibly to airways
- Triple subglottic flushing suction pipes to collect and clear secretions
- A low-volume, low-pressure silicon cuff to provide optimum tracheal sealing and minimize injury to the tracheal mucosa
- A special atraumatic tip for atraumatic intubation and optimum adaptation to airways.
From a design and manufacturing standpoint, the single-use portion of the product required 14 different components which utilized a variety of materials. Achieving the customers’ form, functionality and fit goals required an innovative approach to material selection plus use of specialized molding processes with very critical tolerances. The assembly process also included a specialized dipping process.
Read about the process the team used here.
Moving production to a lower cost region will not deliver significant cost reduction if the supply chain and logistics activities are not optimized for the new region. As a result, a key consideration in selecting a contract manufacturing partner should be evaluating their ability to support identification of regional suppliers and the best logistics strategy for supporting the end market. For example, Forefront Medical Technology was supplying a customer with infusion lines used in a drug delivery system. The bags used with infusion lines were supplied by two manufacturers in Europe. Forefront’s team suggested to the customer that sourcing the entire set of four bags and infusion lines in Asia with Forefront could eliminate redundant logistics costs, increase visibility into inventory levels, improve quality and reduce production costs. The customer had been pleased with Forefront Medical’s performance on the infusion lines and agreed to the transfer the entire project.
The key challenge was ensuring the transfer of work and subsequent validation process was handled as efficiently as possible, since an inefficient process can eliminate any near-term cost savings. From a transfer perspective, Forefront’s team needed to identify a qualified source of roll form raw material for the bags, transfer and enhance the process to eliminate quality issues that were occurring at the previous suppliers and support process validation and regulatory approvals. Read more
Material choices often have impact on preferred production processes. Selecting a contract manufacturer capable of supporting a broad range of production options helps ensure the optimum process is utilized. In this case study, a customer wanted a pharmaceutical bottle made of a flexible, medical grade PVC material developed and manufactured. While blow molding is the preferred choice for bottles utilizing low density polyethylene, the flexible PVC material required an injection blow molding process. The team at Forefront Medical Technology was able to design and construct a mold and machine to meet the requirements.
The customer provided a 3D CAD model of the bottle. Forefront Medical’s engineering team selected an injection blow molding process as the option best meeting the customer’s requirements. There were several advantages with driving this choice:
- Quality and repeatability
- Cosmetic factors
- Cost effectiveness.
Development of specialty drug delivery systems requires both strong materials and mechanical engineering expertise. And, in some projects there can be additional constraints tied to existing supply chains or preferred materials. This white paper looks at the process Forefront Medical Technology used in designing a Class III drug delivery system used in a chemotherapy application.
In this case the customer was a Tier One contract manufacturer, who built specialty kits for an original equipment manufacturer (OEM) of specialty drug delivery systems. The contract manufacturer was looking for a medical disposable manufacturer in Asia who met FDA regulatory requirements and could supply required components for their production operations using OEM-specified materials. The contractor also wanted the supplier to provide long-term cost reductions in line with the OEM’s requirements.
The customer provided the basic design for the mechanism and the components. The key design challenge involved identifying materials that met the customer’s requirement of Di 2-ethylhexyl phthalate (DEHP)-free and had the required bonding strength among components and tubes. This was complicated by the fact that one component supplier had been previously selected by the OEM and any design modifications would need to incorporate that component and supplier. Read more:
One of the key challenges facing medical device manufacturers is determining the optimum mix of mold cavities and machines. High cavity molds enable medical manufacturers to tap economies of scale when fabricating high volume single-use products by reducing the number of machines needed to achieve required production volumes. However, increasing the number of cavities also can increase the project complexity. Forefront Medical Technology recently designed a 64-cavity mold for a customer. This case study looks at the challenges and lessons learned in the project.
Read more here.
A manufacturer of products used for foreign particle management in the esophagus found that the market for its product line was no longer growing. The Company decided that a redesign of the product line was the best way to increase market share.
They turned to Forefront Medical Technology for a solution. Forefront’s team recommended converting the manufacturing process used for the tubing from a dipping process to the combined use of extrusion molding and injection molding. The team also recommended changes in the materials composition for other components used in the product. This case study discusses lessons learned in the redesign and qualification process and the overall results. Read more.
Metal parts are typically used in invasive medical equipment because a machined metal part ensures a tight seal at joints. However, use of metal components can increase cost over the life of the product when sterilization costs are considered. Additionally, even with sterilization, reuse of components exposed to bodily fluids and tissue can increase risk of patient contamination. Single-use precision molded plastic components offer a potential option for mitigating the contamination risks and eliminating the need for a washing/autoclave process, but molding these parts with enough precision to achieve the same performance properties as their metal counterparts has been challenging.
Forefront Medical Technology’s solution to this challenge is featured in Medical Design Technology. Read more.