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Regulatory changes can have significant impact on product design and market competitiveness. One upcoming example of this impact is the expansion of the European Union’s (EU) list of Restricted or Hazardous Substances, commonly referred to as RoHS 3. The phthalates added to the list are driving a switch from polyvinyl chloride (PVC) to polyurethane (PU) in medical products including tubing, catheters and bags. As with other RoHS directives, regions outside the EU have followed suit in legislation that restricts these substances. And, economies of scale considerations ultimately drive medical device manufacturers to alternatives which are not restricted in any market. Forefront Medical Technology’s latest whitepaper looks at the implications of this legislation and ways a contract manufacturing partner can assist in the effort to fully evaluate the range of acceptable alternatives, the cost impact of a change, and efficient development and commercialization of products utilizing the chosen alternative materials. Read the full paper here.
One of the key benefits of using a contract manufacturer for both design and manufacturing is the ability to work with a product design team that is experienced with manufacturing. This can eliminate design errors that could otherwise increase tooling costs and secondary processing costs. However, this option can also result in a design team that limits design choices to in-house production processes. The optimum solution is choosing a contract manufacturer with a broad enough range of capabilities that all design options that would make sense for the product are considered. Forefront Medical Technology’s new whitepaper looks at two examples where Forefront’s team has focused on solutions that incorporated multiple types of manufacturing processes or overcame production-related constraints that have traditionally limited design options. Read the full paper here.
The benefits of outsourcing can vary widely. The determining factor is often the quality of the relationship. Medical device manufacturers know their market, but may not know the best manufacturing strategy to address the challenges they face in commercialization. The best partnerships create a collaborative relationship that blends device manufacturer and contract manufacturer expertise. In identifying potential contract manufacturers, strong focus should be placed on the contract manufacturer’s processes for assuring the voice of the customer is active throughout the commercialization process. Our latest whitepaper discusses our processes in integrating the voice of the customer into each project. Read the full paper here.
Regionalized outsourcing strategies continue to grow in popularity. Gone are the days of shifting outsourcing to the lowest cost emerging market location. Today, most companies base sourcing strategies on a complex equation of factors driving total cost. When all these factors are considered, locating manufacturing within regions close to each end market often results in the greatest degree of responsiveness to market demand and lowest total cost. The underlying logic behind any regionalization strategy is that proximity to the end market reduces logistics costs and complexity; reduces raw material and finished goods shipping time; decreases finished goods safety stock requirements; and contributes to superior quality by minimizing unnecessary handling, transport and inspections. The question becomes: can the contract manufacturer your company selects enable your company to leverage the benefits of a regionalization strategy in your chosen end markets?
In this whitepaper, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery systems and medical device systems highlights several areas to evaluate in determining whether or not a supplier’s capabilities are likely to deliver lowest total cost of ownership (TCO). Read the full paper here.
Tooling design can be critical to achieving commercialization goals. Tool design has a direct impact on product cosmetics, cost and scalability. Sequential injection molding offers both cosmetic and throughput benefits, but in its traditional form has required a bulky mold and use of larger tonnage machines to accommodate the external hydraulic support system. Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery systems and medical device systems, has patented a streamlined sequential tooling design which utilizes a mechanical function inside the tool to eliminate the need for an external hydraulic system. The end result is a tool that easily fits in standard machines of the same tonnage as conventional injection molding tool, but is 50 percent faster than a conventional tool. Read our full whitepaper here.
The unfortunate truth about manufacturing offshore is that unit cost is rarely reflective of total cost. Nor is every low cost country (LCC) contract manufacturer equally equipped to provide the support required by highly regulated medical product design and manufacturing. A strategy based on having your team train or continually audit a low cost contract manufacturer into compliance with your systems, typically doesn’t result in real cost savings if your internal costs as well as the supplier’s charges are measured. In short, for offshore contract manufacturing to consistently save money, the contract manufacturer needs to not only have a competitive unit cost. It must offer the same level of systems and processes found in domestic suppliers. The challenge for a supply chain management team becomes finding a contract manufacturer capable of delivering more than unit price reduction.
Forefront Medical Technology built its business model around examining that equation. This paper looks at the key support elements that are integral to achieving lowest total cost.
Finding the Value
So what are the elements a sourcing team should look for in terms of determining whether or not the chosen contract manufacturer mitigate the cost surprises that can otherwise come with working in a LCC? Seven areas stand out:
- Design expertise
- Focused transfer of work process
- Localized support
- A robust quality management system and a team experienced with working with the regulatory agencies in your product’s end market
- A strong commitment to IP protection
- Capabilities and expertise in line with project requirements
- The ability to identify opportunities for cost reduction over the life of the product.
For questions to ask to better determine supplier capabilities in each of these areas, access our full whitepaper here.
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.