Looking to learn more about outsourcing medical manufacturing? You’ve reached the right place. Watch our blog for white papers, tips, article links and other information focused on helping medical device manufacturers save time and money without cutting quality. If you’d like to learn more about Forefront Medical’s capabilities, visit our About page or our website: http://www.forefrontmedical.com/.
Forefront Medical Technology will be exhibiting at MDM East in New York City June 13-15 with a slight twist. The show organizers changed our booth location without notifying us so all pre-show marketing and the directory listing have the old booth number. The new location is Booth 2366, one aisle over from the old location. We look forward to seeing you there.
It’s almost time for MDM West. Use our promo code “INVITE” to save 20% off Conference Passes, or claim a complimentary Expo Pass, at www.mdmwest.com/invite.
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.