Forefront Medical Technology

Q1 2017 Newsletter

First Quarter 2017revised_Page_1Forefront Medical Technology’s Q1 2017 newsletter looks at five mistakes to avoid in outsourced program transfers, a case study that involved replacing metal parts with precision molded plastic parts and the benefits of working with a vertically-integrated contract manufacturer. Read the full issue here.

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Forefront Medical Technology’s Q4 Newsletter

Forefront Medical Technology now offers a quarterly newsletter focused on Outsourcing Best Practices and Case Studies. This quarter’s newsletter looks at ways to improve logistics efficiency, reducing cost through use of high cavity molds and tips for choosing a product development partner.fourth-quarter-2016ver-b

Click to Read Newsletter

Offshore Manufacturing: Risky Business or the Right Choice for Your Project?

_S3A0114.jpgThe 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.

Case Study: Endotracheal Tube Redesign

FMT 12090096Ventilator-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.

The Challenge

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.

 

Case Study: Reduced Cost Through Supply Chain Realignment

_DSC7278.jpgMoving 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 Challenge

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

 

Case Study: Specialty Pharmaceutical Bottle Production

_S3A0089.jpgMaterial 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 Challenge

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.

Read more