Medical device product development can be a lengthy and complex process. However, there are areas where a technically seasoned contract manufacturer can help significantly cut time to commercialization. This article looks at the product development process at Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug infusion, and medical device systems, and the steps it has taken to drive its average customer product development time down to an average of eight to nine months.
The design team reduces time to commercialization by focusing on several key areas:
- A proactive, standardized approach to product development which minimizes design spins
- Development and use of a database of materials that have passed biocompatibility and other critical tests
- A vertical integration strategy which ensures in-house resources are available to support rapid prototyping and tooling fabrication
- A strong focus on identifying design and manufacturability issues and/or other risks early in the design cycle
A Proactive, Standardized Approach
Forefront Medical Technology is a Singapore-headquartered contract manufacturer with two operations in China and a technical office in the U.S. Product development projects typically involve multi-cultural teams working long distance across multiple time zones. To ensure efficiency, strong focus has been placed on standardizing design tools and processes so that internal teams collaborating globally have the same frame of reference throughout the process. One of the primary reasons for setting up a U.S. Technical Center was to also provide a level of ‘local’ support in one of the dominant regions for medical product development.
Each product development process begins with a design team assessing customer requirements and creating a Design Development Plan (DDP). A customer specification is then developed and market inputs are collected. Once the customer specification is approved, 3D CAD models are developed and analyzed. Design reviews which include functional analysis and risk evaluation are completed. After a customer’s team approves the design, prototyping and verification begin.
Strong Materials Expertise
One element that typically cuts weeks out of the design process is strong materials expertise. The company maintains a database of approved materials which have passed biocompatibility and other critical tests. In addition to eliminating the time associated with required testing, it also enables the engineering team to eliminate the potential issues that can arise if a selected material fails testing.
The company’s vertical integration strategy is strongly focused on minimizing time in the design cycle. Design Engineering, prototyping and tooling fabrication capabilities for liquid silicone rubber molds are located in Singapore. The prototyping capability includes selective laser sintering (SLS) and multi-jet modeling (MJM) systems for rapid prototyping. Additional engineering and tooling fabrication capability is also located in the Jiangsu, PRC manufacturing facility. Forefront Medical Technology’s vertically integrated tool fabrication capability typically shortens product development cycles by two to three months.
This flexible research and development (R&D) structure was designed to leverage the core Singapore-based engineering infrastructure while localizing additional tooling fabrication and maintenance functions within the manufacturing facility. Jiangsu has a full scale commercial tool room with integrated support from the Singapore team. This provides the resources necessary to maintain tooling on-site, while tapping the expertise of the Singapore engineering staff for new tool design. Actual tooling fabrication may be done in Singapore, Jiangsu or at qualified third-party suppliers depending on complexity of the tool and project requirements. Jiangsu’s engineering team utilizes the same design and mold flow analysis software found in Singapore for robust collaboration during the design and development phase. The Jiangsu team handles product prototyping, the scale up of molds and tools, pilot runs, validations and product lifecycle management activities, accessing Singapore team resources as needed.
A Strong Focus on Manufacturability
A gated design process enables tooling development to begin as early in the design process as possible. The tooling design process includes a DFM phase, followed by development of the mold specification. Mold-flow analysis is used to ensure efficient molding with minimal scrap and minimization of secondary finishing processes.
Following a design review, mold fabrication begins. This is followed by a testing and debugging phase which includes a dry run and analysis of product first off the tool. The design validation process looks closely at design assumptions on target labor utilization and run rate, and changes are made if that analysis indicates the initial assumptions need to be modified. Production processes undergo a similar development and validation phase with performance qualification to customer specifications.
Throughout the product development process there is a strong focus on minimizing design spins and tooling iterations by analyzing potential issues as early in the process as possible. In fact, number of design modifications and tooling iterations are key performance indicators (KPIs) for the design team.
The end result over the last three years has been product development cycles which average eight to nine months. Fewer tooling iterations reduces lead times and development costs. A robust process for validating manufacturability assumptions, run rates and scrap, eliminate both hidden and actual costs in the manufacturing process, plus the concomitant redesign costs that can arise when design assumptions in these areas aren’t realized.