The revenue opportunities associated with capturing first-to-market advantage can be huge, while the risks of failing to meet increasingly demanding product development timetables can be disastrous. The importance of adopting production processes that significantly shorten new product development cycles is essential to optimizing business potential. Start-up companies that miss VC-required milestones, or R&D groups in larger organizations facing market pressure for profitability, can see promising projects sidelined or cancelled because they just aren’t progressing quickly enough.

Traditional Development Strategies

Traditional processes for commercializing new medical products are generally linear in nature. The focus tends to be on solving complex engineering and technology issues before moving on to more mundane aspects of project management such as packaging or supply chain management. This approach is only natural, as most project managers are engineers or scientists whose most obvious contribution is in their specific field of expertise. However, it’s often those mundane details that introduce crippling delays. Many OEMs and contract manufacturers don’t reengineer their development processes to “manage out” avoidable risks to deal with the new realities of global competition. Spending an additional three months nailing down a new product logo is the same as taking three months to solve an engineering problem as far as time to market is concerned—and time is money.

Concurrent Engineering Strategies Cut Time to Market

Using the principles of Concurrent Engineering, manufacturers can cut time to market significantly, by as much as 30-40%. Developed by the aerospace industry, Concurrent Engineering relies on the notion that all aspects of the product development lifecycle should be considered in the early design phases and that they should be scheduled in parallel whenever feasible. Cross-functional teams using integrated project management software can theoretically identify the shortest project pathway to a new product introduction. While the process sounds relatively easy to implement, it is an unconventional model for the medical device industry, and competing priorities within organizations often create resource constraints that hinder real-time collaboration. Contract manufacturing can open up new strategies for expediting time to market by relieving these resource constraints.

Parallel Processing Project Management (PPPM) is an adaptation of this process specifically designed to assist medical device manufacturers. PPPM identifies and quantifies the potential risks and opportunities associated with each step of the project planning process, moving the highest risk items or opportunities up as far as possible in the project schedule to ensure:

• Issues that crop up can be dealt with while design flexibility still exists, thereby reducing the need to redesign or reengineer
• Steps with the potential to derail schedules are positioned early enough so delays can be absorbed within the existing timetable

By quantifying the time value of risk and opportunity in terms of market share impact, incremental revenue, or competitive advantage, better decisions can be made with respect to resource allocation, outsourcing and personnel. It’s often surprising just what steps in the project planning process create the most havoc with schedules due to an underestimation of their risk or opportunity factors.

Three common (and avoidable) schedule killers

While every situation is different, there are three areas in which parallel processing has the potential to speed up the project planning process, but they are often overlooked or undervalued. This oversight can occur when the responsibility remains in departments outside of R&D or Engineering; when project managers don’t have a lot of experience with the process; or when concept development and manufacturing are treated as separate phases rather than integrally connected.

1. Not involving package design and graphics from the start. Integrating package design and graphics early the process presents a major opportunity to save resources and expedite time to market. Oftentimes, months of additional time is added to the end of an otherwise tight product development schedule because packaging and design were relegated to the very end of the cycle.

In some cases, making early material or design decisions create unanticipated interactions in later phases of the project. For example, selecting materials that cannot withstand sterilization protocols required during packaging can mandate a time-consuming redesign. In other cases, project managers find that when they submit a request to the corporate art department for package graphics, the answer comes back: “It’s going to take six weeks, we’re backlogged.” You may budget a reasonable two weeks, but with resource issues, legal approvals for copy, and some necessary reengineering, it might take 12 weeks!

What seems like the least important and most easily managed part of your project could turn bad in a big way unless it’s pushed far enough up in the schedule to insulate the potential risks.

2. Not considering your supply chain strategy in the design phase. When working with innovative technologies and new materials, plan on negotiating supply agreements while still in the design phases so alternative materials or sources can be pursued within the original schedule. Finding out that the perfect material for a well-designed component is only available in limited quantities, or is run on a line that operates just four times a year, happens with some frequency.

A supply chain strategy needs to be developed in parallel with the design process to prevent costly last minute fire drills.

3. Exploring tooling and capital equipment requirements too late. Waiting to secure outside vendors until after concept designs are completed can be problematic on two fronts. First, tooling and capital equipment build-outs to manufacture your design may require much more time than you’ve allotted in your schedule. And second, by waiting to engage prospective contract manufacturing partners early in the design phase, you lose out on their potentially valuable ideas for minimizing the expense and time required to fit out the production line.

The earlier you can get your partners involved, the more collaborative the project planning process will be, allowing more aspects of the project to be developed concurrently, shortening time to market.

Conclusion

It seems counterintuitive, but oftentimes it’s the “easy stuff” that adds months to schedules, costing millions in lost revenue and reducing potential market share. Developing a sound contract manufacturing strategy can help relieve resource constraints, foster more collaboration, and provide more opportunities for parallel processing of work flow to cut time to market by as much as 30-40%. In today’s highly competitive global market, linear planning is a luxury that the medical device industry cannot afford.  Learning how to identify time-to-market risks and opportunities and creating parallel project management processes is key to optimizing the business potential of new product introductions.