The golden path towards mass production

The golden path towards mass production

The medical device industry of today is a dynamic market where products are being introduced, developed and replaced in a shorter and faster lifecycle than ever.   The two major forces in this vibrant industry continue to be innovation and time to market.  Creative solutions for solving tomorrow’s challenges and their accessibility in today’s demanding market must be poised to work in tandem.

With steps taken concurrently, your innovative devices need to be pre-designed for mass production. It is the far-sighted, pro-active production thinking that you invest in your product that will predict and ensure its competitive advantage in the marketplace.

Mass production is the end point of a long and complex process of planning and design, in which factors like efficiency, production and assembly, and repeat-ability, are taken into account and embodied into the design of your device.

Here are few rules of thumb to lead you on the golden path of success:
It is NEVER ‘too early’ for process design.  Got a successful design for your device? Great.
Now is the time to start with process design, the critical phase to plan the production process for your device. It is a structured process of hundreds of steps, describing the exact actions required for manufacturing thousands of units that will be replicated and completed in the same quality as the first unit.
Adopt changes in product design. Once you have a foolproof process design, you need to take the next step forward and embrace the changes in the product’s design. That’s right, a successful product is a result of the synergy between product design and process design, and is key to your go-to-market plan.
NPI phase is a must. Any LEAN executive will acknowledge that this is a necessary standard of approval before going mass – start small, validate and move forward.  Begin with a few hundred units before going into mass production. Make sure everything is working “par excellence” per your production process plan.
Work with a trained facility.  A possible cost overrun may lead to a live-or-die decision for your product. Don’t compromise on the production facility.   Choose the best facility that has a specifically medical-device production trained workforce for ALL aspects of planning, engineering, production, assembly and delivery.
Small print matters.  Regulations and QA measurements are a basic skill for the medical device production process. Appoint an experienced production partner that will guide and walk you through this definitive field.

A well planned process and responsible execution is fundamental to your product’s success. Not just as part of the obvious process of entering and winning the marketplace, but as a part that should be considered and implemented as early as possible in your plan of action.

Quasar is a medical device manufacturer with over 30 years of experience, serving major brands worldwide, with complex catheter and disposable, FDA regulated assemblies.
Quasar delivers a full lifecycle array of engineering services, including Design To Cost, Jigs and Tool Design, and a unique production process-design service that allows for the highest levels of efficiency and productivity.

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