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.

Read More

Design Control Medical Device

A Simplified Introduction to Medical Device Design Control

Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]

development of medical device product lifecycle

The Four Phases of Medical Device Product Development Lifecycle

The work that’s required to transition from the conception stage to the mass manufacturing of a medical device product, is as important as it is challenging. Proper management of medical device product development lifecycle can make the difference in bringing medical device products to market quickly and effectively. Here are the four phases you should prepare for when considering manufacturing a medical device product development lifecycle: 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, [...]


Quasar’s new top-technology production facility

We are happy to announce the opening of our new manufacturing facility in Dongguan, China. The facility is now in the validation phase and will fully operational for mass production during Q1-2018. The new facility is our newest asset in our effort to deliver higher quality and newer technologies for innovative medical device mass production and process-design services. Share With Colleagues


The Secret Sauce to high quality

The Secret Sauce to high quality: Preventative Quality Processes and Sisyphean Improvement Cycles. Preventive quality processes and Sisyphean Improvement Cycles are the secret sauce to winning your market. Do you have them built into your production process?