The medical device industry today is a saturated, dynamic market where products are introduced, grow and replaced in a shorter and faster product-lifecycle than ever. The two major forces in such a vibrant industry are, innovation and time to market. How creative you are in solving tomorrow’s challenges and how accessible you become to the demanding market.
The production process for even the most simple of medical devices involves meticulous, long term planning. It is the long-sighted pro-active production thinking you put in your product that will predict its chance to win in its market.
Mass production is the end point of a long and complex process of planning and design, in which factors such as efficiency, production and assembly and repeatability are embodied into the design of your future device.
Here are a few rules to keep in mind when devising a go-to-market plan for your medical device:
Do you have a promising design for your medical device? Great. The next phase is to plan the production process.
This is a structured process of hundreds of steps and details of required actions for manufacturing thousands of units in the same quality.
Throughout the process design phase, you should be prepared to encounter numerous challenges to your initial product design.
It is key to understand the reason for occurring roadblocks and embrace the required changes to your product design. If handled correctly, you will come out with a deeper understanding of your product’s production process. Ultimately, any additional knowledge on your product’s production process is likely to come in handy if not crucial for later stages such as solving future obstacles or potential product upgrades.
Start small, validate and move forward. It’s important to keep a steady pace through transition between the different production phases. Make sure everything is working per your production process plan. In a case where readjusting the process design through production is a regular occurrence or in a worse case scenario, where you are cutting corners on the original process design to keep up, a timeout is needed for the production process and it’s time to go back to the drawing table.
Your cost of mistake is high and can sometimes become a live-or-die matter. Don’t compromise on the production facility and go for one that has specifically medical-device production trained working force for planning, engineering, production, assembly and delivery.
Regulatory and QA measurements are elementary for a medical device production process. Do your homework to find an experienced production partner that can guide you through the fine details that make the entire difference.
A well-planned process and responsible execution are fundamental for your product’s success. Not just as part of the obvious process of going and winning the market, but as a part that should be considered and implemented as early as possible in your plan of action.
In your journey to medical device manufacturing, the right partner with the necessary means and experience can help you in proactively dealing with the complex challenges in medical device product production. Contact Quasar to discover how we combine device development, and manufacturing together with regulatory compliance into one turn key solution, relieving you of costly delays.