Let’s face facts.
Medical device failure can be a devastating event. Encountering negative physical and financial consequences is not the path a #medical company wants to take.
Alleviate device failure
Should cost be the primary determining factor when developing and manufacturing a medical device?
Could that upfront cost savings result in more significant money expenditure due to law suites, fines, and time lost? Let’s consider a new approach.
You can avoid expensive law suites, FDA fines, and loss of time by considering additional factors during the initial stages of development.
These factors include:
- Polymer choice
- Consulting with an experienced #molding professional
- Part design optimization utilizing experienced plastic engineers
You must have noticed that the word ‘experienced’ is used multiple times. If you desire to manufacture a device successfully, it is vital to choose professionals who know what they are doing, from design creation to manufacturing. Otherwise, you are at a greater risk of device failure.
If cost is the only determining ingredient driving your decisions on any of the above considerations, you are putting your company and the patient at risk. Gambling on any of the three factors above will reduce the chances of a successful medical device.
Let’s get into it.
Polymer choice
What is significant about polymer choice?
Let’s recognize that an FDA-approved polymer is mandatory for most medical devices.
From the polymer options the FDA endorses, which is best for your particular design? If you allow cost to drive this decision, it may come out poorly.
At this stage, you should already be consulting a plastics engineer with extensive polymer knowledge. The choice of polymer and its durability will depend on the device’s intended usage and exposure to environmental stresses.
Injection Molding Consultant
It is critical to have an experienced injection molding professional guide you when developing a design for a device. A consultant with a plastic engineering degree is a significant advantage.
Hold up if you are cringing because the costs in your head are adding up. Let’s get through this bit, and I will show you how it saves you money in the long run.
An experienced injection molding professional should have these qualifications:
- A minimum of 10 years in the injection molding industry
- Exposure to multiple industries, e.g., automotive, caps and closures, medical, housewares, etc.
- Fully understand how a polymer will respond during the injection molding process ( this will also affect your choice of polymer)
- Understanding how a polymer will perform in the field
- Recognize that virtual optimization is critical to
the success of your device
The value of an injection molding consultant can’t be understated. They will have full knowledge of the injection molding process, which can impact the part quality and integrity of the mold for long-term usage, the effect the injection molding process has on the polymer as it relates to the design, and be able to troubleshoot any issues that arise during the simulation stage.
This type of information is priceless for achieving a successful device. Using a plastics professional will reduce time to market and increase patient success.
Virtual part optimization
Without Virtual Optimization of the device design, you will be driving a car on only two wheels, which someone can do, but the risk is high.
First, it is vital for your device’s success to employ an individual skilled at optimizing part design. If the supplier has “thrown in” a flow analysis for no cost, granny, get your gun!
Time after time, outsourced optimization provided by suppliers is performed by individuals with limited knowledge of the software, experience, or skills. These individuals lack a thorough understanding of all of the following: injection molding, polymers, processes, and other critical factors needing consideration to produce a successful device. This lack of skills and knowledge leads to unnecessary design iterations, time loss, and poor quality. It’s a hot mess, and no one wins. For a device to succeed in the medical industry, optimizing a design requires an experienced professional who will pinpoint concerns and offer beneficial, feasible suggestions to improve the design as needed.
Can you see where I am going with this? If all the possible and probable kinks and flaws are addressed in the beginning stages of part design, the patient, medical company, and everyone involved has a good day. You will save money from the repercussions of law suites, fines, and lost time (faster to market). Success is yours!
The small investment upfront utilizing the skillset and experience of a skilled plastics engineer, injection molding consultant, and an experienced optimization specialist will get you to market faster, maximize quality and eliminate any financial repercussions from faulty devices. The team at Bozilla Corporation meets all three criteria necessary for you to effectively complete your goals and timing and get to market faster. Contact us today and let’s get started!
Contact Bozilla Corporation today and let’s discuss how we can successfully contribute to your project. Bozilla Corporation’s Injection molding Team has over 21 years of experience analytically and on the floor. We specialize in optimization, consulting, engineering, troubleshooting and Autodesk Moldflow software training. Additionally, our plastics engineers have a full understanding of polymers and how they influence an injection molded part. Your success is our success. Our skilled Team is focused upon meeting the goals and timelines of our customers.
#medicaldevicemanufacturing #injectionmolding
www.BozillaCorp.com, 800-942-0742, info@BozillaCorp.com
About Bozilla Corporation: https://youtu.be/-0xzsMWzxB4