Protecting Your Medical Device Investment: Vetting Clean Room Manufacturing Options
You’ve spent a small fortune developing your medical device, with great expectations for the problems it will solve for patients and clinicians, and the revenue it can put in your pocket for years to come. Next, comes your most crucial step: clean room manufacturing options. Like botched home repairs and homemade haircuts, manufacturing slip-ups can be a bear to recover from, bruising your brand’s reputation and draining profits.
One way to protect your investment is to select the right medical device contract manufacturing partner and medical clean room manufacturing facilities. In this piece, we cover key considerations for a smooth manufacturing process: one that’s free of headaches, wasteful costs or delays.
Exploring Clean Room Manufacturing Options
Strict attention to quality
It goes without saying, but we’ll say it anyway: Quality standards are your greatest non-negotiable. At a minimum, you’ll want FDA-compliant facilities with verified, comprehensive quality systems, specific for the design and manufacturing of medical devices.
At Genesis Plastics Welding — an ISO 13485 certified contract manufacturer — you’ll find Class 7 Medical Clean Rooms that meet FDA requirements for Class I, II and III medical devices and components. Our systems are also compliant with Medical Device Quality System Regulation 21 CFR 820 for Class I, II and III medical device and components manufacturing.
It’s why many global OEMs come to us for the manufacture of infection control, surgical and oncology products — particularly those designed to come in contact with a patient’s body.
Unmatched expertise and uncommon solutions
Invariably, you’ll have questions that exceed the know-how or capabilities of conventional contract manufacturers. Questions your peers have asked us include:
“Can you turn this napkin sketch into a prototype within a week?”
“Is there a blind spot or hidden opportunity in the design or manufacturing of our device?”
“Is there a better material we haven’t thought of?”
“Can you reverse-engineer this component and replicate/make it better?”
“Where can I find a reliable supplier to lower my costs without sacrificing key product criteria?”
“We’ve been told this can’t be done. Can you find a way?”
One medical device client, for instance, came to us because sterilization was hurting the life of its drill battery, causing it to die during surgery. We were able to create a “koozie” to cover the drill and extend battery life. (We’re happy to report we’ve provided solutions for all questions above as well.)
Speaking of uncommon expertise: Genesis’ proprietary radio frequency (RF) welding of plastic products means we’re exceedingly rare in our ability to weld thermoplastics of all types to the quality and safety standards required for patient use. That capability is one reason why the Scottish Life Sciences Association partners with Genesis to innovate, reduce costs and extend the lifecycle of medical devices in its country.
That brings us to our next set of considerations:
Sustainability, toxicity, environmental impact
As hospitals move to adopt greener and less toxic plastics, many OEMs find themselves scrambling to replace traditional materials (like PVC and PU plastics) with more eco-friendly alternatives. That’s a tall order. Biocompatibility, skin sensitivities, the material’s ability to be processed, sterilized and discarded without harmful effects to people or the environment are just a few of a long list of requirements.
Just as challenging, many manufacturers can’t weld those materials adequately for healthcare use. After all, no one wants disrupted fluid flow paths or leaky fluid bags. (A blunder we’ve heard often from OEMs seeking our help.)
These aren’t the kinds of solutions you’ll typically find from “generalist” manufacturers that dabble in medical device manufacturing while their experience lies elsewhere.
Ability to increase capacity without increasing risks, costs
Often, OEMs come to us because their previous medical device manufacturing partner couldn’t keep up with their growth demands without raising overhead costs considerably. At Genesis, we have found a way to continue growing without raising costs, in order to remain competitive.
Whatever your production demand, Genesis provides Class 7 Medical Clean Room production, available ‘round the clock, and expert assembly and packaging of devices, both in and out of the clean room environment. We also collaborate to develop a custom plan, such as weekly shipments and just-in-time delivery, so you can maintain inventory levels and a continuous production flow.
Should the unexpected happen, we respond quickly to your scheduling and order changes so you can keep customers happy.
Finding your best medical device clean room manufacturing fit
As you chew on the factors outlined in this post, it’s helpful to consider whether your potential manufacturing partner has had success producing similar types of devices.
At Genesis, we specialize in the RF welding and heat sealing of medical fluid bag or collection pouches. Types of fluid bags we’ve helped OEMs bring to market include:
- Drainage (urine, brain, chest, negative pressure wound care)
- Cooling & Heating (NICU therapy, surgical warming devices, equipment/device temperature control)
- Feeding & Supply (single-patient use stem cell bags, cell growth, bone cement for orthopedic surgery)
- Storage (cryogenic cord blood stem cells)
In medical device manufacturing, small factors can have enormous impact on the long-term performance and profitability of your device. What changes to your manufacturing process could improve outcomes or accelerate your goals?
We’re at your service to answer questions, provide a quote or help you clarify next steps — even if that’s not working with us. Drop us a note, and we’ll help you discern your best next move.