Contract Manufacturing

Considering all breakthroughs in medical research in the past decade, there is currently an increase in demand for new and improved medical devices that will take advantage of our burgeoning understanding of the human body and technological advances. This increased demand and the constant innovation required, puts an enormous strain on medical device manufacturers. This strain is compounded by long lead times and high level of regulation that dictates to the design and manufacturing processes.

At DirectMed, we strive to relieve this strain by offering solutions at a much faster, more efficient rate. Whether your device requires our OEM components or a customized component, our manufacturing facilities are at your disposal to complete one component or a full assembly. This includes packaging and sterilization of your product. We want your new product offering up and running quickly and can provide you with instant, turn-key, customized manufacturing solutions in a new (2016) manufacturing facility located in North America. We can help you execute your designs right in our backyard. No complicated shipping logistics or any of the risks associated with off-shore manufacturing.

DirectMed’s Contract Manufacturing Advantage

Our capabilities as a contract manufacturer provide our clients with the of peace of mind surrounding a reliable and efficient product supply for a number of reasons:

Supply Chain Optimization

Using us as a contract manufacturer will help optimize your supply chain by keeping component manufacturing and device assembly in one location. Our streamlined supply chain management ensures we can take the device from design to market in one comprehensive project path and in record time.

Fulfillment

Our facilities create and deliver millions of units a year. Each unit is tailored exactly to customer specifications including the device itself, packaging and delivery schedule.

Proactive Troubleshooting

Our team’s 20+ years in design and development and the manufacturing facilities 30+ years of fabrication experience, allow us to identify hurdles associated with your project in advance. Predicting upcoming issues with production before it happens prevents delays in getting your product to market.

Sharing the Load

We will take on all the supply chain, regulatory oversight, manufacturing, and assembly. With us taking on this burden, your time is free to concentrate on the next phase of your product release or servicing your customers more efficiently. We believe that being your contract manufacturer means being a part of your team. It also allows to focus on what you do well and leave the manufacturing to an experienced partner. We follow strict quality control to ensure your product line will be 100% defect-free and always manufactured to your specifications, no deviations whatsoever.

Our Manufacturing Facilities

Our new manufacturing facility is ISO 13485, ISO 9001, and ISO 14644 certified

Location: Reynosa, Mexico

Being just across the border from McAllen, Texas, makes shipping simple and cost effective.
The facility is within minutes of an airport and major roads making it very easy for our design and quality officers to oversee every step of the design and fabrication process.
Customer visits and inspections are easy to implement and coordinate. Travel is minimized as we are a few hours, not days away.

Facility Amenities

165,000 square foot building

  • 90,000 square foot active manufacturing floor
  • An additional 70,000 square feet to be added by 2020

3 Clean Rooms

  • Class 8
  • ISO 14644 certified
  • 25,000 square foot total

3 Tubing extruders with a range of capabilities

  • Multi-lumen
  • Multi-chamber
  • Stripping
  • Rolling

7 Engel injection molding machines

100+ Person staff

Sterilization

All sterilization is handled offsite within the US

Packaging /Labeling

Packaging and labeling are fully customized to client specifications

Shipping Abilities

JIT
Kanban
Blanket-Order

Operating Capacity

Our newest facility is only a few years old, and currently operating at 40% capacity, pushing over 23 million sets per year. With the addition of a new account in Q2/Q3 2019, the facility will be operating at 50% capacity. This leaves 50% of our new operating capacity available for your projects.

Design Consulting

Already have all Design Aspects of your Project Figured Out? Let our Manufacturing Team put their 30+ years of injection molding and medical device manufacturing experience to work for you. This facility is well-equipped and eager to utilize a deep pool of resources to bring your most complex projects to market.

We absolutely want to have a conversation with you about your ongoing project requirements. Contact us, give us a call +1(516)656-3377 or mail us sales@directmed.local.