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Everything You Need to Know Before Hiring a Medical Device Manufacturer

Posted in Medical Device Development

So many different areas of expertise are involved in bringing a product to market, especially in the healthcare industry. When you work with a medical device manufacturing company, it’s helpful to know a bit about the market and what questions to ask a prospective contractor. So first, let’s dive into a few key terms:

  • Contract Manufacturing. Contract manufacturing is a form of outsourcing. Hospitals, distributors, and inventors hire contract manufacturers to produce medical devices or components for retail or their own procedures. This could be medical supplies like latex gloves or syringes, or implantable devices and advanced equipment.
  • Barriers to entry. Barriers to entry refers to the cost of bringing a product to market, including taxes, regulations, patents, and supplier/distributor agreements. Financial barriers level out the industry competition and make it harder for new startup companies to make marketable devices.
  • Iterations. Iteration involves repeating a process or procedure to generate a sequence of outcomes. Each sequence brings a product closer to a desired result. Iterations help engineers improve devices until certain conditions are met that ensure the product will meet with Food and Drug Administration (FDA) guidelines.

Ultimately, the FDA regulates which medical devices can be sold in the United States. Your manufacturing contractor is responsible for ensuring your device meets quality standards and is cleared by the FDA. With the right contractor, you can save time, energy, and money while bringing a successful product to market. Here’s a checklist you should consider before hiring a manufacturer:

The size of the company

The size of the company can indicate their proficiency. Larger companies may have more financial resources but be unpleasant to work with, while smaller companies may be more responsive and provide custom solutions.

What they offer

Medical device manufacturers typically offer services such as design consultation, engineering, drawing, R&D, tooling, mold development, assembly, and quality control. These are all key to the medical device development process, which includes:

  1. Initiation, opportunity, and risk analysis
  2. Product concept, design, and development
  3. Validation and verification
  4. Production
  5. Product launch/preparation: packaging, supply, and delivery
  6. Postlaunch assessment

Focus on quality

Your contract manufacturer should have the technology, equipment, and professionals to test, sterilize, and provide documentation for your new device. What kind of certifications do they have for maintaining compliance with the FDA?

Responsiveness

Maintaining efficient communication with your manufacturer is key to the outcome of your project. In your early interactions with a prospective contractor, note how quickly they call or email back. What type of communication resources do they use to keep their clients informed, and do those methods work for you?

Ultimate goal

A contractor’s ultimate goal can shape the products they produce in more ways than one. Is their aim to make more money? Do they strive to deliver quality? Are they focused on timeliness? Ultimately, the best companies balance all of those qualities and focus on customer satisfaction.

Flexibility and innovation

Product development almost always has its flaws. When things don’t go as planned, a good manufacturer uses problem solving and creative thinking to come up with solutions. Are they committed to making a bulletproof product, or do they compromise on quality just to get things done?

Turnaround time

Does their proposed timeline fit with your schedule? Does it allow leeway for unavoidable delays like a switch in vendors or acquiring new material? Find a manufacturer that is willing to go the extra mile and work outside of business hours to deliver a product on time.

Ask your prospective manufacturer how they manage each of these aspects before you put the critical development of your product in their hands. Via Biomedical offers services for all manufacturing phases, from concept to commercialization. Check out our case studies to see how our commitment to quality, communication skills, customer focus, flexibility, and innovation have helped customers bring their projects to market within their timeline. Contact us to learn more.