Outsourcing medical device manufacturing has become a trend amongst global MedTech giants. OEMs outsource their manufacturing usually when they want to minimize the manufacturing hassle. The core expertise of a contract manufacturer revolves around joining, casting and molding, R&D design, resource planning, and regulatory. It’s crucial to outline several critical factors you must keep in mind while choosing your contract manufacturer. We have highlighted several key aspects to help you make decisions for your manufacturing needs.

Why you should think about hiring a contract manufacturer for your medical device?

  • You save on capabilities, resources, and labor.
  • You can leverage the experiences of a trusted contract manufacturer.
  • Time to market is optimized.
  • You can focus on product branding & marketing.
  • You can hold contract manufacturers accountable for keeping records.
  • You get a vendor network to procure raw materials.
  • Experienced manufacturers might also help you in easy market penetration & regulatory approval.

Top 10 criteria you must keep in mind while choosing a Medical Device Contract Manufacturer:

  1. Choose the Technical Expertise
  2. Opt for a partner serving sustainable engineering services
  3. Supply chain management of manufacturer
  4. Evaluate the pricing model
  5. Check the quality management system
  6. Juggle across their past experience & projects
  7. Keep track of timeliness
  8. Prioritize innovation
  9. Evaluate Accountability and Product Dossier support
  10. Responsiveness and communication

1. Choose the technological expertise of the contract manufacturer

Check and evaluate the specific technical expertise and area of your contract manufacturing partner.

The core vision of the contract manufacturing brand must sync with your idea. If it doesn’t, both ends will eventually run into a loss. The contract manufacturer will give 100% effort but, that will never fulfill your expectations.

2. Opt for a partner serving sustainable engineering services

By sustainable engineering services throughout the process, we mean support in the following areas throughout the production journey.

  • Consistent support for improving product quality and cost.
  • Managing obsolete portions of the product with design support.
  • Compliance support post-launch (i.e. RoHS, WEEE, REACH)
  • Repair support, return, and feature upgrade
  • Enhanced support for field maintenance kits and spares

3. Do not ignore the supply chain potential of Manufacturer

Often, the material cost of the medical device is a bone of contention for manufacturers. It’s necessary to check how your manufacturing partner manages his/her vendors.

Sometimes the material and procurement cost more than half of the manufacturing cost. Check MRP (Material Requirement Planning)  systems and vendor quality control programs. Dig their Vendor network and timelines. Not being strict about supply chain management analysis can increase the time to market.

4. Evaluate the pricing model

Experienced contract manufacturers have connections, ideas, and technology to optimize the manufacturing cost. Many of our clients come to us only with the cost optimization requirement. Being a seasoned player in medical device manufacturing, we have a vendor network across the globe.

We choose vendors based on cost, quality, and connections. Also, be very specific about how your manufacturing partner determines the cost of the finished goods. Clarity on cost prevents arguments and hustle in the end. It also helps in mapping the holes where additional charges may apply.

5. Check the quality assurance system

Quality is the key for a medical device manufacturer. It’s necessary to assess the robustness and track record of the contract manufacturer. Analyze their Device History Records, calibration procedures, and test data to ensure the product meets necessary FDA and ISO 13485 compliance.

The robustness and reliability of medical device manufacturers are proportional to the strength of their Quality Assurance system. At Johari, we also have clients who only require regulatory and consulting support. For 40 years, we assist our clients with regulatory guidance and support for fast-paced market entry.

6. Juggle across their past experiences & projects

It’s always good to glance well through your contract manufacturer’s past work portfolio. Knowing the kind of projects, they have worked on helps you analyze if they are the right choice for your project. Also, it helps to trace the scale of clients and projects they have handled over the years.

7. Keep track of timelines

Your contract manufacturer must give you a realistic timeline. Not being specific about the production timeline eventually extends the time to market.

8. Prioritize innovation

Often, clients come to us with a requirement to upgrade their existing product design. As a contract manufacturer, we have highly skilled technical experts who can innovate and design the product as per our client’s requirements. You must also check your contract manufacturer’s capability around how innovative and trendy they are in their approach.

9. Evaluate Accountability and Product Dossier support

Regulatory submissions (510(k) and CE Mark), as well as regulatory services including the Design History File (DHF), technical file, design dossier, product classification/identification, product labeling / IFU, and risk assessment, play a crucial factor while choosing a contract manufacturer.

10. Responsiveness and communication:

The ability to speak to a real, live human when you need to – and that person being the correct individual to answer a particular question – is invaluable to an OEM. The responsiveness of a CM, especially in the beginning of the due diligence process, is indicative of how the business operates on a day-to-day basis. After making initial contact with the business development team, take a tour of the facility and ask to discuss some specific questions with the engineering and quality team. Their knowledge, method of communication, ownership of the project/product, and responsiveness to your inquiries is an indication of how the business will operate throughout the partnership.

Johari Digital Healthcare as India’s Preferred Contract Manufacturer

Johari Digital Healthcare is a leading contract manufacturer of electronic medical devices in India. We have 40+ years of experience with low volume simple projects to high volume complex projects.

Our strict adherence to US FDA and ISO: 13485 and MDSAP guidelines makes us trusted and worthy manufacturing partners in India.

 

We can offer you the following services as a trusted contract manufacturer:

PCB Assembly & SMT
Box Build & Precision Machining
Product Integration
OEM & Private Labeling
Packaging & Labeling
Supply Chain Management

To avail our contract manufacturing services, please talk to us

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