Outsourcing medical device manufacturing has become a trend among global MedTech companies. OEMs usually outsource manufacturing when they want to minimize manufacturing complexity and focus on their core business priorities.
The core expertise of a contract manufacturer typically revolves around joining, casting and molding, R&D design, resource planning, and regulatory support.
It is crucial to outline the critical factors you must keep in mind while choosing your contract manufacturer. Below are key aspects that can help you make the right decision for your manufacturing needs.
Why Should You Hire a Contract Manufacturer for Your Medical Device?
You save on capabilities, resources, and labor.
You can leverage the experience of a trusted contract manufacturer.
Time to market can be optimized.
You can focus on product branding and marketing.
You can hold contract manufacturers accountable for record keeping.
You gain access to a vendor network for procuring raw materials.
Experienced manufacturers may also help with easier market penetration and regulatory approvals.
Top 10 Criteria to Keep in Mind While Choosing a Medical Device Contract Manufacturer
- Choose the technical expertise.
- Opt for a partner offering sustainable engineering services.
- Evaluate the manufacturer’s supply chain management.
- Evaluate the pricing model.
- Check the quality management system.
- Review past experience and projects.
- Keep track of timelines.
- Prioritize innovation.
- Evaluate accountability and product dossier support.
- Assess responsiveness and communication.
1. Choose the Technological Expertise of the Contract Manufacturer
Check and evaluate the specific technical expertise and focus area of your contract manufacturing partner.
The core vision of the contract manufacturing brand must align with your product idea. If it does not, both sides may eventually face challenges. The contract manufacturer may put in full effort, but the outcome may still not meet your expectations.
2. Opt for a Partner Offering Sustainable Engineering Services
By sustainable engineering services throughout the process, we mean support across the complete production journey.
This includes:
Consistent support for improving product quality and cost.
Managing obsolete portions of the product with design support.
Compliance support post-launch, including RoHS, WEEE, and REACH.
Repair support, returns, and feature upgrades.
Enhanced support for field maintenance kits and spares.
3. Do Not Ignore the Manufacturer’s Supply Chain Potential
Material cost is often a major point of concern in medical device manufacturing. It is necessary to check how your manufacturing partner manages vendors.
Sometimes material and procurement costs make up more than half of the manufacturing cost. It is important to check their MRP systems, vendor quality control programs, vendor network, and timelines.
Not analyzing supply chain management properly can increase time to market.
4. Evaluate the Pricing Model
Experienced contract manufacturers have connections, ideas, and technologies that can help optimize manufacturing cost.
Many clients approach us specifically for cost optimization. As a seasoned player in medical device manufacturing, we have a vendor network across the globe.
We choose vendors based on cost, quality, and relationships. It is also important to be specific about how your manufacturing partner determines the cost of finished goods.
Clarity on cost prevents arguments and confusion at the end. It also helps identify areas where additional charges may apply.
5. Check the Quality Assurance System
Quality is critical for a medical device manufacturer. It is 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 requirements.
The robustness and reliability of a medical device manufacturer are directly connected to the strength of its Quality Assurance system.
At Johari, we also have clients who require only regulatory and consulting support. For over 40 years, we have assisted clients with regulatory guidance and support for faster market entry.
6. Review Their Past Experience and Projects
It is always useful to review your contract manufacturer’s past work portfolio.
Understanding the kinds of projects they have worked on helps you analyze whether they are the right choice for your project. It also helps you understand 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 production timeline.
If the production timeline is not clearly defined, it can eventually extend the time to market.
8. Prioritize Innovation
Clients often approach us with requirements to upgrade their existing product design.
As a contract manufacturer, we have highly skilled technical experts who can innovate and design products as per client requirements.
You must also check your contract manufacturer’s capability to innovate and their approach to current market trends.
9. Evaluate Accountability and Product Dossier Support
Regulatory submissions, including 510(k) and CE Mark, play a crucial role while choosing a contract manufacturer.
You should also evaluate support for regulatory services such as:
Design History File (DHF)
Technical file
Design dossier
Product classification and identification
Product labeling and IFU
Risk assessment
10. Responsiveness and Communication
The ability to speak to a real, knowledgeable person when needed is invaluable for an OEM.
The responsiveness of a contract manufacturer, especially at the beginning of the due diligence process, is often an indication of how the business operates on a day-to-day basis.
After making initial contact with the business development team, it is helpful to take a facility tour and ask to discuss specific questions with the engineering and quality teams.
Their knowledge, communication style, project ownership, and responsiveness to your queries indicate how the business may operate throughout the partnership.
Syrma Johari MedTech Healthcare as India’s Preferred Contract Manufacturer
Syrma Johari MedTech Healthcare is a leading contract manufacturer of electronic medical devices in India.
We have over 40 years of experience, ranging from low-volume simple projects to high-volume complex projects.
Our strict adherence to US FDA, ISO 13485, and MDSAP guidelines makes us a trusted manufacturing partner in India.
Contract Manufacturing Services We Offer
As a trusted contract manufacturer, we offer the following services:
Design for Manufacturing
Value Analysis and Value Engineering
PCB Assembly and SMT
Box Build and Precision Machining
System Integration
Supply Chain Management
Packaging and Labeling
Quality Assurance and Regulatory Assistance
To avail our contract manufacturing services, please talk to us.
