Medical device development is a cascading process involving multiple talents, huge investments, and a lot of effort. From initial idea to final market launch, each step plays a key role in determining the fate of a new medical device. The medical device industry has spawned many new healthcare and medical technology solutions due to an exponential increase in technological advances, a strong emergence of healthcare start-ups, and increased public health attention and investment by governments. is growing exponentially. As a result, the medical device contract manufacturing industry is also experiencing significant growth.
The global medical device outsourcing market, valued at $59,723.42 million in 2020, is projected to reach $137,948.92 million by 2030 at a CAGR of 8.9%. Outsourcing a variety of manufacturing operations to a contract manufacturer offers cost efficiencies, a streamlined supply chain, coordinated logistics, and a wide range of benefits.
The general consensus is that most MedTech practitioners consider “cost of manufacture” to be one of the most important factors in medical device development. It’s still a very powerful factor, but there are other aspects that need to be considered in depth. Overlooking other aspects ultimately impacts productivity and manufacturing costs.
Here’s why COST shouldn’t be the only factor to evaluate when choosing a contract manufacturing partner.
Medical Device Quality: Relevant Manufacturing Qualifications and Certifications
Quality should not be sacrificed for low cost.
It is important to ensure that contract manufacturers do not use substandard raw materials or inefficient processes. To achieve high standards of quality in medical devices, it is important that manufacturers have relevant clearances and audit certifications from licensing bodies such as the US FDA, ISO: 13485 and MDSAP. Accreditation is a testament to the reliability, consistency and process quality of a contract manufacturer. Lack of certification and non-compliance with international regulatory guidelines on the part of the manufacturer may result in the development of products unsuitable for sale in the global market.
Deadlines and Delivery: Supply Chain Efficiency and Logistics Networks
If you miss the timeline, you lose all cost advantage.
A manufacturer may agree on a desired timeline for project delivery in order to close the contract. But then it gets bogged down due to supply he chain issues, cost limitations, and a variety of other reasons. A contract manufacturer’s inventory management system, supply chain efficiency, geography, and distribution network are important factors in determining the estimated delivery date. Evaluating supply chain efficiencies and logistics networks can help clarify whether a manufacturer can consistently meet timelines over the long term, helping to avoid the trap of false or unrealistic commitments. help.
Infrastructure: manufacturing facilities
The ability of the manufacturer and the environment are important!
Manufacturing facilities are another important factor to evaluate when outsourcing medical device manufacturing. Class I, Class II, and Class III medical devices require special environments for manufacturing. It is important to physically visit and assess manufacturing facilities to ensure manufacturing is in accordance with the target country’s market guidelines and standards.
Post-market design and engineering assistance
A reliable partnership ensures the market sustainability of your products!
Once the device enters the market, it will undergo some changes or requests for changes. Developers often struggle to maintain the sustainability of their devices due to a lack of post-market design and engineering support. Contract manufacturing partners with skilled design and engineering teams Having the ability to solve the unique requirements received from the market.
Labor force
Less labor costs mean overhead costs and potential delays!
Team strength and technician skill level are other important factors that must be evaluated when partnering with medical device manufacturers. It is important to have know-how on whether your employees have access to relevant and up-to-date training. The lack of a skilled workforce with proper training doubles the chance of error and can lengthen the production cycle along with CAPA.
Regulatory strength and QMS
Quality control compromises can ruin everything!
A highly regulated industry, medical devices require a very sound quality management system (QMS). Manufacturers must carefully adopt best quality control practices. From transport to manufacturing to final packaging, each step of the process must be recorded in his DHR (Device History Record). Manufacturers must also ensure risk-based medical device development with minimal rework.
Government Policy on Location of Manufacturers
Good location and safe for business!
In addition to manufacturing costs, it is important to evaluate government policies related to the location of the manufacturer. India has favorable medical device development policies, making it a profitable destination for outsourcing manufacturing. With its abundant workforce, reliable outsourcing partners and focus on medical technology development, India is one of the most preferred and sought after destinations for medical device outsourcing.
Intellectual property protection
IP protection is mandatory on the manufacturer’s part.
After Covid 19, IP protection is becoming a pressing issue among Global MedTechs. Confidential information about the project should be treated with caution. This is to ensure that there are not too many imitations of our products on the market. A manufacturer must ensure multi-level protection of his IP through a centralized information sharing system to ensure the safety of design files, confidential transaction data, utility patents, etc. As a trusted contract manufacturing partner of a global medical technology company, the manufacturer must have multiple ways to ensure her client’s IP security. The main measures are as follows.
- Physical security measures for biometric access within the facility
- Only relevant teams and stakeholders have access to technology and data
- Distributed production stages
- Full transparency across standards, processes and security policies
- Easy-to-understand documentation in official language
- A designated IP officer to configure and monitor IP protection at all levels
Communication transparency
Cost savings are no substitute for transparent communication requirements!
Suppose a manufacturing partner has reduced BOM costs by up to 50%, but has not communicated changes in parts and suppliers used. This can increase device safety concerns. At a later stage, miscommunication can cause disputes and create unnecessary legal penalties. Transparent external and internal communication minimizes conflicts and enables hassle-free device to market success.
Expertise in various medical devices
Domain expertise is priceless!
Costs may have been reduced, but what if the manufacturer doesn’t address the technology or segment of the device? Hiring experts to reduce rework is key. Because rework ultimately adds overhead and increases time to market. Surfing through the manufacturer’s past customers, projects and expertise is required. Investing in an experienced manufacturer is much better than investing in a novice and no fees.
Conclusion
A key aspect should not be overlooked in the zeal to accelerate the device’s introduction to the market at a lower cost. You need to understand your project-specific requirements. Making cost a pivotal factor and ignoring the associated risks and impacts can lead to rework, recalls, and significant financial setbacks. Once your design and prototype are ready, you need to list your project requirements and then select a contract manufacturer suitable for scaling. Johari Digital Healthcare Co., Ltd. We employ value engineering to provide compliant contract manufacturing services at the optimum cost. Balancing investment and technology is an art, and as a global medical device manufacturer with over 40 years of history, we ensure successful medical device market launches.
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