Medical Device Development is a cascaded process involving multiple talents, huge investments & numerous efforts. From Initial ideation to final Go-To-Market each step plays a significant role in deciding fate of the new Medical Device. The Medical Device Industry is expanding exponentially with steep increase in Technological advancements creating a host of new healthcare and Med-tech solutions, strong emergence of healthcare startups, increasing focus and investments in public health by Governments across countries. As a result, the Medical Device Contract Manufacturing Industry is also witnessing a 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%. Hiring Contract Manufacturers for a variety of manufacturing pursuits enables cost efficiencies, streamlined supply chain, logistical alignment, and a wide range of benefits.
It is a popular notion that majority of the MedTech players consider “Cost of Manufacturing” as one of the most critical factors for Medical Device Development. While it remains a very strong factor, there are other aspects too which need a deep consideration. Overlooking the other aspects eventually impacts productivity and cost of manufacturing.
Here’s why COST shouldn’t be the only factor to evaluate while choosing your contract manufacturing partner.
1. Quality of the Medical Device: Relevant Manufacturing Credentials & Certifications
Lower cost should not come at the expense of quality!
It is important to ensure that the contract manufacturer does not use substandard raw material and ineffective processes. In order to achieve high standards of quality in medical devices, it’s important that your manufacturer has relevant clearances and audit certifications from authorized bodies like US FDA, ISO: 13485, MDSAP and more. Certifications are testimony for the contract manufacturer’s credibility consistency and quality of processes. Absence of certifications & lack of compliance with International regulatory guidelines at manufacturer’s end may lead to development of products that may fail to qualify for sale in the global markets.
Read More: India’s First MDSAP Certified Company
2. Deadlines & Deliveries: Supply Chain efficiency & Logistics Network
Failure to meet timelines depletes all cost advantage!
The manufacturer might agree to your desired timeline for project delivery to seal the deal. But later falter due to supply chain issues, cost restrictions and various other reasons. Contract manufacturer’s inventory management system, supply chain efficiencies, geography and logistic network are factors which play a major role in determining expected delivery dates. Evaluating supply chain efficiency and logistics network helps in getting clarity on whether your manufacturer will be consistently able to meet timelines in the long run and helps you avoid the trap of false or unrealistic commitments.
3. Infrastructure: Manufacturing Facility
Manufacturer’s capabilities & environment are critical!
The manufacturing facility is another important factor that you must evaluate while outsourcing your Medical Device Manufacturing. Medical Devices of Class I, Class II, and Class III require special environment for Manufacturing. It’s important to physically visit and evaluate the Manufacturing facility to ensure that manufacturing is being done as per the target country’s market guidelines and standards.
4. Post Market Design & Engineering assistance
Dependable partnerships ensure product’s market sustainability!
Once the device has entered the market, it is bound to experience some modifications or change requests. Often, developers struggle to maintain the sustainability of the device due to lack of post market design & engineering support. Having a contract manufacturing partner with a skilled Design & Engineering Team can help you resolve those peculiar requirements that you receive from market.
Lesser cost of labor may incur overhead costs & trigger delays!
The team strength and skill level of technicians are other important factors that you must evaluate while partnering with a medical device manufacturer. It’s important to have know-how about whether their workforce has access to relevant contemporary training. Lack of skilled workforce with proper training, can multiply the chances of errors and trigger longer production cycles along with CAPA.
6. Regulatory Strength & QMS
Compromises in quality control can ruin everything!
Medical Devices being a highly regulated Industry demands a very sound Quality Management System (QMS). A manufacturer must carefully adopt the best Quality Management Practices. Right from Transfer to Manufacturing to Final packaging each step of the process must be documented in DHR (Device History Record). The manufacturer must also ensure risk-based Medical Device Development with minimal redoes.
7. Govt policies of the Manufacturer’s location
Favorable geography assures ease of doing business!
Along with Manufacturing costs it’s important to evaluate relevant Government Policies of the Manufacturer’s location. India has favorable Medical Device Development Policies which makes it a profitable outsourcing manufacturing destination. With an ample workforce, credible outsourcing partners, and focus on Medical Technology development, India is one of the most preferred and sought after Medical Device Outsourcing destinations.
8. IP Protection
IP protection is mandatory at the manufacturer’s end!
Post-Covid 19, IP Protection is becoming a pressing issue amongst Global MedTech. The sensitive information about your project needs careful handling as you don’t want numerous look-alikes of your product in the market. A manufacturer must ensure multilevel IP protection by a centralized information-sharing system to ensure the safety of the design files, sensitive trade data, utility patents, and more. As a trusted Contract Manufacturing Partner of Global Med-Tech Companies, a manufacturer should have multiple ways to ensure IP security for their clients. Some key measures include:
- Physical security measures of biometric access in the facility
- Technology and data access to only relevant teams & people involved
- Dispersed production stages
- Complete transparency across standards, processes & security policies
- Comprehensible documentation in official languages
- Designated IP officer to set and monitor IP protection at all levels
9. Transparency in Communication
Cost concessions don’t replace transparent communication requirements!
Let’s suppose, your manufacturing partner has reduced the BOM cost up to 50% but the parts used and supplier change information has not been communicated. This may add to the safety concerns of the device. At the later stages miscommunication can become a cause of conflict and create unnecessary legal penalties. External and internal transparent communication ensures minimal conflict and successful Go-To-Market of the device without hassle.
10. Expertise across a diversity of Medical Devices
Expertise in the domain is priceless!
The cost may have been reduced but what if your manufacturer has never worked on your device’s technology or segment? It’s important to hire an expert and reduce redoes because redoes will eventually add overhead costs and stretch your time to market. Surfing across your manufacturer’s past clientele, projects and expertise is necessary. Investing in an experienced manufacturer is far better than investing in a novice and less chargeable manufacturer.
Eagerness to expedite a device’s introduction to the market at a lower cost should not make you overlook critical aspects. It’s necessary to understand project specific requirements. Making cost the pivotal factor and ignoring the associated risks and repercussions may lead to redoes, recalls and major financial setbacks. Once the design and prototype is ready you should list down the requirements of your project and then choose the right Contract Manufacturer for scaling. Johari Digital Healthcare Ltd adopts a value engineering to deliver regulatory compliant Contract Manufacturing services at an optimized cost. Balancing investments & technology is an art and as a 40+ years global Medical Device Manufacturing company we assure successful Go-To-Market of your Medical Devices.