Pharmaceutical & medical
1. Check capabilities
Ask targeted questions and visit the facility. Delve into their expertise, equipment, and production processes. Talk to different team members and request references. If agreements allow, ask about specific case study examples of projects that have utilised similar skills, processes and outputs to your requirements.
Tip: Note that CMOs that spread their business across multiple sectors – including consumer, industrial, construction and medical – are less likely to eat, sleep and breathe the certification and validation standards compared to a pure medical device CMO.
2. Fit for purpose
The CapEx cost to create the manufacturing infrastructure can be high and take a lot of time to implement. A CMO with the technical compe- tencies, cleanroom facilities, and regulatory and certification knowledge can take an idea and hit the ground running.
Tip: With so many device types, check that your CMO has relevant experience in the right cate- gories. For example, they may know drug delivery devices inside out, but do they understand the nuances of manufacturing surgical equipment?
3. Hidden costs
One of the major development roadblocks is when pricing structures haven’t been clearly defined. By
Instrumentation Monthly January 2025
virtue, a development lifecycle often includes various component designs and tooling iterations. A good timeline and budget plan can help to ensure costs don’t escalate beyond the project budget and compromise its viability.
Tip: Transparency is vital. Request a full break- down of costs, including details of additional charges and when these would be applied
4.Scalability and supply chain shocks
Competency and capabilities will likely inform your CMO selection. But also examine the unpredictable logistics risks that could potentially jeopardise production timelines, material sourcing, stock holding etc. How proactive is the CMO with their risk strategy? What buffers are in place to mitigate supply chain disruptions? Do they have production capacity to respond to an influx of additional orders?
Tip: Ask the CMO when they last felt a geopolit- ical or sourcing risk could have potentially disrupted their business and how they assured customers. How did they adapt, rebound and recover?
5. Rigorous reporting
There are phases in the formative development lifecycle where product iterations come and go. However, once a device reaches the CMO, the use of formal validation steps and structured communi- cation becomes imperative. An ISO management
system tracks changes to help streamline the regula- tory application process.
Tip: Do the prototyping design tools used by the CMO factor in defined parameters e.g. material, weight, dimensional constraints, performance criteria, tolerance etc. and are they able to simulate how devices will behave in real-world conditions. In the 2024 MedTech study recently published by consulting firm Roland Berger, sourcing and procurement, as well as supply chain were cited by senior executives as two of the most important steps to unlock growth. For processors that are prior- itising profitability over top line growth, outsourcing medical device manufacturing can be the most economic and viable option, claims O’ Keeffe. “Sourcing a reliable medical device manufacturer is critical for ensuring the success and scalability of innovative medical products. By partnering with specialised contract manufacturers, OEMs can leverage advanced expertise, reduce risks, and streamline their path to market. As the medical devices landscape continues to evolve, the impor- tance of selecting a manufacturer that excels in quality, transparency, and adaptability cannot be overstated. With extensive experience and compre- hensive capabilities, the right manufacturing partner can support MedTech companies in bringing their life-changing ideas to fruition,” ends O’ Keeffe.
Europlaz Technologies
europlaz.co.uk
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