How to Transition Your Medical Device from Prototyping to Volume Manufacturing 

April 13, 2023 / Latest Thinking, Resources

The medical device industry is an incredibly important and rapidly changing field, with innovation in technology opening up new possibilities for improving patient care. But the process of transitioning from concept to volume manufacturing can be a difficult one, with many potential pitfalls along the way. There are many steps involved, and each step must be carefully planned and executed in order to ensure success.   

The first step is to create a prototype from concept. This prototype will be used to test the functionality of the design and help define the feasibility of the product as a long term viable medical device product. The prototype phase is a crucial stage in the product development lifecycle of a medical device, where the natural focus is the clinical and technical effectiveness of the product. Often forgot about until much later, is the manufacturing and commercial feasibility and these can have very significant consequences for a successful product commercialisation.  


Transitioning from Prototype to Volume Manufacturing 

The transition from prototyping to volume manufacturing of medical devices is a critical point in the product development lifecycle of any medical device.  

There are several factors to consider when making this transition, including:  

  1. Design for manufacturability (DFM): DFM is an important consideration during any manufacturing feasibility and development process. It becomes even more critical and most effective when the product is still a prototype and where the design teams have the ability to adapt and apply DFM principles into the design before the design is frozen and before future design change efficiencies become much more difficult to implement. 


  1. Process Debugging: This is where a reasonable amount of product can be built through the proposed manufacturing lines at a pilot scale. Allow the product to flow through the process and collate the output data including yield, performance and device functionality. Challenge the process with different operators, different materials, different quantities etc and review the performance outputs in these scenarios. Find the challenges as early as is feasible and deal with these ideally ahead of any significant commercial ramps or supply phases.  


  1. Process validation: In order to ensure a successful and efficient transition to volume manufacturing, it is important that the production process is appropriately validated. The steps process should undergo detailed risk assessment (PFMEA) and a validation approach based on the risk assessment to drive the appropriate validation. Assessments should use the data in step 2 (process debugging) to help identify the risks and inform the decisions for the validation strategy.  


  1. Regulatory compliance: Medical devices are subject to strict regulations, so it is crucial that all products meet these requirements before they can be sold commercially. The transition to volume manufacturing should account for these and the appropriate quality system, controls and assurances should be put into place to support the successful manufacturing and distribution of your product and ensure compliance with the standards in ISO13485 or 21 CFR 820. 


  1. Cost reduction: One of the key goals of transitioning to volume manufacturing is reducing costs to achieve a more profitable product.  A cost of manufacturing plan should be drafted up to identify ongoing cost improvement opportunities. By understanding the cost targets early the manufacturers, designers and commercial teams can collaborate to develop and enhance the commercial feasibility of the product into market. There will be decision points where for example cost improvements are not included for early generation device design that are released commercially due to time constraints but could be incorporated in subsequent design iterations to improve both the device performance and commercial performance of the product. Cost reductions can be achieved in a number of ways including economies of scale, yield improvement, tact improvement and design changes impacting process, materials etc. It is important to carefully assess all options and choose the approach that will best meet the needs of the business and aligns with the overall business plan. 


Tips for a successful prototype to Volume Manufacturing journey  

One of the most difficult aspects of medical device manufacturing is making the transition from prototyping to full-scale production. This process can be resource intensive and time-consuming, but it is essential in order to successfully bring a new product to market. Here are some tips on how to ensure a successful transition from prototype to volume manufacturing. 


  1. Understand your costs and sell price. Before you can start looking for funding, you need to have a clear understanding of the commercial and manufacturing costs associated with production. This should include everything from tooling and equipment costs to labour costs and regulatory compliance expenses. Fundamentally can you sell your product profitably? Understanding this early and building these boundaries into your design will help ensure successful commercialisation. 


  1. Have a well-developed business plan. It is essential to have a well-developed business plan that touches on all the points we have discussed. A robust year-on-year plan will help drive product and process improvements and assist in sourcing the investments required to achieve these improvements. Your plan will change based on what the markets throws at it but it is key to regularly revise the plan and ensure it is understood by all stakeholders. 


  1. Sales and Marketing: In order to sell your product it is essential to get Key Opinion Leaders (KOL’s) on board, publish your data and have your KOL’s champion your product. Ensure the commercial scale can achieve its potential which in turn will facilitate efficiencies with scale, materials and manufacturing setups. 


  1. Funded plan: It is essential to have a solid, exhaustive plan to secure the funding necessary to be able to take your product to commercialisation. It is important to plan for all possible scenarios for example additional funding may be required if there are more sales than expected and extra capacity is required. Product launches can go to plan but sometimes they do not and the flexibility to adapt is important. 


  1. Operational experience and expertise on your team: It is very easy to have the design, clinical and regulatory know how on your team when in product development. However, an element that is often overlooked at this early stage is having the required operational expertise. The operations function is a key enabler to bringing your product to commercialisation successfully and having their experience and skillset as early as feasible will pay dividends over the overall product lifecycle. 


  1. Collaborate with your manufacturing partner: It is key to have a healthy and collaborate relationship with your development and manufacturing partner from an early stage. Sharing your plans openly and thoroughly will allow ‘buy in’ into your journey and allow you solicit their input into your plans. An open and full engagement early can provide key inputs which will be beneficial in the development of your overall plan. 


The transition from prototyping to volume manufacturing within the medical device industry is a complex process that requires careful planning. It is essential to ensure that all steps in the process are completed thoroughly and efficiently, as this will ensure the success of your product. By following these tips on how to transition from prototyping to volume manufacturing for medical devices, you can be sure that you have performed all necessary steps for a successful outcome. With proper preparation, diligence and attention to detail, you should be able to effectively manage your transition from prototyping into large scale production with ease.  


ICS Medical Devices – Your partner in catheter commercialisation 

At ICS we have the experience and capabilities necessary to achieve your individual milestones and accelerate your product from prototype to full-scale production.  

 We know the importance of getting medical device products to market as soon as possible and from the very start of your journey we are already considering the manufacturability of your product. We pride ourselves on our ability to provide truly rapid prototyping outputs. We do it through night shifts; multiple production lines; agile processes; and committed, highly skilled staff. Whatever it takes to help you meet your deadline. Our catheter prototypes are tailored to your needs – from quick mock-ups for bench testing, concept evaluation or show and tell; to high-end, high-quality prototypes for lab trials, bench trials, investor review or design freeze evaluation and testing.  

Our experienced engineers will ask the technical questions you may not have asked yet. If we see an area for improvement to the design or if we see an opportunity for improvement for design for manufacture (DFM) we will provide the input up front.  

 We have the experience and technology necessary to accelerate your product to volume manufacturing. Our flexible and scalable approach enables us to assist you in all stages of your journey from pilot manufacturing of components, complex sub-assemblies and full devices, right up to supplying packaged and sealed products in volume from our cleanroom facility. 

Speak to one of our engineers today about how our facilities and processes can scale with you from pilot to volume manufacturing.  



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