Medical Device Manufacturing Constraints – The Good and the Bad

In the medical device industry, injection molders are specialized in achieving thin walls, close tolerances, and very small component characteristics. In these respects, the design of medical devices has fewer restrictions than other industries in which walls are usually thicker and structural integrity features wider. Generally, in our projects, we do everything possible to minimize undercuts and other troublesome geometry. But for certain medical goods, relatively lower price pressures build economies for the medical devices industry that allow design features that might be cost-prohibitive to achieve in other industries. In order to produce undercut features, collapsible cores can be used, tighter tolerances can be preserved and draught angles can be lower. In this article, we will talk about the challenges of medical device manufacturing.



The main driver behind the high cost of the development of new products is the amount of time needed to take an idea from conception to realisation. These costs can be reduced by establishing a solid basis for a design project with clear and concise requirement specifications, and organisations will realise faster “to-market” times and enhanced ROI.


The significance of understanding who the stakeholders in the design specifications process are and involving them early in the process was addressed. When it comes to coping with the issues posed by the new regulatory landscape for medical devices, your regulatory and quality team are key contributors.It is crucial, however for all team members, especially engineers and project leaders, to have at least a high-level understanding of the requirements, as you are likely to experience problems.


As the Internet of Things (IoT) becomes rapidly incorporated into society and more devices hold essential personal data from users, privacy and trust are a growing security issue for companies in the field of medical devices.

Technology and data integrity criteria were also noted in section 1., above, as an example of a significant consideration from a cost-savings perspective for the early stages of the product design/requirements process.

Organizations need to approach this issue with a ‘security by design’ mentality to ensure regulatory enforcement and consumer confidence and trust, i.e. designing technology and security considerations from the outset, instead of as a post-design necessity. This is why it is important to include IT in the stakeholder team of design specifications from the beginning.

The first step in ensuring user privacy is secured at the heart of the product is the integration of privacy and protection measures into the embedded software systems in the earliest stages (authoring requirements). It mitigates a variety of privacy concerns that may arise further down the development path by integrating protection as functionality. Requirements also allow writers to provide contingency plans on what to do if/when a violation occurs.


Brand recalls are another manner in which the reputation and bottom-line of a business can be easily and devastatingly affected, along with regulatory agency compliance measures and data breaches. More importantly, poor product quality can lead to severe injury to end-users or even death. Although these problems are faced by even the most common medical devices, newer, more technologically advanced products are at even higher risk.


In today’s highly competitive medical device industry, providing a clearly defined, efficient process for requirement preparation is much more important. Companies need to be more efficient and effective than their competition in responding to consumer needs. The key to this is to ensure that all those who have a stake in the process are included, along with streamlining the process of requirements and using resources to ensure that clearly specified requirements are established from the beginning.

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Medical Device Feasibility

Proving medical device feasibility is the first important milestone in bringing a medical device to market.

The bulk of device design and development can’t happen until feasibility has been proven. Read further to understand what medical device feasibility means and what needs to happen before you can prove the feasibility

Medical device development starts with taking an idea for a new or improved device and turning it into a rudimentary design concept. Once you have a concept, you’ll develop it to the point that allows you to be able to build a working model. You’ll use that model to test and determine if it does what you expect it to do. That model – your proof-of-concept – won’t necessarily prove that you have a path to a commercial product. You’ll establish that with the feasibility prototype.

The purpose of a feasibility prototype is to determine whether you can build the envisioned device using already existing components and technologies, or if you’ll need to do some customization and/or invention. That will give you an indication of how big the development effort is likely to be, and the extent of the resources you’ll need to commit. Developing a feasibility prototype is more rigorous that developing a proof-of-concept model  (depending on product complexity, it is sometimes more economical and efficient to forego proof-of-concept activities in favour of moving directly into feasibility). The feasibility prototype will tell you if your concept is technically feasible, and can be produced in a way that makes sense economically.

The feasibility prototype is similar to the working model you built to prove your concept. But whereas the proof-of-concept was most likely a simple device, designed to prove principles, the feasibility prototype is the proof-of-concept model pushed into a form that manifests what the ultimate commercialized product might become. In addition to exhibiting the device’s major functionality, the feasibility prototype will also include user interface elements. You can think about it as the product in its first, very rough embodiment.

The feasibility phase is among the most important parts of the project. For the device to be cleared by the FDA so that you can market it, the development of the device’s design must be done in a prescribed manner and fully documented. This is know as Design Control. The thing about feasibility is, you are free to experiment and try different approaches to achieve your design goals without having the burden of documenting each step. Once you’ve proven feasibility though, and have moved into actual design and development, you will need to have a design control system in place and adhere to its guidelines. That is actually a good thing because it ensures – to the extent possible – that devices are designed in accordance with sound engineering principals, and that any potential for device failure and resultant harm to users or patients has been thoroughly considered.

Design Control does add a significant administrative burden and cost, however, so you wouldn’t want to have to implement it until you’re sure that your device is functionally viable at minimum (commercial viability is another question, and developing the feasibility prototype should provide evidence that the device can be manufactured at a cost that can support a business model).

Proving medical device feasibility sets the stage for the detailed development that will follow. It’s the first significant milestone in your journey, and is often the key to opening the funding coffers.

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