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.
BIGGEST CHALLENGES IN MEDICAL DEVICE MANUFACTURING
1. HIGH COSTS OF PRODUCT DESIGN AND DEVELOPMENT
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.
2. REGULATIONS AND GOVERNMENT
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.
3. TECHNOLOGY AND SECURITY
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.
4. PRODUCT QUALITY AND HIGH RECALL RATES
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.