A fact well known to businesses is that a good idea is not always a viable one. This is why experts from the each facet of the Medical Device Design and Development team come together to create a Design for Manufacturing or Design for Manufacturability (DFM) Plan. The DFM process seeks to ensure that a product or its component meets and exceeds its requirements in terms of: Device performance, Compliance with global regulations (US, EU, etc.), Uses the most effective materials for each of its components, Assembly using cost-effective and waste-free steps, Manufacturing happens within set tolerances and validation tests for quality.
Using Prototypes at each iteration of the design phase enables hands-on testing and validation. Thus, Prototypes serve as pre-production models that can demonstrate each product feature and the benefits of the adopted manufacturing process. It is recommended that the product design team work hand in hand with the manufacturing
Over the past three decades, the world has witnessed major breakthroughs in minimally invasive interventional procedures. Medical devices used for these procedures have had to become smaller ranging from a few microns to a few millimeters. Increasing demands are placed on their level of precision and functionality. Incidentally, the smaller the medical device, the greater the level of precision. However, manufacturing micro-devices is not the same as that of macro-devices. Material properties, electrostatic forces and micro-scale assembly all augment the difficulty of manufacturing
Highly specialized equipment as part of a fully-automated or semi-automated system is vital to successful micro-assembly. Micro-molding and micro-machining are complementary techniques used with micro-assembly. Micro Devices such as balloon catheters, guide wires, micro-electronic components, micro-pacemakers, electrode tip catheters, and much more are manufactured using micro-assembly.
The effectiveness of minimally invasive procedures (diagnostic and therapeutic) has influenced medical practice in cardiology, neurology, nephrology, and many other medical disciplines. Devices such as the balloon catheter can travel through minute blood vessels without disturbing their natural shape. It is widely used to deliver stents, open blockages, dilate blood vessels, and much more. The balloon set on the catheter is controlled by the physician and made to inflate at the clogged site. While the material chosen for catheters is crucial, the manufacturing process used to make them is equally critical to produce the highest-quality device. Balloon catheters provide an ideal platform for deploying flexible circuit combinations, which enables the development of novel techniques. The high-precision manufacturing process involves extrusion of the balloon material into the shape of a tube, the circumference of which can vary from a few microns to a couple of millimeters. This is followed by the
As of 2010, intelligent industrial automation, such as collaborative robots and smart manufacturing equipment, was inaccessible to most corporations. Today, quality, efficiency, and low production costs are vital to contract manufacturers and OEMs alike. Market research shows that automation is driving the MedTech industry. According to MedTech Intelligence, medical device manufacturers that adopted automation in their production lines saw a 40-60% decrease in processing costs. Automation has thus become a much sought-after capability for medical device manufacturers. Today, affordable and ﬂexible automation is accelerating the rate at which manufacturers can strategically automate production, with the extent of automation directly impacting the bottom line—in terms of one-off and per-item costs, quality, repeatability, and customer satisfaction. Strategic automation is the best means for ensuring success.
Full life cycle management
Mass production of a medical device or bringing a new medical device to market requires extensive knowledge and the appropriate supporting technologies and infrastructure. Not all OEMs and device manufacturers have the vast resources required to support the launch of new medical devices. As a device manufacturer (or OEM), your core competency may be in concept generation, product design, or regulatory matters. Ultimately, competency, support, and quality at every stage of the product life cycle will determine how well your product will be taken up by the market. Bringing in veteran contract manufacturers from the earliest stages will result in better product profit margins. They should be involved from the concept stage to design & development—NPD (new product development), PFD (process flow diagram), DFM (design for manufacturing), pre-PFMEA (pre-process failure mode effect analysis)—technology transfers, NPI (new product introductions), and finally, manufacturing and delivery (efficient supply chain).