Managing the Complexities of Hardware Engineering

Modern medical devices have revolutionized patient diagnosis and care. These tools make it easier to diagnose, prevent, monitor and treat injuries or diseases. They improve the quality of life for millions. From glucose monitors to endoscopes to pacemakers, the list of life saving medical devices is extensive. These devices are often highly complex, involving the seamless integration of software, hardware, vision and other advanced technologies. Safety, high reliability and robustness are paramount with these devices. Much of the work on medical devices starts with a quality Hardware engineer.

Hardware engineering deals with the physical. They are responsible for the design and development of systems, from the creation of prototypes to fully functioning devices. 

A successful hardware engineer has much to consider as part of his or her work.

Safety – Principal with any medical device is the safety of the patient. A hardware design must comply with safety standards from organizations such as UL and the IEC. Special attention must be paid to medical device specific safety standards such as IEC 60601. Compliance with these and other standards help ensure that the new device is safe.

Ease of use – While industrial designers often create the initial design of the product, the hardware engineer must take the designs and make them practical and usable. Hardware engineers create designs that are approachable, and support multiple uses without significant reconfiguration. Consider a probe that has replaceable components that must be sterile for each use. The design must be simple enough to allow for swapping of the sterile component in the time between patients.

Clear, full documentation – often overlooked in any design is the need for extensive documentation that describes the functionality of the device. Documentation is critical for the product owner’s ability to internally manage/maintain the device. Often, a hardware engineer is engaged in a project for the sole purpose of helping complete documentation. Occasionally, a project is 80% documentation. A hardware engineer cannot just create an easy to use product for end users, but must also document thoroughly for the customer to maintain the device.

Clearly commented HDL — Hardware engineering includes HDL (High Level Description Language). Well formatted and commented HDL code is critical so that design teams can quickly understand and review prior to performing any additions or changes to the hardware.

Design for Manufacturing (DFM) – The work of the hardware engineer should follow good design practices with an eye towards creating a product that can be efficiently manufactured. This includes activities such as performing a cost benefit analysis to balance features against cost. Other areas of consideration include the time to manufacture and the complexity of manufacturing.

Reliability: DFM and Reliability are connected. Limitations of the manufacturing process need to be considered. For example, is the machinery capable of manufacturing tiny components, or would that have to be performed by hand? Is the manufacturing RoHS compliant?  When using a fine pitch and or high pin count — can the manufacturing line install them? These are all considerations that must be made by the hardware engineer.

In the medical device and life sciences industry, many custom-designed products are in need of a technical update, end of life, or in some cases, have the need to be re-designed because of a less-than-optimal initial design. Complex Hardware design, especially with medical devices requires hardware engineers who are deeply familiar with the nuances required to complete the design as specified and on schedule.

Is your outsourced R&D project stalled in hardware design?  Contact Resolution Development Services to learn about their hardware engineering services.