Posts by Kenneth MacCallum

Kenneth MacCallum

Safety and business implications for lithium batteries in medical devices

Lithium rechargeable batteries achieve some of the highest energy densities available today. Not surprisingly, medtech companies are keen to use lithium batteries in medical devices and benefit from reduced weight or increased battery life. There are a number of safety implications to choosing these batteries as well as practical business implications.

Kenneth MacCallum

4 Tips for using floating point computations in firmware

Digital Health: Floating Away Until very recently I would never have dreamed of using floating point computations in firmware. It required too heavy a penalty in code space and computation time. Suddenly the game changed considerably.  Now there are a number of relatively inexpensive microcontrollers which have single-precision floating point capabilities implemented in hardware. Here […]

Kenneth MacCallum

Toyota, SOUP, and Medical Device Development

Toyota’s recent $1.5 million jury awarded loss in an Oklahoma court illustrates it’s pretty much impossible to write software without some third party code creeping in.  IEC62304:2006 calls this “Software of Unknown Provenance” or SOUP, referring to software with unknown safety-related characteristics, or developed under an unknown methodology.  I know the situation very well.  Operating Systems, code libraries […]

Kenneth MacCallum

What’s the Point of Medical Device Proof of Concepts (POCs)?

Throughout the development of a product there are technology-related project risks that have the potential to negatively impact budget and timeline. At StarFish, our development process defines medical device proof-of-concept (POC) prototypes to mitigate these risks, either by resolving the uncertainty one way or the other, or by testing the use of a new or […]

Kenneth MacCallum

Reinventing the Wheel in Medical Device Development

Invariably when developing a medical device, there will be technologies which are required and which have already successfully been implemented by others. Maybe it’s a circuit, like a DC/DC converter or even a single-board-computer; maybe it’s a software library or a particular logic implementation. It could be the choice of an existing communication protocol versus […]

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