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Why Medical Device Companies Use Priorities Created by Toy Makers

The priorities followed by product developers arise from the ontology they use

The priorities of product development teams arise from the ontology, the beliefs about the nature of reality, they follow. One of the greatest values of defining that ontology is to identify blind spots and wrong assumptions. When the source of priorities is clear, improved, more adaptable options become possible.

As Clayton Christensen (1952–2020, pictured) has said:

To grow profit margins and revenue, he observes, such companies tend to develop products to satisfy the demands of their most sophisticated customers. As successful as this strategy may be, it means that those companies also tend to ignore opportunities to meet the needs of less sophisticated customers — who may eventually form much larger markets.

A hierarchy of products starts with the components, primarily the integrated chips, the operating systems, and control software. Planners evaluate the chips and other components, including operating systems and software, and choose those they will use in their next product. Each system component developer works under the guidance of a set of requirements and priorities. They then self-evaluate, using these requirements, and the results will later be evaluated by management and customers.

For a product that includes wireless, the choice is between one of the radio protocols, Bluetooth, WiFi, or DECT and the chips that implement them. It is, in principle, possible to design a wireless interface from more basic components. But the cost and design advantages of using an integrated chip solution are so great that seldom will a component-level implementation be chosen. What then happens is that the priorities related to security, reliability and other parameters used by the chip designers become constraints for the product developers that use the integrated chip.

Whether it be the design team for a chip or a final product, successful teams focus on the desires of their best customers. They focus their—always scarce—resources on the needs of those customers. This focus is inherently driven by the past. A company’s best customers are those that bought the most from them in the past. As Christensen has correctly pointed out, these may not be their best future customers. Further, the biggest customers, past or future, may not be the customers with the most demanding requirements.

This is true in other areas of a company’s business, past and present, as well. A company’s best past customers may be manufacturers of toys or other comparatively inexpensive consumer products. High-volume applications have the power that comes from buying a lot of chips. Their purchasing power gains and holds the attention of the standards developers and chip manufacturers, implementing new RF protocols. The result is that lower volume, but socially more important applications are forced to use chips and protocols designed to meet the reliability and security needs of toys and consumer products. We end up with medical devices using chips designed to meet the reliability needs of children’s toys.

The problem is that, for most radio interfaces, there are dominant use cases. For example, about 80% of Bluetooth chips are used either in a mobile phone or a headset intended to be used with a mobile phone. While those Bluetooth chips may be used in different applications, they are optimized for this dominant use case. Few would argue that a Bluetooth interface in a medical device has the same needs for reliability and security as a cheap consumer headset, but the chips used are often the same. With the use of common components comes inherently the reliability and security of those chips. But those chips were designed to be used in cheap, high volume consumer products.

The dominate use of Bluetooth chips is for wireless mobile phones to headsets connectivity. A wireless headset for a mobile phone is a fine application. We then find that more than 50% of medical products that use wireless use Bluetooth. The economies and design simplification of using Bluetooth chips dominates alternative choices of using other RF protocols and frequency bands. There are RF protocols and frequency bands intended for the exclusive use of medical devices. However, the advances of Bluetooth are so great that a majority of medical devices do not use those RF protocols or frequency bands. Few would argue that the reliability and security needs of medical devices are the same as those of toys. Yet the forces at work result in medical devices being designed using chips designed to meet the needs of headset and toy makers.

The problem is not that the ontology used by the chip designers is wrong. They are correct to optimize their design to serve its dominant use. The challenge then comes to the product designers, operating with a different set of priorities. They must design products using the available options. There are many things the chip designers could do to help these product developers. This is a lost opportunity. If the protocol developers, spectrum regulators and chip manufacturers could gain insight to the range of needs from the full set of products that will be using their work, those needs could be much more effectively addressed. The chip designers could still optimize their interface chips for the dominant use case but provide adaption options, allowing those with different needs to optimize the chip differently.

The problem becomes more complex when the entire value network is considered. Some companies provide chips, other companies provide software to operate those chips, and the operating system hosting that software is developed by yet other companies or organizations. The final product development team brings these components, operating system, chips, and application software, together to create the final product.

However, it is common that products can be configured by users to allow the end user to focus a product on specific needs. The end user becomes yet another link in this chain. At each step, the developers have priorities and find compromises that satisfy the requirements given by their managers, who in turn get them from their best customers.

The challenge for those trying to advance a specific concern is to do their work in a way that finds its way through this labyrinth of competing value networks and successfully impacts the final, deployed product. Those trying to improve spectral efficiency, security or wireless reliability would do well to analyze the complex set of value networks through which their innovations must pass if their work is to have an impact.


You may also find of interest these articles by Stephen Berger:

We are running out of spectrum but AI might help. Future generations of wireless (radio wave) communications will depend on artificial intelligence (AI)

Radio is changing from hardware to software. New policies are needed. Perhaps surprisingly, theology may play a role in determining how radio will be used.

and

Stakeholders are competing for control of radio networks. Future networks will need to need to safeguard the quality of the data.


Stephen Berger

Stephen Berger is the founder of TEM Consulting, LP. He specializes in developing consensus multidisciplinary solutions for complex public policy issues. He has served on three federal advisory committees. Two of those committees addressed accessibility of telecommunications and information technology for people with disabilities. The third addressed requirements for voting equipment. He has chaired five standards committees that developed standards incorporated by the FCC and FDA into the US Code of Federal Regulations (CFR). A current focus of this work involves improving healthcare through insightful introduction of technology with supporting system change.

Why Medical Device Companies Use Priorities Created by Toy Makers