Rapid Ozone Sleeve Sterilisation (ROSS)

The Problem Statement

Amputees have many daily challenges which many may not be aware of. One of these challenges is to care for liners and sleeves, which are critical prosthetic components. These liners can become the breeding ground for bacteria, mould, viruses, and protozoa which poses a health risk to the amputee (and the potential public embarrassment due to unwanted odours).

The Decisive Competitive Edge

The need for a product to clean these sleeves and liners rapidly and ensuring no unwanted odours and good hygiene is evident. Such a solution would have a significant impact on quality of life and ease the long-term financial burden of sleeve/liner replacement purchases.

The Product Development Process

The Initial Engagement

Two passionate inventors, JC Visser and Barry Geer approached Skeg with a basic Experimental Prototype demonstrating the ability to clean amputee liners and sleeves using Ozone technology. The request was simple: How do we industrialise this prototype in the shortest space of time?

This request is not uncommon and at Skeg we encounter such requests daily. Most start-ups cannot afford having internal development teams as upfront capital is limited and the “cognitive uphill” of industrialisation is steep. The association and endorsement from an established development partner also serve to add credibility and mitigate the investor’s perception of risk. In the case of ROSS, the investor did a due diligence on Skeg to confirm its credibility as development partner capable of delivering the product within the projected timeframe.

What made the ROSS request unique, was that their product value was already clearly defined. The fact that the founders also had prior start-up experience proved a major asset as they navigated the pitfalls of realising their idea. Another major win was that the team had secured international funding from a knowledgeable and engaged investor.

Minimising Time to Value

When addressing the request to minimise the time to market, several factors are at play. The “process of product development” being a critical parameter. Many people assume product development is guided by a fast-iteration / fail-fast methodology only. The reality is that product development is a very structured process. Frameworks such as the Design Thinking and the V-V model guide the process while still allowing for creativity.

Additionally, the pressure on the Bill-of-materials (BOM) is a major factor. The more pressure we place on the BOM, the longer (and more expensive) the development cycle. Quite often the answer lies in ensuring the market’s perception of the product value allows for sufficient flexibility in the BOM price.

In the case of the ROSS project, the stakeholders aligned around a well-defined project development roadmap which was executed in a timely manner. The value of the product and nature of the business model also allowed for sufficient BOM flexibility.

Discovery

The first phase in the Skeg Product Development Process is the Discovery. This serves to discover and/or confirm the Decisive Competitive Edge (DCE) of the project which serves as lighthouse during the development process. In the case of ROSS, the DCE was easy to frame, and the challenge was on realizing this value in a timely manner using a focused and structured development roadmap.

During a Discovery, a key exercise is to identify the business and technical risks of the project. One such risk was the usage of ozone as cleaning agent, which necessitated detailed material exploration as risk mitigation factor. In addition, an in-depth understanding all relevant certifications were explored considering the product would be distributed internationally including in USA and Canada.

Alpha Prototyping

With the Discovery setting the platform for prototyping and equipped with a first experimental prototype, Skeg could focus on refining the system architecture by sourcing and experimenting with specific elements of the design. Such experiments included ozone generation testing, power budgeting to name a few.

With the material and component choices in please, the industrial design could give expression to the product’s look and feel. This included the fitment of all the electronics and wiring (space claiming) and detailed design on the finishes of the product to ensure the desired user experience.

A critical step during Alpha was also pre-compliance testing (EMC/RF) to ensure the product can be safely used in the target application.

The final alpha prototype was well received, and the founders and targeted users could interact and give feedback for minor updating.

Beta Prototyping and Trials

After implementing the updates, batch manufacturing could follow to allow for market trial testing. In this process, Skeg set up production and assembly lines to deliver 60 Beta units. In addition to the manufacturing, a test unit was prepared for final compliance validation (FCC) and the process actively managed until certification was approved. The ROSS product was now read for scaled manufacture.

Project Status

Towards the end of 2022, 10 000 quality assured ROSS units was shipped to the USA for distribution. This is truly a success story, and a testimony of how good stakeholder alignment can yield timely results even in the world of hardware product development.

Time-to-Value

There is a stigma in the development world that hard technology should take several years to reach market. The ROSS project was a great example of how this need not be the case if development focus and proper roadmap planning is followed. We follow a view that all stakeholders subordinate to the product which ensures alignment.

Key Learnings

Stakeholder Engagement

The key stakeholders in the product development cycle were:

Inventors / Founders
Investor
Development Partner (Skeg)

From the onset of the project, regular engagements ensured alignment of motivations. The Inventors were actively engaged and shared a clear passion and drive for the product to reach market. The investor showed a strong belief in the product viability and Skeg shared the vision that this product will make a significant impact in the market. Even more importantly, there was a sense of mutual trust amongst the stakeholders to focus on their respective strengths and each being teachable as required.

Value-focused Development

The ROSS product is a success story where communication and development was centred around a clearly defined value offering. Product features were only included if it subordinated to the DCE (“must-have” versus “nice-to-have”).