CellSense™ – A World's First

Mention mastitis to anyone in the dairy industry and you'll get their instant attention. Mastitis is an infection in the udder of a cow which, if untreated, can result in major discomfort to the cow and a serious drop off in both the volume and quality of the milk it produces. The consequences of a mastitis infection in a dairy herd can quickly become financially crippling so farmers are constantly on the lookout for early signs of detection. However many of the traditional methods are time-consuming or difficult to carry out.

At the Mystery Creek Agricultural Field Days in Hamilton in 2005 a New Zealand based company launched a new product onto the international market. Branded as CellSense™ it was a world first in the ongoing fight to effectively manage this potentially ruinous disease.

Background

The beginnings of the development of CellSense™ can be traced back to 2000 and the start-up activity of a small Hamilton based company called Sensortec. The CEO of the company, Rod Claycomb, emphasises that Sensortec was the first company in the world created to focus solely on the development of sensors to analyse raw milk on-line.

"I guess that whole process of evolution of CellSense™ really started from us looking at the dairy industry and identifying the biggest problems that the industry faced. There seemed to be two big problems in the industry which we could work on with sensor technology – one being fertility management and the other the mastitis problem in cows."

The company had an established network of contacts around the world in the dairy industry and in the dairy research field so were able to immediately engage with a range of experts, "to start picking their brains ...and to try and figure things out ..." as Rod says. And out of that research grew what Sensortec calls its 'Cause-Effect Spectrum for Mastitis'.

"In its simplest form, the root cause of mastitis in cows is the end of the teat getting exposed to bacteria. They enter the gland and start to replicate and the immune system of the cow gets triggered. The tissue starts to get damaged if the infection is not successfully fought off, and once the tissue gets damaged it leads to tissue breakdown in the gland. This leads to clinical symptoms of the disease – which can eventually lead to the death of the animal, if you don't treat it."

At each stage of that cause-effect spectrum there are markers in the milk that can be detected and measured using sensors, and the further back you go towards the start of the spectrum the more specific you get in measuring the root cause, bacterial infection.

With the direction established attention turned to developing the sensor technology which could measure an increase in SCC accurately and reliably.

Delivery

Rod Claycomb explains:

The key breakthrough happened largely by accident. David Whyte, one of our research scientists, was looking around at all sorts of ways to measure SCC in milk.

Being the engineers that we were we were looking at sexy ways to do things – you know, all the new technologies – the latest and greatest. Some of those worked and some of them didn't.

A series of specifications had been developed for a suitable end product. These obviously included tight cost constraints but also that any reagents used should not be toxic. We didn't want any moving parts in contact with the milk, because it makes them difficult to clean, and what we produced had to be easy to use and it had to stand up to a dairy shed environment .

One day David came in to my office and he was carrying a National Mastitis Management Programme manual (SAMM) – the one that's given out to all farmers. He showed me a picture of this California Mastitis Test paddle. It had four little compartments, one for each quarter. The farmer squirts some milk from each quarter into the four wells and then he squirts some soap in on top of this, swirls it around and looks for a viscosity increase. If it turns from milky to egg whitish then there's a high somatic cell count.

There was a picture of one of these paddles in the manual and one of the quarters was really dark blue and a couple of the other ones were lighter blue. I said to David, 'Why can't we measure that?' David said, 'We can develop a simple optical sensor to do that!' And off he went back into the lab.

Well he came back with some good news and some bad news. The bad news was that it turned out that the colour in the picture had nothing to do with the somatic cell count – it was actually a protein stain. However the good news was that there was something in the viscosity increase and it looked like we might be able to measure that.

So things went on from there and we put our heads around some ways in which we could measure viscosity in an automated way. We took out a patent on the technique and things started to move from there.

Marketing

Rod admits that in many ways it's easier to show a proof of concept prototype than it is to actually get the final product onto the market.

"You've got to move through the stage of trusting your design to the point where you know that you can leave this thing out there and its going to run and do its thing, and you're not going to have to go back and touch it, because ultimately when you get thousands of these out there you can't be paying attention to the individual units."

So the majority of the next two years was spent turning that proof of concept into a commercial design that could be manufacturable in large quantities. That process occurred in-house with occasional assistance from local sub-contracted groups.

"Somewhere just following the proof of concept stage we built a number of evaluation units that we could send out to potential licensees. The idea was that they could evaluate those for a period of time and then if they wanted to take a license they could. The concept was that we would get a license fee and they would finish off the development and manufacture the final product."

This proved to be a slow process, so during 2004 the company decided to take the risk and finish off the final phases of development themselves.

Outcome

To be a viable solution to the problem, the final product which Sensortec developed had to be:

• cost effective for the farmer
• easy to implement and understand from a user-perspective
• easy to install and maintain from a milking machine installer's or distributor's perspective
• able to withstand the harshness of a typical milking environment including the user interaction

Branded as CellSense™ the product is designed to be located in the long milk tube at the dairy. It works by mixing the milk sample taken with a specially designed, but inexpensive reagent which breaks apart the somatic cells. This process liberates the DNA in the somatic cells which tangle together to form a complex gel. The viscosity of the gel is measured and correlated to give the SCC reading. The milker simply flicks a switch at cups on and the sensor does the rest. The SCC result is presented in convenient bands on a visual display located at the milking point whilst the cow is still being milked. This provides a practical low cost way for the daily monitoring of each cow's SCC level.

"We left it up to the design engineers to come up with a low cost visual display. They did a good job there, coming up with a simple small box that is water tight and has a magnetic switch so that there's no chances for leakage in a wet environment."

The final product is much simpler to install than a standard milking machine installation.

"There's not the piping and pumping and metalwork involved. There's a bit of welding to be done and some electrical work – power points and that sort of stuff – but that's about it," says Rod.

Manufacturing

Manufacturing has also been kept in house. Sensortec is now located within the Waikato Innovation Park in Hamilton and 50% more space was taken on at the end of 2005 to set up their our own manufacturing suite. An operations manager joined the company and a production team was formed to meet the expected world wide demand for the product.

"We're still interested in licensing technology. We realise we can't market globally as quickly as we'd want to do on our own, so we're looking to partner with existing distribution channels and at the same time we've launched the product in New Zealand through our own direct distribution."

Where to from here?

CellSense™ is a first generation, stand alone device that has been designed by Sensortec specifically to meet the requirements of New Zealand's pasture-based dairy industry, which has relatively low levels of milking automation. Development work continues to devise further versions of this sensor technology to meet the requirements of other global markets with higher levels of milking automation

With CellSense™ and three other products now on the market, Sensortec has expanded to 12 research and development staff with another 5 employed on the manufacturing side of its business.

In order to improve the uptake of its growing range of on-line sensor technologies Sensortec has recently developed a new communications protocol which it has branded MilkCANTM.

This new system has been primarily designed to make the integration of its range of sensors both easier and less expensive for milking systems suppliers and systems integrators. This increases the potential to provide cost effective herd management information to farmers and so expands their market potential.

Until now integration of on-line sensors has been a time consuming and expensive business, requiring milking system suppliers to integrate each sensor application individually. The new MilkCAN™ system means that a single gateway can now be set up that is capable of passing data between the network of MilkCAN™ enabled sensors and the milking system's own process control system.

MilkCAN™ is based on the CAN (Controlled Area Network) bus communications network standard, which was originally developed for the automotive trade. It's now commonly used in a number of process control applications and Sensortec has adapted it to suit the specific requirements of the dairy farm environment.

"This gives MilkCAN™ the potential to become an open communications protocol that could make 'plug and play' sensor technologies a reality on the dairy farm," says Rod.

Curriculum focus activity

This page aims to increase familiarity with and understanding of the curriculum by providing explanations of some terminology followed by starter focus questions/discussion points relating to the case study. The following terms are examined:

Context | Issue | Need or Opportunity | Stakeholders | Technological Outcome | Fitness for Purpose

Context

Context is defined in the Techlink Curriculum support material's Explanation of terms as follows:

'Context' in technology education has been used to refer to the overall focus of a technological development or of a technological learning experience within technology education. In order to ensure that the contexts chosen provide for a range of diverse learning opportunities, programmes should include contexts in both senses as explained above. These contexts should cover a range of transformations associated with technology. That is, the transformation of energy, information and/or materials for the purpose of manipulation, storage, transport and/or control.

When talking about the context of a technological development, the term refers to the wider physical and social environment within which the development occurs. For example:

• The context of Zambesi's work was that of rebranding an airline with a focus on the manipulation of information.
• The context of wind generation is sustainable energy generation with a focus on the storage and control of energy.
• The context of a packaged scallop product is marketable food products with a focus on the manipulation, transport and storage of material and information.

When talking about the context of a technological learning experience the term refers to all the aspects that must be thought about to situate the learning.

Starter focus question:

How would you describe the 'context' of the Cellsense™ development ?

Issue

Issue is defined in the Techlink Curriculum support material's Explanation of terms as follows:

An issue in technology refers to a specific subset of the context that will allow students to identify a need or opportunity.

For example:

• The issue in Meeting Seating was outdoor seating that is designed to promote discussion.
• The issue in ICT programming was developing educational programmes.
• The issue in Hairs your Gift was developing hair products.

Starter focus question:

Describe the 'specific subset of the context' which is being addressed in the Cellsense™ development process

Need or Opportunity

Need or Opportunity is defined in the Techlink Curriculum support material's Explanation of terms as follows:

A need in technology refers to an identified requirement of a person, group or environment. A need is identified from an issue, and sits within a context. Technological practice can be undertaken in an attempt to meet an identified need.

For example:

• The need in Meeting Seating was to develop a seat appropriate for a school garden where students could meet for discussions

An opportunity in technology refers to an identified possibility for a person, group or environment. An opportunity is identified from an issue, and sits within a context. Technological practice can be undertaken in an attempt to realise an identified opportunity.

For example:

• The opportunity in Hairs your Gift was to create a gift for a selected recipient.

Starter focus question:

Discuss the terms 'need' and 'opportunity' as they relate to the Cellsense™ development

Stakeholders

Stakeholders is defined in the Techlink Curriculum support material's Explanation of terms as follows:

Stakeholders are any individuals or groups who have a vested interest in the technological development or technological outcome.

Key stakeholders are those people that are directly influential or will be directly impacted on by the Technological Practice itself and/or its resulting outcomes (including the technological outcome and any other by-products).

Wider community stakeholders are those people that are less directly influential for or impacted on by the practice or outcome. They can, nonetheless, be identified as having some level of influence, often through others, and/or they may be affected by the project or its outcome in the future.

Starter focus questions:

Identify 'key' and 'wider' stakeholders in the Cellsense™ development process

What strategies were employed to involve these stakeholders in the development process? Explain why such importance was placed on this ongoing consultation.

Technological Outcome

Technological Outcome is defined in the Techlink Curriculum support material's Explanation of terms as follows:

Technological outcomes are developed through technological practice for a specific purpose and are defined as material products and/or systems that are fully realised in situ. Technological practice also results in other outcomes that are referred to as intermediate outcomes. These intermediate outcomes are very important in technology and technology education, as they are valuable for developing ideas, exploring, testing and communicating aspects of technological outcomes before they are fully realised in situ. These include such things as feasibility studies, conceptual designs, models, prototypes, etc.

For further information see the Explanatory Papers – Outcome Development and Evaluation, Characteristics of Technological Outcomes and Characteristics of Technology.

Starter focus questions:

Describe the 'technological outcome' produced in the Cellsense™ development

Identify 'intermediate outcomes' and explain their importance in the overall development process

Fitness for purpose

Fitness for Purpose is defined in the Techlink Curriculum support material's Explanation of terms as follows:

The concept of 'fitness for purpose' is commonly used to judge the ability of an outcome to serve its purpose in 'doing the job' within the intended location, where the job to be done is clearly defined by the brief. When 'fitness for purpose' is described as being 'in its broadest sense', the concept is extended to include the determination of the 'fitness' of the practices involved in the development of the outcome (including such things as the sustainability of resources used, treatment of people involved in manufacture, ethical nature of testing practices, cultural appropriateness of trialling procedures, determination of lifecycle and ultimate disposal, etc) as well as the 'fitness' of the outcome itself.

Extending the concept in this way is an attempt to locate both the concept of 'fitness for purpose' and its application within a philosophical understanding of the Nature of Technology whereby the performance of any outcome is but one of the factors that justifies a positive 'fitness for purpose' judgment.

Starter focus questions:

In terms of 'doing the job', how would the fitness for purpose of the final product be determined?

When you consider the fitness for purpose of the Cellsense™ development 'in its broadest sense' what other factors would have to be taken into consideration?

Intellectual property issues

The following questions were put to CellSense™ CEO Rod Claycomb in late 2007 by Susan Corbett, of Victoria University of Wellington, as part of her study, Intellectual property in Technology teaching, identifying intellectual property implications and issues that emerge from selected Techlink case studies. Their replies take the form of edited reported speech.

• The product is described as CellSense™ on the first page of the case study – is this because, at that time, your brand was not a registered trade mark?

Rod Claycomb explains that the product's name is also its brand. However the brand had not at that time been registered as a trade mark . In the meantime, the company wished to warn other companies that it was claiming prior use of the word CellSense as a brand and an unregistered trade mark for its product. This is done by placing the symbol ™ as a superscript next to the brand name or logo.

There are some legal protections available for an unregistered trade mark under consumer laws, but it is not always certain that this will be successful in court. An action under the Trade Marks Act 2002 for infringement of a registered trade mark is more likely to be successful.

Now that CellSense has been registered as a trade mark at the Intellectual Property Office (IPONZ), the correct way to write the name is as follows: CellSense®. Note that it is an offence to use the symbol ® in connection with a word or logo that is not in fact a registered trade mark.

• How did you protect the development of the 'quarter conductivity system' with Fusion Electronics.

This was protected by trade secrecy , meaning that no patents were filed to protect the intellectual property (IP). Rather, the information important to the design was retained as in – house knowledge. In addition, certain features of the design, including software codes, electronics layout and mechanical designs are copyright provided they are original. Use of the product technology has been licensed to Fullwood Ltd (UK).

• Did you encounter any particular problems when you applied for a patent on 'a gelling technique for measuring somatic cell count'?

There were no real problems experienced when filing this patent application in New Zealand. Rod Claycomb explains that the issues, if any, usually arise when the patent application with full specification has been accepted by IPONZ. Following acceptance, the complete specification for the invention is published by IPONZ in the IPONZ journal and on its website (www.iponz.govt.nz).

This step is preliminary to the final grant of a patent. There are three months following the publication of the full specification for another person or company to object to a patent being granted. They might object because they claim an invention is not novel, or perhaps they might claim that an invention infringes their own registered patent.

When Sensortec applied to register the patent in the United States, there were some problems. The United States Patent Office claimed that the invention infringed some 'prior art' (a term used to describe matters already protected by another registered patent or already published somewhere in public). Sensortec had to modify its own application and re-apply. This proved to be a time-consuming process. The registered US patent was only granted earlier this year (2007).

• Did you require the participants in your stakeholder consultation groups to sign confidentiality agreements?

Rod Claycomb explains that there was no need to take this precaution because by that stage the product was protected by a patent.
Although certain parts of the design process remain protected as a trade secret (since it is unlikely they would satisfy the novelty requirement for a patent), these particular parts were not discussed in the stakeholder consultation groups.

• In summary, what IP protection does your final product have?

The product is protected by a combination of patents, trade secrets and the registered trade mark (CellSense®). Sensortec has also registered another trade mark (CellGel®) for the reagent used by the sensor.

• Do you have patent protection for the product in all overseas countries in which you license its production?

Sensortec would prefer to license the product only to partners in countries where patent protection has been granted. However in some countries, notably Japan, the cost of a patent is extremely expensive.

In that situation, sometimes companies will take the risk that their product might be copied. They work hard to build up a good reputation for the quality and service features of their brand, often also protecting it as a registered trade mark. This often means that customers will not be tempted away by other competitors making a similar product.