Periodic Reporting for period 1 - PICSIMA (Next generation 3D print technology (PICSIMA), which for the first time enables the direct full colour printing of silicone to make soft tissue prostheses, orthoses and removable partial dentures.)
Reporting period: 2015-06-01 to 2015-11-30
In 2013 Fripp Design Limited received a €30K grant from the UK Government to explore the feasibility of 3D Printing two part RTV silicones, more specifically silicone rubber. The idea for 3D Printing silicone came from a combination of 10 years industrial design experience (using a variety of commercially available 3D Print technologies, some operated by the company) and a project that was commissioned by the Wellcome Trust, namely to develop a method for 3D Printing soft tissue prostheses using commercially available hardware and software.
The soft tissue prostheses project relied on the creation of a starch based scaffold which was post infiltrated with commercially available medical grade two part RTV silicones. The industrial challenge for the company was to try and eliminate the starch stage and 3D Print silicone directly.
With the UK Grant this technical challenge was achieved. Platinum silicones are widely used in industry where the rubber creates objects through the process of moulding. With the method discovered by Fripp Design Limited, it could now be possible to create rubber parts without the need for moulding. This not only reduces the time and cost in making parts, it introduces new design freedoms which could create new market and business opportunities as well. However the company did not develop the method based on an identified market need, they developed it as an Industrial Design challenge.
The method discovered, which the company has branded as Picsima (for Pixel Silicone Maker), is simple so the company wanted to validate the novelty and inventiveness of the IP.
The Phase 1 grant has allowed the company to research the market opportunities and develop an IP strategy. The company can report that the European Patent Office have confirmed both the novelty and inventiveness of the IP claims. Interestingly the markets the company thought would benefit from Picsima (such as custom shaped breast implants) are not the markets with the actual need (markets such as Medical Simulation/Training aids and custom consumer ear plugs) . The research shows that the global market for 3D Printing silicone rubber is worth up to €500M with interest in the areas of consumer specific devices (ear plugs), medical training/simulation aids, rapid prototyping of gaskets/seals and foot orthotics.
Fripp Design and Research is both a user and inventor of 3D Print technologies. It is in a unique position to develop its discovery for 3D Printing silicone rubber into a commercial 3D Printer for 3D printing silicone.
The first task undertaken was an in-depth analysis of the global RPD, orthotic and prosthetic devices markets specifically targeting the UK, France, Germany and the US – the countries where the company have strong links within the medical field. This analysis was done utilising published market survey reports. The company conducted field specific studies and surveys by engaging with various stakeholders who have a vested interest in the ability to create silicone rubber through 3D Printing rather than moulding. The study was carried out in a 5 month period with the focus on the specific market requirements for each market and assessment of the market acceptance of our proposed product.
Purpose (e.g. to demonstrate viability)
The key purpose was to demonstrate the market need to 3D Print silicone rubber, rather than mould silicone rubber. The principle reasons for 3D Printing any material are:
1. It reduces the time and cost to make a component by eliminating the need to create a mould
2. It introduces new design freedoms where moulding restricts particular types of geometry
3. It allows for the creation of ‘person specific’ products; from custom consumer devices to patient specific medical devices
3D Printing was invented in the early 1980s. In 1981, Hideo Kodama of Nagoya Municipal Industrial Research Institute invented two 3D Printing fabricating methods of a three-dimensional plastic model with photo-hardening polymer, where the UV exposure area is controlled by a mask pattern or the scanning fiber transmitter. Then in 1984, Chuck Hull of 3D Systems Corporation developed a prototype system based on this process known as stereolithography, in which layers are added by curing photopolymers with ultraviolet light lasers. Hull defined the process as a "system for generating three-dimensional objects by creating a cross-sectional pattern of the object to be formed. Hull's contribution is the design of the STL (STereoLithography) file format widely accepted by 3D printing software as well as the digital slicing and infill strategies common to many processes today. The term 3D printing originally referred to a process employing standard and custom inkjet print heads. The technology used by most 3D printers to date—especially hobbyist and consumer-oriented models—is fused deposition modelling, a special application of plastic extrusion .
Many materials are capable of being 3D Printed, however silicone rubber has always been a challenge because:
1. Extruding silicone makes it impossible to create ‘overhangs’
2. Extruding silicone makes it impossible to create complex internal structures (such as internal tubing)
3. Extruding silicone makes it impossible to create variable softness in a single part
The process discovered by Fripp Design Limited overcomes these limitations. An additional important consideration with silicone rubber is that silicone rubber is a material already approved for both industrial and medical use. This differs from all other polymer based 3D Print technologies where materials are created specifically to enable the 3D Print method to work which restricts their application, particularly in medical applications.
Method (summary of the work done)
The company has undertaken a number of methods to validate the market opportunity for 3D Printing silicone rubber.
The company produced a test rig to prove the concept for the method for 3D Printing silicone rubber envisaged. This allowed for the testing and validation of the markets identified with potential customers.
The test rig has allowed for the implementation of internal research. To support the Phase 1 market validation, the company created a website and established a twitter account to communicate and educate the market about 3D Printing silicone rubber.
In addition the company has used the Phase 1 funding to cultivate relationships with key stakeholders within the 3D Print industry (both on the supply side, such as the material providers and with prospective customers) and the 3D Print press where the company has produced a number of press releases that have been picked up and published.
The company has used desktop research to establish vital and precise information about the various market sizes and growth rates. This has provided the company with vital information about the various market sizes and growth rates; however the company believes that the more important activity is the engagement with potential customers to create the market need.
Potential Customer Engagement
Outcome (results of the work, size & composition of market, size of the opportunity)
During the early stages of the research the company attracted interest from a significant number of potential clients, who were prepared to help us understand their various requirements. It became apparent that the markets for 3D Printing silicone rubber operates in specific verticals, rather than geographical horizontals. The company approached Horizon 2020 to ask if it is acceptable to focus on specific market verticals, rather than geographical territories and the response was “IF the market study raise some more markets to study, it’s totally fine. As long as it does not deviates from the original purpose of the project, it can only be an added value. I am not sure what you mean with “at global verticals rather than territorial horizontals”, but I will just say that as long as you keep in mind the European/global dimension if the project, it’s fine.
I hope this answers your question”.
Therefore the focus of the market research switched to global market verticals where those markets have a significant European dimension.
Identified Market Opportunities
The market research was broken down into three fundamental areas. They are:
1. Patient specific medical devices
2. Consumer specific devices
3. Industrial applications
Under pinning this research are the sales leads the company has generated from its own marketing activity. To date, the company has received in excess of 150 qualified sales opportunities (by qualified, the sales prospect sends a .stl 3D Print CAD file and is asking the company to quote to 3D Print it in silicone rubber). Those enquiries can be broken down as follows:
1. Academic – 10
2. Consumer – 43
3. Design Companies – 7
4. Entertainment OEMs – 3 (including the Disney Corporation (US) and Apple (US))
5. Food Manufacturers – 2
6. Industrial OEM – 33 (including Caterpillar (UK), Land Rover Jaguar (UK), Freudenberg (Germany), 3D Systems (US) and L’Oreal(France))
7. Medical OEMs – 34 (including Philips (Netherlands) Bosch (Germany), Johnson and Johnson (Japan)
8. Prototyping Bureaus – 14 (these are companies that provide prototyping services to third party clients and would be an important part of a future sales strategy)
9. Software companies – 2 (one of which is Autodesk)
Although 3D Printing has been around for 20 years, there are few external organisations that the company has confidence in delivering the market research that is required.
Therefore the company decided to acquire specific reports that either focused on the technologies or the markets that the Picsima technology addresses.
The company also commissioned external consultants and interviewed key decision makers to help advise on certain market opportunities. These included:
Consultants and Decision Makers.
Patient Specific Medical Devices
The research into Patient Specific Medical Devices was prioritised based on the following criteria:
1. Where can the 3D Printing of silicone rubber, potentially, disrupt an existing market?
2. Is the market substantial (globally)?
3. Are the routes to market well established?
4. Are the entry barriers high to competitive 3D Print technologies?
(4) specifically relates to materials. With the method discovered by Fripp Design Limited, the materials used are already approved for medical use. With regards to Patient Specific Medical Devices (more commonly referred to as medical implants) there are two fundamental classifications of implantable materials based on a 29 day rule. Materials that are designed to be implanted for less than 29 days are known as ‘temporary implants’. Materials approved for greater than 29 day use are known as ‘permanent implants’. The important thing to understand is that the Picsima method for 3D Printing silicone rubber can accommodate both.
The development of the Picsima technology to address Patient Specific Medical devices will be significant and will form a major part of the Phase 2 application.
Silicone Breast Implants
According to the American Society of Plastic Surgeons 286,000 American women underwent breast augmentation, a growth of 35% since 2000. This is corroborated by the International Society of Aesthetics Plastic Surgeon (ISAPS) report where, in 2013, 55000 Germans, 38000 Spaniards and 26000 Italians under went breast augmentation.
In the UK, in 2013, the British Association of Plastic Surgeons reported just over 11000 breast augmentations; an increase of 13% over 2012.
Where the Picsima method for 3D Printing silicone rubber will be disruptive is best highlighted by the issues caused by the PIP crisis in 2010 (see http://www.nhs.uk/Conditions/Breast-implants/Pages/PIP-introduction.aspx). With Picsima, the entire implant will be cured; there will be no internal leakage and no gels; therefore the problem of leakage will be eliminated altogether. The additional advantage is that the patient will be able to receive an absolutely custom and perfect fitting implant; so with Picsima we will reduce the fear of implantation as well as make the patient feel better about themselves after suffering the trauma of having a breast removed.
As part of the technology research, the company has engaged with a number of Plastic Surgeons who have highlighted the two main criteria for 3D Printing a silicone breast implant:
1. The implant would need to be as soft as a gel filled implant
2. It would need to demonstrate it was capable of minimising Capsular Contracture
All implantable devices are classified as Class 3 devices by the Food and Drugs Administration (FDA) (and other regulatory bodies).
What is significant is that the US Food and Drugs Agency is now approving 3D Printed devices using medical grade titanium . This bodes well for the company because, although the material that is used in the Picsima method is a rubber polymer (silicone), rather than a metal, titanium is an approved medical material as are silicone rubbers.
With the concerns that both patients and clinicians have about breast implant leakage, the Picsima technology could overcome this challenge as it will be feasible to cure the entire implant, eliminating leakage. This would be a significant part of the Phase 2 application.
Being able to custom 3D Print the implant specific to each patient would be a bonus, but getting the correct size and shape is nowhere near as important as solving the leakage problem.
Silicone Foot Orthotics
The manufacture of Foot Orthotics relies on the traditional method of moulding. Companies are starting to explore the use of 3D Printing, particularly in the area of plastics, but with limited success. As silicone rubber is the material of choice and, as there is now interest in customising the orthotic with 3d Printing, Picsima is ideally placed to take advantage of this emerging market in 3D Printing.
Newcastle based Peacocks specialise in Orthotic footwear. Their head of R&D is from the 3D Print industry, is aware of the Picsima Technology and has expressed interest in working with the company to develop a Picsima solution for orthotics. Peacocks have expressed interest in working with the company to develop and market validate the Picsima technology as part of a Phase 2 application.
The US market for shoe Orthotics has grown by 19% since 2010 and is projected to be worth $400M in 2015.
According to GlobalData the global market for orthotics and prosthetics is expected to grow from $3 billion in 2010 to $4.5 billion by 2017 with 42% of the global market based in the US. In 2010, orthotics accounted for 74% of the total revenue. This has been driven by consumer concerns with obesity and the increased interest in undertaking sporting activities, resulting in increased injuries.
The biggest issue when making a foot orthotic is that each one needs to be custom made from a compressible material that can be shaped to make it bespoke. This means you have 2 options for production using techniques other than 3D printing:
1. Moulding - requires the production of a mould which is expensive due to moulding pressures of closed cell foams and inconvenient for storage. Some orthotic insoles also require different levels of compression in different areas of the insole.
2. Machining - creates significant waste material and requires finishing by hand.
3D printing in silicone allows us to create a compressible bespoke component without waste or excessive finishing requirements.
The challenge with silicone is that it doesn't breathe but this can be overcome with a fabric cover, by designing air channels into the insole or through the production in silicone foams which do appear to be suitable for the current system.
Other Medical Markets
The other medical implant markets that have a need for Picsima are, particularly, facial and eyelid surgery. During the Phase 1 research, the company was approached by a US cosmetic surgeon, whose expertise is in these areas . An offer of investment was made, however the shareholders of the company decided that the valuation made was not acceptable.
Medical Simulation Market
There is an increasing demand for surgeons to demonstrate competence in the procedures they undertake. Like airline pilots, they have to demonstrate thet they are up to date with their training. This has lead to a rapid growth in the production of silicone rubber training aids which are, traditionally, made through moulding. This is a market where Picsima is needed because it overcomes many of the limitations of moulding, namely design restriction, time to make and the amount of silicone material wasted because of over moulding.
According to the MARKETSandMARKETS report the Medical Simulation market is forecast to grow from $863M in 2014 to 2.1 billion by 2019 a CAGR of 19% (which is in line with other market data seen on the Internet). This is being driven by the increasing use of litigation in medical procedures and the need for surgeons/consultants to be able to demonstrate they are up to date with their training and knowledge.
Custom Ear Phone Covers/Plugs
With the rapid growth in smart phones and the streaming of music to these devices, comes a desire for consumers to customise their listening experience. Silicone rubber is the natural choice for ear phone Covers/Plugs. Picsima is needed because it is the only technology which allows the consumer to personalise their ear phone covers/plugs in silicone rubber.
According to IDC the worldwide smartphone market grew by 13% year on year in Q2 2015 to 341.5 million units.
In 2014 Apple paid $3.2 Billion for Beats by Dr. Dre confirming that the consumer listening market focus has shifted from high quality home hardware to mobile user experience.
Beats by Dr.Dre have created a mass market of customers prepared to pay €300+ for their headphones; this was unheard of just a few years ago. According to Snugs Ear Phones the long term trend will increasingly be for custom fit earphones, where the major advantage is the improved signal to noise ratio through the dampening of external sounds, significantly increasing the quality of the music being listened to.
In the UK, the market is serviced by a number of independent suppliers. These include:
ACS - http://acscustom.com
Sensorcom - http://www.sensorcom.com/
Emtec Labs - http://www.noisebreaker.com
Protecthear - http://www.protecthear.co.uk/
PC Werth - http://www.perfectfitears.co.uk
Harley Street Hearing - http://www.harleysthearing.co.uk
Earcandi - http://earcandi.com
Proguard - http://www.allearplugs.com
Puretone - http://www.puretone.net/
Larger companies include:
Boots - https://www.bootshearingcareshop.com/CATEGORY/NOISE_PROTECTION
Minerva - http://minervahearing.co.uk/
Looking as these companies accounts, this would suggest a UK market for custom ear plugs in the order of €14M which would suggest a global market in the region of €140M.
In September 2015, UK company Snugs Ear Phones raised £123K on Crowdcube (pre revenue on a valuation of £1.6M) to introduce a retail focused custom ear plug experience. The idea is a consumer has their ear 3D scanned and the output is sent to a third party laboratory for manufacture. Currently custom ear plugs are manufactured using sacrificial moulds. There are companies that are now 3D Printing the sacrificial mould, however Picsima is the only technology capable of 3D printing the custom ear bud directly.
3D Printing/Additive Manufacture In General
In March 2015, Stratasys commissioned some independent research by SMS Research advisers to look at the current trends for the use of additive manufacturing in a manufacturing environment . Here is a summary of what they found:
• 700 interviews were taken from April 10th to May 1st
• All statistically significant results are reported at a 95% confidence level +/- 3.8%
• 26% of respondents were from consumer manufacturers
• 15% of respondents were from medical manufacturers
• 21% of the organisations had turnovers>$300M
• 19% of the organisations had turnovers in the range $50M to $300M
• 60% of the organisations had turnovers of less than $50M
• 79% of respondents saw a major benefit of 3d Printing to allow for more complex design
• 76% of respondents saw a reduction in lead times as a major benefit
• 73% of respondents saw outsourcing as an advantage to access capital equipment they could not afford to purchase
• 60% of respondents saw outsourcing as an advantage to reduce risk
• 53% of respondents saw outsourcing as an advantage to produce parts not capable of being produced in house
• 54% of current users and 46% of potential future users saw limitations in materials as a barrier to investment
• Respondents were asked what one major issue that will have the greatest impact on 3D Printing between now and 2018
o 20% said the cost of equipment
o 16% said the mechanical properties of the parts being made
o 10% said the types of material available
o Only 5% were concerned about the cost of material
o Only 5% were concerned about the accuracy of parts being made
• 36% of respondents see an increase use of outsourcing (with the predominant industries being Consumer and Energy)
• 38% of respondents saw an increase use of 3d printing to make end user parts
• 61% of respondents wanted to see improvements in rubber materials
• 60% of respondents wanted to see improvements in high temperature plastics materials
2. Task 1.2 Technological and IP watch
The company has recruited Withers and Rogers as its IP Attorney.
In 2014, the company did apply for a UK patent for the Picsima method of 3D Printing two part RTV polymers. Under the guidance of Withers and Rogers, the company abandoned the UK application in April 2014 and commissioned Withers and Rogers to apply for a European Patent Office PCT. As part of the PCT application, the company paid for an opinion, by a European Patent Office examiner, about the validity of the claims made.
The opinion of the examiner is that the main claims made are both ‘novel and inventive’.
It is the opinion of Withers and Rogers, based on 40 plus years experience that an opinion such as this leads to the granting of a European Patent. Therefore the company has taken the decision to accelerate the UK patent process.
3D Printing is a broad church so defining the market and competition is important. The market for 3D Printing silicone is targeted at those customers that need to create 3 dimensional geometry from silicone rubber. The nearest technology is one owned by Stratasys called Objet Connex (the material is called Tango). All other polymer based 3D Print technologies (including Stratasys) create soft polymers to make their 3D Print method work. The compromise is those material properties are inferior to those designed for moulding (like silicone rubber) i.e. you can't steralise Tango because it breaks down at 90 degrees and has poor tear strength.
German silicone manufacturer, Wacker has announced a way to 3D Print UV cured silicone, however even they have admitted that their method is not as good as the Picsima method for RTV silicones.
US based start up Carbon3D claim to support 'rubber like' materials but none has been demonstrated (although they have just raised $100m on a $Billion valuation).
Please also remember that Fripp Design and Research is a very well recognised brand in 3D Printing and Industrial Design, meaning the company has very good contacts in the industry, competitors and in the press.
3. Task 1.3: Develop a business plan
We will draw up a comprehensive business plan using information gleaned from the market analysis. The business plan shall detail the cost of production, plausible market penetration and financial projections as well as the stages to be undertaken in Phase 2 to ensure that our product reaches the market.
Purpose (e.g. document planned business case including market needs and opportunity, our value proposition, technology and solution description, commercialisation, marketing, financial and IP strategy and financial projections).
Summary including route to market and commercialisation strategy with expected incomes
Suggest realistic 5 year P&L projections
From a social perspective, the project also demosntrates the potential for consumer demand in consumer specific custom devices (ear plugs being the most prevalent example discovered to date.
The Feasibility project has confirmed demand for the product, freedom to operate and evaluated our planned commercial strategy. We are now preparing a Phase 2 application to further develop PICSIMA. The current objectives are:
a) Continue the IP strategy in securing patents for the UK, Europe, North America and India
b) Develop a Picsima system capable of 3D Printing silicone rubber in a variety of softness and at a sub 100 micron layer resolution
c) To initiate market testing within the identified markets, specifically looking for agents and partners to resell the technology proposition
d) To instigate the research and development to create a Picsima system capable of 3D Printing a variety of softness in a single build (creating multiple shore hardness parts)
e) To instigate research into other two part RTV polymers (such as acrylics and epoxies)
f) To develop plans to move Picsima from an in house bureau service to a global manufacture of 3D Printers
These objectives will be achieved by Q2 2017 subject to funding by Q1 2016.