HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

1.0 Scope of Project

1.1 Intended Design Direction The final design direction of the project is the design of an ergonomic, functional facial mask for use with current and future CPAP equipment. Using both reflectance pulse Oximetry and other monitoring technologies the mask will be able to communicate with its parent CPAP unit and regulate both pressure and oxygen concentrations accordingly to best provide the patient with a constant and comfortable pressure while sleeping. 1.2 Obstructive Sleep Apnea Obstructive Sleep Apnea is one of the most prevalent sleeping disorders in the world today. It has been estimated that 4% of men and 2% of women in Australia suffer from clinically diagnosed sleep apnea; however, as only 50% of sufferers show severe symptoms, namely excessively loud snoring, it is believed a large number of cases go undiagnosed. Whilst there is no universal cure for the disorder, the treatment that is usually prescribed is known as Continuous

Positive Airway Pressure. The therapy Fig. 1.2a A common sleep apnea nasal pillow involves a device blowing a continuous pressure stream to the patients oesophagus via a facial mask to maintain the aperture of the airway. This device must be worn at all times while sleeping making the process extremely obtrusive and uncomfortable for many people.
module. These masks must be worn every night and, in most cases are quite uncomfortable.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

2.0 Customer Needs and Demographics

2.1 Customer Needs List Using an analysis for survey material collected using both electronic and face-to-face interviews, a number of important design elements were identified as necessary for the successful evolution of the project.

Customer Needs List 1 Lightweight 2 Minimize nasal irritation 3 4 5 Minimal facial obstruction Hypoallergenic Easy self calibration and altering of pressure/inputs/etc. Without referring to CPAP unit Simple Interface Biological systems monitoring blood pressure, tracheal aperture, blood oxygen saturation. Minimized strap construction Easy cleaning Ability to comfortably sleep on side Easy to transport Visually aesthetic Customizable Able to wear glasses while wearing mask Reduced air leakage Minimized hose interference while sleeping Increased ability to talk

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8 9 10 11 12 13 14 15 16 17

Fig. 2.1a Customer Needs List

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

2.2

Key User Demographic The target user group of the final product will be clinically treated Sleep Apnea patients who may have been suffering with the disorder for a number of years or have only been recently diagnosed, and hence, are buying their first mask. While a person of any age can suffer from sleep apnea, the target age demographic of the user is approximately 18-65. These patients are commonly already in poor health and may suffer from any of the following conditions:

Hypertension Stroke Heartattack Chronic fatigue Nasal polyps Sinus disorders Muscular weakness

There are no social-economic barrier for the product as final retain prices are subsided in large part by Medicare and Private health insurance in Australia. However, as the mask design can be classified as a medical product the form proposed aim and aesthetics of the project should reflect this. As such, while the product will not be intended for a high socio-economic demographic, the design should, in all aspects reflect the upmost quality and fine detail. The user most likely sleeps in a standard bed with between 1-2 pillows for head support. They potentially sleep with a partner who will require tubing and cabling to minimal as to not cause entanglement during standard sleeping movements. Sleep apnea affects a higher proportion of men than women; as such the design should reflect sensitivity to both male and female facial structures. The product should be marketed as a unisex aesthetic, however, it is possible that male/female specific facial interfaces could be designed to aid fitting and improve comfort.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

3.0 User Considerations

As stated, users suffering from sleep apnea commonly endure a host of other medical issues. While the project will focus on making the design appeal to a large age range to reach the maximum market share, the majority of users are older (>40 years of age) making the symptoms of their medical ailments more serious. Those with cardiovascular hypertension and arthritis may experience some degree of muscle weakness and dexterity degradation meaning clips and fasteners (if any) should be easy to use, in salient locations and be large enough to be operated with minimal force.

3.1 Materials All material choices for direct skin interfaces should endeavour to be hypoallergenic and non-toxic. Users in the target demographic, either through age or other pre-existing conditions, may suffer from skin weakness or be prone to irritation from contact with foreign bodies. Further detail of material selection is available in 8.0 Material Selection.

3.2 Cleaning While it has been identified that a user needs, or should, replace their mask every 3 months, regular cleaning must be undertaken to ensure air quality is maximized and foreign particulate matter is not include in the airstream sent to the patient. Hence, the product should reflect this in feature such as removable casing panels, modular cushion assembles and chemically resistance silicone grades to ensure no degradation of mask components.

3.3 Maintenance Similar to the requirements for cleaning functions, in the case of minor faults with the mask, very limited maintenance should be encourage by the users. However, to promote a positive Cradle-to-Cradle design approach the final design should be easy to disassemble and use minimal parts. This can be achieved through the use of anti-tamper Torx screw heads, internal snap fitting casings and the use of fine tolerancing around part lines and seams.

Further details of Cradle-to-Cradle design methodology are available in 10.0 Environmental Considerations.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

4.0 Product Performance

As a medical product, the final designed unit should have maximum functionality and performance. It will need to be able to achieve a pressure range of approximately 4-20cmH2O, at altitudes up to approximately 1km, consistently with minimal to no air leakage. The input sockets should be able to interface with existing 22mm sockets with the aid of an adaptor or similar. Hose components need to be able function correctly and consistently with a volume air flow of approximately 40L/min for 8 hours a night, 7 nights in a week for approximately 3 months before any degradation causes product malfunction. This equates to 1.6ML lifetime volume capacity. Correspondingly, the filtration and air quality will affect this lifetime rating.

The overall mass should be minimized to be under 500g. By reducing the overall weight strap obstruction can be diminished, hence allowing patients more freedom and movement whilst sleeping.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

5.0 Product Use and Environment

5.1 General Product Usage Patients will use the product in their own homes, most likely in a standard bed. Studies have shown that approximately 70% of people use only one pillow for head support, with 69.4% of people sleep predominantly on their side. Limited use may extend to polysomnogram diagnosis in a sleep clinic environment; however this setting will have similar, if not identical parameters to the patients usual sleeping setting.
Fig. 5.1a Typical CPAP environment

CPAP retailers and manufacturers commonly have product available for display in showrooms or retail stores. As such, the product needs to be visually salient and aesthetically pleasing to engage the target market in such a setting fluorescent lighting, daytime viewing, etc.

5.2

Average Environment The sleeping environment can be approximated by a small to medium size room with little light, especially during sleeping times. Bedrooms commonly have either carpeted or wood floors to maintain ambient temperatures. During normal operation in Australia it is unlikely the environmental temperature will exceed 26C at night however in other countries this maximum temperature may be higher. The pressure ranges with varying temperature will need to be monitored by either the mask or CPAP unit.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

6.0 Human Factors and Ergonomics

6.1 Ergonomics While limited anthropometric studies have been done in the early design process, the mask design must meet all relevant customer needs relating to comfort and ergonomics.

Design elements such as having the ability for patients to sleep on their side, minimizing facial
Fig. 6.1a Facial Anthropometric Data
http://www.cs.rutgers.edu/~decarlo/img/anthrop.gif

obstruction and hose design to reduce tangling need to be considered and applied.

Some of the most common complaint of CPAP users are those relating to mask fit and usability. Some products such as the TrueFit mask by Acurest use custom moulded rigid plates to mount the working components on the face. These moulded plates are tailored to each patient individually and have been shown to improve comfort.

6.2 Human Factors Considering visual and auditory feedback, the mask itself should produce little to no noise at all. Survey results show that many people are moderately to severely affected by noise whilst they sleep and this should be avoided. Some light may be produced by the mask by LED modules as part of the reflectance pulse Oximetry functions of the device, however, by incorporating light shrouds and carefully analysing line-of-sight details during initial form studies this can be circumvented.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

7.0 Manufacture
The manufacturing process will largely consist of plastic injection moulding or injection blow moulded elements. The detailed curvature and rib structure that will be required to house certain components LED modules, peiezoelectrics, etc. necessitates the use of such methods. While this will significantly raise the cost of the product, the added quality will be beneficial to the market performance of the final outcome.

Ideally the product will be manufactured on-shore in Australia sources and utilized overseas.

components

from

Manufacturers in China and Taiwan will most likely provide electronic

Fig. 7.0a Injection Moulding Unit
http://www.copackers.com.au/Portals/27/injection_molding_machine.jpg

components and piezoelectric ceramic elements, while much of the strap material such as GoreTex or bamboo fibre will come from Malaysia.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

8.0 Material Selection

All materials utilized in the construction of the mask should be hypo allergenic and non-toxic if they are to interface with human physiology. These material should conform to standards and regulation as outlined by the Australian Government and International Standards Organization. Medical grade products are highly scrutinized for material usage and implementation. In that sense, recycling of products is difficult and expensive.

Material selection should be performed, taking into account three important product areas: a hard support structure for the hose connections and mask casing, softer yet rigid material for interface components such as facial plates and nose bridge, and a malleable, flexible material for the nasal interface and supports.

That said, the mask casing should ideally also be transparent, hence using a Polycarbonate variant or a rigid Polyethylene would be ideal. Polycarbonate would be more expensive both in raw material form and within the manufacturing environment. However, its longevity would far exceed that of Polyethylene in a long term product and hence would be a better choice. Polycarbonate is also highly sterile and easy to clean, making it ideal. Facial interfaces may employ a malleable polyurethane gel or soft silicone which would be easy to mould and incorporate into overmouding processes.

The strap design, which can be thought of as a largely separate entity, should employ multipart construction including flexible or elastic elements. A Polytetrafluroetylene such as GoreTex would be suitable for this purpose and could be combined with rigid elements for support and sizing purposes.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

9.0 Transportation and Storage

While CPAP machines are largely static devices, when users travel or move house the device must be designed with movement in mind. Many of the customer needs relating to durability such as drop resistance and compression resilience can be applied to reflect sensitivity to this issue. The product will need to be stored and packaged in some capacity over time. Reducing the amount of duct and particulate matter that could enter the chamber during this time would be key. By developing a storage container than could also double as a retail packaging module this could be done quite easily. Especially for the soft, malleable components, ensuring damage does not occur during transport would be the main issue, the storage container would need to have a rigid outer shell to guarantee this. By including a resilient packaging structure the warranty on the product can be somewhat extended and hence make the product more desirable against its competitors in the local and global markets.

Any storage module would need to ensure the mask unit, straps and facial interface was not subject to extreme lighting or heat. By creating customized foam inserts which would cover both the nasal interface and facial plate irritation of the skin could be minimized and longevity of the products extended.

As many people are embarrassed of their need for CPAP treatment, any storage, retail or transportation module should be designed in such a way as to avoid labelling and generalisations of the intended user.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

10.0 Environmental Considerations

Clearly there are a large proportion of environmental factors to consider in using the device, such as air quality and patient health. In manufacturing and latent operations however there are a different collection of factors. The mask itself will draw a small amount of current from the CPAP machine itself which, as standards require, runs off mains power. It is possible the mask may utilize a rechargeable battery backup system using lithium based battery technology at its core. These lithium batteries have significant environmental drawbacks such as toxic mining waste and carbon monoxide air pollution. If possible a cleaner battery type should be utilized.

Manufacturing polycarbonate can result in a number of hazardous chemicals being released into the atmosphere as well. Polycarbonate is probably the most ideal material choice for the project but if a suitable alternative can be identified through the research process it should be incorporated.

10.1 Cradle-to-Cradle Methodology As part of the design intention, it is ideal that the product, as a short life-cycle entity, conform to a sustainable end-oflife methodology. By using Cradle-toCradle principles it may be possible that masks at the end of their life can be reclaimed, disassembled and reused once again in a similar, if not identical manner. The core ideology behind Cradle-toCradle thinking is that of reusing
Fig 10.1a Proposed logo used to certify a product meets Cradle-to-Cradle standards
http://www.allsurfacedesign.com/Portals/0/c2c_si l_RGBlg.jpg

products in a way that retains them at the same functional quality level. Recycling has long been the process of taking one high quality product and destroying it and using the material to create many lower quality products. While the intention is good, the diminishing return on this methodology is not sustainable in the long term.

By using a Cradle-to-Cradle methodology manufacturers can ensure that design elements can sustainably managed while ensuring high quality standards.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

11.0 Costs and Economic Factors

Looking at a subset of current CPAP masks on the market the RRP cost of the mask, in order to remain competitive should not exceed approximately USD$150.00 per unit. The higher manufacturing cost will be producing the mask/nasal pillow unit which will require high precision tooling. It is estimated total tooling cost to product dies and moulds may exceed USD$250,000 if manufactured off shore. This cost will dramatically rise if manufacturing it carried out locally due to high labour and material costs. However, the added quality of on shore manufacture will ensure market competitiveness.

While CPAP units and mask are relatively expensive and must be replaced on a regular basis, Medicare and all private health insurance in Australia, and most private health insurers overseas, subsidise CPAP equipment per year up to the value of AUD$600. That said, retail price of the mask, while it should be minimized to increase relative profit margin, is not a limiting factor in the initial design process.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

12.0

Life Cycle

While warranty information and advice from CPAP manufactures suggests CPAP machines should have a working lifetime of 3-5 years, anecdotal evidence suggests that this varies vastly based on usage type, pressure settings and other factors such as frequency of transport. Recommended life cycles of CPAP components are listed below:

CPAP mask 3 months CPAP headgear 3-6 months CPAP tubing 3 months Disposable Filter 2 new filters per month Non disposable filters 2 new filters every 6 months CPAP chin strap 6 months Full Face Mask 3 months Oral CPAP mask 3 months Humidifier chamber 6 months Nasal Pillows 1 month

As such, this dramatically affects the design parameter of the project in relation to material choice, manufacturing and usability. Using a Cradle-to-Cradle design approach new included features may consist of removable filters, interchangeable facial plates and self cleaning technology. The ultimate goal of the project will be to design a mask with a maximum life span, ideally as long as 6 months.

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HDPD512 PROFESSIONAL PROJECT Product Design Specifications

FACULTY OF ENGINEERING AND INDUSTRIAL SCIENCES Swinburne University of Technology

13.0

Competition

At present the gold standard of CPAP mask is the ResMed Quattro FX full face mask. While this mask is one of the more obtrusive products on the market, the design detail such as strategic overmoulding of part lines and the inclusion of the double wall cushioning system makes it more successful than its rivals from Phillips Respironics and RemStar.

Below is a small subset of product benchmarking that has been undertaken.

Fig. 13a CPAP mask benchmarking table (detail)

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