SECTION I: The product
|1a||The innovation potential of this product is related to:
|The innovation potential of this product is related to a radical new product. Even though automated respiratory sound analysis has been researched by many laboratories around the world, the actual solutions that have reached the market are only a few. Consequently there is strong innovation potential for the development of a new product.|
|1b||What added value for end-users does the product hold?
• higher quality
• Better technical characteristics
• Other …
|The added value of the new product is based on higher quality due to its scientific status. Respiratory system pathologies diagnosis through computers can solve many diagnostic problems and improve cure statistics for patients suffering from respiratory system related diseases.|
|1c||What is the Unique Sales Proposition of the potential product?|
|Accurate and affordable automated respiratory system sounds diagnosis for doctors dealing with patients facing obstructive pulmonary diseases.|
SECTION 2: The Market
|2a||What is the target market for the product? National ¨
Please describe the characteristics of your target market.
|The market for the product is global. The market range can be approached by the number of patients suffering from asthma and COPD.COPD
According to the latest data from the World Health Organisation (2007), 210 million people suffer for COPD worldwide and 3 million died from COPD on 2005. It is estimated that more than 500.000 Greeks presently suffer from the particular disease. Until 2020 it is expected that COPD will be responsible for 6 million deaths worldwide each year, making it the 3rd most lethal disease.
WHO estimates that 300 million people currently suffer from asthma. Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. It is the most common chronic disease among children. Asthma is under-diagnosed and under-treated. It creates substantial burden to individuals and families and often restricts individuals’ activities for a lifetime.
In this case however, the potential product is not addressed to the patients themselves, but to doctors, pneumonologists, health centers and public or private hospitals.
|2b||How the product is characterized from the following options? Number of companies producing similar products in the field.• Base – applied by all companies in the industry
• Leading – applied by a single or limited number of competitive companies
• Key –at a development stage, but has already proven its potential
|The product is characterized as leading. It is applied by a limited number of competitive companies.|
|2c||What type of market demand will be satisfied?• Existing demand – the market is already developed
• hidden (latent) demand – the market has yet to be developed
|The type of market demand that will be satisfied is both existing as well as hidden (latent). Existing demand comes from 2 companies that have promoted competing products in US, Australia and European Markets. However there is also latent demand, as similar products have not reached many markets yet.|
|2d||What is the current stage of the product’s market life cycle?• Implementation, implementation in production (leading to a radically new product offers)
• Growth (rapid spread within the industry or outside it)
• maturity (parameters of the technical characteristics of manufactured products reached their maximum, higher-grade products can be manufactured on the basis of technological substitution)
|The current stage of the product’s life cycle is at the first stage: development and introduction of new products.|
|2e||Strategic partnerships (existing or potential).|
|For the current development of the R&D result so far there have not been any strategic partnerships. It has been developed by Signal Processing and Biomedical Technology Unit of the Faculty of Engineering (Department of Electrical & Computer Engineering – Aristotle University of Thessaloniki). There has been collaboration with Marburg University for the sound data.|
SECTION 3: The Competition
|3a||What is the competition within your target market?|
|Heart & Breath Sounds Simulator (educational)This hand-held device simulates both heart and breath sounds and allows the determination of these by plugging in the different menus each containing different sounds. It includes two external sounders with which students can auscultate the sounds with a stethoscope. A loudspeaker may also be connected. Additionally, the unit has a volume control and two LED’s that illuminate during systole (heart menu) and expiration (breath menu).
The spirometry test is performed using a device called a spirometer, which comes in several different varieties. Most spirometers display the following graphs, called spirograms:
-a volume-time curve, showing volume (liters) along the Y-axis and time (seconds) along the X-axis
-a flow-volume loop, which graphically depicts the rate of airflow on the Y-axis and the total volume inspired or expired on the X-axis
The patient is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible, preferably at least 6 seconds. It is sometimes directly followed by a rapid inhalation (inspiration), in particular when assessing possible upper airway obstruction. The test is highly dependent on patient cooperation and effort, and is normally repeated at least three times to ensure reproducibility. Due to the patient cooperation required, spirometry can only be used on children old enough to comprehend and follow the instructions given (6 years old or more), and only on patients who are able to understand and follow instructions – thus, this test is not suitable for patients who are unconscious, heavily sedated, or have limitations that would interfere with vigorous respiratory efforts.
An number of electronic stetoscopes have recently reached the market. Some of them are the following:
Welch Allyn Master Elite Electronic Stethoscope
It helps doctors listen to either high or low frequencies and easily pick up low diastolic murmurs or high-pitched pulmonary sounds. In addition, accessories can be purchased that electronically capture, record and distribute body sounds or allow multiple users to co-listen, making the scope perfect for teaching or consult situations.
THINKLABS Digital Stethoscope – Model ds32a
A diagnostic stethoscope which allows recording, editing and managing sound files.
Spirit E600 Precision Electronic Stethoscope
Electronic Stethoscope with peizopolymer diaphragm pick-up that improves the purity of amplified sounds by limiting ambient noise. Up to 16 x (24db) louder than a conventional stethoscope.
DeepBreeze – VRI
Deep Breeze is a privately owned medical device company backed by financial partners. It developed the VRIxp system for a variety of pulmonary conditions. It is based on vibration response generated by the air passing through the lungs. The system records these vibrations and then uses an algorithm to convert the data into images. Changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate, and subsequently how the VRIxp images appear on the system’s computer screen. The result offers physicians a dynamic functional lung image obtained passively at the bedside & without radiation.
A computerized solution for wheeze identification, characterization and quantification that uses acoustic technology. This ‘parent’ device is usually only used in hospitals or sleep labs due to its need for professional interpretation. It provides continuous and nocturnal monitoring, used to diagnose and manage a variety of respiratory illnesses, producing data on wheezes and degree of coughing. The device also allows measurement of the response to any treatment the patient may be receiving over a period of time and is particularly convenient for the treatment of infants and the elderly. The device provides quantitative patient data and the ability to archive reports over a given period of time, thus following symptom trends. Detailed graphic spectral display and acoustic playback features allow the review of specific records for secondary data analysis.
The device consists of two acoustic sensors attached to the skin above the trachea and chest and has disposable acoustic adhesive pads, a pneumograph belt sensor that records breathing activity, and an ambient microphone that effectively filters environmental noises. It uses patented software and advanced algorithms to detect wheezing based on certain strict criteria, which are defined by CORSA (computerized respiratory sound analysis) guidelines.
It is a hand-held device for home and general practice use. When placed on the neck with its sensor over the trachea, the WheezometerTM picks up the breathing sounds and determines if wheezes are present. A 30 seconds determination indicates the momentary wheeze rate. Should it be high, the patient (or parent) is instructed to seek medical help.
The WHolterTM is a 24 hour ambulatory digital data-logger / recorder. It is intended to be used for tracking wheezing and coughing for evaluation of nocturnal asthma, occupational asthma and persistent cough in the patient’s own allergen environment. Typically the device is either taken home or used in a specialist’s clinic and returned upon completion of the test, with a fee being paid dependent on the duration and type of testing.
|3b||What competitive advantages will the introduction of the new product ensue?• lower prices based on lower production costs
• product differentiation (uniqueness of the product proposal)
|The main competitive advantage of the new product is product differentiation and lower price. Product differentiation comes from the number of lung illnesses that the new product will be able to diagnose and the accurate methods it will use for the diagnosis. Lower price will come from the lower development costs and it will be used as a penetration method for capturing market share in markets that competing products are already available.|
|3c||Potential products relate to the following price range:• High price range
• Average price range
• Low price range
|Potential products relate to the average price range.|
|3d||Potential products will be marketed:• To regulated markets (e.g. heat supply, water supply, universal telecommunication services, agricultural products, fishing industry, architectural services)
• To markets operating on the principle of free negotiation between agents on the market
|Potential products will be marketed both to regulated markets as well as to markets operating on the principle of free negotiation between agents on the market. This is because potential products will be marketed both to private companies and hospitals, as well as to public clinics, diagnostic centers and hospitals.|
SECTION 4: Indicators
|Estimated cost of the new products||300€|
|Expected market volume (potential / maximum number of users)||Maximum number if users is about 2000 a year|
|Expected sales volume||After the product is developed at about 500 a year|
|Expected market share of the company (proportion between sales and total company sales in the relevant market)||25% of the market|