Innovation CMD

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Innovation through combinational medical devices : 

Innovation through combinational medical devices Muraleedharan CV Biomedical Technology Wing, SCTIMST, Trivandrum, INDIA

Overview : 

Overview Innovation Radical innovation Innovation in healthcare enterprise Combinational medical devices Innovation through combinational medical devices

What is innovation ? : 

What is innovation ? Transforms research into utility Encompasses… Discovery / invention Development Profitable commercialization

Invention Vs Innovation : 

Invention Vs Innovation Invention is creation of new process or product. Innovation is the process of introducing change. All inventions does not become innovations- Why ? Most ideas (inventions) are not really good ! It takes many good ideas and much hard work to arrive at an innovation (Development). Inventors tend to be totally absorbed in the FEATURES of their invention. Eg. Technical superiority and elegance of the idea Innovators, on the other hand, has to focus on the BENEFITS that must be provided by the system / product to the stake holders (customers / investors)

Radical innovation ? : 

Radical innovation ? A discontinuous breakthrough 5 -10 fold improvement in performance >30% reduction in cost, or an entirely new capability Often transformative, disruptive to incumbent technology, existing business models, established markets, or society Addresses problems that are not solvable by normal innovative processes in reasonable time (Leifer 2000)

Radical innovation - examples : 

Radical innovation - examples Fire Wheels Spinning mills Vaccines Cellular mobile telephony World Wide Web Broadband wireless Hydrogen economy Prehistoric Modern Current Future

Discovery of fire : 

Discovery of fire Early Stone Age A million year ago Transformative effect Changed the way people lived

Progress with fire : 

Progress with fire

Invention of wheel : 

Invention of wheel Mesopotamian in ~ 3500 BC Transformative invention Fore runner of all machines

Wheels of progress : 

Wheels of progress

Spinning mills : 

Spinning mills < 400 years old Led to industrialization Led to national revolutions and polarization of world

Vaccines : 

Vaccines Tricks the body’s immune system into producing antibodies to fight virus that is made not harmful Started with vaccination against cow-pox Transformed the way medicine (especially prophylaxis) is practiced Edward Jenner (1749-1823)

Cellular mobile telephony : 

Cellular mobile telephony A sketch from Bell Systems – describing the original concept of cellular telephony (1984)

World wide web : 

World wide web In 1980, the Englishman Tim Berners-Lee, built ENQUIRE, as a personal database In 1989 he wrote a proposal for "a large hypertext database with typed links", but it generated little interest. His boss encouraged Tim to begin implementing his system on a newly acquired workstation. He considered several names, including, The Information Mine (turned down as it abbreviates to TIM, the WWW's creator's name) or Mine of Information (turned down because it abbreviates to MOI which is "Me" in French), but settled on World Wide Web Tim Berners-Lee, Weaving the Web, HarperCollins, 2000

Wireless broad band : 

Wireless broad band Next big thing in communication Poised to happen in next 8 years Will bring down the use of copper by 60% 7 trillion wireless devices serving 7 billion people in 2017 1000 devices per person !!

Hydrogen economy : 

Hydrogen economy Crabtree, Dresselhaus, and Buchanan, 2004

Radical innovation - revisited : 

Radical innovation - revisited Transformative / disruptive to incumbent technology, existing business models, established markets, or society

Innovation in enterprises – core themes : 

Innovation in enterprises – core themes

Innovation road map for enterprises : 

Innovation road map for enterprises

Innovation road map for enterprises : 

Innovation road map for enterprises Innovation is sometimes considered as threat by the stake holders (especially with in the organization)

Innovation road map for enterprises : 

Innovation road map for enterprises

Innovation road map for enterprises : 

Innovation road map for enterprises Chesbrough 2003 Move from the traditional closed business model to open, collaborative, networked models.

Innovation road map for enterprises : 

Innovation road map for enterprises Mission-oriented “Customer-oriented” is too limiting Science-based Much tighter coupling to commercialization Information-driven Collapse time and space between knowledge and application Collaborative Crossing multiple communities of practice Adaptive and self-renewing

Slide 24: 

Now we have a clear vision of the path to innovation !

Medical Devices : 

Medical Devices About 1.5 million different devices Consist of 900 product groups, covering 50 clinical specializations Broadly classified as Diagnostic devices ( Medical instrumentation, testing kits and reagents) Therapeutic devices (Implantables, Disposables & Reusables )

Medical Devices : 

Medical Devices Any instrument, apparatus, appliance, software, material or other article, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of/ or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, (and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means,) (but which may be assisted in its function by such means) Excludes drugs Includes combinational products

Global market scenario : 

Global market scenario Production Consumption

Global market scenario : 

Global market scenario Projected world Market in 2008 ~ $300 Billion Source – WHO MEDICAL DEVICE REGULATIONS Global overview and guiding principles - 2005

Global market scenario : 

Global market scenario Over the past 25 years, medical devices market has grown by approx 9% per year Medical Device and Diagnostic Industry, 2005

Global market scenario : 

Global market scenario Bloomberg, 2003 Relative stock market performance over one decade

Progress in implants : 

Progress in implants Bioinert : Those in which there is minimal interaction between the implant and surrounding tissue Bioactive : Class in which the implant reacts favorably with the surrounding tissue to form an active and beneficial interface Combination : Types in which an implant device incorporates an active biological product or a drug for improved functionality

Intert devices : 

Intert devices Materials : which are inert and had minimal interaction with the biological system. Biocompatibility even synonymous with inertness. Surface : made extremely polished to make sure that nothing (like cellular elements) sticks to it. Success : attributed to minimal long term interaction between the tissue and the implant (minimal degradation, adsorption, leaching and inert interfaces) Example : mechanical heart valves

Bioactive devices : 

Bioactive devices Materials : which interact with the surrounding tissues generating a suitable interface. Biocompatibility got redefined to address the appropriate response of the biomaterial Surface: made textured and conditioned to enhance the development of suitable interface. Success: attributed to formation and long term stability of the appropriate interface between implant and surrounding tissues Example : HAP coated total hip implant

Combinational medical devices : 

Combinational medical devices Employs a passive medical device in combination with a biological product or drug to work in concert to achieve a greater medical benefit. a collection of live cells encapsulated in a membrane drug coating on the surface or loaded in a matrix coating of protein molecules for enhancing surface properties Brings in radical innovation in medical device technology

Combination products : 

Combination products Combinations of different types of products Drug – device Device – biologic Drug – biologic Drug – device – biologic Any thing which is not drug-drug, device-device or biologic-biologic They can be physically or chemically combined Co-packaged in a kit Separate – cross related products

Uniject: ensuring safe drug injection : 

Uniject: ensuring safe drug injection Single use device for intramuscular and subcutaneous injections. The drug is housed in a reservoir. Activation occurs when the user pushes the needle shield and forces a double-pointed needle through the isolation barrier. The dose is delivered by depressing the reservoir with the thumb and forefinger. The collapsed reservoir has a one-way valve that inhibits attempts to refill the device. The device is enclosed in a sealed pouch that must be opened at the point of use.

Glucose biosensor : 

Glucose biosensor Implantable glucose monitor under development draws samples from tissue fluid rather than from blood. Some of the ionic biosensors consists of a coating of bioluminescent bacteria on top of a light-sensitive integrated circuit. The bacteria emit light in direct correlation to the concentration of the analyte.

Bioartificial pancreas – becoming a reality : 

Bioartificial pancreas – becoming a reality The device combines living and nonliving components - active islet of Langerhans cells that sense glucose and secrete insulin, and a thin sheet of polymer material. Polymer pouch contains two to three million living islet cells. Oxygen, glucose, and nutrients diffuse into the sheets to keep the cells alive, while insulin, hormones, and waste diffuse out. Islets in prototype sheets for a bioartificial pancreas and its SEM

Artificial living skin : 

Artificial living skin Dermagraft is a living human dermal replacement used to treat skin that has been injured or destroyed. Produced by seeding dermal fibroblasts onto a 3-D polymer scaffold, Dermagraft is implanted into a diabetic foot ulcer to treat damaged skin.

Smart chip as artificial retina : 

Smart chip as artificial retina The microchip serves to bypass the defective rods and cones. An external laser, along with a tiny camera, is mounted onto a pair of eyeglasses that capture visual images using a CCD. The images are converted and transmitted by laser to the implanted chip. The chip transmits the electrical impulses to the brain by stimulating remaining healthy retinal ganglion cells using an array of electrodes implanted on the retina Artificial retina generates signals similar to those produced by the natural photoreceptor s.

Drug eluting stent : 

Drug eluting stent Used for supporting coronary arteries after balloon angioplasty Components : Metallic stent structure Polymer matrix Drug for retarding stent restenosis Most popular drugs Paclitaxel Sirolimus

Self monitoring stent : 

Self monitoring stent Used for supporting coronary arteries after balloon angioplasty Applications: detect restenosis Measure blood pressure continuously Detects stent stenosis and releases the drug on external instructions Preclinical model of Self Monitoring Stent

Smart drug delivery device : 

Smart drug delivery device

Pilcam – camera on chip : 

Pilcam – camera on chip

Advancing medical science : 

Advancing medical science

Radical innovation in medical device technology : 

Radical innovation in medical device technology The era of combinational medical devices has begun By 2020, it is expected that nanotechnology, combining with biotecthology and tissue engineering would revolutionise the combinational medical device segment Thank You

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