Advances in Bionic Prosthesis and Orthosis


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Advances in Bionic Prosthesis and Orthosis

  1. 1. Advances in Bionic Prosthesis and Orthosis (Technical Insights) Assistive Products to Aid in Achieving Human-like Stability, Strength, and SpeedD2F7-TI2012
  2. 2. ContentsSection Slide NumbersExecutive Summary 5 Research Scope 6 Technical Insights–Research Process and Methodology 7 Key Findings 9 Snapshot 10 Overview 11 Application Areas 12 Global R&D Network Analysis Value Chain Assessment 13 Existing R&D Networks 14 Stakeholder–R&D Focus Areas 17 Emerging Business Model 19 <report code> 2
  3. 3. Contents (Contd…)Section Slide Numbers Global R&D Network Analysis Environmental Assessment 21 Key Technology Drivers 22 Key Business Drivers 23 Regulatory, Geo-Political Factors/Standards Compliance 24 Strategic Management of R&D Industry Trends and Requirements 29 Technical Resource Competency 30 R&D Intensity 31 Infrastructural/Facility Demands 33 Funding 34 R&D Effectiveness Measurement 36 <report code> 3
  4. 4. Contents (Contd…)Section Slide Numbers R&D Management Strategy 37 Technology Strategy 38 R&D Strategy 39 New Product Development (NPD) and Commercialization Strategy 40 IP Protection Strategy 41 Patents 42 Contact Details 46 Appendix 49 Decision Support Database 53 About Frost & Sullivan 58 <report code> 4
  5. 5. Scope of Research The field of Orthotics and Prosthetics (O&P) has changed dramatically in the past two decades. Practitioners today work in a variety of settings and use innovative materials and techniques to restore function and provide relief for various impairments. This research service (RS) is a study on the advancements in the O&P industry from an R&D management perspective. There is an ever-increasing demand for O&P devices and new innovations and inventions needs to be compliant with the ever-changing regulatory scene. There is a lot of competition in the industry today and this RS tries to guide the reader in selecting the optimal path for speedy commercialization, strengthening existing technologies/products, and enhancing future growth. The industry is bound to undergo a change in its outlook as technologies are increasingly converging which will result in fostering a diverse platform for our aging/disabled population. This research service will cover the following key sections in the Orthotics and Prosthetics industry: • Global R&D network assessment with analysis of R&D focus areas and emerging business models. • Global environmental assessment with emphasis of the drivers and regulatory factors and geo-political compliance. • Strategic management of R&D section including technical resource competency, funding, and infrastructural facility demands. • New product innovation and technology management strategies. • Key contacts within the industry. • Decision support database (DSD) tables. Source: Frost & Sullivan.5
  6. 6. Key Findings Orthotics and Prosthetics technologies and products can aid in mimicking lost limbs and show promise in transforming the outlook of disability. The advances in software, hardware, materials, and structures have enabled many different O&P appliances, such as microprocessor knees, Hytrel – polyester elastomer material for O&P devices, solar powered cochlear Technology implants, targeting different parts of the body enhancing mobility and stability for disabled people. Today’s O&P industry is characterized by the convergence of different technologies and sciences, such as neuroscience, electrical engineering, cognitive science, signal processing, battery design, and nanotechnology among others. There is an increase of O&P products required as there is an exponential rise in amputee and elderly population. Similarly, there is a leap of technological advancements in cosmesis and aesthetically attractive orthosis and prosthesis, which has increased amputee acceptance and hence more usage of O&P devices. A good example is the livingskin prostheses from Market TouchBionics which are hand crafted from high definition silicone and hand painted to match skin tone and appearance. The development and usage of non-surgical and minimally-invasive devices also translates to giving patients better ease and less utilization of resources, such as emergency rooms, out-patient visits, and readmissions. Organizations have played a vital role in collaborating and bringing together the technology prowess and product commercialization to the masses. This strategy of bringing like-minded players under one umbrella and addressing the market has helped complement existing technologies and explore other new technologies. A few examples being the National Commission on Orthotic & Prosthetic Education encouraging all residents to create a Legacy Project such as to create a chart of weight limits for prosthetic knee components and so on, which would aid in the future improvement of experience, Strategies education and patient care. Similarly the American Board for Certification in Orthotics, Prosthetics & Pedorthics have created and implemented a practice analysis study of mastectomy fitter profession, the results of which will provide updates and bring about much needed changes in the delivery of care, items and services available, and the technology in use today. The collective learning in the organization aids in coordinating diverse production skills and integrate multiple streams of technologies. Additionally, a strong R&D network also allows the uninterrupted funding and technology transfer between partners to enhance the value of the developed technology/product. Source: Frost & Sullivan.6
  7. 7. Existing R&D NetworksOrthotics and Prosthetics is a specialized healthcare profession, combining a unique blend of clinical and technical skills. Theprofessions of O&P have advanced together, as the same skills and knowledge base are necessary to evaluate for and designcustom orthoses and prostheses. A strong R&D network can result in the technology/product reaching the target audience in ashort span of time. Additionally, the network also allows the uninterrupted funding and technology transfer between partners toenhance the value of the developed technology/product. R&D Institutes/ Companies Universities Associations/ Regulatory Organizations Body Patient Care Facilities Funding Orthotics and Prosthetics Source: Frost & Sullivan. 7
  8. 8. Existing R&D Networks (Contd…) Stakeholders Names • Alliance Orthotics and Prosthetics LLC • Stellar Orthotics and Prosthetics GroupPatient care Facilities • OPGA Patient Care Clinics • Collier Prosthetic Orthotic Care • International Society for Prosthetics and • National Association for the Advancement ofAssociations/Organizations Orthotics Orthotics & Prosthetics • School of Health and Rehabilitation • Biomechatronics group, MIT Media Sciences, University of PittsburghR&D Institutes/Universities Laboratory • The Northwestern University Prosthetics- • Rehabilitation Institute of Chicago Orthotics Center • iWalk • Argo Medical Technologies Ltd.Companies • Ossur Hf • TouchBionics Inc. • Otto Bock Healthcare GmbH • Ekso Bionics • Food and Drug Administration, USA • Ministry of Health, Labour and Welfare,Regulatory Bodies • Therapeutic Goods Administration, Japan Australia • State Food and Drug Administration, China • National Science Foundation • National Center for Research ResourcesFunding Agencies • National Institutes of Health • Paralyzed Veterans of America Source: Frost & Sullivan. 8
  9. 9. Key Business Drivers ImpactHigh Description Short Medium Long An increasingly inactive lifestyle and mounting work Term Term Term (1–2 years) (3-5 years) (6-10 years) pressure are escalating the number of people Amputee/Elderly succumbing to diseased states. Additionally, there is also Population an increasing incidence of amputee and baby boomer population which necessitates increased sales of O&P Advanced devices. Technology Technological developments augment quality orthosis and prosthesis instigating market growth. Increasing innovations and technology uniqueness offers a competitive benchmarking factor that leaves options to Drivers Cosmesis the physicians to decide on suitable therapy for patients. Advancements in cosmesis and aesthetically attractive prosthesis enhance amputee acceptance. Apart from functionality improving, end-users are increasingly conscious of how they look and are keen to blend in with Reduced hospital stay mainstream society. Development and usage of non-surgical and minimally- invasive devices translates to lesser utilization of health resources, such as emergency rooms, out-patient visits, and readmissions. These factors will allow patients to reduce heavy financial burden and also not jeopardize their limited resources.Low Impact High Low Source: Frost & Sullivan. 9
  10. 10. Regulatory, Geo-Political Factors/Standards Compliance. The US Food and Drug Association (FDA) is an agency within the US Department of Health and Human Services responsiblefor protecting and promoting public health. FDA assures the safety, effectiveness, and security of human and veterinary drugs,vaccines, and other biological products, medical devices, food supply, cosmetics, dietary supplements, and products that give offradiation- not required, please delete. Under the FDA, the Center for Devices and Radiological Health (CDRH) regulates orthoticand prosthetic devices, which fall under 21 CFR Part 890 (Physical Medicine Devices). Class III Prosthetic hands via implanted neural sensors High FDA Class II Cranial remolding helmets Complexity (CDRH) Class I Microprocessor Knee, Brace, Multiarticulating Hand Low • According to 21 CFR Section 807.65(i) O&P retail patient care facilities are not required to register with the FDA as manufacturer. However, aspects of FDA regulations can be applied to O&P patient care, including certain manufacturer obligations. • Class I is the lowest classification in terms of patient risk and the degree of regulatory control required. • FDA prefers companies to have a person whose sole function is quality management and regulation (QMR). • There is difference of opinion among some quarters stating that an FDA approval would reduce individualized nature of care provided. Additionally, there is also the case of facilities accreditation where The American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) and Board of Certification/Accreditation, International (BOC), provide accreditation. This makes the need for an FDA approval to be considered as an unnecessary additional layer of regulation. Source: Frost & Sullivan. 10
  11. 11. Regulatory, Geo-Political Factors/Standards Compliance (Contd…)The Health Insurance Portability and Accountability Act (HIPAA) privacy regulations, with which O&P is concerned, involvesthe use and disclosure of personal health information. The Department of Health and Human Services (DHHS) Office of CivilRights is responsible for the enforcement of the HIPAA privacy rule, and there are both civil and criminal penalties forviolations. Single Use Device (SUD) • An entire third-party reprocessing industry has evolved to assist hospitals with reusing medical devices. SUD reprocessing is controversial in both hospital and non-hospital settings. • The level of regulation and oversight of reprocessed SUDs is determined by the FDA device classification and the risk associated with the use of the refurbished device. • Most OEMs resist SUD reprocessing for many reasons, primary among them being that they believe the device is for single use, and reuse has an adverse impact on new product sales. Supporters of reprocessing, such as hospitals, focus on lower cost. • OEMs are subject to heavy FDA regulations when marketing new medical devices, while refurbishers and reprocessors of those devices were unregulated. However, with a new act (Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals) brought around by FDA for SUD, reprocessors are also subject to the same regulatory standards as OEMs.Recycling SUDs make a high impact especially in countries where the danger of unexploded ordnance continues to take aheavy human and economic toll. There are over 70 landmine-affected countries, Afghanistan and Cambodia being some ofthe worst affected countries. There is no proper system to collect statistical data, hence lack of knowledge on the existingsituation, such as rehabilitation services, and so on. In some instances, governments have taken initiative to develop asocial service system to cover the requirements of disabled people. However, it is a hard task considering that thelaw/regulations are ambiguous and the overall system is fragmented and insufficient to cover the complete rehabilitationservices. Additionally, there is no adequate education system, regulations and career opportunities in such countries, whichresult in the difficulty for O&P technicians to obtain new techniques. Source: Frost & Sullivan. 11
  12. 12. Infrastructural/Facility Demands• Players have to decide on time spent fabricating against time spent marketing and attending to other business needs.• Most players rely entirely on outsourcing for its fabrication needs, thereby increasing patient treatment options and outcomes.• The flexibility of outsourcing provides managing satellite offices with non-technical staff with optimal office space. High-quality devices are manufactured with no additional investment in additional equipment and training.• It is advantageous to be an extension of the surrounding medical community, where physicians and other medical personnel within the center can rely on one another to make the patient experience efficient and comprehensive.• Computer-aided design (CAD) and computer-aided manufacturing (CAM) allow businesses to create and produce orthotic and prosthetic devices. These programs help create a design based on specifications gathered by the practitioner and then manufactured with the production system’s built-in tools. This enables the business to efficiently communicated with central lab facilities.• The items are modified on the premises; outsourcing however allows time to focus on other business aspects.• A dedicated wing should be assigned to establish that the company’s protocols fulfill the federal government’s requirements.Factors to be considered when choosing a fabrication facility• Minimum turn-around time of the manufactured device• Warranties entertained and complaint resolution protocol if there is a problem• Number of shifts and their timing• Are there existing templates for the device or can the clinicians establish their own templates• Details of shipping protocols and their speed of delivery• Does the fabrication facility do all the work on the premises or are items outsourced• Do they offer volume discount Source: Frost & Sullivan.12
  13. 13. Funding for Bionics and Orthotics Segment (Contd…) NIH funding (Jan – Jul 2012)Positive Factors for an Investor 2,500,000• Diversified product and service offering 2,000,000• Ability of the company to meet Funding in US Dollars demand with current infrastructure and resources 1,500,000• No pending regulatory, legal or government action• New technology/products/services in 1,000,000 the pipeline• Strong management team with few key personnel 500,000• Weak competitors and healthy market share for the candidate company 0• Favorable O&P industry trendsInvestors prefer a clear roadmap tocontrol costs and guidereimbursements. Source: Frost & Sullivan.13
  14. 14. Patents (Contd…) Publication Publication Number Assignee Name Title Date Orthocare Innovations US 2009/0192619 A1 July 30, 2009 Passive electro-magnetically damped joint LLC, OK (US)The present invention comprises an apparatus, system and method utilizing a passive electro-magnetically damped joint fororthotics and prosthetics. Such a system may be controlled through changing the resistive nature of the circuit in which abraking or damping mechanism can sufficiently replicate and augment biomechanical movement. This may be accomplishedthrough electronic circuitry means only, or through the use of intelligent control through a microprocessor and dynamicambulation replication algorithms. Chas A. Blatchford & Sons US 2012/0130508 A1 May 24, 2012 Lower Limb Prosthesis Limited, Hampshire (GB)Invention relates to a lower limb prosthesis comprising a shin component, a foot component, and an ankle joint mechanisminterconnecting the shin and foot components. The ankle joint mechanism is arranged to allow limited damping pivotingmovement of the shin component relative to the foot component. The wall of the cylinder has a cylindrical outer bearing surfacefor a sleeve which is translationally displaceable relative to the piston and cylinder assembly according to the axial load, thesleeve being resiliently mounted by a compression spring which extends axially within the sleeve and has an integral endportion forming an upper bulkhead of the cylinder. Source: Frost & Sullivan. 14