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    Support in Medical Technologies Support in Medical Technologies Presentation Transcript

    • Nerac Research & Advisory Services For the Medical Device Industry© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Agenda  Introduction to Nerac, Inc.  Nerac Service Offerings  The Nerac Difference  Engaging Nerac© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Who Is Nerac? Global research and advisory firm for companies developing innovative products and technologies Areas of Concentration Energy Pharmaceutical Medical Device COMPANY TYPE: PRIVATELY HELD ESOP Specialty Chemical Founded 1966 Other Employees 95 / National & International Analysts 48 Ph.D.s, Masters, MBAs, Attorneys Clients ~1500 Worldwide© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • How We Serve Our Clients Intellectual R&D Process Property Management Regulatory Process Unique provider of rapid-response research Technical for smaller, mission- critical Product & Business Service Development engagements that require Marketing highly experienced expert advisors.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • What We Do Expert Research & Advisory Services  Research and Product Development Process — Perform opportunity vetting to accelerate critical go/no-go decisions — Expedite regulatory filings and vigilance requirements  Business Development Process — Identify portfolio and alliance opportunities  Technical Products & Services Marketing Process — Understand the size and financial potential of market opportunities  Intellectual Property Management Process — Protect and leverage IP assets through portfolio management© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Research & Development Process Accelerate Critical Go/No-Go Decisions PROCESS STAGE CONCEPT & DESIGN, OPPORTUNITY & RISK PRODUCT FEASIBILITY DEVELOPMENT ASSESSMENT COMMERCIALIZATION ASSESSMENT & VALIDATION RESEARCH & • Opportunity vetting • Technical literature reviews PRODUCT • Technical due diligence • IP review of competitor filings DEVELOPMENT • New market identification • Supplier/manufacturing facility identificationDEPARTMENT OR FUNCTION REGULATORY • Post-marketing safety surveillance • Regulatory hurdles/risk • Regulatory strategy development • Clinical literature reviews identification • Competitive safety and efficacy studies • Meta-analyses for ongoing regulatory compliance MARKETING • Market and competitive • Monitor assessment - Competition - Clinical and cost-effectiveness research REIMBURSEMENT • Reimbursement strategy • Reimbursement strategy LEGAL • Early stage clearance research and risk assessment © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Research & Development Process Examples of Recently Completed Projects  Safety and efficacy studies of contact lens brands — Identified the key value proposition for various competitor’s products compared to client’s proposed in-house product  Unmet clinical needs for a specific spinal treatment procedure — Analysis of clinical literature and clinician opinions enabled the client to understand the key deficiencies in existing products in the marketplace  Clinical evaluation of an orthopedic device in knee and hip applications — Included assessment of failure issues and ease of use by the clinician — Client to use information to identify areas of improvement for their products© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Research and Development Process Client Impact Case Study Issue: The CTO of a European orthopedics company requested assistance in reviewing the IP and competitive landscape for novel biomaterial composite scaffolds used in spine repair. The client sought competitors who were developing new products with new materials in order to identify competitive threats and to uncover new potential licensing opportunities. Analyst Approach: Nerac Analysts identified potential companies and universities that were developing new biomaterials for the spine repair market. The team also reviewed IP and literature for biomaterials beyond the spinal fusion space, in collaboration with client’s IP team. Client Benefit: Client was able to identify two universities and nonprofit research institutes in the United States as potential licensing candidates. In addition, the client gained a better understanding of competitors’ R&D pipelines.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Regulatory Process Examples of Recently Completed Projects  Clinical literature reviews on Class II endoscopic medical devices — The reviews demonstrated safety and efficacy of the devices — Submitted to EU Notified Bodies in partial compliance with EU Directive 93/42/EEC  Safety and toxicity of a chemical composition used in medical devices and implants — Support for client’s FDA submission and assessment of possible adverse effects  Recommendations on hemocompatibility testing to satisfy FDA guidelines — Support for client’s 510k filing© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Regulatory Process Client Impact Case Study Issue: The client, a major cardiovascular stent company, wanted to ensure proactively that their intra-aortic balloon pump (IABP) catheters would comply with new EU regulations. Analyst Approach: The Nerac team reviewed over 1,000 publications to identify pertinent clinical research. A meta-analysis was performed on 260 applicable articles. Client Benefit: The analysis validated the efficacy of IABP catheters for certain indications and built a case for IABP catheters as a preferred treatment approach. In addition, the analysis identified indications where literature evidence was insufficient and clinical trials would be needed to comply with future regulations. Finally, the analysis provided material for publications on the best treatment techniques.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Business Development Process Identify Portfolio & Alliance Opportunities PROCESS STAGE POST- FINAL DEAL PIPELINE & SCREENING DUE DILIGENCE ANALYSES ACQUISITION NEGOTIATION INTEGRATION BUSINESS • Identify target technologies, • Support market and • Monitor DEVELOPMENT acquisitions, licensees/licensors competitive assessment - Competition • Assess patent landscape - Changes in market • Provide competitive intelligence or regulatoryDEPARTMENT OR FUNCTION • Support due diligence process environment OPERATIONS • Provide patent protection • Monitor • Support revised opinion/advice • Develop initial regulatory - Clinical and cost- business • Support informed investment strategy effectiveness strategies decisions with CI • Competitive safety and research efficacy studies - Product releases LEGAL • Provide patent landscaping • Perform due diligence • Monitor patent activity • Support revised services, early-stage clearance analyses to support: IP portfolio research , risk assessment • In-licensing, out-licensing management and acquisition strategies opportunities • Negotiation positions © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Business Development Process Examples of Recently Completed Projects  Technical due diligence and value proposition analysis of a new diagnostic device developed by a potential acquisition candidate — Analysis of key criteria such as accuracy, turnaround time and reimbursement aided the client’s assessment of the candidate  Created a target list of companies working on a therapeutic to treat a bioterrorism induced illness — Target list was used to identify potential partnership and collaboration opportunities  Reviewed segment of the IVD market in order to assess the platform technologies of competitors’ and potential acquisition candidates — Client used the information to identify smaller companies they may have overlooked as potential acquisition candidates© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Business Development Process Client Impact Case Study Issue: Nerac was engaged in order to evaluate acquisition opportunities for a particular type of drug delivery device. The client, a multinational medical device developer and manufacturer, had a goal of generating an additional $100MM annual revenue within 5 years. Analyst Insight: Nerac Analysts determined that the client had a strong IP position relative to competitors. In addition, the analysis enabled the client to understand that competitors had few advantages (e.g. manufacturing capacity, international distribution, etc.) that would be worth acquiring. Client Benefit: Based on Nerac’s recommendations, the client is aggressively pursuing an organic growth strategy which utilizes their strength in low-cost manufacturing and their defendable IP position. Nerac’s assessment allowed the client to realize that an acquisition would provide them with minimal advantages.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Technical Products Marketing Process Accelerate Critical Go/No-Go Decisions PROCESS STAGE DESIGN, OPPORTUNITY & RISK CONCEPT & FEASIBILITY PRODUCT DEVELOPMENT ASSESSMENT ASSESSMENT COMMERCIALIZATION & VALIDATION MARKETING • Market and competitive • Monitor assessment - Competition - Clinical and cost-effectiveness researchDEPARTMENT OR FUNCTION REIMBURSEMENT • Determine • Finalize reimbursement reimbursement strategy strategy • Compile dossier and • Determine cost-effectiveness implications of new product marketing materials • Understand the current reimbursement environment • Prepare a pricing strategy RESEARCH & • Opportunity vetting • Technical literature reviews PRODUCT • Technical due diligence • IP review of competitor filings DEVELOPMENT • New market identification • Supplier/manufacturing facility identification REGULATORY • Regulatory hurdles/risk • Regulatory strategy development • Post-marketing identification • Competitive safety and efficacy studies surveillance and ongoing regulatory compliance © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Technical Products Marketing ProcessExamples of Recently Completed Projects  Created a database of competitor activities related to time/temperature monitoring devices — Early monitoring permits proper positioning of client’s product in the marketplace in response to competitive threats  Comprehensive analysis of the expected clinical and economic benefits of an improved resolution imaging device — Analysis was used to support preliminary decisions on pricing, reimbursement and marketing strategy  Reviewed global market information on hyaluronic acid in order to identify adjacent applications (e.g. cosmeceuticals) — Analysis helped the client to identify niche markets where their technology applies© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Technical Products Marketing Process Client Impact Case Study Issue: The VP of Marketing at a Cardiotech company engaged Nerac to monitor competitors in the electrophysiology market. Analyst Insight: In collaboration with the client, Nerac reviewed recent competitor activities. The analysis enable the company to identify new players in the market and potential acquisition candidates. In addition, the client gained a more comprehensive understanding of how their competition was evolving in the marketplace and how to better position their products. Client Benefit: The report was utilized to help the company understand why they were losing market share and how to correct the problem. They were able to assess the competitiveness of their products and to identify areas of improvement. Nerac continues to provide quarterly updates.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Reimbursement Process Examples of Recently Completed Projects  Created a reimbursement dossier to support discussions with payers for a new diagnostics panel — Dossier used by the client’s customers to demonstrate the value of the newer aspects of the testing panel  Prepared a comprehensive ICD-9 code and DRG landscape for sepsis in order to understand the susceptible patient population and the current reimbursement levels — Research provided background for a preliminary model on the cost- effectiveness of early detection of sepsis  Developed a comprehensive landscape of existing CPT codes and reimbursement levels for a particular bone repair procedure — Client now able to assess if a currently marketed product could gain acceptance for a new application with existing codes© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Reimbursement Process Client Impact Case Study Issue: The client, an in vitro diagnostics company, launched a new panel assay to test multiple targets. After the product was launched, their customers, clinical laboratories, began having difficulty obtaining reimbursement from certain payers. Analyst Insight: Nerac Analysts prepared a dossier that highlighted the clinical benefit of each component of the assay. In addition, a preliminary model was developed to quantify the potential savings associated with early detection. Client Benefit: The client distributed the dossier and model to their customer to support reimbursement discussions with payers. As the company grows, they plan to fill the evidence gaps that were uncovered during the dossier development process.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Intellectual Property Process Enable Effective IP Portfolio Management PROCESS STAGE PATENT FILING OPPORTUNITY & RISK IP PORTFOLIO IP RIGHTS AND/OR LICENSING ASSESSMENT MANAGEMENT ENFORCEMENT NEGOTIATION LEGAL • Provide patent landscaping • Create patent portfolio • Patentability research • Identify enforcement services, early-stage for case and asset • Support in-licensing targets clearance research , risk management due diligence • Support assertion assessment • Analyze out-licensing positioning opportunitiesDEPARTMENT OR FUNCTION RESEARCH & • Provide patent protection • Assess R&D efforts in • Identify patent PRODUCT opinion/advice other business units or protection targets DEVELOPMENT • Support informed investment locations decisions with CI BUSINESS • Assess patent landscape • Link portfolio segments • Support negotiation • Inform decisions to DEVELOPMENT • Provide competitive to costs and revenues positions assert patents intelligence • Identify latent • Identify opportunities for IP commercialization commercialization partners MARKETING • Guide marketing efforts via commercial scope of IP © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Intellectual Property ProcessExamples of Recently Completed Projects  Due diligence research required for a client’s freedom to operate assessment of a gynecology device — Used by client to evaluate the validity of patents issued by their competitors — Reviewed designated companies’ patents for any potential trend in the technology of interest  Prior art search for all patents issued by an orthopedic company in disc replacement technologies — Confirmatory information ensured that a competitor had not developed a more advanced, potentially overlapping, technology — Set up an ongoing alert to monitor future activities  Due diligence research needed for a client’s freedom to operate assessment of a drug/device combination  Analysis provided confirmation that prior art, which would impair the client’s ability to sell and market a new product, did not exist© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Intellectual Property Due Diligence Client Impact Case Study Issue: The CSO of a small foreign diagnostics company requested assistance conducting clearance research for a cancer diagnosis platform based on genetic profiling. This research was necessary to determine the advisability of licensing the rights to the platform from an academic laboratory. Analyst Approach: Nerac Analysts skilled in biosequence research advised the client of the available methodologies with associated costs and limitations for identifying patents claiming the probe sequences. The team also reviewed the identified patent claims with the CSO to illustrate the potential risk associated with developing the platform for commercial use. Client Benefit: Potential commercialization barriers were identified. Counsel negotiated licensing conditions that reduced or eliminated certain royalty payments if any of the risks materialized. In addition, the client was able to propose claim amendments to the licensor to cover the intended product.© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study ExampleEvaluation of IVD ProductClient engaged Nerac for an independent, third party assessmentof their In Vitro Diagnostic (IVD) product’s cost-effectiveness. Theassessment is being used in the client’s marketing materials and indiscussions with payers. The project also enabled the client to refinetheir pricing strategy.Nerac was engaged to evaluate the client’s IVD product based onthe following criteria: a. Clinical effectiveness (life years gained, fatalities avoided) b. Cost-effectiveness (total health care costs, cost per life year gained) c. Profitability of running the test for customers NEGATIVE POSITIVE FAILEDThe cost-effectiveness model enabled the client to communicate thebenefits of the test to patients, payers, and clinical laboratories. Inaddition, the pricing model enabled the client to understand how keyvariables impacted the customer’s profit margin. © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study Example (Continued)Evaluation of IVD Product Clinical and Economic Cost Benefit Modeling Approach: A user-friendly model was developed, based on a review of the clinical and cost-effectiveness literature. The model calculated costs and benefits over Key Results: a 10 year period. The model provided a framework for Economic benefits discussions with payers. Clinical benefits Cost per life year gained Number of patients $60,000 The user-friendly input allowed payers to400 calculate the estimated clinical and economic $50,000 impact of the client’s test for their member300 population including: $40,000 1. Life years gained/quality of life years200 2. Cost per life year $30,000 3. Avoidance of treatment costs Test A100 Test B $20,000 The model became a central component of the client’s marketing efforts with both payers - $10,000 and end users, because it highlighted the # cancers Fatalities message that the client’s test provided a detected avoided (10 $- better standard of care with lower costs. through yrs) screening Test A Test B © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study Example (Continued)Evaluation of IVD ProductPricing AssessmentApproach: An analytical model was developed to calculatethe profit margin of laboratories running the test. Key Results: Potential lab profit versus compliance rate Patient compliance rate vs. Profit / $US (thousands) Modeling of reimbursement and compliance rates enabled the client $15,000 to understand the pricing levels that would result in profitability for $10,000 laboratories and payers. Taken together with health and Above this economic outcomes data, this PROFIT $5,000 threshold, Test A analysis is useful for understanding is more profitable the relative value of a diagnostic to run than Test B $- test for customers/end users. This analysis was used by the $(5,000) client to revise their pricing strategy to account for the profitability advantage of their product over $(10,000) competitive products. Patient compliance rate (%) © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study ExampleOpportunity Identification in the Tissue Engineering Market • Client wanted to explore entering the tissue engineering market through a combination of internal development, partnerships, acquisitions, and/or licensing. • Nerac was engaged to evaluate various market segments based on the following criteria: a. Indications for Use/Unmet Medical Needs b. Competitive Landscape c. Expected Market Growth d. Strategic Fit e. Development Time/Cost f. Reimbursement/ Regulatory Environment • Nerac developed a framework for evaluating the opportunities in various segments. Client utilized the recommendations to make a go/no-go decision that matched their business goals and risk tolerance. © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study Example (Continued)Opportunity Identification in the Tissue Engineering MarketApproach: Nerac researched various aspects of the tissue engineering market through both primary research (e.g. interviews with Tissue Engineering Market - Risk v Reward key opinion leaders in industry and clinicians) and secondary research (e.g. literature High reviews, evaluation of key business and financial disclosures) RISK— An assessment of key criteria guided the WW Research Investment client’s decision making process. Low High LowResult: Client has decided to forgo this market entirely:— Established market segments are highly Low High fragmented and have low profit margins Reward (WW market potential for break-through technology)— Emerging market segments do not fit with client’s risk tolerance © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Case Study ExamplesNerac Analyst Bios Marco Bafan, M.S. Roz Sweeney, Ph.D. Postdoctoral Fellow, Chemical Engineering, M.S., Biomedical Engineering, California Institute of Technology California Polytechnic University Ph.D., Cellular and Molecular Biology, University of Texas at Austin Ron Sills Huidong Yuan, Ph.D. Ph.D., Biochemistry, M.S., Biological Sciences, Chinese Academy of Sciences Southern Connecticut State University M.B.A., Fuqua School of Business, B.S., Biological Sciences, Duke University University of Connecticut© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • The Nerac ExperienceA Turn-Key Research Operation Seamless Partnership. Rapid Progress. In Just Days Confidential Collaboration High Impact Results Nerac can move from with highly skilled research tailored to client scope, scoping client need to staff as an extension timing and budget project execution of your team© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • The Nerac Difference Rapid Response, Highly-Skilled Expert Advisors • Seamless teaming with client staff to form a trusted partnership • Flexible engagements which offer rapid, impactful results • Custom research services tailored to client scope, timing and budget • Unique blend of Nerac Analysts’ keen insights and industry experience • Unwavering integrity and relentless protection of client information • Nerac researchers, analysts and IP advisors bring four decades experience serving thousands of medical device companies© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Engaging Nerac Simple & Flexible Agreements EXPERT RESEARCH RESEARCH & ADVISORY SPECIAL PROJECT SERVICES REQUEST SERVICES SERVICESSource and synthesize relevant information Expert analysis of business and Scope of work to be defined under afrom many sources technical information to produce specific agreement actionable insights Designed for large engagementsAdminister and manage alerts Data-driven evaluation of technical, executed for a fixed priceResearch key resources, including business and intellectual propertyscientific, technical, medical and patent trendssources Designed for individuals whoContact industry, commercial, academic, or want expert analysis and opiniongovernment facilities in addition to sourcing andDiscuss research or business challenges synthesisand needsDesigned for individuals who prefer toconduct their own synthesis andanalysis © 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084
    • Next Steps  Define Need  Assign and Introduce Analyst or Team of Analysts  Schedule Scoping Meeting  Distribute Agreement for Review and Sign-off  Project Launch Meeting/Discussion© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084