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medical device and consumer health commercialization services simbex 603 448 2367 info simbex com medical device and consumer health product design and development design development mechanical electrical design engineering software web development ai development services design human factors commercialization technology planning protecting documenting regulatory quality regulatory services quality as a service expertise portfolio wearables technology transfer offices news blog why simbex about leadership our team our story culture careers get started design development mechanical electrical design engineering software web development ai development services design human factors commercialization technology planning protecting documenting regulatory quality regulatory services quality as a service expertise portfolio wearables technology transfer offices news blog why simbex about leadership our team our story culture careers get started commercialization strategy we share your mission to get your device into the hands of those who need it we help you avoid pitfalls and visualize the pathway to a successful product launch tell us about your project our evidence based commercialization approach how we use the commercialization matrix as a checklist for due diligence as a framework for a commercialization plan as an assessment to de risk investment need opportunity customer characterization competitive landscape rationale regulatory reimbursement need opportunity is there sufficient demand for this product in the real world problem definition we describe the pain points and consequences that a customer would experience if they didn t have your innovation market sizing we quantify the market volume growth and trajectory from the top down and from the bottom up market segmentation we define the subsections within existing customer groups considering divisions caused by opinions attitudes geography socioeconomic factors and barriers customer characterization who is the target customer and what motivates them to buy the product early adopters we help you pinpoint the customer groups who will be first in line to buy and test out your product key opinion leaders our team maps out the professional organizations and individuals with the most influence over your target market launch optimization we formulate a plan for initial sales to the target customer and subsequent expansion to additional market segments competitive landscape what other options exist to solve the problem and what makes your solution the better one technology swot we objectively evaluate the innovation s strengths weaknesses opportunities and threats alternative solutions we analyze the other choices available for solving the same problem value differentiation we work with you to develop a value proposition that highlights the unique strengths of your product and how it aligns with stakeholders needs rationale what proof of effectiveness is required by key stakeholders current practice standards we help you understand the status quo and gauge the resistance to change among potential users of your product care pathway workflow we describe the journey of each stakeholder s interaction with the product along the continuum of care evidence portfolio we examine the appropriate depth and level of rigor for testing the product concept and the product itself regulatory what regulatory barriers must be cleared before this product launches fda submission pathway we help you reduce risk by outlining future regulatory requirements quality requirements we recommend a strategy for documentation and good manufacturing processes industry standards we identify product testing requirements and recommend a verification and validation plan reimbursement will the patient s health insurance pay for this product benefit category coding we determine where your innovation fits within the existing medical insurance framework coverage policy we review existing policy determinations and justifications to predict whether your product will be considered reasonable and necessary for reimbursement payment pricing we evaluate how much payers are willing to reimburse and compare that against what stakeholders are willing to pay need opportunity customer characterization competitive landscape rationale regulatory reimbursement need opportunity is there sufficient demand for this product in the real world problem definition we describe the pain points and consequences that a customer would experience if they didn t have your innovation market sizing we quantify the market volume growth and trajectory from the top down and from the bottom up market segmentation we define the subsections within existing customer groups considering divisions caused by opinions attitudes geography socioeconomic factors and barriers customer characterization who is the target customer and what motivates them to buy the product early adopters we help you pinpoint the customer groups who will be first in line to buy and test out your product key opinion leaders our team maps out the professional organizations and individuals with the most influence over your target market launch optimization we formulate a plan for initial sales to the target customer and subsequent expansion to additional market segments competitive landscape what other options exist to solve the problem and what makes your solution the better one technology swot we objectively evaluate the innovation s strengths weaknesses opportunities and threats alternative solutions we analyze the other choices available for solving the same problem value differentiation we work with you to develop a value proposition that highlights the unique strengths of your product and how it aligns with stakeholders needs rationale what proof of effectiveness is required by key stakeholders current practice standards we help you understand the status quo and gauge the resistance to change among potential users of your product care pathway workflow we describe the journey of each stakeholder s interaction with the product along the continuum of care evidence portfolio we examine the appropriate depth and level of rigor for testing the product concept and the product itself regulatory what regulatory barriers must be cleared before this product launches fda submission pathway we help you reduce risk by outlining future regulatory requirements quality requirements we recommend a strategy for documentation and good manufacturing processes industry standards we identify product testing requirements and recommend a verification and validation plan reimbursement will the patient s health insurance pay for this product benefit category coding we determine where your innovation fits within the existing medical insurance framework coverage policy we review existing policy determinations and justifications to predict whether your product will be considered reasonable and necessary for reimbursement payment pricing we evaluate how much payers are willing to reimburse and compare that against what stakeholders are willing to pay we are your partner we offer expert consultation and education to help you achieve your product and business goals we ve been in your shoes our team leverages a commercialization methodology developed over two decades of bringing our own and client s technologies to market we provide real world solutions our team equips you to bring your innovation from prototype to commercial product we emphasize product market fit so that your device works as well in the real world as it does in the laboratory what makes us different why simbex 500 clients from startups to fortune 500 companies success stories treat methodology from 2010 2020 simbex was the coordinating center and heartbeat of the nih funded center for translation of rehabilitation engineering advances and technology treat read more idea lab airway noodle revolutionizing the process of intubation simbex assisted the idea lab in bringing their product to life by applying our experience in medical device engineering and modeling to visualize the technology for use in investor communications read more why simbex simbex combines industry leading product design engineering commercialization regulatory and reimbursement expertise with an established production pathway and clear market access to provide a holistic ideation to market solution our commercialization team ilsa webeck vp commercialization services karen page phd senior research analyst yuan shi consultant ready to get started let s talk simbex commercialization news simbex simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game changing commercial solutions about our story culture careers our work information engineering services commercialization news blog connect contact 10 water st suite 410 lebanon nh 03766 603 448 2367 info simbex com 2026 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