SWiNTsplint is developing an implant to improve bone healing in spinal fractures. It will target orthopedic surgeons, hospitals, and patients with spinal fractures. Surgeons are the primary drivers of new product adoption but hospital administrators must approve purchases. SWiNTsplint plans to market directly to hospitals and negotiate individual pricing agreements given the small volumes expected initially. Educating surgeons at conferences and building relationships with scientific advisors and key opinion leaders will be important for gaining interest in the new product.
The document summarizes the progress of Team 21's bio-hybrid vascular graft project. It describes initial market research identifying unmet needs for small diameter vascular grafts. Through customer interviews, the team refined their target markets from coronary artery disease grafts to prioritizing peripheral artery disease grafts. Key lessons included identifying referring physicians as important influencers and pursuing CE mark in the EU followed by FDA approval. The team ended their canvas update at a higher level of investment readiness and prepared to apply for further STTR funding.
The document describes the evolution of a biotech startup's efforts to develop a new drug to treat spinal cord injury (SCI). Initially, the team was optimistic about validating the need and market potential. However, through customer interviews, they learned big pharma is not interested in early-stage SCI drugs due to previous failures. The team then developed a new 36-month plan to generate more rigorous preclinical data for FDA approval and attract partners. They also identified new financing options and pivoted to explore opportunities in multiple sclerosis based on stronger customer interest.
The document discusses a new technology for guiding cryoablation of prostate cancer using optoacoustic tomography (OAT) to provide high resolution temperature monitoring and visualization of the ice ball, aiming to reduce rectal damage, impotence, and cancer recurrence. It provides estimates of the total available market, served available market, and target market for the technology, projecting sales of 600 units for $84 million. Customer interviews conducted during an I-Corps program helped shift the business model from direct sales to physicians to partnerships with cryoablation providers.
The team conducted over 100 interviews to validate treating atrial fibrillation using vagus nerve stimulation. Early interviews focused on advanced AF patients but later showed a need to treat early-stage AF patients. The team received funding to develop the approach and acquired a CE marked implantable pulse generator. They completed a feasibility study and are seeking funds for a larger trial to further prove clinical outcomes.
The document outlines the progress of a team developing a magnetic compression device for surgical anastomoses. It includes:
1) The team has developed a device called Magnamosis to create magnetic compression anastomoses and has achieved milestones including animal trials and FDA approval for human trials.
2) Interviews with surgeons found reducing anastomotic leaks to be a key value proposition, as leaks increase costs and morbidity.
3) The team refined their business model based on feedback, deciding to focus early adoption in academic centers and use value-based pricing between $1,200-250 per device.
This document summarizes the business model development process of Nesher Technologies Inc., which is developing a single molecule detection technology. Through interviews with over 90 academic researchers, Nesher learned that researchers are interested in software to analyze single molecule data rather than capital equipment. Nesher also explored partnering with microscope and biotech companies but did not find product-market fit. Nesher pivoted to a software-focused business model, developing single molecule analysis software to sell to academic researchers.
This document discusses GE Healthcare and its role in addressing challenges in healthcare. It provides an overview of GE Healthcare, including its history, size, areas of business, and investments in research and development. It then discusses some key trends in healthcare, such as rising chronic diseases, aging populations, and cost pressures. It outlines GE Healthcare's "healthymagination" initiative which aims to improve quality and access to healthcare while reducing costs. The document also discusses how GE Healthcare is working to address needs in areas like the operating room, ultrasound-guided regional anesthesia, and pain management through innovation and technology.
This document summarizes the progress and findings of Team 12 in developing a drug to treat or prevent chemotherapy-induced peripheral neuropathy (CIPN). Through interviews with 104 people, including physicians, academics, and pharmaceutical companies, the team validated that CIPN is a significant problem with no fully effective treatments. Experts said prophylaxis would be valuable and phase 1 efficacy is possible. The team identified the need for preclinical data on nerve function and relevant cancer types. Pharmaceutical companies indicated interest in preclinical assets for $10M and phase 1 programs for $50-100M. The team plans to submit a grant for preclinical/safety studies and future clinical trials to generate the necessary data.
The document summarizes the progress of Team 21's bio-hybrid vascular graft project. It describes initial market research identifying unmet needs for small diameter vascular grafts. Through customer interviews, the team refined their target markets from coronary artery disease grafts to prioritizing peripheral artery disease grafts. Key lessons included identifying referring physicians as important influencers and pursuing CE mark in the EU followed by FDA approval. The team ended their canvas update at a higher level of investment readiness and prepared to apply for further STTR funding.
The document describes the evolution of a biotech startup's efforts to develop a new drug to treat spinal cord injury (SCI). Initially, the team was optimistic about validating the need and market potential. However, through customer interviews, they learned big pharma is not interested in early-stage SCI drugs due to previous failures. The team then developed a new 36-month plan to generate more rigorous preclinical data for FDA approval and attract partners. They also identified new financing options and pivoted to explore opportunities in multiple sclerosis based on stronger customer interest.
The document discusses a new technology for guiding cryoablation of prostate cancer using optoacoustic tomography (OAT) to provide high resolution temperature monitoring and visualization of the ice ball, aiming to reduce rectal damage, impotence, and cancer recurrence. It provides estimates of the total available market, served available market, and target market for the technology, projecting sales of 600 units for $84 million. Customer interviews conducted during an I-Corps program helped shift the business model from direct sales to physicians to partnerships with cryoablation providers.
The team conducted over 100 interviews to validate treating atrial fibrillation using vagus nerve stimulation. Early interviews focused on advanced AF patients but later showed a need to treat early-stage AF patients. The team received funding to develop the approach and acquired a CE marked implantable pulse generator. They completed a feasibility study and are seeking funds for a larger trial to further prove clinical outcomes.
The document outlines the progress of a team developing a magnetic compression device for surgical anastomoses. It includes:
1) The team has developed a device called Magnamosis to create magnetic compression anastomoses and has achieved milestones including animal trials and FDA approval for human trials.
2) Interviews with surgeons found reducing anastomotic leaks to be a key value proposition, as leaks increase costs and morbidity.
3) The team refined their business model based on feedback, deciding to focus early adoption in academic centers and use value-based pricing between $1,200-250 per device.
This document summarizes the business model development process of Nesher Technologies Inc., which is developing a single molecule detection technology. Through interviews with over 90 academic researchers, Nesher learned that researchers are interested in software to analyze single molecule data rather than capital equipment. Nesher also explored partnering with microscope and biotech companies but did not find product-market fit. Nesher pivoted to a software-focused business model, developing single molecule analysis software to sell to academic researchers.
This document discusses GE Healthcare and its role in addressing challenges in healthcare. It provides an overview of GE Healthcare, including its history, size, areas of business, and investments in research and development. It then discusses some key trends in healthcare, such as rising chronic diseases, aging populations, and cost pressures. It outlines GE Healthcare's "healthymagination" initiative which aims to improve quality and access to healthcare while reducing costs. The document also discusses how GE Healthcare is working to address needs in areas like the operating room, ultrasound-guided regional anesthesia, and pain management through innovation and technology.
This document summarizes the progress and findings of Team 12 in developing a drug to treat or prevent chemotherapy-induced peripheral neuropathy (CIPN). Through interviews with 104 people, including physicians, academics, and pharmaceutical companies, the team validated that CIPN is a significant problem with no fully effective treatments. Experts said prophylaxis would be valuable and phase 1 efficacy is possible. The team identified the need for preclinical data on nerve function and relevant cancer types. Pharmaceutical companies indicated interest in preclinical assets for $10M and phase 1 programs for $50-100M. The team plans to submit a grant for preclinical/safety studies and future clinical trials to generate the necessary data.
CREmedical aims to bring EEG technology into the 21st century with a new platform. They initially planned to manufacture, sell, and service a new EEG front-end product. However, after talking to various medical professionals, they realized a larger market opportunity in providing disposable sterile sensors for EEGs used in operating rooms. This pivot increased their projected gross revenue to $163 million annually with a 21% margin by year 10. They now plan to finalize partnerships and FDA approval to bring their scalable platform technology to market in operating rooms and pursue new treatment opportunities.
Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
The Shift in Care Delivery - As the healthcare delivery system evolves, hospitals may no longer be the first stop for patients seeking orthopaedic care. This is evidenced by the growing trend of surgeons moving to the outpatient setting, as patients seek less invasive procedures. Orthopaedic urgent care centers have also emerged as a viable alternative, due to their ability to address price concerns in the industry by reducing time and overhead costs for both providers and patients.
Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
This document discusses medical device customer segments. It notes that medical device markets are often multi-sided, involving patients, physicians, hospitals/practices, payors, and regulators. It emphasizes the importance of understanding reimbursement and following the money to identify who the real customers are in a given market. The document provides an overview of physicians, patients, hospitals, and medical device companies as potential customer segments and discusses their key pains and gains. It also outlines different types of medical device markets and what they typically mean for startups versus large acquirers.
This document provides an overview of a Lean LaunchPad cohort focused on diagnostics. It discusses how the definition and nature of diagnostics has changed with advances in biology and technology. Diagnostics can now detect changes over time, stratify conditions, and predict outcomes. Value propositions are more complex with varied testing approaches for medical, consumer, and industrial uses. Business models in diagnostics are also changing, with large companies focusing on established markets and smaller companies pursuing niche technologies. The document outlines challenges specific to diagnostics like regulation, reimbursement, and multisided healthcare markets. It emphasizes generating hypotheses from market insights rather than just technical insights to create customer value.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
- The document outlines the initial idea, team, target market size, and interviews conducted for a startup aiming to help oncologists select personalized breast cancer therapies using PET/X technology.
- Over 10 weeks of interviews with 106 participants, the team validated the product-market fit, identified customer segments, and developed initial marketing and financial models.
- Next steps include completing an MVP, partnering with clinical sites, collecting quality data, and submitting a Phase II proposal to further validate the technology and business models.
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
The document summarizes a team's final project presentation for a medical device startup called MammOptics. The team includes four members with engineering and business backgrounds working to develop a non-invasive, non-radiative breast cancer detection technology using optical spectroscopy. The presentation covers the initial technology and business model hypotheses, testing the value proposition with hospitals and doctors, and outlines the steps needed for product development, clinical trials, reimbursement, and company financing.
This document outlines the development of a startup called ResultCare that aims to provide physicians with real-time evidence, guidelines, and expert opinions to help guide diagnostic and treatment decisions. The founders conducted over 100 customer interviews with physicians, laboratories, payers, and other partners to define their customer segments, value propositions, key activities, and partners. They discovered the greatest needs were among specialty laboratories seeking to gain payer coverage and physician users needing diagnostic testing guidance. The founders have raised an initial $75k and are working on the beta release of their evidence and cost guidance engine to begin acquiring users and contracting with specialty laboratories.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.
With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The document discusses developing a recombinant gammaglobulin product as an alternative to plasma-derived intravenous immunoglobulin (IVIG) treatments. It summarizes interviews with potential customers to understand their needs and determine the value proposition. Key stakeholders are identified as patients, healthcare providers, and regulators. Partners discussed include contract manufacturing organizations, clinical trial sites, and specialty pharmacies for distribution.
The document summarizes the findings from 101 interviews conducted by the BCN Biosciences Team over 10 weeks as part of the I-Corps program at NIH to validate the business model for a drug that increases the anti-cancer effect of radiation therapy in lung cancer. Through customer discovery interviews, the team identified fibrosis, specifically lung fibrosis and skin fibrosis, as larger market opportunities than their original focus on radiation mitigation. They evolved their strategy to focus on preventing radiation-induced lung fibrosis, lung fibrosis generally, and using the drug's anti-fibrotic properties for anti-aging applications.
This document provides an overview of the challenges facing life science startups in therapeutics, diagnostics, medical devices, and digital health. It discusses the increasing costs and regulatory hurdles of drug and device development, including higher clinical trial standards and FDA scrutiny. This has led to declining venture capital investment in life sciences as startups face greater challenges in achieving approval and profitability. The author proposes testing a Lean LaunchPad approach to help life science startups commercialize research more efficiently and reverse negative industry trends.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.
With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
This document summarizes meetings and interviews conducted by HaRo Pharmaceutical regarding development of a new drug to treat high-risk neuroblastoma. It discusses key activities like lead optimization, animal modeling, and clinical trials. Experts noted the importance of disease-relevant models and primary cell-based assays to generate convincing data. Clinical partners could support an IND application and initial trials. While the drug may have multiple indications, neuroblastoma requires more institutional support and approval from key opinion leaders. The document outlines HaRo's potential development path and identifies resources and partners needed at each stage.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
This document discusses value propositions for medical device startups. It emphasizes that a compelling clinical need that dramatically improves patient outcomes is necessary to discover a viable business model. Value propositions depend on whether the goal is to make the company acquirable or to achieve sustainable independent growth. Claims of cost reduction must be definitively proven with long-term studies, as payors demand lower costs while existing companies aim to maintain prices and margins. Different stakeholders view value propositions differently. Gains involve enabling new therapies, pains involve reducing adverse effects, and features involve usability.
How might we prevent occipital pressure ulcers in pediatric patients in an ic...Prashant Soni
This document provides an overview of the biodesign process and discusses developing a solution to prevent pressure ulcers in pediatric patients. It begins with outlining the biodesign process of identifying needs, ideating solutions, and developing prototypes. It then examines the need to prevent occipital pressure ulcers in pediatric intensive care patients, noting their high incidence rates. Current solutions are analyzed, finding that most adult-focused solutions fail for pediatric anatomy. The document brainstorms potential design approaches and showcases early prototypes to address the need.
Torotoro es un parque nacional ubicado al norte de Potosí en Bolivia. Es conocido por sus cavernas como Humajalanta, que tiene 7 km de extensión, así como por las cascadas de El Vergel y las huellas fosilizadas de dinosaurios que se pueden encontrar por todo el pueblo y en el cerro Huayllas. El parque alberga una gran diversidad de plantas y animales, y atractivos como la Casa de Piedra y el Cañón de Torotoro de más de 250 metros de profundidad.
Next Steps In Your Digital TransformationVMware Tanzu
This session brings together all the lessons learnt throughout the day and shares with you practical advice on how to get started with, or accelerate, your journey to become a digital business.
Speaker: Andre Muenger, Agile Transformation Strategist, Pivotal, Turkey
CREmedical aims to bring EEG technology into the 21st century with a new platform. They initially planned to manufacture, sell, and service a new EEG front-end product. However, after talking to various medical professionals, they realized a larger market opportunity in providing disposable sterile sensors for EEGs used in operating rooms. This pivot increased their projected gross revenue to $163 million annually with a 21% margin by year 10. They now plan to finalize partnerships and FDA approval to bring their scalable platform technology to market in operating rooms and pursue new treatment opportunities.
Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
The Shift in Care Delivery - As the healthcare delivery system evolves, hospitals may no longer be the first stop for patients seeking orthopaedic care. This is evidenced by the growing trend of surgeons moving to the outpatient setting, as patients seek less invasive procedures. Orthopaedic urgent care centers have also emerged as a viable alternative, due to their ability to address price concerns in the industry by reducing time and overhead costs for both providers and patients.
Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
This document discusses medical device customer segments. It notes that medical device markets are often multi-sided, involving patients, physicians, hospitals/practices, payors, and regulators. It emphasizes the importance of understanding reimbursement and following the money to identify who the real customers are in a given market. The document provides an overview of physicians, patients, hospitals, and medical device companies as potential customer segments and discusses their key pains and gains. It also outlines different types of medical device markets and what they typically mean for startups versus large acquirers.
This document provides an overview of a Lean LaunchPad cohort focused on diagnostics. It discusses how the definition and nature of diagnostics has changed with advances in biology and technology. Diagnostics can now detect changes over time, stratify conditions, and predict outcomes. Value propositions are more complex with varied testing approaches for medical, consumer, and industrial uses. Business models in diagnostics are also changing, with large companies focusing on established markets and smaller companies pursuing niche technologies. The document outlines challenges specific to diagnostics like regulation, reimbursement, and multisided healthcare markets. It emphasizes generating hypotheses from market insights rather than just technical insights to create customer value.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
- The document outlines the initial idea, team, target market size, and interviews conducted for a startup aiming to help oncologists select personalized breast cancer therapies using PET/X technology.
- Over 10 weeks of interviews with 106 participants, the team validated the product-market fit, identified customer segments, and developed initial marketing and financial models.
- Next steps include completing an MVP, partnering with clinical sites, collecting quality data, and submitting a Phase II proposal to further validate the technology and business models.
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
The document summarizes a team's final project presentation for a medical device startup called MammOptics. The team includes four members with engineering and business backgrounds working to develop a non-invasive, non-radiative breast cancer detection technology using optical spectroscopy. The presentation covers the initial technology and business model hypotheses, testing the value proposition with hospitals and doctors, and outlines the steps needed for product development, clinical trials, reimbursement, and company financing.
This document outlines the development of a startup called ResultCare that aims to provide physicians with real-time evidence, guidelines, and expert opinions to help guide diagnostic and treatment decisions. The founders conducted over 100 customer interviews with physicians, laboratories, payers, and other partners to define their customer segments, value propositions, key activities, and partners. They discovered the greatest needs were among specialty laboratories seeking to gain payer coverage and physician users needing diagnostic testing guidance. The founders have raised an initial $75k and are working on the beta release of their evidence and cost guidance engine to begin acquiring users and contracting with specialty laboratories.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.
With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The document discusses developing a recombinant gammaglobulin product as an alternative to plasma-derived intravenous immunoglobulin (IVIG) treatments. It summarizes interviews with potential customers to understand their needs and determine the value proposition. Key stakeholders are identified as patients, healthcare providers, and regulators. Partners discussed include contract manufacturing organizations, clinical trial sites, and specialty pharmacies for distribution.
The document summarizes the findings from 101 interviews conducted by the BCN Biosciences Team over 10 weeks as part of the I-Corps program at NIH to validate the business model for a drug that increases the anti-cancer effect of radiation therapy in lung cancer. Through customer discovery interviews, the team identified fibrosis, specifically lung fibrosis and skin fibrosis, as larger market opportunities than their original focus on radiation mitigation. They evolved their strategy to focus on preventing radiation-induced lung fibrosis, lung fibrosis generally, and using the drug's anti-fibrotic properties for anti-aging applications.
This document provides an overview of the challenges facing life science startups in therapeutics, diagnostics, medical devices, and digital health. It discusses the increasing costs and regulatory hurdles of drug and device development, including higher clinical trial standards and FDA scrutiny. This has led to declining venture capital investment in life sciences as startups face greater challenges in achieving approval and profitability. The author proposes testing a Lean LaunchPad approach to help life science startups commercialize research more efficiently and reverse negative industry trends.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.
With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
This document summarizes meetings and interviews conducted by HaRo Pharmaceutical regarding development of a new drug to treat high-risk neuroblastoma. It discusses key activities like lead optimization, animal modeling, and clinical trials. Experts noted the importance of disease-relevant models and primary cell-based assays to generate convincing data. Clinical partners could support an IND application and initial trials. While the drug may have multiple indications, neuroblastoma requires more institutional support and approval from key opinion leaders. The document outlines HaRo's potential development path and identifies resources and partners needed at each stage.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
This document discusses value propositions for medical device startups. It emphasizes that a compelling clinical need that dramatically improves patient outcomes is necessary to discover a viable business model. Value propositions depend on whether the goal is to make the company acquirable or to achieve sustainable independent growth. Claims of cost reduction must be definitively proven with long-term studies, as payors demand lower costs while existing companies aim to maintain prices and margins. Different stakeholders view value propositions differently. Gains involve enabling new therapies, pains involve reducing adverse effects, and features involve usability.
How might we prevent occipital pressure ulcers in pediatric patients in an ic...Prashant Soni
This document provides an overview of the biodesign process and discusses developing a solution to prevent pressure ulcers in pediatric patients. It begins with outlining the biodesign process of identifying needs, ideating solutions, and developing prototypes. It then examines the need to prevent occipital pressure ulcers in pediatric intensive care patients, noting their high incidence rates. Current solutions are analyzed, finding that most adult-focused solutions fail for pediatric anatomy. The document brainstorms potential design approaches and showcases early prototypes to address the need.
Torotoro es un parque nacional ubicado al norte de Potosí en Bolivia. Es conocido por sus cavernas como Humajalanta, que tiene 7 km de extensión, así como por las cascadas de El Vergel y las huellas fosilizadas de dinosaurios que se pueden encontrar por todo el pueblo y en el cerro Huayllas. El parque alberga una gran diversidad de plantas y animales, y atractivos como la Casa de Piedra y el Cañón de Torotoro de más de 250 metros de profundidad.
Next Steps In Your Digital TransformationVMware Tanzu
This session brings together all the lessons learnt throughout the day and shares with you practical advice on how to get started with, or accelerate, your journey to become a digital business.
Speaker: Andre Muenger, Agile Transformation Strategist, Pivotal, Turkey
Patient Relationship Management Doc&u Care Connectedyakkubali
The document discusses different scenarios for healthcare delivery centers and their systems:
1) Centers with no electronic system have inefficiencies like increased wait times and costs. Docnu's platform allows centers to go digital easily.
2) Centers with partial or standalone systems have issues like spread out data and duplication. Docnu integrates systems and provides centralized data.
3) Centers with full existing HIS just need to consider Docnu's costs for additional features like marketing and communications tools.
The document discusses plans for a new product called Robox. Robox aims to make coding and robotics accessible for teachers, students, and parents through affordable kits. Key points:
1) Robox kits would be much cheaper than competitors and bundled with coding curriculum and an online platform. Users could build their first robot in minutes.
2) The target customer segments are maker teachers, students aged 7-12, parents of children 12-18, schools, and tech enthusiasts. The value propositions focus on teaching/learning coding in an accessible, practical way or helping raise smart kids.
3) The business model involves online and direct sales, an open hardware community for development, manufacturing and importing components,
The document summarizes the progress of Team TRACE over 10 weeks in developing a solution to address forced labor in global supply chains. They initially thought brands just needed more data, but learned remediation is complex, brands lack resources and expertise. They then developed an idea for a platform connecting brands to NGOs for help, but received negative feedback. In weeks 7-10, they partnered with the Sustainable Apparel Coalition to create a platform for brands to pool resources and collaborate on remediating problematic factories, helping workers and saving brands money.
The document discusses trends in consumer tech and media from 2015-2020. It predicts that the industry will grow by over $500 billion in that time period, with the average American spending more time on tech and media than on work or sleep. It also notes that messaging platforms will surpass social networks as the dominant media activity and that the next big winners in streaming audio are already gaining popularity quietly.
The document summarizes the goals and business model of the Global Regenerative Group, which aims to advance regenerative medicine through various initiatives. The Global Regenerative Academy will provide formal regenerative medicine education and facilitate clinical trials to establish evidence. It will host international conferences to connect doctors. The Global Regenerative Trade will distribute medical devices that are scientifically and clinically proven. The Global Regenerative Journal will publish peer-reviewed research. Together these initiatives seek to overcome current issues in regenerative medicine education and promote evidence-based practice, with the goal of enabling healthier aging through regenerative techniques.
Healing Technologies will develop a common web-based platform for different medical sensor apps to transmit bio-data to their diagnostic center. They will demonstrate this by creating an app where an intestine-imaging pill transmits images to doctors remotely for intestinal cancer diagnosis. This could save lives by detecting cancers earlier than current methods while being inexpensive and convenient. However, they must address legal obligations and liability risks to partner with local doctors.
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We’re creating a home blood testing device that with one finger prick, tells you:
(1) What your major health indicators are
(2) Whether they’re at healthy levels or not
(3) If they’re problematic, then recommendations on how to improve your health, and the option to send those results to a doctor
Instant and accurate results for you, your family, and those you care about.
This document summarizes an upcoming conference on biosimilars and biobetters to be held in London from September 29-30, 2014. The conference will include presentations and discussions on accelerating biosimilar drug development, regulatory pathways for biosimilars in Europe and the US, proving biosimilarity to reference products, and perceptions of biosimilars among doctors, patients, and payers in Europe. Attendees can also participate in two interactive workshops on biosimilar regulations and the commercial potential of biosimilars. Various industry experts will speak at the event to provide insights on this emerging field.
April 18, 2015
Decision aids can be highly-effective tools to promote shared decision making and support patients in becoming engaged participants in their healthcare. Join us for the first-ever convening with leaders behind a Washington experiment in certifying decision aids, as state officials, health systems, and on-the-ground implementation experts share lessons learned and discuss policy recommendations for national or statewide approaches to decision aid certification.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/decision-aids-for-patients-with-serious-illness
The document proposes developing an affordable portable ultrasound device to enable widespread screening. It would benefit patients through early detection and be convenient for doctors to use like a stethoscope. The founders aim to market the device to various medical specialties. It outlines the product, team, sales strategy, target customers, costs, revenue projections, potential partners, funding needs, and risks. The goal is for the device to become profitable within 4 years of development and regulatory approval.
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The document outlines the agenda for the Northern Innovation and Networking Event 2017 on the adoption and spread of innovation. The event will include presentations on topics such as the importance of innovation, AHSN commercial support for SMEs, and case studies of innovations. Speakers will discuss the AHSN network and its role in improving health and supporting economic growth. The event aims to provide information to help health and life sciences SMEs engage with AHSNs and the NHS to drive the adoption and spread of innovations.
A regenerative medicine company is developing a patented stem cell therapy using a patient's own stem cells to treat erectile dysfunction. The therapy involves extracting stem cells from the patient's penis through a minimally invasive procedure. Animal research and a human case study showed improved erectile function. A clinical trial at UCLA is underway to establish the therapy as the standard of care. The company aims to be the first to market in 2017 with a full package offering of protocol, clinical trial results, devices, and training to urologists.
Presentation for spbt 2013 meeting background and researchklaffy
The document discusses the changing context of medical practice and the need for pharmaceutical representatives to build value-based relationships with physicians. It provides guidance on how representatives can validate their clinical knowledge through sub-specialty certification programs. The document also summarizes research that found physicians are more likely to meet with representatives who have completed specialized training programs developed by medical societies. Finally, it outlines the structure and attributes of an ideal disease-state training program for representatives.
The document discusses innovation with commercial electronic health records (EHRs) at Partners HealthCare. It describes Partners HealthCare's structure and approach to innovation, which includes advancing core work and creating new solutions. The clinician team focuses on areas like clinical process redesign, clinical informatics, and knowledge management. Guiding principles for fostering innovation emphasize supporting innovators, prioritizing innovations aligned with Partners' strategy, and disseminating innovations across Partners HealthCare. A prioritization framework is being created to evaluate innovative projects according to standard criteria.
Generating Quality Data through Collaborative Research with an ACOTodd Berner MD
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The document provides information about Joe Ryan's business plan for becoming an Atrium Medical Sales Representative. It includes summaries of interviews with hospital surgeons and current Atrium sales reps. It also covers additional research on hernia anatomy and Atrium's product range. The business plan outlines Joe's 30, 60, and 90 day goals which include completing training, establishing his territory routing, scheduling speaker programs, maintaining contact with his manager, and closing new business.
Mayo Clinic is the world's first and largest integrated not-for-profit medical group practice. It spends over $500 million annually on research and employs over 50,000 staff across its three campuses. Founded in 1889 in Rochester, Minnesota, Mayo Clinic pioneered the concept of a medical group practice. It is known for its specialties in heart disease, cancer, respiratory disorders, and urology. Mayo Clinic prioritizes patient care and satisfaction through its emphasis on team-based care, investments in facilities and technology, and valuing all patient interactions.
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(1) The document describes the journey of a team developing a saffron supplement product to address mental health issues like anxiety and depression.
(2) It started with the goal of targeting adults aged 18-40, but through customer interviews and testing, they learned that teenagers were more interested in an anti-anxiety gummy product.
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LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...
SWINT splint Columbia 2015
1. 0
Cohort 1 Team 3
Gaby Sanguineti, Stephanie Schreiber,
Mia Shandell & Eddie Vogel
Total Number of Interviews to Date: 38
Interviews Conducted, Day 4: 8
SWiNTsplint
Improving the bone healing process in spine fractures
2. 11
Business Canvas – Day 4
Partners
• Labs specializing in
nanomaterials
engineering
• Incubators
• Orthopedic research
specialists
• Contract research
organizations (CROs)
Activities
• Design the product
• Design clinical trials
• FDA approval
- “Combination
Product”
- Primary mode of
action: biologic
BLA ($2mil)
- 4-8 years
• Manufacture product
• Sales/Marketing
• Distribution to
hospitals
• Educate physicians
• Build relationships
with investors,
potential acquirers
Value Proposition
• Improved healing for
spinal fractures due to
an implant that
promotes bone
growth, resulting in:
• Orthopedic
Surgeons: Improved
outcomes, ease of
use, reduce feelings
of “what did I do
wrong”, reduced cost,
confidence in patient
conversations that
treatment / healing will
go according to plan;
• Facilities: Reduced
overall cost of care,
improved quality,
filling surgeon
request, being the ‘go-
to’ hospital, being an
innovator in a
specialty area
• Patients: Faster
healing, reduced
incidence of
subsequent nonunion
Customer Relationships
Get:
• Scientific advisory board
• Conferences, magazines,
hospital product fairs
• Sales reps
• Develop relationships with
key opinion/thought
leaders– co-develop, early
adoption
• Target CMEs (continuing
medical education
programs)
Keep:
• Ongoing education
Grow:
• Expand product
indications
Customer Segments
Multi-sided market:
• Orthopedic
Surgeons: key
opinion and thought
leaders
• Facilities: hospital
sourcing divisions
• Patients with spinal
fractures –
Supplement to an
initial fracture
treatment plan
(surgery)
- Initial focus on
spinal surgery
(common
patients: males
who work as
physical
laborers, 40-60).
• [Investors]
• [Acquirers]
Resources
• Patents / Licensing
agreements
• IP lawyer
• Orthopedic surgeons
• Scientists
• Manufacturers
• Marketing / Sales
• Materials
• Lab space
• Manufacturing space
Channels
• Inpatient facilities
• Outpatient facilities
• Ambulatory surgical
centers
• Skilled nursing facilities
(SNF)
• Inpatient rehab facility
(IRF)
Costs
• Patents
• Clinical trials (!!)
• Research and development: lab space, labor, equipment
• Production costs: manufacturing space/equipment, labor
• Materials (i.e. nanotubes, molecular biology tools)
• Marketing / sales force
• Physician education
Revenue Streams
• Hospital payments
• Group Purchasing Organizations (GPOs) – drug wholesalers
3. 22
Learnings and Next Steps
What We Thought What We Did What We Learned What Next
Price is the primary driver of
hospital administrator
decision-making
Talked to hospital
administrators and
surgeons
Administrators will approve more
expensive products:
• Surgeon tends to be primary driver of
decision
• Want to be the ‘place patients want to
go’
• Particularly in areas where hospital is
‘known for’, want to be on cutting edge
Identify examples of
more expensive
products that were
approved
Hospitals and surgeons
make decisions about which
products to purchase
Talked to hospital
administrators and
surgeons
Decisions are made via a steering
committee that includes representation
from many hospital functions (finance,
reimbursement, clinical, sourcing)
Talk to more
administrators
SWiNTsplint would distribute
its product through a
wholesaler
Talked to hospital
administrators and
drug distribution
experts
Since the product is new/ innovative with
fairly small volumes in the early years, we
would manage our own distribution
Talk to product
managers at med
device companies about
distribution decision-
making
Drugs are ordered in bulk by
hospitals from drug
manufacturers
Talked to hospital
administrators about
drug pricing
decisions and
negotiation
For new/ innovative products,
administrators will often negotiate
arrangements such as ‘on demand’
ordering and trial periods (e.g. try it in 5
patients, analyze financial and clinical
outcomes, then decide on larger order)
Ask other biotech
startups what deals
they’ve created with
hospitals
Surgeons learn about new
drugs from literature and
conferences / trade shows
Talked to surgeons
and administrators
Trade shows / conferences are key for
getting surgeons excited about new
products
Discuss marketing
tactics with biotech
companies; identify key
spinal trade shows
4. 33
Revenue Stream: Value-Based Pricing
SWiNTsplint will be sold on a per-unit price – we learned from surgeons and
reimbursement experts that it can save ~7k on average per treated patient
Cost of Care: Bone Fuses Cost of Care: Bone Does Not Fuse
$150 Pre-op consultation with surgeon
$27,000 Spinal fusion surgery
$27,150 Total episode
$150 Pre-op consultation with surgeon
$27,000 Spinal fusion surgery
$1,450 6-month CT scan
$120 6-month follow-up
$1,450 1-year CT scan
$120 1-year follow-up
$30,000 Second spinal fusion surgery
$60,290 Total episode
Higher-risk, receive SWiNTsplint during surgery
SWiNTsplint saves:
$33,130 in patients with bone non-fusion
$7,245 per patient across treated population
Spinal Fracture Population Receiving Surgery
Sources: Primary interviews, ModernHealthcare, New Choice Health. Assumes SWiNTsplint is implanted into 40% of the highest risk spinal
fusion patients and prevents second surgery in 75% of patients that would have suffered a nonunion (10% of surgical population).
5. 44
Cost Analysis vs. Competitor Price (Benchmarking)
Our primary product cost will be materials as SWNTs are expensive—but our
cost is still well within the range of our closest competitor’s price
Average Cost/Unit: $3000
Materials: $2000
• SWNT - $1200
• Gel - $750
• Growth Factors - $15
Labor: $800 (5 day process)
• One Lab Tech
• Salary: 18/hour (8 hour/day) - 720
• Benefits: 80
Facilities (Epibone incubator rate) - $200
• Rent: $1000/month - 8 hours/day open –
5 day production - $165
• Utilities (5 day period) - $35
SWiNTsplint Medtronic INFUSE
Average Price/Unit: $5500
6. 55
Channel: Direct Distribution to Hospitals
Spinal Fracture
Patient
Orthopedic
Surgeons
Biotech / Life
Sciences
Company
Key Insights:
• Given the type of product
and expected volumes, we
would likely manage our
own distribution selling
directly to hospitals
• Once hospital decides to
purchase SWiNTsplint, we
would negotiate on price
– Discounts are typically
given on price
• Since the product is new /
innovative, we may
negotiate “trial” sales and
on-demand distribution
• Product will be reimbursed
as a “medical benefit” and
not distributed through a
specialty pharmacy
Health Insurance
Companies
Hospital
Administrators
$
Copay
Insurance
coverage
$
Reimbursement
for product
Treatment
Product
recommendation
ProductProduct price
(net)
$
Marketing
Outofpocketexpenses
$
7. 66
Channel: Hospital Decision-Making Process
Spinal
Fracture
Patient
Orthopedic
Surgeons
Biotech / Life
Sciences
Company
Health
Insurance
Companies
Hospital
Administrator
s
Surgeon develops
interest in product
Surgeon
discusses with
Chief of Specialty
Surgeon submits
request to
hospital
administrators
Hospital
Steering
Committee
convenes
Negotiations
and
procurement
• Surgeon is introduced
to product
– Frequently at trade
shows
– Spinal in
November
• Reviews literature /
studies
• Decides he or she is
interested in trying
out the product
• Surgeon discussed
product with Chief of
his or her specialty
• Receives sign-off
from Chief to move
forward in
procurement process
• Surgeon submits a
standard form to
hospital sourcing
• Hospital sourcing
prepares for Steering
Committee:
– Reviews literature
on product
– Competitive
assessment: cost
and efficacy of
other products in
the market
– Checks
reimbursement
– Discuss with
finance team
• Steering Committee
typicaly comprised of
all service lines and
various functions
within the hospital
– Clinical
– Finance
– Reimbursement
– Sourcing
• Meets ~1x/ month
• Debates adding the
product “to the shelf”
• For newer products,
decision process is
typically 2-3 months
• Sourcing negotiates
price with drug
company
• For new/innovative
products, may not
submit a full purchase
order upfront
– May say, let‘s try it
in 5 patients,
review results and
then decide on
larger order
– May also order on
demand when
patients are
scheduled for
surgery
9. 88
Advertise at orthopedic conferences
(AAOS, ORS)
Advertise in orthopedic journals
(JBMR, Spine)
Present at biotech
product fairs
Choose KOLs as principal
investigators in journals
10. 99
Identify respected scientists
to advise on product
Help spread word of
progress and potential
Build reputation
amongst
scientific/medical
community
14. 1313
Customer Segments
• ~28k US orthopedic surgeons
• Older generations tend to be
less willing to try newer products
than younger (on average)
– Even if reimbursement,
regulatory approval in place
• Always think “what did I do
wrong” if surgery doesn’t go well
– Highly motivated by success
– Difficult conversation to have
with patient if surgery or post-
op doesn’t follow the plan
• Product that improves likelihood
of success makes physicians
more confident in pre-op, in
operating room and in post-op
• 5,723 hospitals in the US
• Sourcing / procurement
departments make decisions on
which medical products to make
available
– Heavy input from doctors
• Hospitals are a low- and
declining-margin business
– Administrators motivated to
keep costs down
– Paid a single fee for each
hospital admission based on
procedure – incentivized to
keep length of stay down
• More than ~700k patients per
year suffer a spinal fracture
• Risk of bone not fusing – and
need for a 2nd surgery – is high
– Higher if patient has
comorbidities, smokes, more
elderly, physical labor
• Healing process is very lengthy
and painful
– 3-7 days in hospital
– Can be 6 months before
physical activity allowed
• Cost of each surgery is ~$27k
– Patients may have a high
deductible ($6k-$8k)
Orthopedic Surgeons Spinal Fracture PatientsHospital Administrators
Sources: Primary interviews, American Academy of Orthopedic Surgeons, Department of Orthopedics and Rehabilitation at Yale, ModernHealthcare
15. 1414
Value Proposition
• Improved likelihood of
success in spinal fracture
surgery
– Reduce feelings of “failure”
(even if not surgeon fault)
– Easier to interact with
patients when operating
and treatment is going
according to plan
• Increased confidence in
interactions with patient
– Since healing takes 3+
months, feel more confident
reassuring patient in month
3 even if not fully healed if
have faith in product
• Reduced overall cost of care
– Particularly for hospitals in
value-based contracts
– Avoid second surgery
• Higher quality ratings
• Reduced healing time – back
to work / on feet sooner
• Reduce pain from nonunion
fracture
• Avoid second surgery to
repair a fracture
Orthopedic Surgeons Spinal Fracture PatientsHospital Administrators
16. 1515
Clinical Trial Process
Source: Pharmaceutical Research and Manufacturers of America, FDAReview.org, Parexel Statistical Sourcebook
Preclinical Clinical Approval Market
Phase I Phase II Phase III
Description • Evaluation of
implant’s toxic
and
pharmacologic
effects through
laboratory animal
testing (rabbit)
• Shows that the
implant is
biologically
active and is
reasonably safe
for human
testing
• Initial
introduction
of new drug
into humans
• Tests safety
• 20-100
volunteers in
clinical trials
• Unethical,
have to do
spinal
surgery
• Studies the
effect of the
implant in
patients with
spinal
fractures
• Tests safety,
dosing,
efficacy
• 50-100
injured
patients in
trials
• Can’t do
placebo!
• 2 clinical
trials to prove
the implant is
safe and
effective in
the target
population
• Also tests
side effects
• 1,000-5,000
injured
patients in
trials
• Can’t do
placebo!
• Review of ALL
pre-clinical and
clinical data,
approval by
FDA
• Known as
Phase IV
• Post-market
surveillance
Cost Varies based on
amount of R&D
~$15 million ~$25 million ~$90 million Varies by
market
Varies by
duration
Time 3 to 5 years 0.6 to 2 years 11 to 14 years4 to 8 years
Submit BLA, Pre-
IND meet with FDA
End of Phase II
meet with FDA; if
positive, move to
Phase III
17. 1616
Clinical Trial Design (Phase II – Safety/Efficacy)
Estimated
Enrollment
Spinal fusion rate of targeted vertebral bodies (L5-S1), evaluated by CT scan [Time Frame: during 12-15mo. after
surgery]
Rate of (serious) adverse events with a potential relation with SWiNTsplint [Time Frame: 24-27mo. after surgery]
Inclusion /
Exclusion
Primary
End-Points
Study Type Interventional, single group assignment model, randomized, double-blind (subject, outcomes assessor)
Secondary
End-Points
Reduced incidence of 2nd surgery due to non-union, evaluated by CT [Time Frame: during 12-15mo. after
surgery]
Reduced incidence of re-hospitalization [Time Frame: During the first year (12-15mo.) after surgery]
Reduced pain, evaluated by visual analogue pain scale [Time Frame: During two years (24-27mo.) after
surgery]
Spinal fusion rate after two years [Time Frame: Two years (24-27mo.) after surgery]
100 patients
Endpoint
Classification
Safety/Efficacy study
Primary
Purpose
Treatment
Conditions –
active
comparator,
experimental
Patients who require
surgical graft for L5-S1
spinal fractures
SWiNTsplint
Ilial crest
autograft
Randomization Autograft/SWiNTsplint both implanted in one patient, randomized side of injury
18. Product Company Status
INFUSE Bone Graft Medtronic - Reached $900 million in sales in 2011
- 2011 review of product revealed many unlisted side
effects (including high risk of cancer, sterility, nerve
damage, etc.)
- Hundreds of lawsuits filed
BIO Osiris
Therapeutics, Inc.
- Acquired by NuVasive, Inc. for $35 million in 2008
- Strategically partnered with Stryker Corporation in 2014
- Evidence presented that this is no more effective than
other current allograph products
Spinal-Stim Orthofix - 2008 earnings: $170 million
- Lawsuits filed for misleading providers of device effects
- Effectiveness remains inconclusive from review studies
- Half of fracture patients make use of product
Proxies
Similar attempts at solving the bone fracture fusion problem
Medtronic INFUSE Orthofix Spinal-Stim
19. 1818
Market Size
Market Description
Total Available
Market
Bone Graft Substitute Market
(Biomaterials)
Total Served
Market
Bone Graft Substitute Market
for Spinal Fusions
(Biomaterials)
Target Market Bone Graft Substitute Market
for Nonunion Spinal Fusions
(Biomaterials)1
Source: Millenium Research Group, 2014. 1. Estimate of 10% based on orthopedic surgeon interviews.
Total Available
$1.6 B
Total Served
$1.12 B
Target
$112M
With our changed goal – augmenting
existing surgical technique and not just
treating non-union, our market expands a
to graft substitutes for spinal fusions
20. 1919
Type of Business
Intellectual Property - Niche Market
Intellectual Property
Copyrights
Patents
Trademarks
Designs
Trade Secrets
Utility Patent Timeline
Provisional
0 months
Cost: ~$10k
Full
12 months
Cost: ~$25k
National Stage
30 months
Cost: ~$40k
Total Time
30 Months
Total Expense
$100-150k
21. 2020
Proposed Experiments
Key hypotheses Proposed experiment Pass/Fail
In making product purchase
decisions, hospital administrators
balance several factors including cost,
outcomes and surgeon satisfaction
Interview hospital sourcing divisions
to understand better decision-making
process
Pass: Hospital administrators identify
factors beyond direct cost of material
as being important
Fail: Direct cost of materials is only
factor
There is a subset of orthopedic
surgeons willing to try “cutting edge”
technologies and be a champion for
our product in the market
Interview orthopedic surgeons to
identify surgeons on the “cutting
edge” of research
Pass: We are able to identify 3-5 key
opinion leader surgeons in the
orthopedic market
Fail: We are not able to identify
10% of spinal fracture patients
experience a non-union post-
procedure
Interview orthopedic surgeons
specializing in spinal injuries
Pass: 10% or more patients
experience non-unions
Fail: <10% experience non-unions
Product will be classified as a
Combination Product (BLA) by the
FDA
Interview people that have worked in
the FDA
Pass: Our product is classified as a
Combination Product (BLA)
Fail: Product classification is different.
The DRG fee for spinal procedures
(and our potential share) is large
enough to justify R&D and operating
costs
Talk to insurance companies about
bone fracture DRG rates and
research pricing for bone fracture
episodes
Pass: DRG fee is large enough to
cover the cost of the material
Fail: DRG doesn’t completely cover all
the costs and patient might have to
pay out of pocket.
The primary patient demographic for
our product is middle-aged males
Interview orthopedic surgeons Pass: Primary patients are middle-
aged men
Fail: Primary patients are NOT
middle-aged males.