This presentation focuses on the surgeon entrepreneur perspective on how to balance design discipline before creativity and provides recommendations on what surgeons seek in new devices.
Integrating Mobile Health into Product Development - OMTEC 2017April Bright
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
Surgeon Executive Keynote: Volume and Value - OMTEC 2018April Bright
The phrase “Volume to Value” has become so overused that it’s devoid of meaning. What hospitals mean when describing “Volume to Value” are changes that need to be made to the mix of product and service offerings in order to answer patients' demands and increase profitability, strategies any smart business should adopt. After all, if a product is properly priced and perceived as providing value to customers, there should be a rise in demand and volume. Dr. Mark I. Froimson, a surgeon executive and thought leader on value-based healthcare, will provide guidance on what’s driving hospital decisions for products and services and the impact on device company price and value.
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.
Business Models in the Non-Profit and Public SectorsPaul Boos
The document discusses using a business model canvas to analyze the operations of the Office of Pesticide Programs at the EPA. It provides an example business model canvas of the EPA office, including its key activities, resources, partners, costs, and revenue. It then discusses assessing how the business model would be impacted by adding a new customer segment of farmers and a potential financial crisis causing reduced pesticide use and sales. Attendees are then instructed to create their own business model canvas to analyze their own organization.
UCSF Life Sciences: Week 7 Devices Resources, Activities and CostsStanford University
This document discusses critical resources, activities, and costs for medical device startups. It identifies physical, intangible, human, and financial resources needed. Key activities include generating data through clinical trials to demonstrate safety and efficacy, obtaining FDA regulatory approval, and achieving reimbursement. Costs include fixed costs like capital and overhead as well as variable costs during revenue generation. Unit economics and metrics like cash to milestones are important measures. Intellectual property is also a core asset that requires careful development and protection to support commercialization efforts.
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
Integrating Mobile Health into Product Development - OMTEC 2017April Bright
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
Surgeon Executive Keynote: Volume and Value - OMTEC 2018April Bright
The phrase “Volume to Value” has become so overused that it’s devoid of meaning. What hospitals mean when describing “Volume to Value” are changes that need to be made to the mix of product and service offerings in order to answer patients' demands and increase profitability, strategies any smart business should adopt. After all, if a product is properly priced and perceived as providing value to customers, there should be a rise in demand and volume. Dr. Mark I. Froimson, a surgeon executive and thought leader on value-based healthcare, will provide guidance on what’s driving hospital decisions for products and services and the impact on device company price and value.
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.
Business Models in the Non-Profit and Public SectorsPaul Boos
The document discusses using a business model canvas to analyze the operations of the Office of Pesticide Programs at the EPA. It provides an example business model canvas of the EPA office, including its key activities, resources, partners, costs, and revenue. It then discusses assessing how the business model would be impacted by adding a new customer segment of farmers and a potential financial crisis causing reduced pesticide use and sales. Attendees are then instructed to create their own business model canvas to analyze their own organization.
UCSF Life Sciences: Week 7 Devices Resources, Activities and CostsStanford University
This document discusses critical resources, activities, and costs for medical device startups. It identifies physical, intangible, human, and financial resources needed. Key activities include generating data through clinical trials to demonstrate safety and efficacy, obtaining FDA regulatory approval, and achieving reimbursement. Costs include fixed costs like capital and overhead as well as variable costs during revenue generation. Unit economics and metrics like cash to milestones are important measures. Intellectual property is also a core asset that requires careful development and protection to support commercialization efforts.
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
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.
The document summarizes a study that examined the criteria orthopedic surgeons use when selecting a vendor for hip and knee implants. It found that surgeons reported being most influenced by improved patient outcomes, implant longevity and design, and scientific evidence. They also considered the sales representative's level of service important. While vendor relationships and payments did not impact criteria, surgeons demonstrated loyalty to vendors they had trained with or been exposed to historically. The study concludes that comparative effectiveness research could help influence product choice and that minimal differentiation among vendors may help hospitals in purchasing decisions.
This document discusses partners and suppliers for life science startups. It identifies key types of partners including manufacturing, technology, channel/sales and marketing, and strategic partners. Manufacturing partners help with building, components, and outsourced functions. Technology partners contribute core technologies. Channel partners aid in sales and marketing. Strategic partners provide benefits like marketing support, intellectual property, or complementary products. The document also discusses front-end partners like distributors and research labs, and back-end partners such as chip manufacturers, packaging companies, and reagent suppliers. Maintaining valuable partnerships that evolve over time is important for startups.
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
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.
Four Practical Approaches To Managing A More Effective Device TrialDavid Levin
This document discusses four practical approaches to managing effective device trials:
1) Consider the appropriate regulatory path and reimbursement strategy to maximize trial and product success.
2) Understand the patient population and customer setting to ensure the trial design reflects real-world use.
3) Incorporate complete trial visibility with technology-driven processes to efficiently manage operations.
4) Clinical trials require significant investment but technology can reduce costs while improving processes like enrollment and data management.
The document summarizes the retail business environment for optometry practices in Malaysia. It discusses opportunities in different practice settings and data from eye health surveys on refractive errors and visual impairment prevalence. The document also covers the ophthalmic market size, common business practices and services offered. It analyzes the internal environment using SWOT and discusses factors in the external environment like demographics, politics, economics, technology and social responsibilities that can impact an optometry business.
Ricardo Leaño is a physician, anesthesiologist, and healthcare executive with extensive leadership training and certifications in business administration, quality improvement, and Lean Six Sigma. He advocates applying Lean and Six Sigma principles through the H.O.R.S.E. framework to empower healthcare organizations, reduce waste, and improve processes, patient outcomes, and financial sustainability. The presentation emphasizes eliminating variation through data-driven problem solving and focusing on continuous process improvement.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
It is all about the following statment :
"The ability to simplify means to eliminate the unnecessary so that the necessary may speak."
Hans Hofmann
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.
10 ways to increase the revenue of your surgery center practice in 2013ango mark
The document provides 13 tips for surgery centers to increase revenue in 2013, including ensuring correct reimbursements, including anesthesia time codes, boosting surgeon buy-in, upgrading systems, collecting copays upfront, rigorous claims follow up, physician credentialing, renegotiating with insurers, verifying patient information, calling patients before appointments, and using a rapid sheet for physicians after surgeries. The tips are presented by Angomark MedicalBillingStar to help surgery centers "pump in more greens" or increase their revenue.
The document discusses strategies for analyzing a business's internal strengths and weaknesses and external opportunities and threats using the SWOT analysis and TOWS matrix tools. It explains that SWOT analysis identifies key business characteristics but does not guide strategy selection, while the TOWS matrix integrates SWOT factors to suggest strategies by matching opportunities/threats with strengths/weaknesses. Examples of different types of strategies produced from the TOWS matrix are provided.
Sharing a New Ideal: How Tomorrow’s Understaffed, Multi-Site Lab Organization...mhartman1309
This presentation was presented by Chris Christopher at the Lab Quality Confab Conference on Nov 2, 2010. It shows how medical laboratories are using automation, technology and lean sigma improvement methodologies to meet organizational needs.
Presentation of Detlev Breyer (MD) at the ASCRS 2017 in Los Angeles. Title: Quality of Life Patient Questionnaire after Refractive Lenticule Extraction (ReLEx) SMILE. Comparison of the First and Last Consecutive Cases.
Driving risk management through intelligent intake technologyMyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut presents the case for driving risk management through intelligent intake technology.
Andrew outlines how pharmacovigilance professionals can move from passive to active PV fuelling better decision-making.
This presentations covers:
Pharmacovigilance and risk management challenges
Evolving PV landscape
Addressing the challenges
Reviewing the possible architecture
A glimpse of the technology
Implementation benefits
For more info see: www.mymedsandme.com
This document announces a conference on risk-based monitoring in clinical trials taking place on November 5-6, 2015 in Philadelphia. The conference will discuss how risk-based monitoring involves more than just monitoring and focuses on managing risk throughout the entire clinical trial process from protocol design through analysis. Speakers will address topics like how FDA inspections have adapted to risk-based monitoring, the impact of risk-based monitoring on the role of monitors, integrating technology like eSource data capture to enable risk-based trials, and how smaller organizations can implement risk-based monitoring.
This course covers what is Innovation and why everything needs to start with alignment.
If you don’t know where you’re going... Chances are you won’t get where you want to go.
Alignment is the foundation of effective growth and Innovation. It is about finding what is important to you (MISSION) and matching this with what the market wants (NEEDS) and plan to deliver and extract value. It is also about an honest assessment of who you are. (CULTURE)
Deliverables: After this course you will be able to identify 3-4 True North priorities for your company /division (True north) priorities can be:
1. Changing what you are doing and why
2. Changing how you work to generate or extract more value
3. How to work smarter and / or get your culture supporting your innovation objectives
An introductory overview of three individual presentations:
* Marketing Systemization - Creating Your Marketing Machine
* Applied Business Innovation to propel sales in a competitive market
* Most Powerful Cutting-Edge Marketing Strategies
* Maximizing Your Marketing ROI
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.
The document summarizes a study that examined the criteria orthopedic surgeons use when selecting a vendor for hip and knee implants. It found that surgeons reported being most influenced by improved patient outcomes, implant longevity and design, and scientific evidence. They also considered the sales representative's level of service important. While vendor relationships and payments did not impact criteria, surgeons demonstrated loyalty to vendors they had trained with or been exposed to historically. The study concludes that comparative effectiveness research could help influence product choice and that minimal differentiation among vendors may help hospitals in purchasing decisions.
This document discusses partners and suppliers for life science startups. It identifies key types of partners including manufacturing, technology, channel/sales and marketing, and strategic partners. Manufacturing partners help with building, components, and outsourced functions. Technology partners contribute core technologies. Channel partners aid in sales and marketing. Strategic partners provide benefits like marketing support, intellectual property, or complementary products. The document also discusses front-end partners like distributors and research labs, and back-end partners such as chip manufacturers, packaging companies, and reagent suppliers. Maintaining valuable partnerships that evolve over time is important for startups.
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
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.
Four Practical Approaches To Managing A More Effective Device TrialDavid Levin
This document discusses four practical approaches to managing effective device trials:
1) Consider the appropriate regulatory path and reimbursement strategy to maximize trial and product success.
2) Understand the patient population and customer setting to ensure the trial design reflects real-world use.
3) Incorporate complete trial visibility with technology-driven processes to efficiently manage operations.
4) Clinical trials require significant investment but technology can reduce costs while improving processes like enrollment and data management.
The document summarizes the retail business environment for optometry practices in Malaysia. It discusses opportunities in different practice settings and data from eye health surveys on refractive errors and visual impairment prevalence. The document also covers the ophthalmic market size, common business practices and services offered. It analyzes the internal environment using SWOT and discusses factors in the external environment like demographics, politics, economics, technology and social responsibilities that can impact an optometry business.
Ricardo Leaño is a physician, anesthesiologist, and healthcare executive with extensive leadership training and certifications in business administration, quality improvement, and Lean Six Sigma. He advocates applying Lean and Six Sigma principles through the H.O.R.S.E. framework to empower healthcare organizations, reduce waste, and improve processes, patient outcomes, and financial sustainability. The presentation emphasizes eliminating variation through data-driven problem solving and focusing on continuous process improvement.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
It is all about the following statment :
"The ability to simplify means to eliminate the unnecessary so that the necessary may speak."
Hans Hofmann
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.
10 ways to increase the revenue of your surgery center practice in 2013ango mark
The document provides 13 tips for surgery centers to increase revenue in 2013, including ensuring correct reimbursements, including anesthesia time codes, boosting surgeon buy-in, upgrading systems, collecting copays upfront, rigorous claims follow up, physician credentialing, renegotiating with insurers, verifying patient information, calling patients before appointments, and using a rapid sheet for physicians after surgeries. The tips are presented by Angomark MedicalBillingStar to help surgery centers "pump in more greens" or increase their revenue.
The document discusses strategies for analyzing a business's internal strengths and weaknesses and external opportunities and threats using the SWOT analysis and TOWS matrix tools. It explains that SWOT analysis identifies key business characteristics but does not guide strategy selection, while the TOWS matrix integrates SWOT factors to suggest strategies by matching opportunities/threats with strengths/weaknesses. Examples of different types of strategies produced from the TOWS matrix are provided.
Sharing a New Ideal: How Tomorrow’s Understaffed, Multi-Site Lab Organization...mhartman1309
This presentation was presented by Chris Christopher at the Lab Quality Confab Conference on Nov 2, 2010. It shows how medical laboratories are using automation, technology and lean sigma improvement methodologies to meet organizational needs.
Presentation of Detlev Breyer (MD) at the ASCRS 2017 in Los Angeles. Title: Quality of Life Patient Questionnaire after Refractive Lenticule Extraction (ReLEx) SMILE. Comparison of the First and Last Consecutive Cases.
Driving risk management through intelligent intake technologyMyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut presents the case for driving risk management through intelligent intake technology.
Andrew outlines how pharmacovigilance professionals can move from passive to active PV fuelling better decision-making.
This presentations covers:
Pharmacovigilance and risk management challenges
Evolving PV landscape
Addressing the challenges
Reviewing the possible architecture
A glimpse of the technology
Implementation benefits
For more info see: www.mymedsandme.com
This document announces a conference on risk-based monitoring in clinical trials taking place on November 5-6, 2015 in Philadelphia. The conference will discuss how risk-based monitoring involves more than just monitoring and focuses on managing risk throughout the entire clinical trial process from protocol design through analysis. Speakers will address topics like how FDA inspections have adapted to risk-based monitoring, the impact of risk-based monitoring on the role of monitors, integrating technology like eSource data capture to enable risk-based trials, and how smaller organizations can implement risk-based monitoring.
This course covers what is Innovation and why everything needs to start with alignment.
If you don’t know where you’re going... Chances are you won’t get where you want to go.
Alignment is the foundation of effective growth and Innovation. It is about finding what is important to you (MISSION) and matching this with what the market wants (NEEDS) and plan to deliver and extract value. It is also about an honest assessment of who you are. (CULTURE)
Deliverables: After this course you will be able to identify 3-4 True North priorities for your company /division (True north) priorities can be:
1. Changing what you are doing and why
2. Changing how you work to generate or extract more value
3. How to work smarter and / or get your culture supporting your innovation objectives
An introductory overview of three individual presentations:
* Marketing Systemization - Creating Your Marketing Machine
* Applied Business Innovation to propel sales in a competitive market
* Most Powerful Cutting-Edge Marketing Strategies
* Maximizing Your Marketing ROI
Panel discussion: Being a successful healthcare entrepreneur: lessons from Boston to Barcelona, with numerous experts from CIMIT, Boston, in economics, development and strategic planning of medical devices; in prototypes and patents and founders of several startups.
This document discusses the challenges facing digital health startups and how doctors and entrepreneurs can better work together. It notes that few digital health startups have found success so far due to issues like a lack of clinical expertise and an unwillingness to understand doctors' needs. However, it maintains that when doctors and engineers collaborate effectively by addressing each other's perspectives, digital health startups show promise in improving healthcare access and quality. The document advocates for doctors to play a more active role as investors, entrepreneurs and customers to help startups succeed. It also provides advice for doctors on becoming entrepreneurs themselves and stresses the importance of learning from failures.
This document discusses the challenges facing digital health startups and how doctors and entrepreneurs can better work together. It notes that few digital health startups have found success so far due to issues like a lack of clinical expertise and an unwillingness to understand doctors' needs. However, it maintains that when doctors and engineers collaborate effectively by addressing clinical needs and gaining trust, digital health startups show promise in improving healthcare access and outcomes. The document advocates for doctors to play a more active role as investors, entrepreneurs and customers to digital health solutions. It also provides advice for doctors on becoming entrepreneurs themselves and partnering with startups.
The document summarizes key ideas from the EyeForPharma Summit 2010 conference. It discusses 10 big ideas that were heard at the conference: 1) Pharma is looking to personalized medicine to deliver business health by expanding patient pools and improving clinical trials. 2) Connecting diagnostics to treatments has been a challenge. 3) Pharma is trying to institutionalize idea generation but organizations are not adapting fast enough. 4) Common myths about innovation need to be overcome. 5) Pharma is shifting growth strategies to emerging markets which have complex differences. 6) Pharma marketing budgets undervalue digital even though consumers trust the internet more than other sources. 7) Media proliferation has created a lot of shouting in more channels. 8) The
The 5 Key Principles of Process ImprovementMark H. Davis
To improve, one must change. But deep inside, we all fear change to some degree. How, then, can we improve? This presentation outlines a basic framework to initiate change, as well as the 5 key principles for examining the current state and designing the future flow.
- Medical corruption has become systemic in India, with doctors taking and giving kickbacks and cuts for referrals, harming patients, doctors, and the reputation of the medical profession.
- Doctors must stop the practice of giving and taking cuts and kickbacks, which increases costs for patients, results in overtreatment, and destroys trust in the doctor-patient relationship.
- Doctors should invest in their own websites and digital presence to attract patients directly without middlemen and provide trusted medical information online in local languages. This establishes expertise, puts patients first, and avoids the need for cuts or referrals.
This document discusses how obtaining a dental degree provides opportunities to become a specialist in one's own practice. It profiles Dr. Nathan Jeal who has opened 5 dental practice locations in Canada focusing on orthodontics, dental implants, and sleep apnea treatment. Dr. Jeal discusses how he has grown his Invisalign practice from 0 to over 100 cases per year, generating over $800,000 in revenue. He emphasizes identifying and prioritizing high-revenue patients, using Invisalign to attract new patients, and training associates to expand orthodontic service offerings.
The document discusses approaches to innovating healthcare experiences through design thinking. It explores researching patient needs and values, developing insights, and prototyping and testing new solutions to improve areas like communication, personalization, and support. The goal is to create a world-class experience that delivers greater care by understanding what people really need and want.
Trends From The Trenches - Mastering the Front and Back End of InnovationAndrea Simon
Healthcare Innovation: Trends From The Trenches
Mastering the Front and Back End of Innovation
Featured Speaker:
Andrea (Andi) Simon, PhD and President of Simon Associates Management Consultants
In this next webinar, we will be talking about healthcare innovation in three areas:
- Taking data and ideas and envisioning new ways to solve old problems simpler, easier and better.
- Taking these ideas and turning them into testable innovations.
- Building this into a culture of innovation for your institution.
Dental Clinic management is most essential talent young dentist should posses to ensure they make private practice a well management both financially and professionally.
Think Tank V Key Takeaways & Best PracticesJustin Barnes
Care Strategy, Care Collaboration, Innovation, Industry Disruptors & Social Determinants of Health best practices directly and unscripted from thought leaders on the front lines of healthcare
This document discusses the promise and challenges of digital health startups in India. It notes that while startups like Practo have received funding, there have not been major success stories that have generated significant returns for investors or meaningfully improved patient care. It identifies some common reasons why health tech startups often fail, such as focusing on solving problems without doctor input or understanding clinical needs. The document advocates for more collaboration between doctors and engineers/entrepreneurs, and proposes models like medical innovation centers located in hospitals to facilitate this. It also discusses the roles doctors can play in digital health as angel investors, entrepreneurs, and customers of startups.
As I watch my organization within the last 4yrs of its existence, I have seen innovation leading disruptive changes and giving us big leaps in our earlier days, only to see Bureaucracy emerging to water down these growths. I am forced to confront both experiences, as I lead my team into a new growth trajectory.
Topic 1. Different concepts of enterpreneurship part 2023 (1).pptxJesseThomas45
The document defines and discusses various concepts related to entrepreneurship including:
- Entrepreneurship is the process of recognizing opportunities, finding resources to pursue opportunities, and creating a team to do so. It involves implementing change through new combinations or innovations.
- An entrepreneur is someone who has a new business idea, is creative and innovative, takes risks, and starts a new venture or startup. Intrapreneurship refers to entrepreneurial initiatives within existing companies.
- Reasons for becoming an entrepreneur include profit, independence, unemployment, or a desire to be creative. Myths about entrepreneurship include beliefs that entrepreneurs are born not made or are always innovators.
- Types of entrepreneurship include small
Matt Lazenby, a design manager, discussed challenges in medical product development. He described a wrist support product invented by a cardiologist to aid radial access that took 2 years to develop and is now sold worldwide. The presentation addressed challenges such as identifying unmet clinical needs, spending $1.5 million to develop a failed product, getting feedback from multiple clinicians who want different things, and designing products that can be manufactured and sold long-term in New Zealand.
Title: Establishing ROI and Forming Partnerships: Growing mHealth Collectively
Description: In the third session, attendees gain an understanding of best practices to assess new technology from two perspectives. The first is focused on forming partnerships with hospitals and health systems for assessment of new technology with the goal of forming a sound evidence base for use. The second perspective includes assessment of new technologies and implementation into clinical workflow, and how it impacts care transitions and affiliated cost savings. As the mHealth industry matures providers require a detailed accounting of changes in clini
Speakers: Neal Sikka MD & Juan Pablo Segura
Objectives: Compile best practices for evaluating new technology. Discuss the mHealth sales cycle and how hospitals and health systems can take advantage of low cost technology solutions. Evaluate population health management tools which leverage mobile and wireless devices for care transitions, decreasing costs and improving outcomes through community based Care transitions and care coordination technology.
Ryan Lilly of Matter and Tara Auclair of Modernizing Medicine's HITMC presentation: “How to Build a Diverse Media-Facing Thought Leadership Bench” took place on Thursday, April 5 at the New Orleans Marriot. Attendees learned how specialty-specific health IT leader, Modernizing Medicine, partnered with Matter to create engaging and impactful platforms for its spokespeople.
Similar to Balancing Implant Innovation and Price - OMTEC 2017 (20)
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 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.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018April Bright
Medical devices fabricated from additively-manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Several test methods for characterizing these devices are presented in this session, as well as the differences between testing additively-manufactured devices and those fabricated with traditional machining methods.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
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Green Synthesis of Magnetic Nanoparticles and Their Biological application.pptxAhmedSaeed181245
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This presentation explores the innovative green synthesis methods of magnetic nanoparticles (MNPs) and their diverse applications in biology. It covers the synthesis techniques emphasizing environmental sustainability, the unique properties of MNPs, and their role in biomedical applications such as targeted drug delivery, imaging, and biosensing. The presentation also discusses challenges, future directions, and the potential impact of MNPs in advancing biotechnological and medical fields.
12. I’m in a Dead Specialty
• Lookalike products from
company S and Z and D
and W and I and pretty
much everyone else
• Large companies have
a stranglehold on the
sales channel
• “New Technology” is priced at
an unaffordable premium
• Innovation is DEAD
16. Now Dr. Bueller,
Your Press Ganey
scores are in the 50th
Percentile. Your
infection, complication
and readmission rates
are worse than your
peers. We have
no choice but to
let you go.
Today.
17. CH CH Changes
• >50% of our time is in documentation
• We are pushed to be more efficient in an ever
increasing regulated environment
• We are instructed (beaten up) to
be cost conscious
• We have our “results” publicly disclosed
21. Innovation: Where
does this occur
• Academic Institutions - Haphazard, “Gatorade Syndrome,”
Very little ROI for NIH, academic wanderings. “We are
really smart, of course people will buy it!”
• Lone Wolf or “Garage” - No or Limited Resources and
limited knowledge of the process; sales are a mystery
• Small Company - Just trying to survive “Death Valley”
and worrying about the next financing
• Large Company - Top Heavy Bureaucracy, looking for
acquisitions. No venture or co-investing like Pharma, so
this creates even less likelihood for new products/services
22. Whose Problem (Pain)
is it, Anyway?
• Everyone
• Surgeon
• Surgical Staff
• OR
• Tech Committee
• Hospital
• Insurer
• Patient
• Employer
• Patient’s family
25. A Recent Innovation?
• Single packaging of implants
• Surgery Center/Hospital
has less to sterilize
• My reality - Ankle Fracture is
typically a plate and 8 screws
• The time from single box
opening to the start of
implantation is 3 minutes
• 24 minutes of OR time
is $700-$1,500
• My last ankle fracture, total
time was 21 minutes
27. Real Innovation
• Improves lives
• Effortless
• May be a stepping stone
to more positive changes
• Seems easy
• Habits; it’s all about habits, wants and then needs
30. Efficacy
• Does it work as advertised?
• White papers are like toilet
paper - just for flushing
31. Failure
• Fail fast -
because I can’t
• Don't fail so
often that you
are no longer
credible or your
business
can't exist
32. Innovations I’ve seen
• Intuitive - not just the robot, but the
sales/marketing strategy
• OrthoHelix
• Anodized implants as a code to size
• P-nut plate - a static or compression staple
• Variable locking mechanism in
the screw, not the plate
33. Execution
• The best innovation ever will not make
up for sloppy execution and planning.
34. Innovation Method
• Solve a real problem
• Make somebody(s) better
• Elegant
• Intuitive
• Cost aware
• Not spreadsheet driven or
blind to real objective data
• Prove it