A presentation delivered June 4, 2009 describing the impact of the economic crisis on venture and angel investing and common sense steps for fundraising for Medical Device Startups. No one is an expert now.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Regulatory strategy for medical device start-upsRina Nir
If you are a medical device entrepreneur thinking how to take regulatory requirements into account when creating your business plan, you might find this presentation useful.
This presentation was given at a TTC round table event in Maastricht, NL.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Regulatory strategy for medical device start-upsRina Nir
If you are a medical device entrepreneur thinking how to take regulatory requirements into account when creating your business plan, you might find this presentation useful.
This presentation was given at a TTC round table event in Maastricht, NL.
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.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Design for reimbursement in medical device developmentAmber Hol Horeman
In medical device development it is essential to start with reimbursement strategy from day one to enhance the chance to successful implementation in the healthcare system. This presentation shows the outcomes of a 5 month graduation project to the role of reimbursement in medical device development. The design for reimbursement framework proposed provides an overview for starting entrepreneurs in the complex field of medical devices.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.
As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.
During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."
We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
Medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system to support the new methods and ensure regulatory compliance.
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.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
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.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
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.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
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.
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.
A 50 page, easy-read E:Book taking you through the key considerations for deciding whether your Medical Device idea could eventually become a viable business.
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.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Design for reimbursement in medical device developmentAmber Hol Horeman
In medical device development it is essential to start with reimbursement strategy from day one to enhance the chance to successful implementation in the healthcare system. This presentation shows the outcomes of a 5 month graduation project to the role of reimbursement in medical device development. The design for reimbursement framework proposed provides an overview for starting entrepreneurs in the complex field of medical devices.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.
As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.
During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."
We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
Medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system to support the new methods and ensure regulatory compliance.
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.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
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.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
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.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
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.
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.
A 50 page, easy-read E:Book taking you through the key considerations for deciding whether your Medical Device idea could eventually become a viable business.
"Stan Lapidus: Profile of a Medical Entrepreneur."Paulo Martins
Higgins, Robert F., and Sophie LaMontagne. "Stan Lapidus: Profile of a Medical Entrepreneur." Harvard Business School Case 805-087, December 2004. (Revised July 2010.)
Medical Device Development - Trends, Challenges and RisksDina Sifri
Med-Dev Design is an innovative company specializing in medical device development.
The Med-Dev team of exceptional software engineers bring more than a decade of broad range experience in developing medical devices.
Company services cover all aspects of medical device development, including: product and project management, software design, software development, software architecture, software verification and validation as well as documentation for the regulatory bodies.
The Center for Entrepreneurial Innovation (CEI) is a leading business incubator in Phoenix, Arizona, providing services and support to tech entrepreneurs in the region. This presentation, from Susie Pulido of the Maricopa Corporate College, will showcase how to build a incubation program and facility that offers relevance for startup companies for optimal impact and also diversified revenue streams for sustainability. *Note: This presentation was first given at the National Association for Community College Entrepreneurship (NACCE) 2015 Annual Conference in Houston, Texas; October 2015.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
Angel & Venture Capital Finance: Where is the Money Moving?dbeisel
"Angel & Venture Capital Finance: Where is the Money Moving?" presented by James Geshwiler (Managing Director of CommonAngels) at December 2008 Web Innovators Group
DealMarket Digest Issue86 - 8th March 2013Urs Haeusler
SEE WHAT’S NEW AND NOTEWORTHY IN PRIVATE EQUITY THIS WEEK /// ISSUE 86 - 8th March 2013:
- Mutual Attraction: Family Offices and PE Fundraisers
- Survey Finds Investor Appetite for Big Buyout Funds
- PE Investors Eye Ista for $3.9 bn
- Doubts Linger About IPO as Exit in Europe
- Investments on the Rise in Latin America
- Quote of the Week: Sales Booster
The Halo Report is a nationwide survey of Angel Groups' investment activity produced by the Angel Resource Institute, Silicon Valley Bank and CB Insights. The Q1 2014 Halo Report finds median round sizes increased to $980K per deal, and pre-money valuations rose to $2.7 million in the quarter. Investments in Internet-related companies jumped significantly, while dollars invested in mobile and healthcare companies dropped.
Angel Group Investing Heats Up: Q1 2014 Halo Report sdickey
The Angel Resource Institute (ARI), Silicon Valley Bank (SVB) and CB Insights released the Q1 2014 Halo Report today, a national survey of angel group investment activity. The report finds median round sizes increased to $980K per deal, and pre-money valuations rose to $2.7 million in the quarter. Investments in Internet-related companies jumped significantly, while dollars invested in mobile and healthcare companies dropped.
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
Recruiting in the Digital Age: A Social Media Masterclass
Funding A Medical Device Startup In The Current Economy
1. Funding a Medical Device
Startup in the Current Economy
Michael J. Weickert, PhD
President and CEO
S.E.A. Medical Systems, Inc.
President, Wit Creek Consulting
2. Who Am I?
• Michael J. Weickert
• PhD Genetics, UW Madison, NIH, NCI
• Biotech Industry since 1992
– Bay area since 1998; Nektar, CBO StrataGent, CBO Corium
• President and CEO S.E.A. Medical Systems, Inc.
– Medical device company in Sunnyvale, CA
• President Wit Creek Consulting
– Business strategy, business plan consultancy
• Member Life Science Angels
– Member medical device and Bio screening committees
• Start-up Advisor
– Lypro Biosciences, NanoBioSciences
• Venture Partner Kranenberg Fund
• Limited Partner Quantum Technology Partners
3. Agenda
• What has the current economy done to
investing?
– How bad is it?
• What can a medical device company do to
raise funds now?
– Is there any hope?
4. We have fallen off a cliff: 1Q09 dollars
down 61%, deals down 45% from 1Q08
Quarterly investment activity was down 47 percent in dollars and 37 percent in
deals from the fourth quarter of 2008 when $5.7 billion was invested in 866 deals.
The quarter, which saw double digit declines in every major industry sector,
marks the lowest venture investment level since 1997.
Q1 2009 US Report; www.pwcmoneytree.com
5. Steep declines across all industries
The Life Sciences sector (Biotechnology and Medical Devices combined)
experienced a 40 percent decline in terms of dollars and a 31 percent drop in deals
with $989 million going into 133 rounds. Investment in Medical Device investments
fell 27 percent to $412 million.
Q1 2009 US Report; www.pwcmoneytree.com
6. Deals down all over the country
Drop >61% in Silicon Valley
Silicon Valley continued to garner the lion’s share of venture capital dollars,
capturing 39 percent of the $3.0 billion invested in US-based companies
throughout the quarter. The New England Region maintained its customary
number two position despite a 51 percent decline in dollars and a 36 percent
drop in deals from the fourth quarter of 2008.
Q1 2009 US Report; www.pwcmoneytree.com
8. Not the best of times
• IPO mkt weak
– 6 VC backed IPO’s in US in ’08, lowest since 1977, raised $0.5B
vs $10.3B in ‘07
– 0 VC backed IPO’s in Q2’08 & Q4’08
– 1 VC backed IPO in Q3’08
– 28 IPO’s in China
• 2002-08: 19,300 companies received funding, 351 IPO’s
• Time to IPO: ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08
• # Years from Series A: 4.5 3.3 5.7 5.7 5.6 6.2 7.1 8.3
• M&A weak
– 260 deals (down 27%), $13.9B (down 51%) in ’08 vs. ‘07
– 40% drop in ’08 to $300B
– 32 deals >$1B in ’08 vs 80 in ‘07
– Median M&A about $80M
Q4 2008 US Report; www.pwcmoneytree.com
9. Summary/Facts/Predictions
• VC’s stop funding many portfolio companies
• More layoffs/cost cutting, unemployment up
• New Deals must be perfect
• All Deals Series A, lots of down rounds
• Fewer Deals per fund, higher reserves
• VC syndicate quality more important
• VC’s fear capital calls produce LP defaults
• VC Fundraising problematic
• More Government regulation
Q4 2008 US Report; www.pwcmoneytree.com
12. What can a medical device
company do to raise funds now?
First things first
• Are you ready to raise funds?
• Are you incorporated?
• Have you set your equity (stock) pool?
• Do you have a business plan?
• Do you have a budget to key milestones?
• Do you have your complete team?
13. What can a medical device
company do to raise funds now?
• Friends and Family $1-300k
• Grants $100k->1M
• Angels $300k->1M
• Venture Capital Firms $1M->20M
• Strategic Partners $200k->20M
• Product Sales ??
14. Friends and Family $1-300k
• Investors (even Angels) expect you to
raise $200-500k from friends and family
before seeking professional investment
• Lowers risk
– Fund early, often riskiest milestones
– Shows people are willing to trust you with
their money
15. How do you raise friends and
family funds?
• Most should qualify as “Accredited Investor”
• Treat as professional investors
– Provide Business Plan, presentation, prospectus,
investment contract
• Investment is opportunity for people to
participate in an exciting company with
tremendous growth potential
– If you don’t believe this, don’t ask ANYONE to invest
16. Type of Friends and Family
Investments
• Priced round
– Equity (stock) sold at set price – investors receive a
percentage of the company
– Pros: investors like clear stake in the company
– Cons: sets price that can be difficult to increase in
subsequent investment rounds
• Convertible debt
– Investors loan money which can be converted into
equity at the first professional venture round, often at
a discount
– Pros: professional investor(s) set the price
– Cons: cash is owed to the investors if no equity
conversion takes place
17. SBIR, STTR Grants $100k->1M
• SBIR (Small Business Innovative Research) is a federal
set-aside program aimed at supporting R&D in US
owned small businesses (companies with less than 500
employees)
– Success rate on first time SBIR Phase I grants ~15%
• NIH and NSF are among 10 federal agencies which set
aside 2.5% of the total funds they award for research
grants to be distributed through SBIR/STTR
• NIH solicitations are published on its website and are
used to support research in a well defined scientific area
and/or in a high priority program.
– In 2003 more than 80% of the awards allocated were unsolicited
(investor-initiated research grants). The investigator initiates the
research and submits a grant application within an area that is
relevant to the NIH
– http://grants.nih.gov/grants/guide/index.html
18. Top 10 recipients of NIH SBIR and STTR
Funds in fiscal year 2007
(millions of dollars)
19. Angel Investors $300k->1M
• “Accredited Investors” who provides capital for a
business start-up
• Some angel investors organize into angel groups or
angel networks to share research and pool their
investment capital
• Angel investment accounts in total for almost as much
money invested annually as all venture capital funds
combined, but into more than ten times as many
companies (US$26 billion vs. $30.69 billion in the US in
2007, into 57,000 companies vs. 3,918 companies).
• Average angel funding in 2007, ~$450k. Range from a
few thousand, to a few million dollars.
20. Angel funding is down too
• Angel investing dollars dropped by 26.2 percent
last year ($19.2 billion vs. $26 billion in 2007)
• Entrepreneurs receiving funding was relatively
unchanged from 2007 (55,480 entrepreneurs
last year vs 57,120 in 2007)
• Angel investment 2008 sectors:
– Healthcare-related businesses = 16%
– Software = 13%
– Retail = 12%
– Biotech ventures = 11%
– Energy = 8%
– Media = 7%
2008 Angel Market Analysis by the Center for Venture Research at the University of
New Hampshire
21. Angelsoft* deal funnel from last 12
months
21112 Submitted
1718 In Screening
1185 Invited to Present
679 In Due Diligence
444 Invested
Only a small number of companies who apply get funded. This chart shows
how many make it through the different stages of the Angel Group process,
based on data from our most active groups.
*As the exclusive deal management tool to 451 angel groups and VCs and 17,551
investors, Angelsoft processes over 3,200 funding applications a month. This live access
to investment data allows us to report trends in the early stage investment market.
22. Venture Capital
• Provide private equity capital typically to early-
stage, high-potential, growth companies
• Generate a return through an eventual
realization event such as an IPO or trade sale
(M&A) of the company
• Venture capital investments generally made as
cash in exchange for shares in the invested
company
• Venture capital investors invest primarily in
companies in high technology industries such as
biotechnology and ICT
– VCs fund ~2% of companies they review
23. Even now some VCs are investing:
most active venture investors 1Q2009
Q1 2009 US Report; www.pwcmoneytree.com
24.
25.
26.
27. Strategic Partners
Who has…
• Expertise to develop your product
• Markets similar/related/complimentary
product(s) to the same customer(s)
• Competes with a product inferior to yours
• Has aspirations to sell to the same
customers you are targeting
• Might be a potential acquirer of your
company/product(s)
28. Engaging Strategic Partners
• Technology conferences for related
industry scientists
• Partnering conferences for medical
devices
• High level introductions to strategic partner
management
• Contract Business Development
professional
29. Strategic partnership models
• Support for technology/product development
• Feasibility = modest cash for Proof-of-principle
demonstration ($100k-1M)
• Option = first right of refusal for license/acquisition of
technology/product ($100k-2M, may include equity
purchase)
• Partnership = development support for defined
product/technology effort (≥$500k up front, development
costs, milestones, royalties, may include equity
purchase)
• Structured buy-out = pre-priced acquisition in which
shareholders receive cash when pre-agreed milestones
are achieved
30. Reasons for optimism for medical
device companies
• Medical device is a strong industry in
California and the bay area
• Less affected by downturn than other
biotechnology - viewed as:
– More conservative investment than drug
development
– More capital efficient
31. Michael J. Weickert, PhD
President and CEO
S.E.A. Medical Systems, Inc.
President, Wit Creek Consulting
www.seamedical.com
www.witcreek.net
mweickert@gmail.com
650-218-1840