Empfohlen
Empfohlen
Weitere ähnliche Inhalte
Was ist angesagt?
Was ist angesagt? (10)
Andere mochten auch
Ähnlich wie 2017 MTGT Idea to Seed Overview_v2
Ähnlich wie 2017 MTGT Idea to Seed Overview_v2 (20)
Kürzlich hochgeladen
Kürzlich hochgeladen (20)
2017 MTGT Idea to Seed Overview_v2
- 1. MedTech’s Got Talent Actuator the THE MEDTECH JOURNEY: FROM IDEA TO SEED POWERED BY:
- 2. • Define ‘medical device’ and ‘MedTech’ • Understand the path from idea to seed investment • Explain what cons<tutes a Seed round • Begin to prepare your startup for Seed investment LEARNING OUTCOMES By the end of this workshop, you should be able to:
- 3. • Diagnoses, cures, mi<gates, treats or prevents a disease or condi<on, or • Affects the func<on or structure of the body, and • Does not achieve intended use through chemical ac<on, and • Is not metabolised What is a Medical Device? AS DEFINED BY An ar<cle, instrument, apparatus or machine that is used in the preven<on, diagnosis or treatment of illness or disease, or for detec<ng, measuring, restoring, correc<ng or modifying the structure or func<on of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means. FDA WHO
- 4. What is a Medical Device? AS DEFINED BY Any instrument, apparatus, appliance, material or other ar<cle (whether used alone or in combina<on, and including the soIware necessary for its proper applica<on) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: • diagnosis, preven<on, monitoring, treatment or allevia<on of disease; • diagnosis, monitoring, treatment, allevia<on of or compensa<on for an injury or handicap; • inves<ga<on, replacement or modifica<on of the anatomy or of a physiological process; • control of concep<on; and that does not achieve its principal intended ac<on in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its func<on by such means; or an accessory to such an instrument, apparatus, appliance, material or other ar<cle. TGA
- 7. What is MedTech? BIONICS Can we use this picture?
- 9. What is MedTech? DIGITAL HEALTH
- 10. What is MedTech? HEALTH SERVICES
- 11. The definition of MedTech is evolving with increasingly blurred lines between MedTech, health IT, health care services and even therapeutics
- 12. It is not often a single breakthrough that drives new venture success. Success is often buried in the lab notes, sketches and e-mails of an entrepreneur trying to bring an idea to life.
- 13. Basic Research Preclinical Development Clinical Development Regulatory Approval Manufacturing PATHWAY 1 2 3 4 5
- 14. he Path to Market is Complex nd Non-Linear As a generalisa+on, double whatever +m and $ you think it will take a9er you’ve diligently crunched the numbers
- 15. For Example... DID YOU KNOW? A typical <me for an ethics applica<on to complete the review process is 3 months Clinical trials can cost $5,000-$10,000 per pa<ent… or more for more complicated or extended endpoints Tes<ng & registra<on for regulatory compliance is an oIen-overlooked budget item Many early-stage entrepreneurs don’t consider the cost of servicing devices (parts, labour, transport, technical and customer service) early enough in the process of determining the price of their product Typical medtech <me to market is 3-7 years Have you thought about – or priced – which insurances you’ll need? A survey of >200 medical device companies es<mated a total cost of approximately $31M to bring a low-to- moderate risk device to market ($94M for high risk)
- 16. CONCEPT DEVELOPMENT Class 2 Class 1 FOUNDERS ROUND PRE-SEED 12-24 MONTHS PROTOTYPE DEVELOPMENT ANGEL ROUND CLINICAL DEVELOPMENT 12-24 MONTHS 12-24 MONTHS SERIES A ROUND $3.5-5M 3-6 YEARS EXIT? + TECHNOLOGY DEVELOPMENT + PRECLINICAL DEVELOPMENT 12-24 MONTHS 12-24 MONTHS $10M+ 7-12 YEARS MANUFACTURING DEVELOPMENT MARKET DEVELOPMENT PRODUCT INTRODUCTION EXTERNAL VS INTERNAL MANUFACTURING EXTERNAL VS INTERNAL SALES TEAM REIMBURSEMENT EXIT? EXAMPLE PATHWAY
- 17. How to be ready for seed investment? GET TO PRODUCT- MARKET FIT
- 18. • Intellectual Property (IP) = intangible assets (patents, trade secrets, business methods, names, phrases, logos) that have an inherent value (e.g. they can be bought or sold • Confiden<ality & Disclosure – Don’t discuss the “secret sauce” or the core of your innova<ve step without signing a confiden<ality agreement first or you may invalidate your ability to patent it as that innova<on is now in the public domain and therefore not patentable. – But also don’t ask everyone and their brother to sign a confiden<ality agreement – You need to develop a rich understanding of what you can and cannot discuss publicly – if in doubt, consult with a patent acorney – Be prepared to discuss your idea non-confiden<ally but with enough detail to garner interest 0 Do You Have Something to Protect? INTELLECTUAL PROPERTY
- 19. • Without this, you have no business • See the world through the eyes of your customer, users (seriously… shadow someone for a day!) Starting Point CLINICAL NEED 1
- 20. From there, the order of the following may be slightly different for different opportunities...
- 22. • You don’t want to be a solu<on in search of a problem – you should focus from the outset on solving a specific problem for a specific customer • You may have many poten<al customers… brainstorm as many customer segments as you can think of 3 Who Is Your Customer? MARKET SEGMENTATION
- 24. • Do a first pass of the market – understand who the big players are, growth rate of the market, market size, and key trends and drivers impac<ng this market (this is a top- down analysis) • Do some bocom-up calcula<ons: Total Available Market (TAM) & Serviceable Available Market & Serviceable Obtainable Market (SOM) • Define your market type: – Single- or mul<-sided market – B2B or B2C 5 Can this Customer Support a Business? MARKET LANDSCAPING
- 25. • A single product is not a company unless it has a large standalone market poten<al • If a product poriolio is not possible, analyse the benchmark market value to be acrac<ve as an acquisi<on versus acrac<ng investment to build the business • This decision may impact how you set up the corporate structure 6 Is This a Product or a Company? EXIT STRATEGY
- 26. CraI a clear statement that describes the benefit of your offer, how you solve your customer's needs and what dis<nguishes you from the compe<<on 7 Compelling Reason to Buy UNIQUE VALUE PROPOSITION
- 27. • Iden<fy and rigorously test your assump<ons about the problem, opportunity and solu<on • There are a lot of resources on how to conduct these interviews and how to get useful feedback to guide your product development (search term: lean methodology) 8 Test Your Assumptions CUSTOMER DEVELOPMENT
- 28. • Write a blueprint for how you will launch and grow your startup • Generally addresses core issues like: solu<on, market size and poten<al, corporate structure, equity structure, risks analysis, IP strategy, regulatory strategy 9 Write the Strategic Plan BUSINESS CASE
- 30. • Part of figuring out if you have something to protect is performing a robust patent landscaping, followed by a freedom to operate analysis • There are some areas where the IP landscape is quite crowded (e.g. catheters), and future investors will want to see that you know you can protect (and defend) your IP • Use WIPO and other online patent directories to search for all related patents • Analyse the companies and organisa<ons involved to becer understand who the players are • Analyse the claims to becer understand whether you have Freedom to Operate • The DIY approach can help reduce your costs, but investors will want to see that a reputable firm has signed off on the analysis Robust Patent Landscaping AND FREEDOM TO OPERATE 1 1
- 31. • Every startup has different IP strategy drivers • Filing a provisional patent starts a clock <cking whereby your inven<on will become public knowledge, limi<ng your ability to secure a patent on this inven<on at a later date if you don’t take the patent to comple<on • Delaying filing can help you stay “under the radar” for longer, if that is a desirable strategy • Filing for a patent sooner may increase your ability to defend your innova<on, and may make your startup more inves<ble when the patent is granted • Remember that patents are not the endpoint – a poorly wricen patent provides licle defensibility for your business, and your ability to defend your patent from infringement should not be overlooked Define Your IP Strategy WHAT, WHEN, WHERE TO PATENT 1 2
- 32. • You need to know how your device will be regulated, as this dictates your clinical development plan • Searching for predicate devices and understanding their regulatory pathway is a great first start • Have you considered soIware regulatory requirements that apply to your product? • What is your Intended Use (clinical issue your product addresses)? What are your Indica<ons for Use (clinical applica<ons use, environment, and end user)? • Example: 510k FDA clearance a common pathway: check out what’s involved What is Your Regulatory Pathway? CLASS OF YOUR DEVICE 3 1
- 33. • Where you intend to seek regulatory approval first is an important business decision that should be based on deep research, not convenience of loca<on • The decision should always be <ed back to the customer and market research • There are regulatory strategy experts that can help guide you through this process What is Your Regulatory Strategy? TGA, FDA, CE MARK, OTHER? 4 1
- 34. • Reimbursement hinges on clinical data – you should plot reimbursement strategy in parallel with clinical and regulatory plans • There are reimbursement strategy experts that can help guide you through this process • Clinical effec<veness? Cost effec<veness? • Regulatory approval does not guarantee coverage (or sufficient coverage) Who Pays? How Much? REIMBURSEMENT STRATEGY 51
- 35. • What are your endpoints? • What analysis needs to be done? • How many pa<ents will you need? • What level of data is required considering your regulatory pathway? • Which pa<ent popula<on is most appropriate? • Which healthcare center or pa<ent/ user access channel is most appropriate? • There are clinical development plan experts that can help guide you through this process What’s Your Clinical Development Plan? CLINICAL TRIALS 6 1
- 36. • How will you prototype your device for early user feedback? • Do you have well-defined and stable product requirements? • What is required of your device in order to start gathering clinical data? • How much will it cost to develop the prototype? • How much will it cost to manufacture that design? Will you require ISO13485, GMP or other quality systems? • Have you been doing prototype itera<ons under a quality management system (e.g. do you have a Design History File)? • There are product development experts that can help guide you through this process How Will You Make It? PRODUCT DEVELOPMENT 71
- 37. • User needs describe how the product is going to be used • User needs help establish the framework for your products design What Do Users/Customers Think? PRODUCT DEMO 8 1
- 38. • Honest self-assessment – are you the right person to lead this startup now? To grow it? To exit it? – If so, have a good answer when asked “why you?” – If not, consider how you will acract the right talent at the right <me • What can/should you outsource? • Dream Team: Supergeek technical founder, cluey- scrappy business founder, voice of the user/ customer, strong and influen<al mentor/advisor set • Set aside some stock in the company for poten+al use to issue to key employees who stayed with the company during the hard <mes and you want to keep them for the long term future but you can’t give large salary increase to them. Build a Team SKILLS GAPS ANALYSIS 9 1
- 39. • x 2 What are the Risks? RISK ANALYSIS 0
- 40. • x 2 Get Your Ducks in a Row DUE DILIGENCE 1
- 41. • Deal Room • IM • Pitch Deck • Investor intros • Raise money. Many inventors make the mistake of thinking that acrac<ng venture capitalists and angel investors is the first step of launching a new company. But usually most funding sources, whether a bank or a corporate partner, won’t even pick up the phone un<l you’ve undertaken the brunt of the start-up process. And with good reason. They don’t want to risk their capital (or someone else’s) without fully seeing that the inventor has thoroughly thought out the basic elements of launching a new medical technology product, and put in their fair share of sweat and equity. • Apply for every grant, compe<<on or funding opportunity you can find. You may only win a small por<on of these grants, but without the funds to con<nue, the “Valley of Death” will become a frightening reality. • A realis+c funding strategy • We should add a disclaimer that most, if not all, of the above men<oned items require money to execute upon fully. Thus, a realis<c funding model, including how much will be funded through personal, angel and/or venture capital (or other: check out MediCoventures blog post on medical device funding op<ons) as well as the <meline for acquiring such funds, must be iden<fied. This is where having a seasoned business execu<ve is crucial as they can help facilitate this process; if you don’t have a business partner, you can always seek out mentorship within your startup ecosystem. 2 Raise Money INVESTMENT MEMORANDUM 2
- 42. • Typical pre-money valua<on $750,000 - $1.5M 3 What are you Worth? PRE-MONEY VALUATION 2
- 43. Opinion leader influence plan • Startups should also have a strategy for dissemina<ng that data to peer-reviewed publica<ons and at medical conferences once it’s collected.
- 44. Those steps will get you packaged and ready to pitch for seed investment... but what is that exactly?
- 45. • Friends, family & fools (FFF) • Angel investors • Venture capitalists (VC) Common Startup Funding Types
- 46. Basic Research Funding R&D Funding Pre-Seed Seed Series A
- 47. • Seed typically $500k — $1.5 million • A = $2–3 million (up to 5) • It is less about actual money and more about structure of your Cap Table. If you have raised $2–4 million from a bunch of high-net-worth individuals I simply don’t see it as an A-round. If you raised $2 million from two small seed funds I probably don’t either (although in the past I would have). But if you raised $3–5 million from well-known seed funds or from a VC and you’re asking for $8–10 million in your next round … that next round is a B-round no macer what we collec<vely decide to call it when we VCs fund you. • I think an easier defini<on is “first ins<tu<onal capital” which is what most A-round VCs think about what their personal funding strategies are. They want to be early and first. What is a Seed Round?
- 49. • TRL/IRL
- 51. Over 50% of MedTech exits are for <$100M 75% are for <$150M To ‘go public’, device companies typically have substantial revenue (and therefore invest heavily in sales & administrative expenses) Licensing preclinical technologies to larger companies is less common than in pharma/biotech