Ldb 145 Geni Mutanti_2014-11-27 calasso - make a good company
A company in MedTech ?
Key points to consider
Irio Calasso, PhD
Table of content 1/2
• Challenge your idea
• User requirements
• Technology and product development
• Secure IP
• Competitors and differentiation
• Business model, SWOT
• Plan / Financial needs
Table of content 2/2
• Put together the right people
• Establish business plan
• Important agreements
• Investors & dilution
• Establish collaborations
• Regulatory and Quality
Challenge your idea
• What is the problem you are solving or improving
• Why somebody needs your product ?
• What are the constrains (reimbursement, learning, establishing,
• Does your product fit into the market ?
• What is your strategy to enter into the market?
• Why it will be profitable?
• Do you have the right solution , is it working ?
User requirements /needs
• Before you start developing clarify the user requirements (ISO
• Ask your target market , key opinion leaders, etc.
• What is important? What is optional?
• Propose solution to be assessed.
• Listen carefully! Consider also what you do not want to hear
=> Define product specifications
There is a big difference between technology development an
By developing technology you are free to play , the goal is making it
working, show the proof of concept with a prototype considering
The step into product development should be well thought!
Consider that you enter then into a well regulated environments.
You might need to comply to Regulatory and Quality standards. This
will increase the costs! Consider it in the plan!
Start the product development after you have demonstrated the
• Have a clear understanding of the third party IP application
• File the “Key Patents”
• Negotiate License agreement at the beginning (later it will cost
• Describe the features of your product for a FTO clearance
Consider : No patent rights = No value
USP (unique selling proposition)
Unless you’re fortunate enough to be the only player in your
industry you’ll need to differentiate yourself from your competition
through your unique selling proposition, or USP.
Consumers don’t want to buy products ! – they want to solve their
What will motivate people to by your product?
Consider that a problem to solve could also be related to the lack of
glamorous, confidence or style:
• Take the cosmetics industry, for example. Companies in this space
don’t just sell make-up
• Take Nespresso
Competitors and differentiation
• Who are your competitors?
• Understand well their product, service
• Tray to understand what could be their next steps
(remember : you need time to develop..)
• What could compromise your product ?
• What are the strength of your product /proposition?
- Brings innovation in XY market
- Cost effective
- Easy to use, small and therapy
- Meets unmet customer needs and
- IP: concept secured due to new
- Few contract manufacturer
- Lack of marketing experience
- Adaptable to other applications
- Merge, joint venture or
- Complex IP situation
- Competition from Medtech
companies are attracted from the
- Low COG (< 1 Euro) is fundamental
Find the right people
• Consider that investors are investing in an idea therefore in the
people that are behind the idea
• Put together a competent group of people that support the idea.
• Think that the success depends on the people you involve!
• Think how investors looks at you group, are you convincing?
Do you have the right skills? Have the people experience?
Alone you will not do it -> share !!
• Shareholder agreement
• HR agreements
• NDA *
• Term Sheet *
• License agreement *
• Collaboration agreements *
• R&D assignment agreement *
* Big companies will propose their version
Investors & dilution
Each time you have investor money you are diluted
Dilution in function of company evaluation !
Company value =1 mio EURO pre money
Investment = 0.5 mio Euro
=> Investor obtains: 0.5/(1+0.5) = 33 % of the company
The company value is based on negotiation !
(you have no revenues)
Your arguments are :
• # of patents
• Technology status -> to reduce technology risks
• Market analysis -> to reduce business risks
• Regulatory analysis -> to consolidate planning and investment
• NPV value
• Invested money
- reduce R&D risks
- reduce Market risks
- require less investor money (grants.. )
Describe in the agreement :
- Exit scenarios !!
- Ev. Penalties
Your company need to be visible:
- Participate in competitions
- Apply for grants
However consider well:
What type on information you are disclosing !
Regulators & Quality
Stepping out technology developments into product development
might involve to follow regulatory and quality standards!
This because you need to register before launching a new product
- Clarify the Q standard to follow (e.g. ISO 13485)
- Involve an expert to roadmap the registration patch
- Introduce it into the company
Do not underestimate the efforts, and costs !!
= >outsource as much as possible !
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