Mission statement
  • The Pharmaceutical and Medical Device industries are highly regulated businesses where new technologies will compete in a global sector controlled by dominant large companies.
  • For small and medium sized companies, crisp and clear business focus and strong project leadership is needed from day one. Strong partners and outsourcing strategy is needed simply as they can’t do it all themselves.
  • There is only one reason to develop the technology – to help patients to have better outcomes.
  • Transparency, rigor and governance in all development steps are critical.

Fikkan Pharma is a dedicated networked global consulting company that can help you grow and reduce business, project and portfolio risk.

Strategic Marketing
To ensure meaningful development, a deep understanding of the likely product utility in a clinical setting must be formally discussed and agreed from early stage development.

What will the new and promising technology do for mankind?

  • What will change in clinical practice? Likely patient outcomes?
  • What kind of evidence exists?
    • Feedback from Key Opinion Leaders
    • Advisory Boards
    • Competititive intelligence
    • Scientific literature
    • Strategic Market Research (few potential customers will understand the breakthrough technology. Academia will understand, but might not use the product in clinical setting…)

    A sharp Mission Statement is needed. Technology in itself is not relevant. Formalities and rigor needed to avoid the project drifting into long-lasting, expensive and meaningless R&D. The business case will reflect the needs in the market.

Project Leadership
  • A leader of a pharmaceutical or medical device R&D project need to be crossfunctionally skilled with sufficiently deep expertise in regulatory, clinical, manufacturing and safety related matters.
  • A robust development plan need to cover a crisp and  clear Target Product Profile, key go/no-go milestones, financial and human resources needed as well as risk profiles and timelines.
  • Undertaking pharmaceuctical and med tech R&D is indeed a risky business, and technical, regulatory, commercial risks needs to be dealt with throughout the development path.
  • All projects should have strong business cases, starting with the unmet clinical needs, ending with a full assessment of risk-adjusted net present values describing options for development and the associated costs, risks and profits.
Portfolio Planning
For companies having multiple development projects and research activities but limited human resources and financial funds – a clear portfolio priority is needed. The problem is rooted in the question ‘’how can I compare the activities with each other to make the best priorities?’’
 

  • First step is to create draft business cases for all relevant projects. The higher costs needed, the more rigor needed in strategic marketing efforts, resources plans and financial modeling.
  • The best measure is to use risk adjusted NPV as optimal comparator for mature projects.
  • Comparing early stage activities, human and financial resources needed to the next milestones shall be discussed in light of technical probabilities and likely longer term financial returns.
Partnering and Go-to-market Strategies
Small and mid-sized companies can’t do it all themselves. A partnering strategy shall include clear decisions on outsourcing of activities and might include ways to penetrate USA and Europe as well as complex markets such as China and Japan.
 

  • Networks, business and market intelligence as well as deep personal relationships critically important to successfully locate and contract with local Pharma or Medical device companies.
  • R&D, manufacturing, marketing, co-marketing, co-promotion, distribution and sales must be assessed and contracted in/out in light of needs and success criteria for the negotiation.
  • Contracts might involve organic growth, acquisitions, Joint Ventures or pure licensing deals.
  • Locate global industrial partners that can have contractual rights to develop, market and sell your product in certain geographies and potentially with rights only to certain fields of development and use.