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Molecular biology

Life Sciences

The advent of AI, organoids, nano-scale robotics, whole genome sequencing and a whole new universe of new technologies in imaging, high throughput screening and many others have led to an explosion of opportunities in the bio- and medtech industries.

But how to capitalize on those, what market to enter first, deciding it is time to launch the MVP, choosing the right preclinical model for testing, these are only very few of the questions that need to be answered by a start-up at any stage of development.

7 topics

29 questions

we provide  answers.

    • Are we solving a clearly defined unmet medical need with measurable clinical benefit?

    • Is our product essential (vs. optional) for clinicians, hospitals, or patients?

    • How do we demonstrate superior outcomes (e.g., safety, efficiency, patient quality of life) compared to standard-of-care?

    • How does our product align with the shift toward value-based care and cost-effectiveness in healthcare systems?

    • Where should we launch first — based on regulatory timing, reimbursement, and KOL support?

    • Which distribution strategy makes sense: direct hospital sales, strategic partnerships, or licensing?

    • Can we leverage digital health platforms, AI diagnostics, or remote monitoring to enhance adoption or data collection?

    • How do we localize clinical and marketing strategies for different healthcare ecosystems?

    • What is the reimbursement pathway in our target markets—codes, coverage, and payment?

    • How can we participate in national or regional funding or innovation programs?

    • Can we embed AI, digital workflow, or decision-support tools to enhance clinical value or differentiate our offering?

    • Do we need to consider FDA/EMA/Health Canada regulations for Software as a Medical Device (SaMD)?

    • How do we ensure our data strategy complies with privacy standards (GDPR, HIPAA, PHIPA) and delivers real-world evidence?

    • Can we use AI to accelerate our R&D, regulatory documentation, or commercialization efforts?

    • Is our product scalable under ISO 13485 / GMP requirements for our intended markets?

    • Does our regulatory plan that align with our commercial milestones?

    • Do we need a contract manufacturer or automation partner to achieve quality, cost, and speed targets?

    • Are we prepared for increased post-market surveillance and unique device identification (UDI) obligations globally?

    • What is our optimal business model: capital equipment, disposable, SaaS, hybrid?

    • Can we justify premium pricing with clear clinical and economic evidence?

    • Are we exploring risk-sharing or outcome-based contracts with providers or payers?

    • Can we build recurring revenue (e.g., service contracts, consumables, licensing) to improve valuation and investor appeal?

    • How do we position ourselves to investors as a compelling platform or acquisition target?

    • What non-dilutive funding (e.g., grants, accelerators, EIC, SDTC, NIH) can support early development?

    • Should we pursue co-development, licensing, or distribution partnerships with strategic corporates early?

    • What exit scenarios are realistic—IPO, M&A, licensing—and how do we build toward them deliberately?

    • Are we proactively addressing environmental impact, diversity, and data ethics in product design and operations?

    • Can ESG alignment strengthen our appeal to institutional investors and hospital procurement teams?

    • How do we ensure transparency, traceability, and ethical AI use in our products and data collection?

References

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