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Which?

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ASSESS
IMPACT
Section 1
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Situation:

  • Proof of Concept
  • Problem to Marketable Solution 
  • Non-Dilutive Funding, e.g. SBIR/STTR
Analysis: 

  • Identify the problem it is solving 

  • Consider non-dilutive funding, e.g. SBIR/STTR

  • Determine status quo and how it is better, faster, or less expensive 

  • Review prior research funding agreements 

  • Identify supporting data, publications, and results showing feasibility  

  • Determine how easy or difficult it is for it to replace entrenched status quo  

Impact: 

  • Determine the long-term roadmap 

  • Establish short-term critical path milestones 

  • Protect the idea with IP 

  • Identify proof of concept funding 

  • Identify development funding 

  • Prepare basic market sizing and potential customers 

  • Seek publication opportunities for awareness 

  • Setup ability to apply for grants as a small business with Halo Venture Studio  

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Situation:

  • Health IT & AI
  • Clinical Decision Support
  • Analytics for Health Leaders
Analysis: 

  • Identify the specific clinical, diagnostic, therapeutic, or operational problem

  • Determine target audience (physicians, administrators, patients, beneficiaries)

  • Size the market

  • Analyze competition to differentiate technology

  • Assess regulatory requirements and hurdles

  • Determine data requirements and scalability

  • Assess security standards and quality control

Impact: 

  • Build prototype

  • Conduct technical validation

  • Collect stakeholder feedback on utility, workflow integrations, perceived benefits

  • Ensure compliance (FDA, HIPAA, ISO, GDPR)

  • Build validation plan

  • Establish strategic partnerships

  • Secure funding

  • Go-to-Market strategy

Section 2
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Situation:

  • Cell Biology & Biologic
  • Small Molecule
  • Lab to Clinic
Analysis: 

  • Determine the specific patient population and unmet need or demand, refractory conditions, or limited treatment options 

  • Evaluate existing therapies and their limitations 

  • Document the mechanism of action (MOA) to understand how the therapy works 

  • Assess current preclinical studies in-vitro or in-vivo 

  • Highlight what makes your therapy different or superior 

  • Determine feasibility to scale-up production

Impact: 

  • Engage stakeholders 

  • Secure funding through non-dilutive grants 

  • Prepare regulatory submission 

  • Conduct pre-clinical studies required by the FDA for IND approval 

  • Develop and validate manufacturing process 

  • Assess short and long-term investor pools for access to larger dilutive investments 

  • Prepare GMP-grade materials for clinical trials and long-term human use 

  • IND enabling studies

Section 3
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Situation:

  • Medical, Surgical, or Imaging Device
  • Durable Medical Equipment
  • Device Launch 
Analysis: 

  • Identify clinical need for device, and how proposed solution addresses it 

  • Assess target audience (surgeons, radiologists, pathologists, hospitals) and beneficiaries (patients) 

  • Assess current devices or practices, and how this is better 

  • Evaluate technical feasibility, durability, and maintenance

Impact: 

  • Engage key stakeholders 

  • Determine device classification (FDA PMA, De Novo, 510k) 

  • Assess requirements for ISO, CE marking 

  • Bench testing, simulated use, and safety  

  • Determine billable reimbursement coding 

  • Create prototype 

  • Scale-up manufacturing for large scale GMP compliant production 

  • Seek non-dilutive grant funding and dilutive investor funds 

Section 4
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Situation:

  • FDA Regulatory Approval
  • Scale-Up Manufacturing & GMP
  • Clinical Validation 
Analysis: 

  • Develop a robust FDA approval plan

  • Assess prospective trial, retrospective data, or exempt

  • Secure resources through grants, partnerships, and private investors

  • Prepare the application

  • Assemble investigator and operations teams

  • Select sites, prepare training

  • Develop and validate study materials

  • Identify patient recruitment strategy

  • Setup data management services

Impact: 

  • Ensures reliable, high-quality, and reproducible results

  • Reduces delays and manages costs effectively

  • Builds sponsor reputation and attracts partnerships

  • Minimizes patient risks and ensure ethical compliance

  • Enhance patient trust and participation

  • Communicate cost savings for healthcare systems and improvement to public health

  • Supports future clinical programs and strategic decisions

  • Optimize revenue potential to cover product/service and recover R&D costs

Section 5
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Situation:

  • Sales and Marketing
  • Assess Competition
  • Revenue Growth
Analysis: 

  • Develop and implement effective strategies that drive sales

  • Provide sales pipeline and client persona profiles

  • Prepare specific BANT model (Budget Authority Need Timeline) 

  • Enhance marketing efforts and support business growth while navigating the unique complexities of the product or service 

  • Involve key opinion leaders and clinical partners to gather unique insights

Impact: 

  • Accelerate market entry by navigating complex healthcare and biotech buyer landscapes

  • Boost conversion rates through strategic sales, challenging assumptions and status quo

  • Utilize data-driven strategies and targeted messaging with proven results

  • Optimize pipeline through lead generation

  • Personas to identifying high value champions, influencers and supporters

Section 6
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