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THE PROGRAM

  • The program is structured in modules that begins with an assessment of the company's commercial strategy and readiness.  We use a structured toolbox to assess and provide recommendations to enhance commercial readiness.

  • Program participants will have access to “qualified/recommended” vendors and a bank of “consultation” hours with executives appropriate to their industry and stage.

  • If accepted into the program, participants will be asked to pay a small program fee. The bulk of the program is funded by external stakeholders, friends and volunteers who support the initiative.

  • Companies will be qualified to next “package” based on their seriousness and effeteness of implementing prior packages. Longevity with the institute will signal certain level of quality from commercialization perspective

PROGRAM MODULES AND PACKAGES

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  • Start with a target product profile (TPP) that outlines the product's treatment position, patient populations, clinical outcomes, and unique selling points.

  • Continuously refine the TPP based on new information gathered through clinical development and market research.

  • Use the TPP to set minimum thresholds for competitive advantage and plan development accordingly to test these thresholds as early as possible.

  • Ultimately, the goal is to have a product that fits the market and has a sustainable competitive advantage.

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  1. Prioritize disease indications by going through the disease state identification exercise, listing different options and looking at each disease individually.

  2. Create a funnel for each disease to identify the target patient population within the disease.

  3. Look at clinical practice guidelines and market research to understand the standard of care and patient pool for each disease stage.

  4. Understand the clinical and regulatory hurdles you will face in developing and getting approval for your product by looking at the standard of care for each disease stage.

  5. Look at competitive late-stage and other clinical programs to understand if there will be enough patients for your clinical trials.

  1. Care pathway mapping involves analyzing the patient's journey through a disease state or condition, from early symptoms to ongoing management.

  2. It is important to consider all healthcare professionals involved in the care pathway, including non-physician caregivers.

  3. The type of location where care is provided is also important to consider in the mapping process.

  4. The equipment and technology used in the care pathway should be taken into account.

  • Understanding reimbursement and market access is crucial for successful commercialization of a medical product or service.

  • Important considerations include finding the right code and ensuring coverage and payment from relevant payers.

  • Generating pharmacoeconomic evidence and developing health technology assessment tools can help convince payers to reimburse and accept the technology.

  • Convincing regulators is only the first step; convincing payers and customers is equally important for successful commercialization.

Conduct a competitive mapping exercise to evaluate your product's advantages over existing and developing competitors.

Look ahead to anticipate future direct competitors based on mechanism of action or specific technology.

List meaningful parameters for comparison that can demonstrate impact on product safety and efficacy in the clinic.

Consider the competitive risk, weaknesses of competitors, and product position to determine potential success in the market.

  1. Evidence is crucial in the commercialization process and needs to be backed up with research and data.

  2. Three key stakeholders to consider when presenting evidence are regulators, payers, and customers.

  3. Evidence can include publications, official guidelines, and consensus summaries from relevant societies.

  4. The evidence needs to support the product and service definition, care pathway mapping, and cost effectiveness of the product.

  5. Evidence should be tailored to the specific stakeholder, such as clinical trial data for regulators, cost data for payers, and patient outcomes for customers.

  1. Identify potential gaps in the company's evidence and plan accordingly.

  2. Ensure that the exact required evidence agreed with the regulator is available.

  3. Collect feedback from potential customers to understand what evidence they need to be convinced to use the product.

  4. Have the required economical evidence needed for coding coverage and payment.

  1. The FDA label and indication for use are critical for commercializing and promoting medical devices in the US.

  2. Companies need to carefully plan and design the label and claims for their product based on the FDA clearance and scientific evidence published.

  3. All claims made about a product must be substantiated with scientific evidence.

  4. Strong claims require multicenter randomized clinical trials published in high-impact peer-reviewed journals.

  5. Startups should be aware of limitations and restrictions in the label and indication for use, as well as any off-label use that is not allowed.

  6. It is important to consider the target age group for the product and ensure that it aligns with the FDA clearance.

  • Identify the decision makers and gatekeepers in the healthcare market and target them with marketing efforts to move them along the awareness-interest-repeated use-advocacy axis.

  • Use care pathway mapping to identify stakeholders along the patient journey who influence the decision to accept, use, or buy your offering.

  • Design a targeted marketing plan to be most effective in the point target group, including identifying venues, conferences, key prescribers, and influencers.

  • Determine the size of the target call point and whether it requires a strategic partner to cover it, and use call point analysis to identify potential partners or acquirers.

  • The four Ps of marketing are product, price, place, and promotion.

  • Product: A sustainable competitive advantage is key in ensuring the product fits the market.

  • Price: Considerations include expected COGS, market competitive price, expected competition, credit policy, and large customers.

  • Place: Determine the target audience and the channels for distribution and promotion, and consider whether to sell directly or use agents, distributors, or strategic partners.

  • Promotion: Consider marketing venues, treatment sites, marketing message, brand identity, taglines, campaign, materials to generate, training for own team and customers, and creating centers of excellence or user meetings.

  • TAM (Total Addressable Market): Represents the total revenue opportunity available if a product or service achieves 100% market share.

  • SAM (Serviceable Available Market): Refers to the portion of the total addressable market that can be reached and is suitable for your product or service.

  • SOM (Serviceable Obtainable Market): The realistic sub-sector of your target market that can be effectively targeted in the short term, considering resources, competition, and market awareness.

  • TAM, SAM, and SOM are crucial for investors and business planning, helping assess market potential, identify target customers, set realistic goals, and allocate resources.

  • Calculating these metrics involves both top-down analysis (broad market data narrowing down) and bottom-up analysis (primary research and realistic estimations based on target customers and pricing).

THE ASSESSMENT AND COACHING JOURNEY

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