We build product development processes that help your products clear regulatory hurdles (FDA/CE), provide a safe and engaging experience, and comply with regulations throughout their lifecycle. 

Through our ecosystem, we can stitch together high-value clinical, quality, and manufacturing partnerships to launch validated products and scale.

The stage of the venture and the type of product(s) it makes profoundly influence the approach we take in solving product-related challenges.

Having worked on products that went from 0-1, those that experienced recalls, and those at the end of their lifecycle, we can differentiate signal from noise on what to prioritize; we understand how to balance limited resources and the need for validation while maintaining a competitive pace to market.

Our typical product strategy offering involves putting together

1. Product + user requirements, necessary design and information standards to comply with, and traceability
2. Product Development Plan and execution strategy (differs from product to product)
3. Product Usability (IEC 62366), Design Safety, and Risk (ISO 14971) guidelines specific to your product
4. Product Lifecycle Management - Post-market surveillance (21 CFR 803), CAPA management

For devices:

1. Manufacturing (21 CFR 11, GxPs) and Supplier/Purchasing (21 CFR 820.50) vetting process
2. Setting up Supply Chain (UDI, 21 CFR 203 for biologics) and distribution
3. Packaging requirements (ISO 15223-2021)

For Software only products and devices with software:

1. IEC 62304 compliance
2. HIPAA/ ISO 27001/ AICPA SOC2

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Pre-revenue

Burn Rate on this function: HIGH

At this stage, requirements, time-to-market, and value proposition to the beachhead market help unlock the next door in the product and business lifecycles of the company.

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We answer questions like

1. Who will be my primary market?
2. What claims do I want to make? Does a more demanding regulatory path offer a long-term moat?
3. What features do I need to build for my beachhead customers/users?
4. How can I maintain a good execution velocity despite building a hardware product?
5. How can I get feedback from patients/primary users even before regulatory submissions?
6. What kind of partnerships offer an advantage at the time of launch?
7. How do I package my core technology into a minimum-sellable product?
8. What are good design practices - human interfaces, human factors, and safety systems for my product? How do I execute and monitor that our work is following this?
9. What design standards do I need to comply with?
10. For hardware start-ups, manufacturing, and supplier vetting process to get me through verification, validation, and first manufacturing run?

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Launch and Growth

Burn Rate on this function: MEDIUM

Network effects, keeping CAC manageable, and managing the unpaid pilot/phases will be critical at this venture stage. We identify high-value device vs. non-device functions and optimal regulatory burden to maintain frequent release cycles.

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We answer questions like

1. What new features and functions can I build within my product? What is the regulatory impact and time to market?
2. What are good ways to assemble a robust post-market surveillance system that functions beyond inbound complaint management?
3. How do I build and automate non-device functions that enable network effects and easier product adoption in the market?
4. How do I balance between active products in the market v. R&D and new feature releases?
5. How do I manage documentation overheads for products regulated by FDA Class 2, 510k, and beyond while keeping the team motivated and engaged?

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Scale-up

Burn Rate on this function: LOW-MEDIUM

At this stage, the business model has proven to work well. The product user base has grown significantly. Significant field data is available, along with market intelligence, to determine what to build next and how to enrich the offering. Often, this is the time for a second act, finding a new market or launching another set of offerings that further strengthen your moat in the market, expand into other markets for example - a digital diagnostics maker expanding indications to diagnose additional diseases, a bronchoscopy maker incorporating AI to assist in diagnosis or to reduce CT-to-body divergence for safer surgery.

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Enterprises

For enterprises, we work with innovation, strategy, and M&A teams to find answers to the critical drivers for innovation:

What should my new product portfolio look like to be competitive in a changing market? Which ones should I pursue first? What are the essential requirements I need to fulfill?

1. Should I build this in-house? How?
2. Should I buy it? What are my criteria? What to buy first?

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