SOLUTIONS / GLOBAL DEVELOPMENT & MARKET ACCESS

One operating model for the decisions that shape a programme.

Hope Focus helps teams decide what to do next across product type, target market, evidence strategy, quality readiness and partner delivery.

START WITH THE DIRECTION OF TRAVEL

Two journeys. The same discipline.

Select the direction that reflects your programme. The work changes by jurisdiction; the operating model stays accountable.

01

CHINA → GLOBAL

Build a credible route from Chinese innovation to priority markets.

Sequence markets and evidence around the product’s maturity, intended use and available data — then coordinate the work required to reach submission readiness.

STRATEGY

Decide the order

Target-market comparison, development order and pathway logic across pharmaceuticals, devices, IVD, SaMD and combination products.

EVIDENCE

Reuse what is strong

Map existing clinical, RWD/RWE, CMC, non-clinical, quality and technical evidence to each market’s needs.

DELIVERY

Coordinate the work

Bring specialist partners into one programme with milestones, work packages, risk ownership and clear interfaces.

02

GLOBAL → CHINA

Translate global innovation into a China-ready evidence and access plan.

Assess China market entry, Lecheng and real-world evidence opportunities, local clinical needs and the readiness of the product package.

ENTRY

Assess feasibility

Product classification, China pathway, existing evidence acceptance and local execution requirements.

EVIDENCE

Close the bridge

RWD/RWE, clinical, non-clinical, CMC, technical and quality activities needed for a credible China programme.

ECOSYSTEM

Activate local capability

Coordinate medical institutions, CROs, data partners and specialist regulatory support around the same plan.

PRODUCT-SPECIFIC DEPTH

Different products. Different evidence logic.

Product typeWhat needs to alignTypical starting question
PharmaceuticalsDevelopment order · CMC · clinical · RWE · lifecycleWhich market and evidence package should lead?
Medical devices & IVDClassification · QMS · technical documentation · clinical evaluationWhat pathway matches intended purpose and risk?
SaMD / AI-enabled devicesPerformance · clinical evaluation · software lifecycle · change controlHow will the product remain safe, effective and explainable?
Combination productsMode of action · evidence combination · multi-party governanceWhich regulatory logic governs the integrated product?

FIRST USEFUL DECISION

Start with a product or pipeline assessment.

Receive a structured view of target markets, pathway options, evidence gaps and the professional work packages needed to move forward.

Request an assessment