DIAGNOSTICS
INNOVATION ROADMAP
DISCOVERING
Milestone: Identify unmet health need and state of the art technologies.
Step 1: Understand product-market fit through consultation with diagnostic technology end-users.
ECOSYSTEM
PARTNER
ADEPT
Contact: Jennifer Reid, Director
ADEPT SERVICES
Consultation with end-user organization representatives to discuss clinical need, clinical context of use, current technologies and gold standard tests used in Alberta.
1
Connections with clinician subject matter experts for additional
feedback on unmet clinical need and state-of-the-art technologies in the field.
2
IDEATING
Milestone: Describe, evaluate and select diagnostic solutions to
address unmet need.
Step 1: Define product-market fit by defining target patient population and current clinical care pathway and diagnostic workflow through consultation with clinicians and/or end users.
Step 2: Define target market, key stakeholders, and benefits for patients, payers and diagnostic service providers.
Step 3: Understand regulatory requirements and processes.
Step 4: Select appropriate technology for conceptualization.
ECOSYSTEM
PARTNER
ADEPT
Contact: Jennifer Reid, Director
Insights on market opportunity within the Alberta health system context, including pathways to adoption.
3
Guidance around regulatory requirements and processes for bringing new technologies to market in Alberta.
4
Initial technology assessment and proof of concept study design.
5
Consultation with diagnostic and subject matter experts to define target patient cohorts, describe care pathways and diagnostic workflows including transportation logistics; sample collection, handling and storage considerations; laboratory workflows and procedures; and quality requirements.
1
Feedback on appropriateness of technology for the Alberta healthcare system and connections to subject matter experts for additional insights on product-market fit.
2
ADEPT SERVICES
CONCEPTUALIZING
Milestone: Demonstrate proof of concept to demonstrate value proposition.
Step 1: Describe care pathway and diagnostic workflow in the context of the proposed technology and value proposition with quantifiable health outcome targets.
Step 2: Define competitive landscape, reimbursement pathway, and stakeholder management plan to develop business model.
Step 3: Define regulatory strategy.
Step 4: Define product based on proof-of-concept studies, including performance specifications, device prototype description, and IP strategy.
ECOSYSTEM
PARTNERS
ACAD SERVICES
Prototype development and refinement
Proof of concept studies
Mass spectrometry and biomedical engineering services
1
2
3
ADEPT
Contact: Jennifer Reid, Director
ALBERTA CENTRE FOR ADVANCED DIAGNOSTICS (ACAD)
Contact: Troy Feener, Director of Operations
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
1
2
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
Contact: Paramita Chaudhuri Basu, Director, Programs & Ecosystem Development
U OF C LIFE SCIENCES INNOVATION HUB SERVICES
Business advisory services
1
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
IHE SERVICES
Health technology assessment, health economics, clinical practice
guidelines.
1
INSTITUTE OF HEALTH ECONOMICS (IHE)
Contact: Kate Harback,
CEO and Executive Director
ADEPT SERVICES
Consultation with diagnostic and subject matter experts on care pathways and diagnostic workflows which need to be considered in product development, ongoing feedback and end-user engagement.
1
Generation of proof-of-concept data, functional requirements, and performance specifications under real-world conditions.
2
Define preliminary intended use case to support regulatory filings.
3
Feedback on competitive landscape and bench mark comparisons to guide innovators in business model development. ADEPT will also refer innovators to business advisor partners.
4
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
1
2
3
COMMITTING
Milestone: Demonstrate feasibility of whole solution.
Step 1: Describe care pathway and diagnostic workflow in the context of the proposed technology to define use-case scenario and form clinical advisory team.
Step 2: Refine business model based on feedback from business and economic advisors. Form business advisory mentorship partnerships.
Step 3: Prepare initial regulatory paperwork, including instructions for use and cybersecurity plan.
Step 4: Complete formal documentation of prototype features, including data and performance specifications, and functional requirements.
Step 5: File provisional patents and perform freedom to operate assessment.
ECOSYSTEM
PARTNERS
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
1
2
3
ACAD SERVICES
Prototype development and refinement
Proof of concept studies
Mass spectrometry and biomedical engineering services
1
2
3
ADEPT
Contact: Jennifer Reid, Director
ALBERTA CENTRE FOR ADVANCED DIAGNOSTICS (ACAD)
Contact: Troy Feener, Director of Operations
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
1
2
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
Contact: Paramita Chaudhuri Basu, Director, Programs & Ecosystem Development
U OF C LSIH SERVICES
Business advisory services
1
UNIVERSITY OF CALGARY (U of C)
LIFE SCIENCES INNOVATION HUB (LSIH)
IHE SERVICES
Health technology assessment, health economics, clinical practice
guidelines.
1
INSTITUTE OF HEALTH ECONOMICS (IHE)
Contact: Kate Harback,
CEO and Executive Director
ADEPT SERVICES
Consultation with diagnostic and subject matter experts on care pathways and diagnostic workflows and development of use-case scenarios and clinical trial design.
1
Advise or refer to business advisory and other ecosystem partners to support business model development and regulatory compliance.
2
Feedback on product design, including prototype, performance evaluation studies and software compatibility.
3
VALIDATING
01 Milestone: Demonstrate value of the solution for all stakeholders.
Step 1: Receive feedback from stakeholders, including clinicians, consumers, end-users and key opinion leaders and publish experimental results in peer reviewed journal.
Step 2: Complete business plan with economic modelling and reimbursement strategy. Secure pre-seed investment and feedback from advisors. Identify advisory board members and key team members.
Step 3: Prepare for clinical trials, including regulatory and ethics approvals, and draft product claims. Draft GMP plan and cyber security plan.
Step 4: Complete all prototype refinement and documentation activities. Manufacture prototype device.
Step 5: Complete IP protection.
02 Milestone: Complete initial trials to establish clinical and end-user safety and feasibility.
Step 1: Conduct validation trial with end-user partner to collect performance data, end-user feedback, and economic data.
Step 2: Secure new investments and ongoing feedback from advisors.
Establish advisory board.
Step 3: Receive ethics approval. Confirm data requirements for regulatory approval, and ensure GMP-compliance and cyber security certification in place.
Step 4: Establish performance and safety specifications based on validation trial and collect usability data.
03 Milestone: Demonstrate feasibility of whole solution.
Step 1: Conduct larger scale efficacy trails and publish peer reviewed data from initial trial.
Step 2: Updated business and economic models based on trial data. Secure procurement intent from buyers and additional investments. Finalize reimbursement strategy.
Step 3: Complete regulatory submission package and develop quality system plan.
Step 4: Update performance and safety specifications and usability documentation based on pivotal trial.
ECOSYSTEM
PARTNERS
ADEPT SERVICES
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
1
2
3
APEX SERVICES
Pre-clinical and clinical trial support
1
ADEPT
Contact: Jennifer Reid, Director
ALBERTA PRECISION EXCHANGE (APEX)
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
1
2
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
Contact: Paramita Chaudhuri Basu, Director, Programs & Ecosystem Development
UNIVERSITY OF CALGARY (U of C)
LIFE SCIENCES INNOVATION HUB (LSIH)
IHE SERVICES
Health technology assessment, health economics, clinical practiceguidelines.
1
INSTITUTE OF HEALTH ECONOMICS (IHE)
Contact: Kate Harback,
CEO and Executive Director
U OF C LSIH SERVICES
Business advisory services
1
UCeed and investor programs
2
ADEPT SERVICES
Consultation with or connections to diagnostic experts, subject matter experts and key opinion leaders.
1
Pre-clinical and clinical trial design support, resource identification and APL coordination.
2
Patient recruitment for trials and sample collection and transportation.
3
Clinical, end-user and economic data review and feedback.
4
Referrals to ecosystem patterns for business, investor, and regulatory support.
5
SCALING
Milestone: Real-world implementation
Step 1: Complete real-world implantation trial with supporting training materials and technical support established. Publish peer reviewed data from efficacy trials.
Step 2: Prepare for product launch, including investments, buyers and reimbursement.
Step 3: Register with regulatory agencies and implement quality system.
Step 4: Finalize product and receive patent approval.
ECOSYSTEM
PARTNERS
ADEPT SERVICES
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
1
2
3
ADEPT
Contact: Jennifer Reid, Director
ALBERTA PRECISION EXCHANGE (APEX)
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
Contact: Paramita Chaudhuri Basu, Director, Programs & Ecosystem Development
UNIVERSITY OF CALGARY (U of C)
LIFE SCIENCES INNOVATION HUB (LSIH)
Contact: Nima Najand,
Senior Director, Innovation Hubs
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
1
2
Dedicated space for startups
3
U OF C LSIH SERVICES
Business advisory services
1
UCeed and investor programs
2
Dedicated space for start-ups
3
APEX SERVICES
Real-world implementation trials
1
ADEPT SERVICES
Real-world implementation trials, including review and feedback of supporting documentation.
1
Partnership coordination with APL.
2
Feedback on final product design.
3
Referrals to ecosystem partners for business, investor, manufacturing and regulatory support
4
ESTABLISHING
Milestone: Establish technology for routine clinical use.
Step 1: Publish peer reviewed data from real-world trials. Demonstrate use of technology in local clinical practice guidelines.
Step 2: Secure sales and recurring revenues, develop scale-up plan and secure additional investment to launch new products.
Step 3: Complete regulatory agency inspections.
Step 4: Develop product improvement plan based on feedback from stakeholders and end-users.
ECOSYSTEM
PARTNERS
ADEPT SERVICES
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
1
2
3
APEX SERVICES
Real-world implementation trials
1
ADEPT
Contact: Jennifer Reid, Director
ALBERTA PRECISION EXCHANGE (APEX)
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
Contact: Paramita Chaudhuri Basu, Director, Programs & Ecosystem Development
UNIVERSITY OF CALGARY (U of C)
LIFE SCIENCES INNOVATION HUB (LSIH)
U OF C LSIH SERVICES
Business advisory services
1
UCeed and investor programs
2
Dedicated space for start-ups
3
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
1
2
Dedicated space for startups
3
ADEPT SERVICES
Partnership coordination with APL and Lab Formulary Committee to establish use of technology in clinical practice guidelines.
1
Ongoing product and technology development advice.
2
Referrals to ecosystem partners for business, investor, manufacturing and
regulatory support.
3
LEADING
Milestone: Product recognition as standard of care.
Step 1: Seek recognition of product as routine practice by medical specialists supported by peer-reviewed data.
Step 2: Gain market share, aiming for 30% or greater.
Step 3: Incorporate obsolescence planning in quality planning and product development strategy.