DIAGNOSTICS
INNOVATION ROADMAP
LEADING
ESTABLISHING
SCALING
VALIDATING
COMMITTING
CONCEPTUALIZING
IDEATING
DISCOVERING
Alberta offers a vibrant ecosystem for health innovation with numerous partners that can engage with innovators from start-up resources and incubator space to business expertise, regulatory and health economics. ADEPT is the entry portal to the diagnostics ecosystem in partnership with Alberta Precision Laboratories (Alberta's provincial diagnostics service provider), the Alberta Centre for Advanced Diagnostics, the University of Calgary and the University of Alberta.
We have created the following Diagnostics Innovation Roadmap for each stage of the innovation journey to guide innovators towards successful translation and commercialization of new diagnostic technologies. Below each stage, you will find specific milestones and checklists that can be followed to ensure that the appropriate steps are taken to advance your technology. Each stage also includes a list of ecosystem partners and the services that they offer in order to achieve each milestone. As your primary partner for diagnostics innovation and translation, ADEPT will guide you through each stage and facilitate access to other partner resources as described below.
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.
Connections with clinician subject matter experts for additional feedback on unmet clinical need and state-of-the-art technologies in the field.
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.
Guidance around regulatory requirements and processes for bringing new technologies to market in Alberta.
Initial technology assessment and proof of concept study design.
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.
Feedback on appropriateness of technology for the Alberta healthcare system and connections to subject matter experts for additional insights on product-market fit.
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
ADEPT
Contact: Jennifer Reid, Director
ALBERTA CENTRE FOR ADVANCED DIAGNOSTICS (ACAD)
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
U OF C LIFE SCIENCES INNOVATION HUB SERVICES
Business advisory services
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
​
IHE SERVICES
Health technology assessment, health economics, clinical practice
guidelines.
INSTITUTE OF HEALTH ECONOMICS (IHE)
​
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.
Generation of proof-of-concept data, functional requirements, and performance specifications under real-world conditions.
Define preliminary intended use case to support regulatory filings.
Feedback on competitive landscape and bench mark comparisons to guide innovators in business model development. ADEPT will also refer innovators to business advisor partners.
INNOVATE CALGARY
IMPACT SERVICES
​
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
ACAD SERVICES
Prototype development and refinement
Proof of concept studies
Mass spectrometry and biomedical engineering services
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
ADEPT
Contact: Jennifer Reid, Director
ALBERTA CENTRE FOR ADVANCED DIAGNOSTICS (ACAD)
​
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
U OF C LSIH SERVICES
Business advisory services
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
IHE SERVICES
Health technology assessment, health economics, clinical practice
guidelines.
INSTITUTE OF HEALTH ECONOMICS (IHE)
​
INNOVATE CALGARY
IMPACT SERVICES CALGARY
ADEPT SERVICES
Consultation with diagnostic and subject matter experts on care pathways and diagnostic workflows, development of use-case scenarios and clinical trial design.
Feedback on product design, including prototype, performance evaluation studies and software compatibility.
Advise or refer to business advisory and other ecosystem partners to support business model development and regulatory compliance.
Mass spectrometry and biomedical engineering services
ACAD SERVICES
Prototype development and refinement
Proof of concept studies
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: Update 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
ALBERTA PRECISION LABORATORIES
Pre-clinical and clinical trial support. Contact ADEPT for further discussion.
ADEPT
Contact: Jennifer Reid, Director
ALBERTA PRECISION LABORATORIES
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
​
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
IHE SERVICES
Health technology assessment, health economics, clinical practiceguidelines.
INSTITUTE OF HEALTH ECONOMICS
INNOVATE CALGARY
IMPACT SERVICES
​
U OF C LSIH SERVICES
Business advisory services
UCeed and investor programs
ADEPT SERVICES
Consultation with or connections to diagnostic experts, subject matter experts and key opinion leaders.
Pre-clinical and clinical trial design support, resource identification and APL coordination.
Patient recruitment for trials and sample collection and transportation.
Clinical, end-user and economic data review and feedback.
Referrals to ecosystem patterns for business, investor, and regulatory support.
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
ADEPT
Contact: Jennifer Reid, Director
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
​
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
INNOVATE CALGARY
IMPACT SERVICES
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
Dedicated space for startups
U OF C LSIH SERVICES
Business advisory services
UCeed and investor programs
Dedicated space for start-ups
ALBERTA PRECISION LABORATORIES
Real-world implementation trials. Contact ADEPT for further discussion.
ADEPT SERVICES
Real-world implementation trials, including review and feedback of supporting documentation
Partnership coordination with APL
Feedback on final product design
​Referrals to ecosystem partners for business, investor, manufacturing and regulatory support
ALBERTA PRECISION LABORATORIES
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
ALBERTA PRECISION LABORATORIES
Real-world implementation trials. Contact ADEPT for further discussion.
ADEPT
Contact: Jennifer Reid, Director
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
INNOVATE CALGARY
IMPACT SERVICES
U OF C LSIH SERVICES
Business advisory services
UCeed and investor programs
Dedicated space for start-ups
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
Dedicated space for startups
ADEPT SERVICES
Ongoing product and technology development advice.
Partnership coordination with APL and Lab Formulary Committee to establish use of technology in clinical practice guidelines.
​Referrals to ecosystem partners for business, investor, manufacturing and
regulatory support.
ALBERTA PRECISION LABORATORIES
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.
ECOSYSTEM
PARTNERS
ADEPT SERVICES
INNOVATE CALGARY AND IMPACT SERVICES
IP management
Regulatory consulting
Business advisory
ALBERTA PRECISION LABORATORIES
​Feedback on workflow challenges and areas for improvement. Contact ADEPT for further discussion.
ADEPT
Contact: Jennifer Reid, Director
ALBERTA PRECISION LABORATORIES
UNIVERSITY OF ALBERTA
HEALTH INNOVATION HUB​
UNIVERSITY OF CALGARY
LIFE SCIENCES INNOVATION HUB
INNOVATE CALGARY
IMPACT SERVICES
U OF C LSIH SERVICES
Business advisory services
UCeed and investor programs
Dedicated space for start-ups
U OF A HEALTH INNOVATION HUB SERVICES
Business advisory services
IP management
Dedicated space for startups
ADEPT SERVICES
Ongoing product and technology development advice for improvements,
updates and obsolescence planning
Connections to specialists, key opinion leaders and subject matter experts to facilitate outreach and knowledge transfer
Referrals to ecosystem partners for business, investor, manufacturing and
regulatory support
