Development Overview - Your Ideas Consulting

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Development Overview

Product Development

Product Development Overview

We support your IVD product development with the provision of results/ document deliverables during the full lifecycle of the product. This service potentially targets:

new developments,
existing products,
also products, moving from research level to an IVD labeled product.

Our major focus is linked to the provision of key deliverables/ documents , which provide structure and interdisciplinary integration for the project as well as for the product.

The deliverables are mainly linked to the four processes of IVD system development:

Further focus is directed to the analysis and interdisciplinary confirmation of requirements linked to high level design contents in early project phases e.g. compilation of the results/ deliverables:

reliability analysis,
product scenario alternatives,
throughput analysis,
safety design,
automation roadmap,

especially considering solution alternatives and customer needs.

Deliverables of one process are matched regularly with plans and reports of the other three processes.

A simple design control model is provided below to later on sort deliverables with their initial creation accordingly into phases.

Design Control Model

A simple design control model was defined with the following phases and milestones:

Proposal

During this mainly business driven phase market analysis leads to different product scenarios with related business cases and high level concepts and first customer- and product requirements.
Successful end of phase is followed by the beginning of a feasibility phase, approved by senior management.

Feasibility

Existing content (e.g. business case, market analysis, requirements, concepts) is further refined and pre-product components are provided and utilized to proof initial product performance.
These activities now require substantial R&D effort; an interdisciplinary team is set up including serious project management resources.
Alternative scenarios/ realizations are still considered, with the goal to present the best product solution at end of phase.
Requirements are defined on customer and product level down to component requirements (hardware, software, reagents, disposables) as design input artifacts on an approx. 90% level, feasibility reports document accomplished performance.
A product risk analysis is provided on 90% level.
Successful end of phase is followed by the beginning of a formal realization phase.

Realization

Formal development is introduced with this phase by creation of compliant design control documentation under version control and also applied version control for all product components (hardware, software, reagents, disposables).
Project management is challenged to coordinate R&D resources and manufacturing interfaces.
Work breakdown of development activities and V&V activities is critical.
Requirement changes still do occur. Verification of individual components (hardware, software, reagents, disposables) is part of this phase and executed as planned.
Substantial R&D effort is consumed by end of phase.
Successful end of phase is followed by the beginning of a validation phase.

Validation

Final components (developed & manufactured) will be integrated into a product as planned.
Validation activities are executed and reported as planned (design output artifacts) .
Late changes challenge the whole team and venture.
Design control documentation needs to be finalized including successful passing of all V&V activities also considering deviations.
Usability is shown, clinical utility is shown.
Preparation of market introduction by interfacing with vendors, customers and approval authorities, also executing planned stock up of materials and components is critical for launch.
Successful end of phase is followed by the product launch.

Commercialization

Product is manufactured.
Product is sold to customers.
Lifecycle management proceeds still further executing change management within the four development core processes listed above.

Deliverable Overview

Following table lists project critical deliverables:

#	Deliverable	Phase initially compiled	Description
1	Automation Strategy Automation Road Map	Proposal	Analysis, plan and rationale for the provision of automation elements (e.g. instrumentation, hardware, software, disposables, customer workflow) utilized in existing and/or new products in a timely order. May be linked with assay portfolio plan.
2	Product Scenario	Proposal	Analysis of solution space for a product in scope. Identify and decribe product alternatives by applying different target focus e.g. time to market. Refine individual scenarios with e.g. features, automation, R&D effort prior to further facilitate selection.
3	Customer Workflow Analysis	Feasibility	Functional analysis and compilation of manual and automated steps for the customer application, performed by operators in lab environment
4	Technology Assessment	Proposal	Comprehensive technical assessment/ compilation of a technology and/ or prototype IVD instrumentation system ( e.g magnetic bead capturing, detection) with: - functional features and capabilities - manufacturing aspects - in comparison to reference technology
5	Intellectual Property Analysis	Proposal	Analysis of selected intellectual property content regarding: - coverage - infringement - gaps and overlaps
6	Requirements (Product and/ or Components)	Proposal	Requirements documents as defined in the requirements management plan on e.g. customer-, product- and component level. Compilation of individual requirements with attributes (e.g. owner, traces, configuration version, cost estimate). Templates are recommended. Tool may be used from a certain complexity level on.
7	System Design Scenarios	Feasibility	Analysis of solution space for automation architecture. Identify alternatives by applying different target focus e.g. single tube processor, throughput variants, batch analyzer, modularization, disposable variants. Refine individual scenarios with e.g. features, automation, R&D effort prior to further facilitate selection decision
8	Safety Design Scenarios	Feasibility	Analysis and compilation of failure detection (single failures) methods and concepts to be applied.
9	Product Risk Analysis	Feasibility	Compilation of product risk analysis according to ISO 14971 containing risks estimates and mitigation measures. Analysis views applied: e.g. customer workflow, hardware, software, disposables, reagents, manufacturing, environmental. Mitigations may be defined as safety requirements.
10	Event Risk Management	Realization	Event driven risk analysis for individual (design) changes occurring from end of realization phase. Assessment links and tracks into change control for requirements, V&V documents, version control of components and respective revalidation effort, confirms successful mitigation of change.
12	Requirements Management Plan	Feasibility	Defines requirements management process for a specific projects, including: - team organization - requirements document structure with traceability and V&V layers - links into respective vendor documentation - defines attribute use - change control process and deliverables - tool use
13	Requirements Management Report	Feasibility	Reports execution of requirements management process for milestones.
14	Risk Management Plan	Feasibility	Defines plan for execution of product risk management for a specific project: - team organization - intended use (platform & assays) - vendor interfaces - structure of risk management file with plan break down - format/ forms for risk analysis table
15	Risk Management Report	Realization	Reports execution of product risk management process for milestones.
16	Master Validation Plan	Feasibility	Breakdown of all V&V activities for a product (platform & assays) with its components including manufacturing. Document may link into sub plans.
17	Master Validation Summary Report	Realization	Bottom up reporting of all V&V activities executed, with pass/ fail indicators provided and deviations described. Document may utilize sub reports for reporting.
18	Validation Plan (Component)	Realization	Sub plan of V&V activities for a component. Document may link into sub plans or protocols.
19	Validation Plan Summary Report (Component)	Realization	Sub report for execution of V&V activities for a component. Document may utilize sub reports for reporting.
20	Configurations Management Plan	Feasibility	Plan for product configuration scope and release along the lifecycle. Describes interfacing of platform versions with reagent lots. Plans introduction of upcoming changes (design change, obsolescence ...) in configurations.
21	Configurations Management Report	Feasibility	Reports execution of configurations management process for milestones.
22	Reliability Analysis	Feasibility	Analyses and defines reliability factors throughout the product (platform & assay), assigns variation estimates, reports overall expected variation.
23	Project Plan	Proposal	Plan for project (assay and platform); including team organization, resources, applied design control and processes, vendors, budget plan, schedules, milestones.