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Our diverse capabilities mean that Optimum Technologies can start anywhere in your development process—as early as a napkin sketch, or as late as a design-for-manufacturability exercise on your working prototype. At your option, we can execute on a narrow scope, or deliver a complete turnkey project. Regardless of project scope, we communicate with you as often as needed to ensure a targeted, efficient, product development process. More»
| Tasks / Functional Groups |
| Cross-Functional Management |
| Markets & Marketing |
| Writing and Publications |
| Research & Development |
| Design Documentation |
| Industrial Design |
| Legal/IP |
| Regulatory |
| Reimbursement |
| Manufacturing & Operations |
| Quality |
| Pre-Clinical |
| Clinical |
| Data and Statistics |
| Sales |
| PHASE 0 | PHASE 1 | PHASE 2 | PHASE 3 | PHASE 4 | ||||
|---|---|---|---|---|---|---|---|---|
| Evaluation / Opportunity & Risk Analysis |
Demonstration / Concept & Feasibility | Design & Development/Verification & Validation | Final Validation / Product Launch Preparation | Product Launch & Post-Launch Assessment | ||||
| Financial Review Business Model Development |
Project Core Team Selection; Hire Specialists for Expertise Gaps; General Project Plan & Timeline; Fundraising Activities | Cross-Functional Project Management Budgeting/Fundraising Activities |
Cross-Functional Project Management Business Development Budgeting or Fundraising Activities |
Cross-Functional Project Management | ||||
| Market Analysis;
Competitive Assessment; PRD (Product Requirements Document) |
Customer Input/VOC Customer Prototype Evaluation |
Customer Prototype Evaluation | Product Branding Market Launch Plan/Forecast |
Physical Training & Continuous Sales Efforts | ||||
| Business Plan & Presentations Literature Search |
Business Plan & Literature Search Updates | Meta Analysis White Paper; Data Summary, Analysis White Paper, Publish Peer Review Papers | Meta Analysis White Paper; Data Summary, Analysis White Paper, Publish Peer Review Papers | Meta Analysis White Paper; Publish Peer Review Papers | ||||
| Early Risk Assessment & Concept Approach | Early Concept Prototype Design & Build; Prototype Evaluation; Initiate & Maintain Design History File (DHF); Initial Design Risk Analysis (dFMEA); Update Design Per Review & Analysis/ Multiple Discipline Input Driven | Product Development & Test; Maintain DHF & Project Timeline; Design Verification & Validation; Design Risk Analysis (dFMEA); Update Design per Review & Analysis/Multiple Discipline Input Driven | DHF Completion dFMEA Update & Review Final Design & Documentation Release |
Sustaining Engineering/Product Improvements as Needed | ||||
| Quick CAD Layouts, Preliminary Engineering Specs | CAD Models, Minimum Drawing Set, Engineering Specification | Complete CAD Models & Drawing Set, Updated Engineering Specs, Other Design Files | Full Released Documentation Per ISO13485 | DCO Maintenance | ||||
| Sketches, Renderings (Paper, Digital) | Renderings, Size/Feature Mockups, Appearance Models (Hard Foam, RP/Rapid Prototyping Methods) | “Looks-like/Works-like” Prototypes, Aesthetic Refinement, DFMA/Design For Manufacturability & Assembleability (RP & Production Methods) | “Looks-like/Works-like/Made-like” Cosmetic Refinement, Pre-Production Units, Packaging, (Production Methods) | Support Release | ||||
| Legal/IP Analysis, Clearance Opinion | IP Landscape Review & Review of Filings | Patent Review/Inlicense & Outlicense Review | Final Patent Review with R&D | Patent Litigation | ||||
| Regulatory Path | Initial Regulatory Strategy | Regulatory Strategy Update | Regulatory Submission Obtain Regulatory Clearance (FDA, CE, UL, etc) |
Post-Market Surveillance/MDR | ||||
| Reimbursement Path | Initial Reimbursement Strategy | Finalize/Pursue Reimbursement Strategy | Pursue Reimbursement | Update Reimbursement as Needed | ||||
| Manufacturing Plan | Initiate DFM (Tooling, Fixturing) | Detailed Productivity Analysis; Supplier Collaboration; Manufacturing & Process Engineering; Initial Process FMEA (pFMEA); Order Tooling | Manufacturing/Operations Scale Up | Process Improvements as Needed | ||||
| Quality Plan | Initiate Quality Management System (QMS)/Document Control | Begin Process IQ/OQ/PQ/PPQ | Full Process Qualification Finalize Process IQ/OQ/PQ/PPQ |
Update Design Control Doc as Needed Quality Audits |
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| Pre-Clinical Path | Pre-Clinical Tests | Biocompatibility Testing (If Possible) | Physician Pre-Clinical Training, Biocompatibility Testing | Physician Pre-Clinical Training | ||||
| Clinical Path | Assemble SAB & MAB; Determine Endpoints & Variables | Clinical Validation Plan | Clinical Validation | Continued Clinical Validation | ||||
| Market Forecast | Survey Analysis; Pre-Clinical Data Analysis | Survey Analysis; Literature & Data Meta Analysis | Clinical Data Analysis | Summary White Paper | ||||
| Sales Path | Sales Plan | Recruit Sales Team | Sales Training | Reps Attend Cases |
Product Definition Acceptance / Concept Charter
Decisions:
Market Opportunity
Tech, Regulatory, IP Approach Feasible
Basis for Competition
Manageable Risk & Executional Gaps
Feasibility Demonstrated / Initial Design Acceptance
Decisions:
Value Proposition Viable & Sustainable
Product Risks Acceptable
Technical Feasibility Proven & Optimized
Manufacturing & Value Chain Confidence
Final Design Acceptance
Decisions:
Commercialization Readiness
Design Freeze
Design Output Meets Targets
Risk Mitigation Confirmed
Product Launch Acceptance / Launch Readiness
Decisions:
Final Validations
Regulatory Submission, Testing Complete
Sales Launch, Business Launch Plan Adjust