Biomedical Innovations

Our Process

For Design, Development, and Manufacturing


In developing core competencies in customized solutions as an OEM provider, Biomedical Innovations has perfected a streamlined process to proving out your concept.

We help our customers anticipate and prepare for unexpected changes with agility. Our customers trust us to provide innovative design, manufacturing, and distribution services — overcoming the challenges of the production process.

  • Idea Generation & Layout
  • Added Innovation & Enhancement
  • Project Outline & Scheduling
  • Project Enhancements to Final Product
  • Cost Reduction Initiatives

Our world-class system ensures efficient, high-quality results — from the earliest stages through project completion.

 


Concept and feasibility stages prove essential steps in design and development. Gathering information and completing tests during stages of concept and feasibility minimizes risk in product development and prevents unexpected test failures in design verification and validation testing.

Taking time early in design and development to explore the concept and ensure its feasibility can prevent costly delays due to product redesign and retesting.

After defining the purpose and requirement for the prototype, determination of fabrication method(s) follows. Criteria for fabrication method can include piece part and tooling cost/lead time, finish, dimensional accuracy, and strength of materials.

Innovations Team Approaches include:

  • Molding
  • Thermomolding
  • 3D Prototyping

 


From early concept to design transfer, our team collaborates closely with customers and physicians to best understand and meet user needs. Backed by state-of-the-art technology and global resources, our experience saves you time and money, freeing up resources to funds and focus on strategy, sales, and expansion.

Innovations Team Approaches include:

    • Idea Generation & Product Layout
    • 3D Design
    • Rapid Prototyping
    • Design Proofing & Enhancements
    • Design for Excellence (DFX)
    • Dedicated Program Management
    • Stage Gate Review Process
    • Access to Global SME's

Committed to empowering your vision and contributing widely to society, we value customer trust and satisfaction — empowering your vision through quality, cost, delivery, services, and speed. In partnership with our customers, we pursue a standard of zero defect in our products and conform to relevant legislation and regulations.

We establish and maintain a quality management system and continually improve efficiency. Biomedical Innovations brings valuable knowledge of your geographic region and its regulatory requirements. As a leading manufacturer of best-in-class products for worldwide distribution, we offer global diversity and experience in certifications and quality standards.

Integration of quality standards from concept to commercialization ensures we meet the highest standards of design and delivery.

Innovations Team Accreditations include:

  • ISO 9001-2008
  • ISO 13485-2003
  • MDD Annex V
  • FDA
  • CE
  • CSA
  • UL
  • ANVISA GMP

We are registered with the USFDA and licensed with Health Canada as a manufacturer of medical devices. We also have experience in UL, CE, and CSA accreditations.

Certification by independent third parties assures customers of a quality management system (QMS) which meets the requirements of international standards. These standards represent international consensus on best practices. Our adherence demonstrates organizational reliability and instills confidence in our provided solutions.

Clinical & Pilot Manufacturing

Biomedical Innovations provides specialist manufacturing support during the development stage of the product lifecycle, from concept prototypes to full product builds for pre-clinical and clinical requirements — optimizing your production line for FDA approval and scaling.

  • Dedicated pilot line manufacturing and assembly area
  • Extensive equipment available for use without capital expenditure
  • Process FMEA / FMECA
  • Validation/verification pre-clinical builds
  • Design for assembly (DFA) and Design for manufacturability (DFM) assistance

Commercial Manufacturing

Biomedical Innovations performs as the premier medical device contract manufacturer — offering one partner manufacturing from prototype to commercialization. Our total capabilities, ultimate components, and unique global footprint empower your vision, making innovation reality.

Our skilled engineering team holds many years of experience in transitioning engineered designs to manufactured devices. The team is equally equipped to evaluate and transfer existing manufacturing lines or assembly processes.

Innovations Team Methods include:

  • Thorough review and transfer of customer documentation
  • Execution of process characterizations and improvements
  • Facilitation of component qualifications, equipment, and tooling IQs
  • Performance of OQs and PQs
  • Management of packaging and sterilization re-validation

 

Low-Cost Manufacturing

Biomedical Innovations can expediently transfer products from low volume production in any facility to high volume, cost-effective production in our Dominican Republic based manufacturing facility. Our site in the Dominican Republic includes products transferred from existing customer facilities, as well as products from customers with new and innovative technology just released to market. The facility of 120,000 square feet employs over 400 people.

Production Value Benefits include:

  • Low cost manufacturing
  • Production facilities 105,000 sqft & additional lease options
  • Cleanroom Manufacturing
  • FDA registered & ISO 13485
  • Manual and semi-automated assembly
  • Expertise in adopting specialty process
  • Complex sub assemblies & finished devices
  • Extremely low turnover rate <3%
  • Value improvement engineering

 

 
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