Biomedical Innovations

Our Process

For Design, Development, and Manufacturing


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

We can help you anticipate and prepare for unexpected changes with agility. Our customers trust us to provide design, manufacturing, and distribution services to enable them to overcome the challenges they face.

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

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

 


Concept and feasibility stages are very important steps during design and development. Information gathered, and testing completed during concept and feasibility minimize product risk during product development and prevent unexpected test failures during design verification and validation testing.

Taking time early in design and development to explore the concept and ensure that it is feasible can save costly delays due to product redesign and retesting.

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

Approaches include:

  • Molding
  • Thermomolding
  • 3D Prototyping

 


From early concept stage to design transfer, our team collaborates closely with customers and physicians to assure that user’s needs are well understood and met. Using state-of-the-art technology and our global resources, our highly experienced team strives to save you time and money by freeing up your resources to focus on strategy, sales and expansion.

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

We are committed to contributing widely to society through customer's trust and satisfaction of quality, cost, delivery, services and speed. Aiming for quality that stands up to the customer's expectations, while pursuing zero defects in our products and conforming to relevant legislation and regulations.

We establish and maintain a quality management system and continually improve it's effectiveness. Biomedical Innovations already has an understanding of your geographic region and its regulatory requirements. Our diversity gives us years of experience in certifications, and quality standards as we already manufacture products for worldwide distribution.

Quality is integrated into everything that we do so you can be confident in all phases, from concept to commercialization, that the highest standards will be met.

Our Accrediations:

  • 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 our customers that our quality management system (QMS) has met the requirements of international standards. These standards represent international consensus on best practices. Our adherence demonstrates that we are a reliable organization 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 is the premier medical device contract manufacturer offering one partner manufacturing from prototype to commercialization. Let us use our total capabilities, ultimate components and our unique global footprint to bring your vision to life.

Our skilled engineering staff has many years of experience in transitioning engineered designs to manufactured devices. They are equally equipped to evaluate and transfer existing manufacturing lines or assembly processes. Our methods include: a thorough review and transfer of your documentation; executing process characterizations and improvements; facilitating component qualifications, and equipment and tooling IQs; performing OQs and PQs; and managing re-validation of packaging and sterilization.

 

Low-Cost Manufacturing

Biomedical Innovations low cost manufacturing facility has the unique ability to transfer products from low volume production in any facility to high volume production in the Dominican Republic. Our business in the Dominican Republic includes products transferred from existing customer facilities, as well as from customers with new and innovative technology just being released into the market. There are over 400 employees and facilities in excess of 120,000 square feet.

  • 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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