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What does it cost to set up a Medical Device Company and just do it myself?


Introduction

The world is becoming more expensive... Interest rates, inflation, cost of capital, financing, etc. What does a medical device company do when it's time to set-up their own office?


I just want to do it myself.


Setting up a medical device office can be a complex and costly endeavor, but it is a necessary investment for companies looking to bring innovative medical devices to market. From regulatory compliance to manufacturing and distribution, there are various components to consider when budgeting for a medical device office.


This article is meant to list the items and general costs associated with setting up your own medical device office.


Foundation

There is a lot that goes into setting up the foundation of your medical device company. It is important to consider the entire development cycle (R&D) from Phase 0 to Phase 5. The standard in the medical device industry that is agreeable is the following. However, let's explore the categories from a different perspective.


Development Process



Medical Device Company Costs


Categories

  1. Setting up the Office

  2. FDA Quality Management System

  3. Research and Design Team

  4. Manufacturing Equipment and Testing Equipment

  5. Die Mold and Tooling Equipment and Engineers

  6. Medical Device Contract Manufacturing facility

  7. ETO Sterilization

  8. Distribution Costs

  9. Medical Device Sales Team

  10. Medical Device Marketing Team


Sub Category of FDA Regulatory

  1. FDA Quality Management System

  2. Regulatory Consulting

  3. Documentation and Record-keeping

  4. Quality Control and Testing

  5. Compliance Audits

  6. Product Registration and Listing

  7. Post-Market Surveillance

  8. Labeling and Packaging Compliance

  9. Training and Education

  10. Legal and Regulatory Affairs


Budget and Timeline:

  • Estimated Time: 3 - 6 months

  • $20K - $60K Per Month

  • *Dependent Upon Multiple Variables


Overall Category Estimates


Phase

Description

Our Speed

Our Cost

Setting up


Leases, Insurance, Furniture, Tables, Phones, Internet, IT, Taxes, etc

2 months


$20,000 - $50,000


FDA QMS


Grand Avenue, DocuSign, Consulting, Computers, ERP System, IFU, etc

2 months


$20,000 - $50,000

RD Team

Engineers, Benefits, Taxes, Insurance, 3D printers, Materials, Computers, Desks, Chairs, etc

1 - 2 months


$20,000 - $50,000


MFG equipment and testing

Engineers (etc), Manufacturing Equipment, Testing Equipment, etc

2 - 4 months


$10,000 - $500,000


Die Mold and Tooling


Engineers (etc), Manufacturing Equipment, Testing Equipment, etc

1-2 months


$80,000 - $750,000


ETO Sterilization

Engineers (etc), Manufacturing Equipment, Testing Equipment, etc

4 months

$175,000 - $250,000

Distribution Costs

Warehousing, Associated Costs as such

1 - 2 months

$2,000 - $10,000


Medical Device Sales Team

Sales (Benefits, etc)

1 - 2 months


$5,000 - $100,000

Medical Device Marketing Team


Websites, Literature, Online Ordering Platforms, etc

1 - 2 months


$5,000 - $20,000


Total

3 - 12 months

$20k - $200,000+


  1. Setting up a Medical Device Company office:

    1. This includes leasing office space, purchasing office furniture, internet, phone, chairs, desks, computers, and setting up an IT infrastructure. Costs may vary depending on the location and size of the office.

  2. FDA Quality Management System:

    1. FDA Quality Management System: This may involve the cost of implementing a quality management system that complies with FDA regulations, including the cost of software, training, and hiring a regulatory quality team.

    2. Regulatory Consulting: Companies may need to hire regulatory consultants to help navigate the complex landscape of FDA regulations and ensure compliance with all necessary standards.

    3. Documentation and Record-keeping: Companies need to invest in systems and personnel to maintain thorough documentation and records to demonstrate compliance with FDA regulations.

    4. Quality Control and Testing: This includes the cost of setting up quality control measures and testing procedures to ensure that medical devices meet regulatory standards.

    5. Compliance Audits: Companies may need to budget for internal or external audits to ensure ongoing compliance with FDA regulations.

    6. Product Registration and Listing: There are costs associated with registering and listing medical devices with the FDA, including submission fees and administrative costs.

    7. Post-Market Surveillance: Companies need to budget for post-market surveillance activities to monitor the safety and performance of medical devices after they have been commercialized.

    8. Labeling and Packaging Compliance: Ensuring that labeling and packaging meet FDA requirements may involve costs for design, printing, and regulatory review.

    9. Training and Education: Companies need to invest in ongoing training and education for employees to ensure that they understand and comply with FDA regulations.

    10. Legal and Regulatory Affairs: Companies may need to hire legal and regulatory affairs personnel to navigate the complex regulatory landscape and ensure compliance with FDA regulations.

    11. These are just a few examples of the regulatory compliance costs associated with setting up a medical device office. Each company's specific costs will depend on the nature of their products, the scale of their operations, and the regulatory requirements that apply to their specific market.

  3. Research and Design Team: A dedicated team for research and design is essential for developing new medical devices. This may include costs for hiring engineers, rapid prototyping equipment, and laboratory space.

  4. Manufacturing Equipment and Testing Equipment: Companies need to invest in specialized equipment for manufacturing and testing medical devices. This may include costs for cleanroom facilities, 3D printers, and testing machines.

  5. Die Molds, Tooling Equipment and Engineers: For companies that manufacture their own medical devices, there may be costs associated with die mold and tooling equipment, as well as hiring engineers with expertise.

  6. Medical Device Contract Manufacturing Facility: Some companies may opt to outsource their manufacturing to contract manufacturing facilities. Costs associated with this may include contract manufacturing fees, transportation, and quality control.

  7. ETO Sterilization: Sterilization is a critical step in the manufacturing process for medical devices. Companies need to budget for equipment and facilities for ethylene oxide (ETO) sterilization.

  8. Distribution Costs: Warehousing, receiving, and inspection are all essential aspects of the distribution process for medical devices. Companies need to budget for storage facilities, transportation, and quality control measures.

  9. Medical Device Sales Team: Companies need to invest in a sales team to promote and sell their medical devices. This may include costs for hiring sales representatives, training, and their associated monthly expenses.

  10. Medical Device Marketing Team: A dedicated marketing team is essential for promoting medical devices to healthcare professionals and consumers. This may include the costs for literature design, website design and maintenance, social media campaigns, digital advertising, and trade show participation.


Conclusion

In conclusion, setting up a medical device office involves a wide range of costs, from office setup to regulatory compliance, research and design, manufacturing, distribution, sales, and marketing. While the initial investment may be substantial, it is a necessary step for companies looking to enter the highly regulated and competitive medical device industry. By carefully budgeting for these line item costs, companies can set themselves up for success in bringing innovative medical devices to market.


About VitaTek

VitaTek stands at the forefront of the medical device industry as the world’s only in-house, vertically integrated medical device company. With a comprehensive range of capabilities under one roof, including research and design, prototyping, FDA regulatory, in-house tooling, manufacturing, clean room assembly, sterilization, and sales. VitaTek offers an unparalleled level of efficiency, quality, and control throughout the product development process. VitaTek is the uniting of two very capable medical device companies (Vita Group and I-Tek), located in the heart of Minnesota's Medical Alley, St. Paul, MN.


Vita Group is a medical device incubator that works with various companies and inventors to bring ideas from napkin-sketch to manufacturing, commercialization, and in-the-field sales. We have worked on over 35 products, we currently have 9 OEM products in manufacturing, and have 3 OEM products in the market.


I-Tek Medical is an ISO 13485 certified and FDA-registered contract design, development, and manufacturing company and has offered an extensive range of medical device manufacturing services for 20 years, from early concept prototyping, tooling, injection molding, clean room assembly to sterile barrier packaging and sterilization coordination, as well as project and supply chain management. I-Tek Medical has designed, developed, and manufactured over 120 medical devices representing 70+ medical device companies, and the employees are trained in all areas of medical device development and manufacturing. We manufacture Class I to Class III devices. The unique combined company allows us to offer an unmatched vertically integrated solution to achieve high-speed, low-cost medical product development. We also have in-house ETO sterilization capabilities, enabling us to complete sterilization faster and batch process smaller quantities as needed, all in our facility.


Additionally, I-Tek's die mold and tooling shop offers a broad range of services, including part design, review for moldability, mold flow analysis, 3D modeling, custom mold building, mold transfer, mold modification, and mold repair. The manufacturing facility includes Class 7 (10,000) and Class 5 (100) cleanroom manufacturing environments and cost-efficient white room manufacturing areas. As a result, VitaTek is the best and most cost-effective solution to medical device development and manufacturing to decrease development time and increase your speed to market.



Jason Scherer

VitaTek, Chief Executive Officer

Cell 303.775.2211

390 Commerce Drive

Woodbury, MN 55125




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