Medical Device Design and Development (MD3) LLC

Here is some free help from MD3-LLC. Tips to attract investors and raise funds for your Medical Device Startup There are 7 tips in total. #1 and #2 are presented here - please follow my other posts for the remaining #3, #4, #5, #6 and #7. Is your medical device company raising funds or planning to begin the process soon? There are many stages of the fundraising process, each presents their own unique set of challenges. How can you position yourself for successful fundraising. What do medical device investors want to see? #1. Build the business case for your medical device. One of the best ways to create a compelling business case is by conducting thorough market research and build a prototype to show proof of concept. Market Research Define the core information about the device. What need does the device meet? Is there a proven clinical need for my medical device? Why is the medical device necessary? Are there similar existing medical devices on the market? identify the end-user(s) of the device. Define who will purchase the device? What is the potential market size for the device? ? Proof of Concept Prototype Building a prototype. It needs to prove the concept of your device. The prototype doesn’t have to be in its final design or go-to-market state. Prototypes are very useful for communicating the vision of your medical device. Prototypes allow all stakeholders, including investors, to better understand the long-term goals and vision of your product. #2. Know investor types Put yourself in the shoes of an investor. What do they need to see to write the check? You need to demonstrate that your technology is worth funding and that your team has the knowledge and skills to deliver. It is important to familiarize yourself with the different types of investors. Low-risk investor - looking for safe investment opportunities with companies that bring little risk to the table. High-risk investor - may be willing to invest based on prototypes and ideas, rather than established processes and plans or submission paperwork. ? Investors are concerned with 3 types of risk Technical Risk - Does the idea work? Business Risk - Is there a market for it? People Risk - Does the company have the right people to do the job?

MD3 - Providing Engineering Consulting to Medical Device Designs Biomedical Engineering and Medical Device Design MD3 applies a risk-based approach to medical device designs and commercial realization. This technique delivers substantial results in productivity while maintaining the highest assurance of product designs and human safety. We deliver cost-effective, FDA-compliant solutions. We employ a Total Quality methodology for design, validation, and manufacturing. We partner with our clients to develop and deliver innovative engineering solutions supporting project initiatives. Medical Device Design, Validation, Manufacturing Automation, and Machine Design MD3 is experienced with the FDA's requirements for medical devices. We incorporate good documentation practices (GDP) and validation strategies into our designs. We consider the impact of the design on manufacturing techniques, cost control, cleaning, and sterilization procedures. Our engineering staff produce medical device prototypes and provide documentation for 510K submission, UL, CE, and other certification. Risk-Based Validation Engineering Services MD3 manages the validation process by developing a strategy that includes requirements, risks, and test procedures to ensure compliance with good manufacturing practices. MD3 can develop Installation, Operation, and Performance Qualification protocols for any type of manufacturing process, facility, or equipment. Computational Methods to Support Regulatory Filings for Medical Devices Utilize FEA to reduce product development costs, limit liability risk, reduce time to market, and support FDA 510k filings. Identify and analyze worst-case implantable device size for use in mechanical testing. Verify radial force, anchoring, dynamic compliance, and fatigue loading conditions. Manufacturing Automation & Machine Design MD3 designs fully automated manufacturing systems that incorporate industrial robots, vision systems, and QC testing. We specialize in building turnkey processes and equipment solutions that are reliable, cost-effective, and GMP compliant.

Medical Device Design and Development (MD3) LLC Wants You to Be Safe Online A few months ago, we sent an email and placed an alert on our website asking you to be on the lookout for email scams. Unfortunately, these scams are an ongoing problem and a part of our lives. The criminals behind these scams send emails that look like they were sent by Medical Device Design and Development (MD3) LLC or another company using realistic logos and other features designed to trick you so they can steal your information. Typically, their emails ask you to provide information, complete a survey, or fill out a form. These emails are NOT from Medical Device Design and Development (MD3) LLC, and the criminals who send them did NOT get your email address from us. We want you to know about these scams so you can protect yourself and your personal information. Here are a few tips to help you avoid email scams: Be suspicious of any email that asks for any of your personal or business information, any credit card number, or any password or account information. Look for spelling or grammar errors - email scams are often poorly written. Review the actual email address from the sender - scam emails often come from unusual addresses. Medical Device Design and Development (MD3) LLC will NEVER ask you for your credit card number or address in email. Please be careful with your financial and personal data, and if you receive a scam email that looks like it came from Medical Device Design and Development (MD3) LLC, please let us know. Thank you, Medical Device Design and Development (MD3) LLC Support Team ?

MD3 - Providing Engineering Consulting to Pharmaceutical Engineering MD3 is proficient regarding Good Manufacturing Practices (GMP) MD3 will design and build an individual piece of equipment or a complete manufacturing line to mechanize or automate and improve your processes. We use GMP compliant designs to create turnkey solutions that are reliable, cost-effective, and suitable for statistical validation. Our risk-based approach to pharmaceutical engineering is a proven strategy for managing process design, development, and change. MD3 partners with you to determine the best solution to meet your goals. Our engineering team are highly skilled and experienced with the latest technologies. We deliver innovative equipment and system solutions using nonproprietary technologies (including open standards whenever possible) to accelerate adoption and simplify validation. MD3 understands current GMP requirements and follows the proven Total Quality Approach providing sound engineered solutions. Process Engineering, Facilities, and Safety MD3 provides support services for production and utility systems in FDA approved facilities. Our engineers design, improve, and support the systems that run manufacturing operations. Risk-Based Validation Engineering and FDA Compliance Our engineers provide turnkey validation services that cover the entire validation process. We develop and execute qualification protocols for equipment, facility systems, and processes. Our documentation packages comply with regulatory requirements. MD3 performs validations of automated control systems in accordance with 21 CFR Part 11.

MD3 - Providing Engineering Consulting to Medical Device Designs Biomedical Engineering and Medical Device Design MD3 applies a risk-based approach to medical device designs and commercial realization. This technique delivers substantial results in productivity while maintaining the highest assurance of product designs and human safety. We deliver cost-effective, FDA-compliant solutions. We employ a Total Quality methodology for design, validation, and manufacturing. We partner with our clients to develop and deliver innovative engineering solutions supporting project initiatives. Medical Device Design, Validation, Manufacturing Automation, and Machine Design MD3 is experienced with the FDA's requirements for medical devices. We incorporate good documentation practices (GDP) and validation strategies into our designs. We consider the impact of the design on manufacturing techniques, cost control, cleaning, and sterilization procedures. Our engineering staff produce medical device prototypes and provide documentation for 510K submission, UL, CE, and other certification. Risk-Based Validation Engineering Services MD3 manages the validation process by developing a strategy that includes requirements, risks, and test procedures to ensure compliance with good manufacturing practices. MD3 can develop Installation, Operation, and Performance Qualification protocols for any type of manufacturing process, facility, or equipment. Computational Methods to Support Regulatory Filings for Medical Devices Utilize FEA to reduce product development costs, limit liability risk, reduce time to market, and support FDA 510k filings. Identify and analyze worst-case implantable device size for use in mechanical testing. Verify radial force, anchoring, dynamic compliance, and fatigue loading conditions. Manufacturing Automation & Machine Design MD3 designs fully automated manufacturing systems that incorporate industrial robots, vision systems, and QC testing. We specialize in building turnkey processes and equipment solutions that are reliable, cost-effective, and GMP compliant.

As the end of the year approaches, it's important to plan ahead for any upcoming projects and programs. If you're considering a project or program, know that there is still time to schedule your Request for Quotation (RFQ) before the year ends. To make the process as seamless as possible, we encourage you to call our office at 954-925-1779 for a consultation to discuss your requirements. Our team of professionals is here to assist you with any questions or concerns you may have. Don't wait until it's too late, reach out to us today and let us help you with your program needs. We are incredibly grateful to have customers like you. Your support allows us to do what we love, and we couldn't be more thankful. As the holiday season approaches, we want to extend our warmest wishes to you and your loved ones. We hope this time is filled with joy, peace, and happiness. Thank you again for your continued loyalty, and we look forward to serving you in the future. Eamonn and the MD3 team