General

We provide end-to-end services for medical device companies of any size from concept and business formation to post-commercialization activities. To learn more, go to the "Services" tab on the website menu.
Backed by our network of over 350 consultant experts, we are strong in many technology types and therapeutic areas. To view our competencies, go to the "Expertise" tab on the website menu.
The Fractal Network is our extended network of industry experts who contribute to Factor 7 projects. We only work with consultants we know and trust through our collective medical device experience.
Factor 7 Medical is a state of Ohio registered LLC, but our team is spread across the United States, with affiliates in other countries.
We work with virtually companies of every size. To learn more, go to the "Who We Serve" menu on the website.
We can get started at any stage of a project -- even pre-funding. To engage in a meaningful conversation with us, please fill out the Contact Us form. We'll get back within 1-2 business days!
While some projects are confidential, you can take a look at the "Case Studies" page of our website. To get a more general sense of the wide variety of products we have worked on, go to the "Our Expertise" tab on the website menu.
Factor 7 Medical provides resources and is engaged throughout your entire project.
We generally do not take on projects for "placements" although can perform that for the right searches.

Product Development

The average time to develop a project can depend on many factors including product type, device uniqueness, regulatory pathway, and current phase of the development project. Each project will be different; we'd be happy to discuss yours and provide a custom proposal.
We typically provide a project manager to ensure timelines are being met as well as supporting resources for all disciplines your project needs (e.g. engineering, quality, regulatory, operations, reimbursement, etc.)
The members of our Fractal Network can be embedded directly into your internal team to provide support and expertise as needed.
We can quickly deploy our resources mid-project to immediately make an impact and start turning the ship the right direction, as appropriate. While it’s always better if we are involved from the concept phase, we regularly jump in the middle or even towards the end of development projects.
Factor 7 Medical uses a network of several prototype shops with fast lead times to quickly make your concept a reality.
Our teams work with trusted 3rd party testing facilities to perform all Verification and Validation testing.
While other firms with full-time staff force-fit existing resources to customer projects to keep them billable, our Fractal Network allows us to provide a project resource for our customers simply because they're the best.
Yes, we provide services in software engineering (front end and back end), AI, and data analysis.

Quality & Regulatory

Factor 7 Medical maintains its own Quality Management System (QMS) and can set up customers with their own QMS as needed.
We are not currently ISO 13485 certified, but do have an ISO 13485 compliant QMS.
We primarily focus in the major device markets of the United States, European Union, United Kingdom, and Canada. However, our team collectively has experience across the globe. Reach out to us for any specific requests and we'll be happy to discuss further.

Capital Formation

We do not currently have a fund. We have access to and knowledge of various funding sources and will guide our startup clients to the ones most appropriate for them.
We support our startups on a variety of sources, as appropriate for their specific needs. This includes:
- Angel Investors
- Family Offices
- Venture Capital Firms
- Private Equity Firms
- Investment Banks
- Strategic Partnerships: Collaborating with another company that provides capital, resources, or distribution channels.
Factor 7 does support startups across the various needs that arise. We are not an "incubator" in the sense of a structured program with weekly classes. We are a guide, working and executing alongside our clients.
Before you start pitching to investors, you should:
- Create a business plan: Clearly outline your business model, market opportunity, competitive landscape, and financial needs.
- Build a pitch deck: Develop a concise and visually appealing presentation that covers the problem, solution, business model, team, financials, and milestones.
- Organize your financials: Prepare up-to-date financial statements and projections that align with your business narrative. GAAP accounting is preferable to cash accounting.
- Build your network: Attend industry events and leverage online platforms to connect with potential investors and mentors.
- Organize legal documentation: Gather all relevant legal agreements, intellectual property filings, and a clean capitalization (cap) table.
- Prepare for due diligence: Be ready to provide additional documentation and transparently address any weaknesses in your business.
There is no single right answer, but you should have a thoughtfully calculated "runway" that considers your monthly burn rate. You should raise enough capital to achieve significant milestones that will attract the next round of funding, including an added buffer for unexpected costs and delays.
Valuation is what your company is worth, and it is most often based on comparable companies in your industry. Investors will ultimately determine the final valuation, but a strong financial model allows you to enter negotiations with realistic expectations.

FAQs

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