Starting a medical device company is a great way to move your idea to market. The industry is on track to be worth $500 billion globally. If you have an idea for a new device, take some time to consider if you should build a company around your product. Before starting your medical device manufacturing company, here are some things to consider.
1. Understand the Details
Medical device manufacturing comes with its own unique set of challenges. Good practice (GxP) strategies and governmental regulations dictate processes your company must follow. Be prepared by developing GxP compliance procedures. These processes improve efficiency, increase approval time, and manage data. All of these help you manage Food and Drug Administration regulations.
2. Know Your Market
As with any new product, take the time to identify if there is a need for your device. A well-defined target market helps you build a strong marketing plan. It also provides data regarding the overall demand for your product. Ask yourself:
- How many people would benefit from this device?
- What specific conditions do we treat?
- Does the device have a higher success rate than current treatment methods?
- Is this treatment less expensive than traditional treatment?
- Will it provide a better quality of life for the client?
- What are the demographic characteristics of the patient?
3. Build a Regulatory Plan
A plan documenting the steps necessary to obtain approval through the FDA, specifically the 510(k) section of the Food, Drug, and Cosmetic Act. Obtaining regulatory approval is a stressful process; stay organized with written plans. Some manufacturers use a Clinical Research Organization or clinical trial consultant to help them manage the process.
4. Consult With Insurance
Investigate the possibility of insurance reimbursement. Ultimately, your device will be most successful if insurance companies cover a portion of the cost of the equipment. Before you invest in clinical trials, take the time to understand what information you need to provide to be approved by insurance companies. Reimbursement can take five or six years. It is cost-effective to start the process when you begin clinical trials. The easier it is for the client to afford the device, the more likely your patient will implement it.
5. Invest in Investors
Getting a new medical device from design to market takes three to seven years. During this time, you are not generating revenue. Investors provide a revenue stream to your company. Recruiting them is necessary to continue developing the device. Start by creating a business plan that defines how your product can benefit individuals and the medical industry. From there, you must design a marketing strategy targeted at investors. Develop a dynamic communication strategy using email and social media. Targeted advertising can attract individual investors. You must provide information about your business operations, ensuring investors that you are an efficient owner and good steward of their money.
6. Ask for Assistance
A trusted colleague can provide valuable advice about your device from initial design to final approval. Have them sign a confidentiality agreement to protect your information. Keep all of the data about your design in one location, from the initial concept to plans to marketing schedules. Be sure to date materials as you work on them. This helps you establish a timeline if you need to protect your project.
7. Get a Patent
Patents are another vital layer of protection on your device design. With a patent, you have the exclusive right to your product for up to 20 years. As the patent expires, you can request an extension. Start with a provisional patent which gives you up to a year to transition to a utility patent. Investors understand how patents protect their financial investments.
8. Recruit Strategically
After your product design, employees are your most valuable asset. Most business attorneys encourage you to keep the operations of both companies separate. This allows you to maintain a balance between both enterprises without pulling yourself in too many directions. Hire professionals that can help you build the best company, including:
- Insurance Specialists
- Human Resources Manager
- Manufacturing Employees
Building your company’s strategy around these factors helps you develop a more viable business plan. A dynamic business plan will help you identify your medical device company’s needs.