Medical device manufacturers can use a variety of strategies to recruit skilled workers. They can sponsor science, technology, engineering and math (STEM) programs and host job fairs to promote the industry and attract applicants.

To bring a medical device to market, you will need to identify the class of your device and determine the type of submission required for clearance. You will also need to register your device in the countries where you intend to sell it.

Develop a Business Plan

A business plan is a comprehensive document that outlines the goals, strategies and assumptions of your medical device manufacturing company. It helps you plan and organize your company and determine whether it has the potential to be profitable. A good business plan will also guide you through the complex process of obtaining FDA and/or Notified Body approval for your medical device.

The first section of your business plan should include a description of your company and its products. This includes information about your company history, legal structure, and key personnel. It’s also important to include a competitor analysis, including both direct and indirect competitors. This analysis will help you understand what sets your products apart from others in the industry, and identify ways to improve your market positioning.

Next, include a detailed financial analysis of your business. This will cover your projected costs for manufacturing, research and development, and marketing and sales. It will also include a projection of your revenue potential, based on your pricing and expected demand for your products.

Finally, you’ll need to develop a cash flow forecast for your company. This will show how much money your business will need to consume or generate each year, and it will help you determine if your venture is financially viable. Your cash flow forecast will also include information about your sources of capital, such as how much will be invested by shareholders and how much will be secured through bank loans.

Create a Marketing Plan

Creating and implementing a marketing plan for your medical device company is essential to establishing your brand and increasing market share. The marketing plan should include a thorough market analysis, a description of your target prospects and how you will reach them, and a detailed strategy for converting prospects into loyal customers.

Bringing a medical device to market requires a clear and well-defined plan that covers all aspects of the development and testing process. In order to avoid costly mistakes that can delay the launch of your product, you should consult with a regulatory specialist early in the design phase and establish a project timeline with realistic estimates for each stage of development. This will help you determine which markets to focus on and how much your product will cost to bring to market.

You should also research competing products to determine what features will give your device a competitive edge in the marketplace. The more you know about your competitors, the better chance you have of developing a superior product that will attract hospitals and physicians.

During this stage, you should also consider hiring contractors or outsourcing the production of your device to contract manufacturers in order to save time and money. Hiring contractors can also help you manage regulatory requirements in new markets and meet the FDA’s 21 CFR regulations or ISO 13485:2016 guidelines without too much extra work.

Develop a Manufacturing Plan

Having a clear manufacturing plan will help you estimate project timelines, budgets, and the amount of capital needed. It will also ensure that your team has a complete understanding of all the steps required to bring your medical device from concept to market.

This is particularly important since, in the eyes of the FDA, your company will be considered the manufacturer of record for any device you bring to market — regardless of whether you build everything in-house or subcontract the work to a third party. You will need to qualify any manufacturing suppliers you want to work with and apply quality management system principles internally, requiring time that needs to be built into your project plans.

You should start working on a manufacturing plan during the strategy phase of your medical device design process. It is inextricably interwoven with all of the other decisions you will make.

Your manufacturing plan should address a variety of issues, from production workflows to how your company will handle reviews and approvals. It should also cover the need for documentation, which is necessary to comply with regulations.

Most people who start a medical device company have an idea of the type of product they want to develop, but they are concerned about how difficult it will be to get their product into market. The good news is that there are ways to streamline the development process and reduce some of the obstacles. For example, you can use a software platform like Greenlight Guru to get feedback on your prototype from experts in the field.

Build a team

Many aspiring medical device entrepreneurs are discouraged by the complexity of bringing a new product to market. From FDA regulatory requirements to usability testing, it can feel like a daunting and endless process. But if you have a plan, you can minimize the stress and uncertainty while increasing your chances for success.

One of the most critical components of your planning process is creating a team. This is especially true for medical device manufacturers, who must be strategic in their recruiting efforts. They need to fill new positions and replace aging workers who are taking their decades of knowledge with them as they retire. It’s a tall order, and many companies are finding their growth stunted by a lack of skilled workers.

To make sure you have the right people in place to bring your device to market, start by developing clear and detailed job descriptions. These can be used to attract the best candidates and to help you screen resumes and conduct interviews.

Once you’ve built your team, be sure to set up a system for tracking and monitoring project milestones. This will allow you to predict how long each phase of the project should take and to budget accordingly. In addition, it’s important to have a thorough quality management system in place. This will ensure you have full traceability of your design controls, which is required by the FDA and ISO.