8 Tips to Manufacture Your First Medical Product

New medical products are being introduced on a daily basis. In 2015, the global medical device market was valued at $394 billion and is projected to grow to over $745 billion by 2030.

As such, it may be worthwhile for entrepreneurs looking to develop a new product to consider developing a medical device rather than a traditional pharmaceutical drug.

The process of producing a new medical product is not easy, however. A medical product must go through a lengthy FDA approval process before being able to enter the market and generate sales revenue, which can take years of research and development (R&D).

This article will outline 8 tips that can help guide you through this process, from idea generation all the way to commercialization of your first medical product.

1. Identify a Clear Market Need

While many people believe that manufacturing a medical product begins with an idea for new technology, often it is actually several years later.

Instead, entrepreneurs should start by identifying significant unmet market needs and then work backward to identify technologies that provide potential solutions. After doing so, they can then evaluate their ideas using feasibility studies and create prototypes before engaging in expensive R&D activities.

Some examples of areas where there may be significant unmet needs include:

– Development of diagnostics to detect diseases earlier, such as Alzheimer’s Disease and cancer

– New types of therapies for existing conditions that current treatments do not provide relief or cures (e.g., autoimmune diseases)

– Treatments for less common conditions that do not have a large market to attract the interest of pharmaceutical companies

– Preventative medicine to reduce the risk of future diseases (e.g., Alzheimer’s Disease and cancer)

2. Know if Your Product Already Exists in the Market

The first thing you should do before starting the journey of manufacturing your own medical product is figuring out whether or not it actually exists on the market already.

If so, then you need to know that all the research and development has likely already been done by someone else. If something like this is available, you need to ask yourself why someone would buy yours instead of what is currently available on the market. However, just because it’s already been done doesn’t mean that there isn’t room for new products in the same space – just check into how large that space is first.

3. Identify How Much it will Cost to Develop Your Product

Before you put too much time into developing your medical product, you should have a good sense of what it will cost.

This information can come from any number of sources, including patent lawyers or medical experts in the field. If you are not able to estimate the cost yourself, try to get help from people who have already gone through this process.

A large factor in cost is the manufacturing method you use to create your product. There are benefits of using CNC machining to make medical products. Or you could create a functional prototype using 3D printing and save it.

Often, manufacturers will pay for this upfront cost, though there are exceptions to this rule.

4. Find an Experienced Manufacturing Partner

A key aspect of successfully bringing a medical product to market is finding a reliable manufacturer that has experience producing products for other companies in the past.

You may want to find more than one potential manufacturer and get quotes before partnering with one of them. As part of this process, ask about previous products they have produced and what they learned from each one.

5. Design and Develop the Prototype

This step can be broken down into two different paths: the traditional route and the rapid prototyping option. For those following the more traditional approach, another important thing to consider is how you plan on testing and proving your concept before bringing it to market.

3rd party certification: Whether you need FDA approval or European community certification, this process will probably take many months to complete.

You should budget for potential additional costs here as well if you are not familiar with certifications already.

2nd party design verification testing (DVT): This is often an area where companies cut corners early on during development, which later bites them when it comes time to get their product into the market.

In addition to costing time and money, design verification testing also requires that your product be destroyed after the test is complete.

This means you will need a new sample for every test run, meaning more time and money spent.

6. Test it for Safety and Efficacy 

The most important part of your product development is now complete.

Now you can test the product for safety and efficacy, ensuring it meets its intended purpose without causing harm to users.

After completing these tasks, if you are still confident in the design process and feel you have done everything possible to bring a safe and effective medical product to market, you can submit an application to the FDA for clearance.

7. Be Wary of Counterfeiters

There are numerous companies that exist only to make knock-off medical products, but convince buyers they are the real thing. To combat the threat of counterfeiters, always invest in a good brand name and logo and be sure your packaging is secure and not overly similar to other products on store shelves. Before launching a new medical product, think about doing some market research to see if there are any counterfeits already out there for your product or others like it.

8. Expect and Accept Failure

Many medical products do not work as expected on the first try. For example, failure rates of new product development programs vary from 30% to 60%. In order for an entrepreneur to be successful, they must learn from their failures as well as successes as quickly as possible in order to improve upon their initial design and eventually bring it to market. Areas where entrepreneurs can make mistakes include:

In some cases, taking a step back and asking simple questions can prevent undesirable project outcomes. These may include:

Thus, in order to save time and energy (and money), it is best to get the answers to the following questions early on. Doing so will help prevent unnecessary setbacks later down the road.


While not all projects are guaranteed to be a success, the 8 tips outlined above will make it more likely for your project to reach its potential as quickly as possible. With hard work and dedication, you too can manufacture your first medical product.