how to get into medical device manufacturing

So, you want to start a medical device software development company? That’s great! But where would you start? How would you do it? These are just a couple of questions you have to ask yourself before even thinking of making your first move. 

There’s no doubt that technology has increased the overall efficiency and reliability of medical devices. The bar is constantly raising for medical device companies thanks to the importance of medical processes and equipment that help keep patients alive and well. It’s important to take the proper steps when starting and maintaining your medical device manufacturing company and remaining successful. 

What Are Medical Devices?

A medical device is any instrument, material, appliance, machine, apparatus, implant, or diagnostic reagent, etc. and/or any part or accessory that is intended for use for the diagnosis, treatment, mitigation, cure, monitoring, or prevention of disease, physical or mental condition, or abnormal or mental states or symptoms, etc. 

Some of the most commonly used medical devices manufactured today include, but are not limited to: 

  • I.V. Cannulae
  • Bone Cements
  • Heart Valves
  • Scalp Vein Set
  • Orthopedic Implants
  • Cardiac Stents
  • Catheters
  • Drug-Eluting Stents
  • Orthopedic Implants
  • Internal Prosthetic Replacements

Requirements for Your Business

  • Factory
  • Trained technical staff
  • Machinery
  • Lab equipment
  • Office accessories
  • Water supply
  • HVAC unit
  • Sterilization unit
  • Electricity
  • Machine workers
  • List of medical devices being manufactured
  • Non Objection Certificate if required

Required Licenses

  • Registration for your company
  • Manufacturing license
  • Laboratory license
  • Tax number for goods and services

How To Start Your Medical Device Company

Do Your Research

You can’t start a business without first doing a little research. You should become well aware of your customer base. If you don’t know what the customer base is, you’re in for some serious trouble. Knowing the size of your customers is the key to avoiding being overwhelmed by the demands of your customers. 


You should thoroughly research what the preexisting market demands are, population, target customers, and the cost of the healthcare system. You can find this information in journals, newspapers, or through online research. Additionally, you could take the extra step and hire an actuarial consultant. 

Start Small

We’re sure you have some pretty big dreams, but when it comes to manufacturing medical devices, you need to start small. The smaller your medical device product designs are, the easier they are to produce. This will allow your small business to have the room to grow to allow you to achieve bigger business objectives down the road. Not only that, but smaller medical devices are quicker to produce. Quick turnaround times are ideal for new businesses. 

Get Certified

Some may argue about this first step, but we think that it’s an important one to list first. Getting certified by the FDA and other international regulatory agencies is a must. Your medical devices are going to decide the fate of a patient, which is why there are more strict regulations that come with the business. 


As a startup, it’s possible that you may have some trouble navigating through the regulatory processes. There are actually many experts that can help you meet all of the regulations that will help keep your business in compliance with the law. 


If you have a unique idea, then you need to protect it. You should protect the name of the brand, ideas, processes, logos, and more through patents or trademarks. You can certainly consult with an IP attorney who can help you protect your business and ideas. When your ideas are patented, you can sell unique products that no other company produces, giving you a competitive edge in the market and the opportunity to grow larger than other companies. 


You’re going to need funding to start up a company of this magnitude. You will need enough funds to establish the base of your company. You will need to purchase machinery, renting or purchase a suitable work office, factory, and much more. 

Types of Funding

There are several types of funding you can choose from. Here is a couple: 

  • Angel Investors: These are individuals who have an interest in a specific disease or condition. They can pay top dollar to fund your business if you are manufacturing a machine that can benefit their interest. 
  • Private Placement: Private placement is the sale of securities to a small number of investors. They will fund your vision by raising money from individual donors. 
  • Entrepreneurial Competitions: A lot of the time, universities or large companies try to attract technology partners by offering technology contests with large payouts in cash and in-kind services. 
  • Crowdfunding: We’re sure you’ve heard of this one. Crowdfunding is the most effective way to raise money without getting involved with the bank. It uses small amounts of capital from a large number of individuals to finance a new business. This is ideal for the development phase when funds are needed for prototyping or validation. 
  • Loans
  • Sell Assets
  • Form Partnerships

Acquire Competent Technical Staff

When operating a medical device manufacturing company, you must be in the presence of technical staff. These are some of the requirements for the technical staff: 


  • Must be a graduate in Pharmacy or Engineering from a recognized University 
  • A graduate in science from a recognized University
  • A diploma in Pharmacy or Engineering from a recognized college


In order to stand out in the market, you need the best products. Producing high-quality products is also the one and only way to make sales and remain profitable. If your team is highly qualified, they’ll be able to create the best products to keep your business running and reputable. 


Picking a strong team will certainly make all of the difference and it could be what makes you stand out from your competition. It’s no secret that startup work environments are extremely challenging and this stands true in the medical device manufacturing field. Choose a team that can stick with you through the rough times and ultimately leads you to success. They should work hard to help you achieve your goals. 

Final Thoughts

It’s crucial to remember to take constructive criticism. As with all startups, there are going to be critics. They are there to help you. The companies that succeed the most are the ones that take customer feedback seriously and incorporate client suggestions. The first year of business is always the hardest, especially for medical device manufacturing companies. As long as you comply with the regulations, you will have no problem operating your company. 

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