Medical laboratories bear an important responsibility in the healthcare field. Labs’ tests and analyses help doctors diagnose and treat patients’ problems, and labs help healthcare workers understand a patient’s conditions throughout the course of treatment.
Starting a lab business requires extensive research and planning. And it’s important to hire professional staff members who can follow the proper procedures so that your lab can maintain or earn accreditation. Learn more about the process with this step-by-step guide to starting your own laboratory business.
1. Research and Create the Business Plan
Every great business starts with research. Then, you compile this research into a business plan. Your business plan helps you plan for success, outlining your goals and how you will achieve them.
Knowing the parts of a business plan will help guide and then organize your research. The key components of any successful laboratory business plan are:
- The executive summary: This is the largest part of your plan and highlights key parts from the entire plan. After reading the executive summary, the reader should know your mission statement, what your business does, how it does it, who it’s targeting, and what differentiates It from the competition.
- Products and services: This includes pricing and unique features and benefits.
- Market analysis: This includes information about your target market, your coemption, and potential changes in the industry that could impact your business.
- Marketing strategy: A marketing strategy determines how your lab will attract and retain customers.
- Budget and financial planning: These concerns cover potential costs and how to manage them. Include a pro forma statement that projects future income and expenses. The pro forma is helpful for attracting lenders and investors.
2. Establish the Business Structure
Next, decide on your lab’s business structure. The structure determines the activities your business can do, legal responsibilities, and your lab’s tax obligations. Seek legal and tax advice from experts to help you determine which structure best suits your business goals and needs.
The four main types of business structures are sole proprietorship, partnership, corporation (C or S), and limited liability company (LLC). Here is basic information about each business structure type.
- Sole proprietorship: This is the simplest structure, with one individual responsible for operating the business. Business income and expenses are included on the owner’s tax return.
- Partnership: This is the simplest structure for a business with two or more owners. The partners are personally liable for business debts.
- Corporation: This complex business structure requires owners to meet more tax requirements and follow more regulations. But this gives your business a separate entity from the owners. Choose between a C-corporation or an S-corporation.
- LLC: This structure combines elements of partnerships and corporations. It gives owners personal liability protection and reduces tax requirements.
3. Fund the Lab
The next step in this guide to starting your own laboratory business is to determine who will fund your business. If you want to self-fund, you might rely on people you know for capital or take money from your savings or investments. But you’ll likely want to finance your lab with investor money or by taking out bank loans. Seek expert financial advice while you make the important decision on how to finance your lab.
Getting venture capital from investors involves sharing your business plan and working out the terms of your financial agreement. The potential investors will look through your business plan, so it’s a good idea to create a presentation that includes visuals that highlight why they should invest in your company. And to get a business loan, expect to share your business plan and financial projections for the next five years with banks or other lenders.
4. Secure the Lab Facility
After financing your lab, it’s time to find your facility and get equipment. When looking over your facility options, think of the site location. Choose a location that supports rather than hinders your work. For example, think of how far samples will need to travel to and from your lab and where they need to go.
Another thing to consider is the facility’s size. You want to avoid space that’s too small for your future growth, but you want to balance your space needs with cost.
Also think about your lab’s utilities, including electrical and plumbing needs. Labs need greater electrical capacity than most facilities. And you need to outfit your space for uncommon plumbing fixtures such as handwash sinks, emergency shower stations, and floor drains.
5. Purchase Equipment
Once you have decided on the space, it’s time to purchase lab and office equipment. Think strategically about what you want your lab equipment to accomplish so that you buy equipment with features you’ll use.
Next, find vendors. You could choose to buy new equipment directly from the manufacturer. This way, you’ll benefit from the warranty and service contract. Or you could buy discounted devices from third-party vendors. These sellers often sell products from multiple manufacturers, making it easy for you to compare features and costs.
Ask your vendors to demonstrate equipment. Once you’ve narrowed down your vendor options, negotiate between the vendors so you can get competitive pricing, longer warranties, or better service contracts in case the equipment malfunctions after the warranty expires.
Office equipment includes ergonomically designed chairs and tables. You’ll also need to purchase software to handle things such as billing, reporting, and managing data.
6. Hire Personnel
Follow federal and state employment and labor laws as you create employee benefits, write job descriptions, and draft communication resources like employee handbooks. Using a laboratory consulting firm gives you access to the best candidates for every job position.
You can work with a lab consulting agency to staff your lab at all levels, from technicians to directors. You’ll quickly build a team of professionals that can perform all the duties your lab needs. And moving forward, as your business grows and your staff needs further develop, the agency can help you fill more positions or hire seasonal or traveling employees.
Get Business Support from Lighthouse Lab Services
If you’re starting a medical laboratory business, keep in mind that you’ll also have to address administrative tasks such as credentialing for required state and CLIA certificates and implementation of your standard operating procedures. Fortunately, the industry experts at Lighthouse Lab Services will get your lab going in as little as 90 days using our six-step startup process. No matter where you are in your business journey, contact us today for a free consultation.
How much does it cost to get all the permits needed in Florida?
Hi Mauricio, thanks for your question. The total cost will depend greatly on the type of testing you’d like to perform and a number of other variables. If you’d like to reach out to us directly at info@lighthouselabservices.com, we’d be happy to have an initial free consultation with you.
If there are only normal testing going on for example: LFT,KFT, hemoglobin , CBC, then how much is cost to open a pathology laboratory??
Thanks for your question, Anusha. We’re reaching out to our team for a general estimate and will get back to you once we have a response!
Here is the response from our internal expert: “There are two primary factors: 1. Specimen volume, which impacts equipment and the size of the space 2. The actual physical structure where the lab will be located, as construction can vary dramatically. On average, the startup costs to open a pathology lab could range from $300K to $500K.”
Don’t hesitate to let us know if you have any follow-up questions!
Do you have to be a licensed provider to own a clinical lab?
Hi Traci,
An owner personally does not have to be a licensed provider to own a clinical lab, however, there are many regulatory and compliance checks you have to complete prior to going live. We’d be happy to walk you through the process in more detail if it’s something you’re considering.
Please can you help me with what it requires to open a laboratory in Libya, Zawiya to be precise.
Hi Azuli! Unfortunately, we only currently assist labs within the U.S. and Canada.
Please can you help me with what it requires to open a laboratory in Camden, New Jersey to be precise.
Thanks for your question, Shamir, and for providing some location information for our team to go off! We’ve passed your email on to our business development team so they can follow up with you directly and provide some initial information. Regulations and necessary certifications can also vary depending on the type of testing and complexity of your lab, so our team will be better equipped to provide you with specifics.
what LIS software do you use or do you recommend any software to manage the samples?
We offer our own LIS solution with Beacon LIS, and you can learn more about its benefits here: https://www.lighthouselabservices.com/lis-software-solutions/. However, depending on the size and volume of your lab, another LIS may be more beneficial to your lab. Feel free to reach out to us directly if you’d like a free consultation.
What license do you need to open a lab? How about opening lab outside united state? Do I need a PHD?
Hi Naica, thanks for your question. The type of licensure you need to successfully open a lab depends on the state or country you’ll be located in. Typically, the lab owner does not need a PhD to operate a lab, however, you will need individuals who meet certain qualifications in various technical and oversight roles. We currently only assist labs in the US in Canada, so feel free to email us at info@lighthouselabservices.com if you’d like to discuss your idea further.
Do you also help in opening a new testing laboratory in environmental testing sector?
Hi Krishna! Could you email us at info@lighthouselabservices.com with a few more details so we can better understand the scope of your project? Thanks!
I work for a laboratory now but I want to open my own lab. I do have a doctor who will be helping with an office space. I want to be able to collect blood and urine samples only and have a courier collect or drop them off. what all would I need to do to get this started?
Hi Lisa, that’s great to hear you’re exploring opening your own lab and have already explored office space. We’d be happy to provide a free consultation about what you need to get started and next steps to consider if you’d like to reach out to us at info@lighthouselabservices.com and schedule a time to talk!
Which lab equipment do I need to purchase to start my small lab
Hi Nana, thanks for reaching out to us with your question. Equipment needs will vary great, especially for smaller labs, depending on your exact needs. However, here are some baseline items and costs for you to consider. These are just estimates and examples, so please don’t hesitate to follow up with us directly for more accurate estimates.
-Benchtop Chemistry Analyzers – $25,000-$45,000
-Floor-Model Chemistry Analyzers – $40,000-$80,000
-PCR Instrument – $25,000-$125,000
-Automated Extraction – $25,000-$75,000
-LCMS – $120,000-$300,000
-Next-Generation Sequencer – $100,000-$500,000
-Ancillary Equipment – $15,000-$50,000
HI
I*M LIVING IN VIRGINIA AND IM SPECIALIST
I WANT TO MAKE SPECIAL LAB WHAT TYPE OF OFFICIAL CERTIFICATES REGULATORY BODIES DI I NEED
IM LIVING IN FAIRFAX COUNTY
Hi! Thanks for reaching out to us. We’ll need to know more about the specifics of the lab you’d like to start to accurately answer your question. Someone from our team will be reaching out to you shortly at your email address.
Hi There,
Is there any opportunity to open a Quest Franchise in US? How much it costs ?
Hi Seshu,
Thanks for you question. Unfortunately we do not have a business relationship with Quest and can’t help you open a franchise with them. For more information on that, you would have to reach out to them directly. However, can assist lab start-ups of any kind if you’re interested in opening your own laboratory business. Feel free to reach out to us directly if you’d like to learn more or schedule a free consultation!
Hello
I am 75 years old , working as a lab supervisor in New York and Illinois
I would like to continuing working at the lab but is not easy due to my age , can you help me ? Do you know any company where I can applied ?
Hi Yolanda,
We may be able to help you, depending on your qualifications and our current openings! Feel free to send a resume along with any other relevant info about yourself to recruiting@lighthouselabservices.com and someone with our team will connect with you.
are the requirements for a non-medical lab the same as a medical lab?
Thanks for your question. Requirements for scientific vs medical labs have some overlap, but in general, there are numerous differences depending on the type of testing you’re performing and the state you’re doing it in. We primarily assist medical/clinical labs, so if you have any questions with regard to starting that type of lab, don’t hesitate to follow up with us!
Hey, I am a phlebotomist/lab assistant. I have been working in lab for 9 years and now I’m looking to open my own lab. I want to offer some urine and blood testing services, respiratory testing, and some clia waived test. What all will I need to get started?
Hi Ladinah! A lot of what you’ll need will depend on the state(s) you’re planning to operate your lab in. If you’d like to reach out to us by emailing info@lighthouselabservices.com with that additional information, we can connect you with someone who can give you a better idea of the scope and requirements for your potential lab!
Coming from primary care as a cma, my clinic has a lab and uses quest and lab pro how can I use these companies for my own lab?
Thanks for the question. Are you wondering about using Quest as a potential reference laboratory? We also likely have solutions for your lab if there’s a specific area of need you have! If you’d like to provide a bit more background, we’d be happy to connect you with a rep from our Business Development Team for a free consultation.
Hi there,
What is the procedure and eligibility for acquiring a medical laboratory license and operating a medical laboratory company for a specimen collection center in Ontario?
Hi Emmanuel, our Business Development Team would be happy to speak with you about the steps for establishing a medical lab in Ohio. Since there are different rules depending on the complexity of testing you’ll be performing, I want to connect you with an expert instead of laying out general requirements. You can reach out to us directly at info@lighthouselabservices.com, or you can let me know if you’d like for me to set up a free exploratory meeting.
Can you help open my own mobile phlebotomy? Would I still need license equipment ? Can I just draw an spin blood and ship out or ask a courier to pick samples?
Hi Belinda, we can definitely assist with opening a mobile phlebotomy service or lab. Even if you won’t be testing samples on-site, you will still need some certification and licensing depending on the state(s) you plan to operate in. If you’d like to email us with some more information we would be happy to schedule a free consultation! You can reach out to info@lighthouselabservives.com.
What insurance companies would a start up lab in Florida want to credential with if they want to go after primary care offices
Hi EJ, thanks for reaching out to us with your question. That question would be best answered by our payer strategy team after they have a sense of the type of testing you’re looking to perform, volume, and complexity. If you want to provide some initial details to us at info@lighthouselabservices.com, we can get you scheduled for a free consultation to get a better sense of the best payers to target.
Do I have to get a collection certification if I’m a licensed MLT and have worked in hospitals collection urine specimen and running waived drug tests to open my own drug lab
Hi AC,
In many states, yes, you will still need that certification! If you’d like to reach out to our recruiting team by emailing recruiting@lighthouselabservices.com, you can provide more details and they will be able to better guide you.
Hi I want to open a lab in Maryland doing tests on hiv patients… what are the guidelines?
Hi Joy! Thanks for reaching out to us with your question and we’re glad to hear you’re considering starting your own lab. This is something we’ll want our experts to speak with you directly about to ensure we understand the full scope of your project and the complexity of the testing you intend to offer. It looks like you reached out to us through a web form as well, so someone should be in touch soon!
Hy I would like to open up a lab, what are the requirements.
I’m based in south Africa, I’m not sure if you’ll be able to assist with south african requirements.
Thanks
Hi, thanks for reaching out to us with questions about starting your lab! Unfortunately, we don’t currently assist with lab builds outside of the United States and Canada, so we can’t speak to requirements in South Africa.
Hi,
I want to open a lab service collectiong blood and urine in Ontario, Candad. What type of certeficate and licence do I need to operate one?
Hi, thanks for reaching out to us! While we do work with labs in Canada, the regulations are different than most states in the US. If you send us an email at info@lighthouselabservices.com with some additional details about the plan for your lab, we can connect you with a business development rep to see what requirements you’ll need to meet!
Hello There,
I am planing to open a medical lab in Toronto, ON.
I would like to know what are the licening and permits I need to be eligable to open the medical lab. Also I would like to know about the budget as an estimate not precise.
Thank you
Hi Isra,
Thanks for reaching out to us. To guide you correctly, we’ll need a bit more information about the type and size of lab you plan to open. I passed your name and contact information along to our business development team and someone will connect with you soon to schedule a complimentary follow-up call.