By Chad Sulak, Brand Manager – PRP, Crown Aesthetics
When platelet-rich plasma (PRP) first came to the private market, there were only a handful of companies that developed this product for use. As time went on and medical spas and aesthetic-focused practices started learning about the science behind PRP, the market began to expand, with new PRP companies popping up every day. Today, a quick Google search will deliver dozens of PRP companies providing different claims, pricing, marketing resources, centrifuges, etc. The list can be exhausting and overwhelming, especially if you are only starting to offer PRP at your practice.
In this post, we are going to discuss what values to look for when determining what PRP product is best suited for your practice. We are going to focus on test tube-based systems, as they are generally similar and deliver around a two-times concentration. Market research has shown that these types of systems are most widely used by medical spas and aesthetic-based practices and deliver encouraging results.
When evaluating which PRP system or company to bring into your practice, the main questions you should be asking are:
Am I working with an established company?
As products gain popularity, there will always be new players that enter the game trying to claim their piece of the pie. This competition is welcome, as it forces companies to focus on innovating their products and offering competitive pricing.
An “established” company is not necessarily one that has been selling PRP exclusively for more than 10 years; it can be a company in the aesthetics space that has recently added a PRP product to their portfolio. These companies usually have proper logistics, billing, medical affairs and support staff to help you with your purchase and subsequent training needs.
In addition, established companies tend to be more critical of products they are choosing to add to their portfolio. This results in products that have undergone rigorous testing and validation to ensure customers are getting the best product possible.
Does the Company Adhere to FDA Guidelines?
In order to answer this question, you need to understand what the U.S. Food and Drug Administration (FDA) guidelines around PRP are. According to a paper on the U.S. definitions and the current stance of the FDA on PRP:
…nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered “off label.”
In layman’s terms, product manufacturers are not legally allowed to promote the usage of PRP for anything other than enhancing bone graft handling properties in orthopedic practices. However, a private practice is allowed to market and administer the product differently, as it falls under “practice of medicine.”
The easiest way to figure out the answer to this question is to read the company’s website. If it mentions any specific uses of PRP, provides any marketing material or provides any training for procedures related to the aesthetics field, it is not adhering to FDA guidelines. Its website should only offer information about its product relating to concentration levels, how its system works and general information regarding PRP, including the science behind it.
Another aspect to consider is if the company has FDA 510(k) approval for its PRP product. This clearance means the company went through the steps with the FDA to develop a product and received approval that it is safe to use. Without this approval, your practice could be utilizing a non-FDA 510(k) approved device, which can lead to potential legal risk for your practice.
The easiest way to determine if the company you are considering purchasing PRP from has the proper clearance is to visit the FDA Establishment Registration & Device Listing website.
Once on that page, you can search by specific company name and see all products a company currently has registered with the FDA. If you click on the specific PRP-related product, you should see a line item titled “Premarket Submission Number” and a clickable submission number next to it. Clicking on that submission number will take you to the product’s specific FDA 510(k) Premarket Notification.
If it does not comply with FDA guidelines or does not have proper FDA 510(k) clearance for its product, the company runs the risk of severe financial penalties or even closure.
Where Is the Product Manufactured?
This standard may be important to you or it may not, but it is something to keep in mind. Shipping times and ability to adapt to problems are the main reasons to consider where a product is manufactured.
A majority of PRP companies utilize product that is manufactured overseas. Many of these companies act as “re-packagers” or “re-sellers,” putting their company name on a mass-manufactured product. Any product that is manufactured overseas will require an extended shipping window from the manufacturer to the U.S.-based supplier or distributor. There may also be potential delays involving U.S. Customs and Border Protection and any political sanctions involving imported goods. This is an especially major concern given current events and the restrictions provided by COVID-19.
Resolving issues related to the product is another factor to consider. Should there be any issue related to product quality, how quickly can the company communicate the issue with the manufacturer, get the problem resolved, test the corrected product and then get the corrected product shipped from manufacturer to supplier?
This specific criterion is in no way meant to question the quality of a PRP product manufactured from an overseas manufacturer; it is simply another factor to consider when evaluating your purchase.
Can I Grow My Practice with This Company?
When most of us begin shopping for a new product, we instinctively hunt for the lowest-priced option. We all want to save money, and if you are running a business, a lower-priced product equates to higher profit margins.
When it comes to PRP, a question that needs to be considered is, “Am I shopping for a product or for a solution?”
Shopping for a product means adding a product to your portfolio for the sole purpose of being able to tell people you offer it. Usually, this is a result of keeping up with the market or your competitor across the street, but it is typically not going to be a heavily marketed product.
Shopping for a solution means you have identified a need or problem relating to your business and are searching for the correct way to solve that problem. These needs or problems can relate to wanting to expand your business, become a market leader or fill in some portfolio gaps with a new revenue stream. This solution is going to be a heavily marketed product and one you believe can bring value to your business.
This is where a strategic choice of business partner becomes crucial. You can purchase PRP from just about anyone these days, but only a few PRP companies are truly worth doing business with. Some good questions to ask when determining your PRP business partner include:
Do they have a Medical Affairs division that is staffed by PhDs and/or MDs who are able to answer your questions or provide access to studies in a timely manner?
Are their sales staff subject-matter experts in PRP, capable of answering your questions without hesitation?
If the sales staff members are not able to answer your question, can they connect you with someone who can?
Are they familiar with the limitations set forth by the FDA and do they operate within those parameters?
Can the company provide you with marketing assistance, including social media content and easy explanations for patients?
How else can this company benefit my practice in ways unrelated to PRP?
There are a variety of PRP companies and an even wider variety of deciding factors when deciding who to work with. They each have their own set of positives and negatives, most of which are determined by the individual needs of your practice.
Regardless, there are some key criteria to consider in addition to price when determining who to work with. By asking the company’s sales representative these four questions, you will gain a much better understanding of whether they want to become a business partner or simply be a product vendor.
Crown Aesthetics helps physician-directed practices grow their businesses by providing efficacy and safety. Its non-invasive innovations include technologies such as SkinPen, the first FDA-cleared microneedling device on the market. SkinPen is the only U.S. engineered and manufactured microneedling pen, and its safety and efficacy have been proven through the company’s clinical trial and more than 90 validation studies.