Welcome Avatar! This is the inaugural post of BowTiedTogo’s MedTech substack. I will be providing an introduction to this cartoon animal’s area of expertise. That being Sterility Assurance. Believe it or not, it is all but a guarantee that at some point, everyone has interacted with a sterile item. Its impact on health and safety is definitely dependent on adequate sterilization.
But first, a little bit of housekeeping. This substack aims to provide its audience of scientists, engineers, and healthcare with investors actionable information. MedTech in general is often ignored in favor of its “cousins” in the biotech & pharma industries. However, this industry is full of opportunities if you know how to position yourself. A neurologist once told me, “MedTech is begging for innovation from you engineers. Some of the tools we use have been more or less the same since the 80s”. Sounds like a call to action to me.
STERILITY ASSURANCE LEVEL
Let’s begin! As the subtitle says, nothing is actually “sterile”. Rather, the sterilization process provides something called a Sterility Assurance Level (SAL). This is the probability of a single viable microorganism occurring on an item following exposure to a sterilization process. To label something as “sterile”, the manufacturer has to show to regulators the item has achieved adequate SAL. Achieving the adequate SAL level varies as different items have different SAL requirements. Medical devices which enter the body require a SAL of 10^-6. Products meant to be topical use only require a SAL of 10^-3. So, cartoon husky... There’s still a chance that bugs proliferate on a sterilized item and end up giving me an infection? Well yes, anon. However, the probability of that is very unlikely. Sterilization processes are typically designed to achieve a SAL of 10^-12. These processes also have high regulatory oversight. Every sterilization process requires a validation and is often audited by regulatory agencies.
STERILIZATION METHODS
There are many ways to sterilize something. What method a manufacturer chooses to use often depends. Factor to consider are the characteristics of the product and regulatory oversight. Regulatory agencies generally prefer the use of one of the “Big 3”. These methods have a long history of use and are very well understood. They are Heat, Radiation, and Ethylene Oxide (EO), classified as Category A by the FDA. Category B is for other, more niche methods. Still emerging in terms of general adoption, they are Hydrogen Peroxide (H2O2), Ozone (O3), and custom approaches to using EO. Category C contains methods that are still novel and need further development/definition. Examples include Vapor Peracetic Acid (VPA), High intensity light/pulse light, Microwave Radiation, Sound Waves, and UV Light.
SUB-INDUSTRY ROLE WITHIN HEALTHCARE
Players in the space generate revenue by selling sterilization equipment and services. The global sterilization equipment market's value was around $7.2B in 2021. The global sterilization services market’s value was around $4.1B in 2021. With a total market size of around $11.3B, Sterility Assurance is neither the smallest nor the biggest within the sub-industries of MedTech.
Note: For a more detailed analysis of MedTech sub-industries, feel free to read my guest post on BowTiedBiotech’s substack. You should consider subscribing to it if you haven’t already.
The diagram above is a VERY SIMPLIFIED example of the role sterilization equipment manufacturers and service providers play within the healthcare supply chain. Equipment is often sold to healthcare systems or laboratories for small-scale sterilization. Services are often sold to medical device and drug manufacturers since it is not common for them to sterilize their products in-house. Note that this diagram does not take into account miscellaneous revenue streams. These include the use of test microorganisms some of these sterilization processes require. Regulatory agencies demand their constant use which makes them a recurring revenue stream.
OPPORTUNITIES
This market is set to grow at least in line with broader MedTech but there are opportunities here…
The COVID-19 pandemic has increased the general public’s interest in keeping things clean. A by-product of this is seen in healthcare sites’ increased emphasis on the need for and importance of maintaining a product’s sterility. This has driven demand for sterilization services to the point that contract sterilizers are very backlogged.
Note: A colleague of mine at a start-up was quoted 18 months (absurd lag time) by one of the big players to complete a standard EO process validation.
The second largest market for medical devices and sterilization equipment and services (the EU) is currently undergoing a massive regulatory framework change (EU MDR). The change affects all aspects of the MedTech supply chain including Sterility Assurance. There is now a need to review, update, or correct existing sterilization processes.
The demand for sterility assurance professionals is rather high (along with the compensation) while the supply of talent remains relatively low. This may be due to Sterility Assurance not being something you generally learn in university, regardless of what degree you obtain.
Small medical device/drug manufacturers struggling with regulatory oversight is not that surprising. Their audits are just as harsh as the big players' but lack the same resources to defend themselves. Not possessing a robust sterility assurance program facilitates the following risks. Lost revenue, increased regulatory oversight, and bad PR. Definitely headaches executives are keen to avoid.
Getting involved in the industry in some capacity has the potential to be a fruitful venture. Unless you are selling a healthcare app or something with a similar interaction with the human body, you will need to prove to regulatory agencies (in any market you wish to enter) that your product is sterile. Sterility Assurance interacts with every other function of a healthcare company. Included but not limited to R&D, packaging, regulatory affairs, and post-market surveillance.
CONCLUSION
As mentioned in the introduction, the substack's goal is to provide actionable information to its audience. Sterility Assurance is a lesser-known niche of the healthcare industry, but it is an invaluable cog. Get involved in developing/investing in novel technologies/approaches. Become an in-demand professional in a field lacking the traditional university talent feeders. Be aware there are opportunities here.
See you in the jungle.
DISCLAIMER
None of this is deemed legal or financial advice of any kind. All information is obtained from publicly available sources. Insights are simply the opinions of an anonymous cartoon animal/engineer/investor.