Without fail, one of the first questions prospective clients ask me is “how long does it take to develop a product?” As I know that ‘how long is a piece of string?’ isn’t a helpful reply, we have gathered the key steps, processes and ballpark expected timelines across the product development process.
- Time can vary significantly depending on the complexity of the formulation and desired claims
- 2-4 weeks to the first samples from receipt of brief is achievable (when materials are readily available and approved immediately)
- Allow 4-6 months when undertaking stability testing
- Allow 6-12 weeks for high level claims to be substantiated (eg SPF testing)
- Allow an additional 3-6 months for manufacturing and production
The development process – what will impact timing?
The time required to develop a product from the initial concept to having an order fulfilled can vary considerably. Below are some of the key factors that influence this timeline.
- Researching product requirements and completing a new product brief
- The number of products in development
- Complexity of the formulation and necessary experimentation
- Whether there are any unusual, hard to source ingredients
- Time required to evaluate and provide feedback
- Number of iterations required to reach the target
- Required claim substantiation (SPF particularly)
- Whether preservative efficacy or accelerated stability testing is undertaken (as related to the proposed shelf-life)
1. Researching product requirements and complete a new product brief
Although it can be time consuming, it is imperative for a brand owner to have completed thorough research and have an unwavering understanding of the product to be developed before the process begins.
The more detailed the research, the less uncertainty there will be when the formulation process starts. This means the formulator can work more efficiently towards ensuring the first iteration is as close to target as possible and minimise potential for problems downstream.
Despite the time initially required, the research stage can act as both a time and cost saving step. As an example, a formulator may create an amazing shampoo, closely replicating a market-leading benchmark with some unique points of difference as per the brief. The approved formula then proceeds to shelf-life and preservative efficacy testing which it passes. The brand later becomes aware of negative sentiment associated with the use of ‘alcohols’ in hair care and learns the shampoo contains phenoxyethanol (a common preservative). The brand then requests the phenoxyethanol be removed from the formulation. In such an instance, there would be a need to reformulate and restart the testing process again, adding unwanted delay and unnecessary cost to the process.
2. The number of products in development
The number of products that are to be developed won’t typically multiply the time required to create the formulation. As an example, three products won’t take three times longer to develop than one would, however it does have a tendency to prolong the time required to develop each, and will depend heavily on the available resources (human and otherwise) involved in the development process.
In some cases, there may be multiple variations on a single product being developed, for example a moisturiser with 3-4 different fragrances and extract combinations, or various shades in a range of foundations. In these cases, starting the formulation development on one variation, obtaining approval and finalising that formulation is preferable. By getting the ‘base’ right, then a team can transition this base to the remaining variants simultaneously and with far more efficiency than approaching each variant simultaneously.
3. Complexity of the formulation and necessary experimentation
Although all products have their nuances, some can be comparatively straight forward, whereas others at times, frustratingly difficult. An oil-based serum for example, is likely to take less time to prepare in the lab because usually all ingredients can be mixed freely by hand at cold temperatures with little that can go wrong in terms of instability.
A sunscreen in contrast has greater formulation complexity , will require all ingredients to be checked for permissible use and needs to be developed with a measurable performance (SPF and broad spectrum). The majority of sunscreens are also emulsions, containing many more ingredients where the sunscreen chemicals need to be properly dispersed (emulsified) in water requiring intensive mixing (homogenisation), heating and cooling and is much more likely to undergo some form of instability.
4. Whether there are any unusual, hard to source ingredients
Many commonly used ingredients are held within a formulator’s library or can be accessed within a few days through their network of suppliers.
Occasionally however, a brief may require something pretty special, for example an active ingredient needing to be flown in from France, or a key functional ingredient found in a benchmark product that has to be sourced from Japan which may take a few weeks to a month. Fragrances also often take some time to source, fragrance benchmarks need to be made available to the fragrance house who then creates a fragrance for inclusion in the product.
5. Time required to evaluate and provide feedback
Once a sample has been prepared by the formulator it will be submitted to the brand owner for evaluation. Understandably, the time required for a sample to be reviewed and observations consolidated and provided to the formulator varies dramatically by client, sometimes it can be within a few days, sometimes it can be weeks.
6. Number of iterations required to reach the target
The more iterations required, the more times the cycle of experimentation, sample preparation, submissions and evaluation are required, compounding the time to finalise the formulation.
Occasionally, the first submission is approved, more often 2-3 versions are required to really refine the initial iteration, get the colour or fragrance intensity just right or make it ‘just that bit thicker’. Where a product is particularly unusual or complicated, the number of iterations can extend well beyond this.
A general rule of thumb is that when there is a clearly defined, strong benchmark product, the number of iterations will be low. The more the target product deviates from a benchmark, the more iterations will be required until the formula is signed off.
As an example, a benchmark for a foundation may be available that ticks most of the boxes for colour and texture, but the benchmark is silicone based and the brief is for the product to be silicone-free. In this instance it is going to be more complicated to formulate and more iterations are likely to be necessary to refine.
Where there isn’t a tangible product that can be used as a benchmark, a project becomes ‘ground up’ research, in these instances it’s likely a project can’t be properly quoted and work will need to be approached on an hourly basis in phases.
7. Required claim substantiation
Once formulation development is complete, depending on the proposed product claims, additional testing may be required before transitioning to shelf-life and preservative testing.
SPF and broad spectrum testing is required to substantiate any SPF type claim, regardless of whether it is a cosmetic, colour cosmetic, lip balm or primary (therapeutic) sunscreen. The time taken to complete testing will vary depending on the third party laboratory selected for testing, their location (Australia, US, UK etc), whether they have a backlog, their frequency of testing and schedule and how that aligns itself with the availability of a sample for testing. A sample may be ready for testing immediately, but if the next test starts in five days and it’s going to take six days to get the sample safely sent to the UK for testing, the next intake may be another two weeks later.
Other common tests relate to dermatological suitability, for example Human Repeat Insult Patch Testing (HRIPT) to substantiate claims such as:
- Non irritating
- Non sensitising
- Kind to skin
- Safe for (sensitive) skin
- Dermatologically tested
- Dermatologist tested
- Clinically tested
8. Whether shelf-life testing or preservative efficacy is undertaken (as related to the proposed shelf-life)
In Australia, these tests are not legally required for cosmetics and personal care products, although are a requirement of any listed medicines (i.e. primary sunscreens). Despite any legal requirements, they remain industry best practice and often are required in other jurisdictions outside of Australia, including the EU and ASEAN.
The duration for shelf-life testing using traditional ‘accelerated’ testing techniques can vary, however for a typical personal care/cosmetic product, it is a 3-4 months process to substantiate 2-3 years of real-time shelf-life.
For therapeutic products, it will depend on some variables, including the proposed shelf-life (most frequently 2-3 years) and the labelled storage temperatures (either 25degC or 30degC) and the difference relative to the stability storage temperatures (either 40degC or 45degC) in terms of being either +10degC or +15degC between the label and test temperatures. It can vary between 4 and 9 months, for a product labelled with a 25degC storage temperature aiming for 3 year shelf-life, the test duration will be 6 months when tested at 40degC (this is the skinterest preferred test temperature).
Shelf-life predictions from short-term testing of listed therapeutic sunscreens at elevated temperatures
Source: TGA Australian regulatory guidelines for sunscreens (ARGS) Version 2.0 last updated 06/03/23 - https://www.tga.gov.au/resources/publication/publications/australian-regulatory-guidelines-sunscreens-args
In some cases, the first production batch may utilise data to support 2 year shelf-life (expiry), but subsequent batches with additional data accumulated, can then be labelled with 3 year expiry. Using the example above, the test duration will be 4 months.
For therapeutic products, there will be a delay on the availability of a final report as testing of active ingredients (sunscreen chemicals or other ingredients that support a label claim) is often performed by a third party and can take 2-3 weeks to be finalised.
Preservative efficacy testing (PET)
Preservative efficacy testing (PET) is critical to ensuring the microbiological safety of a product, it is critical in any water-based product, which is the vast majority. Where a product is oil based or has low levels of water (eg toothpaste), there is no need for PET in these instances, water activity testing is recommended to confirm the product does not require PET. Water activity testing can be completed in less than 1 week.
Preservative efficacy testing is a 28 day test (4 weeks), however brands should allow 6-8 weeks. This ensures there is ample time for samples to be prepared and submitted for testing, the testing laboratory to receive and log samples, initiate testing per their schedule and consolidate and report results.
For therapeutic products, this process is required to be performed at the start and end of shelf-life related testing. In this case samples would be available, but does add 6-8 weeks to the end of the shelf-life testing.
What can the product development timeline look like?
Generally speaking, and subject to a variety of factors, the time required to develop a project is around 8-12 weeks. Please click below to download an example product development timeline.
Who can influence the development timeline and how?
- Provide project briefing template
- Experience and knowledge to understand project requirements, minimise unnecessary experimentation and reduce the potential for issues down stream
- Utilise contacts and capabilities
- Understand client feedback and minimise iterations required
- Have the appropriate equipment to accurately and reproducibly prepare samples
- Have the time required to give the development project the necessary attention
- Provide appropriate level of detail when completing the provided briefing document
- Provide relevant benchmark product/s
- Seek independent regulatory advice (especially relevant for products being sold outside Australia and/or that are therapeutic products
- Not to alter the agreed brief after development begins
- Resources to evaluate samples and provide feedback in a timely manner
- Provide quality sample feedback
Things outside the control of the brand owner and formulator
While every effort is always made for the process to go as quickly and smoothly as possible, unfortunately issues can arise and cause delays.
- Raw material lead times – if the material is not in the formulators library they will attempt to ‘hedge their bets’ and source from multiple suppliers
- Changes in the project brief as a result of new information or regulatory, industry or environmental factors
- Unforeseeable incompatibilities or instability unique to the formulation requiring more intensive experimentation
- Postage delays, including lost samples
- Third party testing laboratories delays
- Packaging availability for the purposes of compatibility/shelf-life testing
- Material shortages, especially for larger batch requirements
How to speed up (or not slow down) the development process
- Ensure the brief is as detailed as possible, the better the brief, the closer the first sample will be to target and the less iterations required
- Avoid deviating from the brief to avoid confusion and the application of ‘band-aid’ solutions to a formulation, increasing the risk of problems
- Have good quality, relevant benchmark products. As an example, if the brief required a natural formulation, a benchmark that is synthetic, is not relevant)
- Evaluate samples quickly, however ensure the evaluation is thorough to avoid issues cascading through subsequent stages
- Provide concise and detailed feedback to maximise the formulators understanding of what changes are necessary
- And perhaps most importantly, be nice to your formulator (we’re sensitive!)
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