Medical Device Testing Cost
When it comes to medical device certification, a recurring question in our client conversations is, “How much does medical device testing cost?”
In the global medical device market, estimated at ~$736 billion worldwide, the Testing & Validation of Medical Devices market stands at ~$8 billion globally, growing at a robust 9%. This growth rate is double that of the overall medical device market, underscoring the significance of understanding the costs associated with testing.
Nothing new here—companies are consistently working to optimise budgets, with cost ranking as one of the most critical considerations up there with laboratory certification and other credentials. Faced with the challenge of gathering multiple quotes before making decisions, businesses often pose the question, ‘Why does your cost differ from others?‘.
Answering the question of testing cost isn’t straightforward. Medical Device testing cost depends on various factors, ranging from the type of device and claims being made to numerous product-specific parameters. In this discussion, our aim is to highlight the elements that influence pricing from a laboratory perspective.
Factors Influencing Medical Device Testing Costs
1. Geographic Location
The cost of testing, like any other expense, is influenced by geographic location. Infrastructure, labour costs, and local economic factors contribute to the overall testing cost. Laboratories based in the US and EU countries typically have higher overheads compared to those in countries like India or China.
2. Accreditations and Certifications
Laboratory accreditations and certifications are significant factors affecting testing costs. Conducting a study under GLP or ISO 17025 incurs higher costs compared to a laboratory with non-accredited quality management system. The need for accredited test reports depends on regulatory requirements and the risk tolerance of the medical device manufacturer.
3. Technical Expertise, Equipment, and Facilities
The complexity of the device, along with specific claims, may necessitate specialist equipment and facilities. Laboratories with the required expertise, equipment, and facilities may command higher prices for testing services. Venturing into bespoke testing methods can also contribute to an increase in testing costs.
The duration of a study directly affects its cost. Longer studies, particularly those involving service life validation tests, typically result in higher costs. Reporting intervals, interim assessments, and similar factors contribute to the overall cost. Regulatory requirements and the claims associated with the device influence the time required for testing.
5. High Demand
Laboratory capacity and the demand for specific tests are additional factors impacting pricing. Studies in high demand may experience price hikes due to finite resources. Market dynamics are influenced by the price, and shifts in regulation and end-user requirements can further affect market behaviour.
How does Test Labs compare?
Obviously, there are many more factors that influence the cost of medical device testing. These five factors stand out as universal, exerting the most significant impact from a laboratory perspective. Operating Test Labs in the United Kingdom, we recognise the paramount importance our clients place on the convenience of having their testing laboratory local to them. A local laboratory not only resolves logistical and communication challenges but also aligns with our commitment to providing accessible services.
Being accredited by UKAS under ISO 17025 and holding other BSI certifications positions us in a higher price bracket. Our clients place considerable value on the peace of mind associated with accredited reports.
The potential cost ramifications of regulatory pushback cannot be understated – having to re-test a product can double expenses.
What may initially seem like a competitively priced service could, under regulatory scrutiny, become more expensive than the highest quote available. Our commitment to producing robust reports for medical device technical files necessitates continuous investment in our Quality Management System.
Being the only UKAS accredited facility with a focus on reusable medical device cleaning, disinfections, and sterilisation validation increases the demand for our specialised services. Consequently, we often find ourselves positioned at the higher end of quote comparisons, driven by our dedication to quality, industry expertise, and the focused services we offer.
Please keep in mind that all insights shared here are based on our own industry knowledge, experience and feedback from our clients.
We hope you now have a clearer understanding of the factors influencing the cost of your medical device testing. Should you wish to obtain a precise quote for your medical device testing inquiry, please don’t hesitate to reach out to our dedicated team.