Perhaps you’re developing a combination product (drug product and medical device for its administration) for inhalation or injection?
Maybe it’s a medical device for hospital or home use?
It could even be an app for use in managing a health condition.
These are some of the 63 devices we’ve helped organisations develop, successfully, over the past 10 years. They span from “simple” measuring devices through to home dialysis and endoscopy. It’s only when we took a step back, that we appreciated the range we’d helped clients cover.
A common theme over the past year is for clients to be seeking help with transition from thinking of pre-filled syringes as container-closure systems to that of them being part of a combination product. They told us that they benefited from guidance and support, to ensure they’re taking care of the medical device requirements (e.g. Design Controls and Human Factors).
It’s probably helped that most of our team came from a pharmaceuticals background into medical devices, so understand the complexities presented by combination products.
Medical device project split
For the curious among you, here’s the split of what clients asked for support with:
Quality projects included a range of activities, including some or all of:
- Design Controls,
- Independent Design Review
- Risk Management,
- Pre-approval inspection support,
- project quality support,
- Specific quality issue resolution.
Human Factors projects included activities from across the whole development process, such as; User Research; Formative and Validation study design, execution and reporting; integration of HF study results into the design and risk management activities.
Perhaps your project could use some support in 2017, to help unstick a thorny issue or simply to bolster your resources.
Get in touch today, to secure the right support for your needs.