System Integration
Effective system integration can be critical to the success of combination products for pharmaceutical companies.5
As your partner, we leverage our deep industry expertise to help enhance device related aspects of your combination product's development. Through our robust data and supportive evidence, we provide critical insights to help your combination product get to market on time.
At BD, we know that total system integration – where your drug formulation, primary container and secondary device require reliable combination to deliver dependable performance under real-life conditions – is critical to getting your drug to market quickly, efficiently and safely. To give you every advantage, we will help you anticipate and address a range of needs, from human factors aspects and use-related hazards to the complex regulatory environment.6,7
BD capabilities can support your combination development means.
Patient safety is our top priority. As such our innovation process begins with patient requirements and is enhanced by our vast experience, providing integral insights to help support the success of your drug in the market.1,4
Our design considers human factors to help your combination product provide a positive injection experience. Our advanced drug delivery systems aim to support enhanced:
- Patient safety
- Comfort6,7
- Adherence
Insights on patient resource links:
MEETING THE INCREASING REQUIREMENTS FOR HUMAN FACTORS CONSIDERATIONS
In drug development, project delays can equal meaningful increases in costs that can impact your profitability and the viability of bringing your drug to market.5 Our goal is to help you anticipate obstacles, mitigate risks and solve for operational challenges, so your combination product meets timelines and performs under real-life conditions. BD can help augment your combination development capabilities and support efficiency through:
- Reliable performance during fill, finish and assembly to minimize operational expenses and waste
- Reproducible performance across millions of units. From 2010 through 2018, BD has received less than 3 reported complaints per million associated with system integration for BD Physioject™ disposable autoinjector annually.2 At BD, we take complaints seriously but also as an opportunity to understand how that product is performing in a final combination product or as a subsystem with other systems. This experience strengthens our expertise to support and help de-risk future combination product development.
Launching a combination product can come with many challenges.5 As a global partner with deep expertise in drug delivery solutions and drug device combination products, BD can help you bring your drug to market smoothly and efficiently by1:
- Helping de-risk development activities
- Providing robust system data on specific combination products to inform your development decisions
- Supporting you in a complex regulatory environment for registration and regulatory filings
The impact of our extensive industry experience:
- More than 11 billion BD glass barrels and stoppers sold from 2014 to 20181
- More than 51 million BD autoinjectors sold from 2014 to 20181
Resources:
- Analysis of BD sales from 2014 to 2018 [internal analysis]. Pont-de-Claix, FR: Becton Dickinson and Company; 2019
- Physioject™ post market surveillance quality statement [internal report]. Pont-de-Claix, FR: Becton, Dickinson and company; 2015
- BD External R&D Document: Design Control Evidence Intevia™ 1ml: PIR Number: 2014-0137 Document reference: ERD20200058
- BD design control procedure 103.107.350GP WW Product Design Control [internal document], Franklin Lakes, NJ, USA
- Market Research, “Challenges with System Integration" [external study], Franklin Lakes, NJ, USA: GLG 2019
- Zhaoyang Li & Rachael Easton (2018) Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics, mAbs, 10:1, 18-33, DOI: 10.1080/19420862.2017.1392424 - ref-16128
- DeGrazio F, Paskiet D. Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes. J Pharm Sci. 2020 Jul;109(7):2101-2115. doi: 10.1016/j.xphs.2020.03.020. Epub 2020 Apr 6. PMID: 32272133 - ref-17453