The pharmaceutical industry is embracing Pharma 4.0 concepts, leading to increased investment in digital transformation. Due to the industry’s distinctive features, pharmaceutical manufacturers are driving the adoption of digital technologies. According to a report by ABI Research, the digital factory sector is projected to generate over US$4.5 billion in revenue by 2030, with a 27 percent compound annual growth rate (CAGR) expected in spending by pharmaceutical manufacturers on data analytics, reaching US$1.2 billion in 2030. This surge in investment is aimed at improving operational efficiency, tracking processes and enhancing productivity.
The digital health market has experienced notable expansion since 2010, with the COVID-19 pandemic significantly accelerating digital transformation in the pharmaceutical and healthcare sectors, as per a Statista survey. About 74 percent of the participants acknowledged this trend.
However, the main concern for successful digitalization in the pharma and healthcare sector is balancing the “3Cs”:
- Cost-effectiveness
- Comfortable to use and configure
- Compliance with regulatory norms
As their top priority, organizations typically seek cost-effective solutions that satisfy both their compliance and user requirements.
Major healthcare and pharmaceutical companies prioritize compliance and user comfort while also considering the cost of the application. They carefully plan all digital implementations using proven and mature software and tools that do not compromise compliance or end-users’ comfort.
Small and mid-size healthcare and pharmaceutical companies prioritize the “3Cs” (cost, compliance, and comfortable to use) when finalizing and implementing any solution. Balancing costs with the other two elements can be challenging for these organizations. In an effort to save on application costs, they may opt for solutions from tier 2 and tier 3 providers, which can cause delays in design, compliance and user comfort. These solutions may not be as proven as those from larger providers, which could potentially compromise their effectiveness.
However, by following a better 3A (analyze, assess, adopt) approach we can achieve the best 3Cs (cost-effectiveness, compliance and comfortable to use)
3A-3C Approach:
The 3A-3C approach illustrates the steps for implementing a solution effectively. This includes conducting proper requirement analysis, evaluating software in alignment with those requirements and ensuring proper adoption of the application to achieve compliance, cost savings and user comfort.
To achieve the desired 3Cs (compliance, cost savings and user comfort), it is essential to carefully plan and execute the 3As (requirement analysis, software assessment and application adoption).
Analyze:
Thoroughly analyzing all requirements is crucial before finalizing the URS (User Requirement Specification). Inadequate or incorrect requirement documentation may result in poor implementation. Proper requirement analysis is essential to ensure that accurate requirements are communicated to the vendor in order to obtain an appropriate solution. The following steps should be followed in order to sign off on the URS:
- Identify key stakeholders and end-users who need clear idaeas on the required solution
- List all initial requirements, including for compliance
- Categorize requirements based on priority
- Record the finalized requirements with mutual agreement
- Sign off and communicate to vendor/solution provider
Assess:
Once the requirements have been finalized, the appropriate vendor and application must be evaluated to ensure that they meet the URS. Also, firms must assess their infrastructure capability, digital literacy and other aspects which will impact the respective implementation. During this stage, the following key points should be taken into consideration:
- Technology expertise
- Product maturity and functionality assessment
- Support services
- Cost-effective and easy to use
- Integration capabilities
- Vendor culture and values
- Regulatory knowledge
- Firm’s infrastructure capabilities and end-user’s digital literacy
Adopt:
After finalizing the application, the adoption process should include comprehensive user training and acceptance testing, followed by validation and ongoing maintenance. The adoption phase is critical to save the cost of implementation and to ensure compliance. During the application adoption process, it is important to consider the following key points:
- Proper planning for implementation as per approved procedures and policies
- Training and education
- Validation as per approved procedures
- Quality assurance strategy to ensure patient safety, product quality and data integrity
- Maintenance, support and periodic reviews as per standard procedures
If the aforementioned 3As (requirement analysis, software assessment and application adoption) are executed correctly, the implementation process will result in a compliant regulatory norm and a cost-effective and user-comfortable application.
To conclude, for an implementation manager, balancing the demands of end-users, quality teams and finance teams can be a challenging task. In order to achieve a successful implementation, equal priority must be given to cost, compliance and user comfort.
In many cases, small and mid-size pharmaceutical firms tend to prioritize the cost of the solution over other factors, which leads to unsuccessful implementation. However, by taking sufficient care during requirement analysis, application assessment and adoption phases, it is possible for these organizations to achieve a compliant, user-friendly and cost-effective solution.
