A bio-science US-based medical devices firm that specializes in manufacturing various components used in PCR kits for diagnostic testing. One of their flagship products is the optically clear PCR plate, which is essential for real-time PCR analysis in monkeypox detection. The company’s aim was to increase its product sales in the PCR diagnostic segment and to expand its market reach by strengthening the company’s supply chain network to all approved commercial laboratories that work on monkeypox detection. However, as the company faced significant challenges it pitched assistance from "DiseaseLandscape Insights (DLI) Healthcare Consulting," a trusted consulting organization with experience in the healthcare industry.
Challenges Faced by the Company:
- The company faced challenges with global regulatory standards for the distribution of optically clear PCR plates across different countries. Along with that, the organization also encountered challenges in obtaining necessary approvals and maintaining compliance with various health authorities for monkeypox detection in different countries.
- For the expansion of its supply chain, the company required robust distribution channels in various regions. The company was seeking to minimize the issues related to compliance with import/export and logistic regulations across different countries.
- The company faced challenges in maintaining consistent product quality throughout manufacturing and distribution to facilitate reliable PCR testing for monkeypox diagnosis. It was important for the firm to deliver quality-driven products to the laboratories so as to gain remarkable trust and customer retention.
- As the market for PCR diagnostic kits for monkeypox detection was competitive, the company aimed to differentiate its PCR plates from competitors while ensuring competitive pricing.
- The organization wanted to gain reliable information about the topmost laboratories working on Monkeypox detection to build a healthy partnership with them.
Solutions offered by DiseaseLandscape Insights:
- After conducting thorough market research and analysis on monkeypox diseases,
we helped the company to identify countries with a higher demand for monkeypox detection such as (the United States of America, Spain, United Kingdom). This helped our client to identify the most advantageous country l for the deployment of its PCR kits.
- DLI as a consulting firm had prior experience in medical device regulations. Those insights helped the company to navigate all complex regulatory requirements worldwide which included obtaining necessary certifications and approvals for each market and authority.
- DLI recommended establishing regional warehouses, aiming at geographical areas like (the United States of America, Spain, United Kingdom) to improve the distribution of PCR plates and reduce shipping times. This approach recommended by DLI facilitated compliance with local regulations and customs procedures, thereby easing the entire process.
- DLI assisted in partnering with established local distributors in target regions that helped the company to overcome barriers their differences, and regulatory challenges specific to each country like Spain and UK.
- DLI supported the client in implementing a robust quality management system, ensuring consistent quality of PCR plates and compliance with the stringent g international quality standards for diagnostic kits.
- DLI suggested the adoption of a track and trace system for each batch of PCR plates to prevent misplacing and recall of products.
- The thorough market research and analysis on monkeypox diseases conducted by DLI helped the company to accurately identify regions with a higher demand for monkeypox detection such as (the United States of America, Spain, United Kingdom). The study on monkeypox diseases by DLI proved instrumental in curating target marketing campaigns and promotional efforts catering to specific regions across diverse countries.
- With the assistance provided by DLI, the company established a robust supply chain, enabling them to connect with approved laboratories worldwide. This expanded market reach resulted in greater accessibility and availability of their optically clear PCR plates in different regions.
- By partnering with commercial labs, the company got a clear understanding of all the regulatory norms and standards used for PCR plates while detecting the monkeypox virus. This elevated the company’s competitive advantage in terms of superior performance and quality.
By implementing the solutions offered by DLI, the US-based company was able to overcome its supply chain challenges worldwide while establishing fruitful collaboratings with approved labotories. This led to a significant expansion in the sales of optically clear PCR plates used in PCR tests for detecting monkeypox. DLI further guided the company in developing a strategic plan to achieve its goals while maintaining high-quality standards and ensuring end usersatisfaction.