Product Packaging/Production Regulations

Product Packaging/Production Regulations.

It was a pleasure speaking with you on September 3, 2019 to discuss your goals for exporting Negative Pressure Wound Therapy (NPWT) devices into Nigeria. You will see below an outline of the history of Devon International Group and our strategy for expanding NPWT device distribution into the Nigerian healthcare system.

Background

In our first meeting, our team gained a better understanding of your company’s operations and product, for the purpose of determining the best strategy for fulfilling your business expectations and goals abroad. You identified Nigeria as a target market because it has a rapidly growing population base and economy. To enter into this market, we must create a distribution channel in the country which is cohesive with Nigeria’s current healthcare distribution channel to appeal to as many consumers as possible.

Our initial meeting has given the team an understanding of how your product operates and how the company distributes and prices to its current markets. Devon International Group has created medical devices that help heal wounds and prevent debilitating amputation, using negative pressure; the average wound healing period is two months. The company’s goal is to decrease the effects of small vessel disease, resulting from diabetes, by simulating normal blood flow around a wound. The device applies negative pressure (by “sucking” through a tube) to stimulate blood flow in the wound area to allow healing to begin. It also sucks out infected liquid/puss in the wound; the bacteria in the area prevents the wound from healing, and often exacerbates its condition. Devon International Group is based in King of Prussia, PA and is currently distributing in X,Y, Z countries, with efforts to expand into Nigeria and Russia.

Based on the discussion, our team will first investigate the economic and medical environment in Nigeria to determine how to position this product in the company, largely based on demand and distribution capability. By surveying the macroenvironment in Nigeria, we will understand which elements of the country’s microenvironment to further explore and understand, and which national needs to address. Then, we will create an in-depth country analysis into those microelements to develop and cement our market entry strategy. This analysis will address governmental and legislative implications on future sales, and other factors that affect and inform our market entry strategy. In our meeting, you discussed previous sales on a business-to-consumer basis, but those were specific cases, so we will explore business-to-business distribution, to discover which method is more conducive to growth.

Please see the following outline for our team’s strategy for Devon International Group’s market entry into Nigeria.

Research Strategy:

We will begin with extensive research into Nigeria’s healthcare system, and the general health status of its population. This will help us determine where the need is in Nigeria, and how we can shape our strategy to address that need. Moreover, researching the legal and regulatory environment of the country will help us avoid costly obstacles when obtaining permits or begin importing products. We will also reach out to Devon International Group’s current distributor in Kenya to get an understanding of the supply and sales chain in that country from a direct source, with the intent of taking much of the Kenyan strategy and applying it to the Nigerian market. 

Industry Research:

We will analyze the current state of the health care distribution system in Nigeria, paying special attention to political and regulatory factors, and any challenges or opportunities those systems present. Despite rapid population and economic growth, the Nigerian healthcare system seems to drag, and we need to evaluate the causes for this, and find any possible solutions. We will also look to similar countries, economically, and evaluate strategies that have been successful to inform our approach. Finally, we will examine the dynamic between healthcare providers and consumers, including the effect of prices, to determine the best method for getting Devon International Group products to the appropriate consumer group.

Market Research:

The largest market for Negative Pressure Wound Therapy (NPWT) devices is in diabetics with small vessel disease, which is a direct result of diabetes. This disease prevents the body from healing properly, particularly in the feet and legs, threatening total debilitation for those afflicted. Diabetes is a growing concern worldwide, particularly in growing economies, as access to food and luxuries increases. Approximately 2%, or 1.7 million, of Nigerian adults are afflicted with diabetes, making this a prevalent concern. Researching to understand the market for these devices, not just for diabetes, but other afflictions will help us determine where the need lies in Nigeria.

Other Regulations

Nigeria requires that all medical devices register new medical devices for approval before entering the market; this entails submitting:

1.       Application form

2.       CFS

3.       Quality system certification

4.       Declaration of conformity

5.       Description of device and intended use

6.       Clinical and preclinical data

Medical devices are organized into four levels according to risk level: A – Low; B – Low-Moderate; C – High-Moderate; D – High.

Engagement

The International Business Student Research Team will:

•  

Evaluate the market potential for entry into Nigeria by:

•  
  •  

Considering the regulatory and political environment of medical device sales and

•  
  •  

Analyzing the size and depth of consumer demand for this kind of medical device;

•  
•  

Analyze and determine the best sales strategy for market entry by:

•  
  •  

Evaluating the opportunities of business-to-business distribution and

•  
  •  

Evaluating the opportunities of direct-to-consumer distribution;

•  
•  

Recommend a market entry strategy that capitalizes on Devon International Group’s differentiation and provides significant opportunity for growth; and

•  
•  

Respect the strict confidentiality of the company information that they obtain in person or in writing and of the research data that they will find.

•  

Client will:

● Provide specific information about their goals, and the product’s features and advantages.

● Participate in at least two (2) meetings/conference calls throughout the duration of the project to discuss progress and updates.

● Respond promptly (within 24 hours) to team requests for information and feedback on findings.

● Encourage the team keeping in mind that this is an academic engagement with the purpose of learning without any compensation.

● Provide the team with feedback and suggestions on further direction of research, as needed.

● Assume all the risks associated with any error and/or omission that the students may have unintentionally made.

Conclusion

Our team would like to thank you for joining us to discuss the potential opportunities for your company’s market entry into Nigeria. If you have any questions or concerns, please do not hesitate to contact us through the team leader,

http://devonmd.com/npwt-devices/extricare-2400/

http://www.devonintlgroup.com/about-us/company-history/

Work:

Product packaging/production regulations

Product Packaging/Production Regulations

 

"If this is not the paper you were searching for, you can order your 100% plagiarism free, professional written paper now!"