In this hypothetical company, for the sake of clarity we will name it BioStents. BioStents is a privately owned company based in the US, and is primarily focused in R&D, in which they are developing new materials and innovative structures for their internal stent technology. A short SWOT analysis may be drawn from the information provided:

S: BioStents is creating some new innovative technology will give them a competitive edge towards others in the market

W: BioStents is relatively small and does not have same amount of capital and resources as some of the larger companies.

O:There is a need for the device which BioStents is creating, and may potentially replace other methods, allowing them more market share.

T: Stents are classified as Class III devices therefore they need a premarket approval.

In this scenario, a small division of a big medical device company will start developing stents. The company primarily focuses on orthopedics and is starting to develop smaller divisions to branch out into different areas in the medical device world and see which ones do well. The SWOT analysis for a division focused on developing a stent could look something like this:

Strengths: Well-established company that comes with a lot of resources and experience with regulation and quality.
Weaknesses: Unexplored territory for the company, so a lot of time, money, and effort needs to be put into researching vasculature and innovation in stents.
Opportunities: As a big company, they have their hands in a lot of foreign markets, where stents have not been introduced.
Threats: This company needs to deal with foreign regulatory bodies and comply with them if they are to sell in those untapped markets.

For the scenario of stents, here is a SWOT analysis:

Strengths: since there is a large need in the US for improved stents, this start-up company has a substantial growth opportunity for reaching its targeted audience. 

Weaknesses: there would be multiple regulatory hurdles for the company to go through before the product can be used and this would be time-consuming as well as costly. 

Opportunities: the company could have the opportunity to use telemedicine to its advantage by providing remote monitoring technologies to support stent implantation through online means. 

Threats: since medicine is constantly and rapidly advancing, there may be a chance that the stent could become obsolete or less appealing to healthcare providers and patients. 

This SWOT analysis changes if the company was based outside of the US (taking a UK-based company for example). 

Strengths:

• Innovative Product: The internal stent utilizes cutting-edge technology, potentially offering improved patient outcomes.
• Experienced Team: A skilled team with expertise in medical device development and regulatory compliance enhances the company's credibility.

Weaknesses:

• Limited US Market Knowledge: As a UK-based company, there may be a lack of familiarity with the US healthcare system and market dynamics.
• Resource Constraints: Operating in a new market may strain financial and operational resources, especially in regulatory submissions to the FDA and shipping between the US and UK.

Opportunities:

• Large Patient Population: The US has a significant population with cardiovascular conditions requiring stent interventions, creating a strong market demand.
• Growing Healthcare Investments: Increased investments in healthcare and medical technology provide opportunities for partnerships and funding.

Threats:

• Intense Competition: The medical device industry is competitive, with established companies dominating the market.
• Regulatory Challenges: Navigating the FDA approval process can be complex and time-consuming, posing potential delays and additional costs.

My SWOT analysis of a start-up stent company is as follows:

Strengths - The innovative technology and advanced material is able to enhance the performance and durability of the internal stent significantly. Having an experienced medical device design team who are well-versed in regulatory affairs creates a well-equipped group to navigate any industry challenges. Also, this team would be strong and able to create a clear strategy for the FDA approval process, facilitating faster market entry while a patient-centric design aims to improve quality of life and fosters greater adoption rates.

Weaknesses - As a new company, the start-up faces a significant problem with branding. Their brand recognition may hinder their credibility in comparison to their established competitors. Another problem that may arise is resource constraints. Their funding or personnel could halt research, marketing and even product scaling. Lastly, as there are benefits to a small team, it poses potential risks if a key member leaves, and a high development cost may affect cash flow.

Opportunities - With the aging population and cardiovascular disease, the market has plentiful market opportunities. The start-up is able to capitalize on recent advancement of biomaterials like bioresorbable materials or drug-eluting coatings. While regulatory incentives for innovation may support entry to the market, they are also able to partner with medical facilities or other medical device companies to further their research and distribution.

Threats - A significant threat would be the challenging landscape with more established competitors leading price wars and market share struggles. Also, when it comes to the FDA, there are many uncertainties when it comes to the approval process creating delays and increased costs. Additionally, the changing in healthcare polities, reimbursement rates and the economy can all impact the demand and pricing strategies. Lastly, technological advancements can potentially threaten the competitiveness if the start-up does not keep up, and other companies make breakthroughs.