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Six Things Some Medical Device Manufacturers Have to Do to Place a Product on the Market

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Developing a new product is never easy. Obviously, it all depends on what industry you belong to, and what kind of product you are trying to sell.

In the medical device industry, the product development process is governed by a lot of regulatory requirements. This is true for quite a few industries, but the medical device industry is characterised by the manufacturers being audited continuously by regulatory bodies or organisations that have been designated to audit manufacturers.

Areas that are particularly emphasised in the medical device industry are design control, risk management, and post-market surveillance.

Here are six important requirements for medical device manufacturers to observe.

1. Have a playbook or a QMS

As simple as it might seem, a playbook for the product development process is essential. But for companies working with more formalised product development, it is usually not referred to as playbook, but rather a QMS, which is short for Quality Management System. As the name suggests, the QMS is focused on the quality of the products of the company, and it comprises procedures for the processes of the company.

Medical device companies are required to have about 30 documented procedures according to the quality management standard ISO 13485 and then a handful more according to the Medical Device Regulation and Quality System Regulation.

2. Verify the effectiveness of training

A general requirement in most industries is to provide employees with the training they need to perform their jobs. In the medical device industry, this is also a requirement. But in addition to training people, medical device manufacturers are required to verify the effect of training actions taken.

Verifying the effectiveness of training is easier said than done, but it can be done by using quizzes or practical tests.

3. Implement corrective actions

Mistakes happen. A lot of companies will try to correct mistakes, and that is all good. But for medical device companies the requirement is to also prevent making the same mistake again. This, of course, makes perfect sense. But strong corrective actions can be hard to identify and implement.

4. Collect and process any complaints submitted

Not listening to feedback is not a smart move, especially because the very purpose of feedback is to present us with a point of view different from ours, or with first-hand experience from a user. The same goes for complaints.

In the medical device industry, everyone should be trained to recognise when they come across a complaint. And complaints should be recorded and investigated. Complaint statistics would also be included in the data analysis process and brought to management’s attention during management review. All of this is required.

5. Verify all changes to products and software 

When you implement changes to the product or its software (if included), you will need to verify that the product still meets the design inputs or product requirements. This should include the impact the change has on the safety of the device as well as the usability of the device.

6. Invest in usability engineering

Most companies will strive to make products with a great user experience and invest in usability. In the medical device industry, the usability has a slightly different purpose. It is to ensure that the product is safe from a usability point-of-view. This includes showing that users understand the instructions for use and other information provided to them.

This is important in every industry, but when it comes to the medical device industry, this is, in most cases, essential, simply because a single misunderstood instruction can lead to injury or even death.

Which of these principles do you adhere to in your industry?

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How Has E-commerce Evolved?

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E-commerce has a relatively short history in business. The earliest incarnations of e-commerce stretch back to the 1970s, when early technologies such as teleshopping and Electronic Data Interchange helped to create a primitive version of this form of commerce.

However, modern e-commerce started to take off in 1994 when the entrepreneur Jeff Bezos set up Amazon from his garage. Initially, Amazon was an online marketplace just for books. In the years that followed, the range of products available increased.

Today, millions of unique products can be bought on the site, which has led it to become known as “the everything store.” Today, there are estimated to be over 26 million e-commerce websites worldwide, with around 13 million based in the US.

The e-commerce sector has grown rapidly and is predicted to continue to enjoy year-on-year growth for the foreseeable future.

However, in its relatively short history, there have been several developments that have shaped how companies operate online. In addition, consumer behavior and shopping preferences have changed as people regularly buy products and services online.

In this article, there will be a discussion of how e-commerce has evolved. Some key examples will be used to support this.

Social media promotion is integral to the sector

In the early days of e-commerce, there was far less competition between businesses because there were far fewer e-commerce firms. The internet has grown at an exponential rate since the early 1990s, and consumers can now find virtually any product, service, or specialist e-commerce firm online.

Due to the massive growth in the e-commerce sector, online firms now need to have a comprehensive marketing plan to promote their site and their products. This is vital to allow companies to stand out in an increasingly crowded online marketplace.

A key marketing strategy for millions of e-commerce firms is leveraging social media promotion’s power. Popular social media sites such as TikTok have around 1 billion monthly users, which makes the site a prime avenue for online promotions.

There is a global community of visitors to the site, which encompasses a wide range of demographics and target markets. Today, most e-commerce sites will have a marketing budget specifically for social media promotions.

They will create short but memorable adverts (typically using video) and will ensure that a hyperlink is embedded in the advert that takes the viewer to the product page of their website.

This simple strategy transforms customer interest into a sale with the lowest number of steps required on the part of the consumer. In short, social media promotion is a vital activity for any e-commerce firm and helps them to stand out in an increasingly crowded online marketplace.

The changing attitudes to delivery

In the early years of e-commerce, consumers understood that delivery timescales may be relatively long. Many customers were starting to buy from international sellers or fledgling e-commerce firms in their own country. During the early stages of e-commerce, there were few advanced delivery networks for online firms.

During the 1990s typical delivery timescales were far longer than today. Most products would take at least five days to arrive and potentially could be in transit for weeks.

Whilst consumers tolerated these timescales in the early days of e-commerce, they now expect quicker delivery schedules. In addition, if the stated delivery period is not adhered to and there are delays, many customers will stop using the e-commerce site.

As consumer delivery expectations increase, e-commerce firms must ensure that they can work with dependable and efficient shipping and courier firms. Companies such as Shiply USA may be ideal for smaller e-commerce firms that do not have their own delivery networks.

Such firms can offer highly competitive prices for shipping a range of goods. In addition, they have built a reputation for delivering to pre-stated timescales, with minimal levels of damage to items in transit.

In short, all e-commerce firms need to forge strong working relationships with professional shipping firms who can deliver on time and with competitive fees.

The rise of chatbots in online customer service

Finally, modern online shoppers expect that any queries or questions that they may have will be answered swiftly with excellent customer service. Not receiving a timely response to their correspondence creates a negative perception of the company and may make them less likely to purchase from the site.

 E-commerce firms have been quick to recognize the value of swift responses to customer queries and are increasingly using AI to facilitate this. Chatbots are now widely used in e-commerce. They are programmed to understand language and detect the key question raised, directing customers to specific web pages with information on the topic.

This can help customers get the information they need and reduce the reliance on a large human customer service team, keeping such staffing costs low.

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8 Tips for Better Product Consistency

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Tips for Better Product Consistency

When it comes to building a business that people trust and recognize, there’s no replacement for consistency. More specifically, you need the quality and output of your products to be consistent across the board.

However, with so many different moving parts involved, this is often easier said than done.

  1. Standardize Your Processes

Start by examining your current processes and how things are being handled at every step of the production process:

  • Are they documented?
  • Where are they documented?
  • Is there a clear blueprint that everyone can follow?

Standardization is the backbone of consistency. It involves setting clear guidelines for every stage of your production, from the initial design to the final output. This means having detailed, step-by-step instructions that leave no room for ambiguity.

It’s a smart idea to implement checklists and workflows, which are easy for people to follow. This ensures every product goes through the same procedure, minimizing variations that can lead to inconsistencies.

  • Implement Rigorous Quality Control

Quality control is non-negotiable. With that in mind, introduce systems that scrutinize your products at multiple stages of the production process. This might involve regular spot checks, pre-shipment inspections, and even post-market quality assessments.

The goal of quality control is to catch and address any deviations before they reach the customer. Consider adopting statistical quality control techniques like Six Sigma, which can help you measure, analyze, and reduce variability in your manufacturing process.

  • Leverage Technology and Automation

Don’t ignore the resources you have available at your fingertips. This includes technology and access to outside partners.

In terms of tech, automation has the ability to reduce human error and ensure that each part of your product meets exact specifications. When it comes to outside partners, you can always hand off parts of your process to an experienced contract assembly company to make sure you get the same result every single time a product is packaged.

  • Train and Engage Your Employees

Your employees are the real MVPs behind your product, and their skills and commitment play a pivotal role in consistency. Even if the majority of the production is happening with the help of automation, it ultimately comes down to the people who are implementing the systems, spot-checking the production processes, and keeping everything running.

The best thing you can do is invest in comprehensive training programs that teach your employees about the technical aspects of their jobs while instilling a deep understanding of the importance of consistency. Engaged employees who share a commitment to your brand’s standards are less likely to cut corners and more likely to maintain high quality in every task they perform.

  • Gather and Utilize Feedback

Feedback is a powerful tool – don’t ever forget it. While not always comfortable – and quite often painful – gathering feedback forces you to come eye-to-eye with how you’re actually doing. (Not just how you think you’re doing.)

Gather input from your customers, employees, and even suppliers on a regular basis to find out where there might be inconsistencies in your product. This can provide invaluable insights into areas that may need adjustment. Use this feedback to fine-tune your processes and training, ensuring that your products continually meet customer expectations and industry standards.

  • Monitor and Adapt Your Supply Chain

The consistency of your product is also highly dependent on the materials you use. Variability in materials can lead to variability in the final product. Keeping this in mind, build strong relationships with reliable suppliers whose products meet your quality standards.

Regular audits and supplier evaluations can also go a long way towards helping ensure that the materials you receive remain consistent in quality and function.

  • Set Realistic and Clear Expectations

While striving for perfection, set realistic expectations for your team and your processes. This might seem like an oxymoron, but it’s all about your mentality. Perfection is always the goal, but you also have to remember that people are people – meaning they will make mistakes.

Don’t accept these mistakes, but also don’t ruin relationships when people don’t live up to the goal of perfection. Instead, go back to the drawing board and find ways to limit those mistakes in the future.

  • Prioritize Continuous Improvement

The journey to product consistency is one that never ends. Markets evolve, technologies advance, and customer preferences change. Maintain a mindset of continuous improvement, regularly reviewing and refining your processes to adapt to new challenges and opportunities.

This proactive approach will keep you ahead of the curve, ensuring your products consistently meet the high standards your customers expect.

Invest in Consistency

If you make a commitment to product consistency, you’ll never regret it – not even for a day. It can be costly and time-consuming on the front end, but it’s one of the most financially rewarding investments you’ll ever make in the long run.

Start with the tips highlighted in this article and begin shifting your focus in a new direction!

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Contrasting Dynamics: Industrial Space Rental Markets Across Major US Cities

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The industrial space rental market in the United States varies significantly across different regions and cities, each with its own unique characteristics, economic drivers, and challenges.

By examining examples from cities like San Francisco, Chicago, Houston, and Boston, we can gain insights into the diverse dynamics of the industrial real estate landscape.

San Francisco, California

The market around San Francisco industrial space for lease is characterized by high demand, limited supply, and premium rental rates. The city’s status as a global technology and innovation hub drives demand for industrial space to support research, development, and manufacturing activities.

However, stringent zoning regulations and land use restrictions limit the availability of industrial properties, leading to scarcity and driving up leasing costs. Additionally, the city’s dense urban environment presents logistical challenges for transportation and access, further impacting the rental market.

Chicago, Illinois

Chicago’s industrial space rental market benefits from its central location and extensive transportation infrastructure, including major highways, railways, and access to waterways like Lake Michigan and the Chicago River.

The city’s strategic position as a transportation and distribution hub makes it an attractive location for logistics, warehousing, and manufacturing operations.

With a diverse industrial base and a large inventory of industrial properties, rental rates in Chicago tend to be more competitive compared to coastal cities like San Francisco.

However, rental rates can vary significantly depending on location within the metropolitan area, with prime logistics corridors commanding higher rates.

Houston, Texas

Houston’s industrial space rental market is influenced by its role as a leading center for energy, petrochemicals, and manufacturing. The city’s proximity to the Gulf of Mexico and its extensive network of pipelines and transportation infrastructure make it a major hub for oil and gas-related industries.

Industrial properties in Houston cater to a wide range of sectors, including manufacturing, distribution, and logistics. Despite fluctuations in the energy sector, Houston’s industrial real estate market remains resilient due to its diversified economy and strategic location for domestic and international trade.

Boston, Massachusetts

Boston’s industrial space rental market reflects its position as a center for education, research, and innovation.

The city’s strong presence in sectors such as biotechnology, healthcare, and technology drives demand for specialized industrial space, including research laboratories, clean rooms, and manufacturing facilities.

Boston’s industrial properties are often located in close proximity to academic institutions, research centers, and innovation clusters, facilitating collaboration and knowledge exchange.

However, limited land availability and high development costs in urban areas like Cambridge and Somerville contribute to higher rental rates and competition for industrial space.

Overall, the industrial space rental market in the US varies across different regions and cities due to factors such as economic specialization, infrastructure, land availability, and regulatory environment.

While some cities like San Francisco face challenges of limited supply and high costs, others like Chicago and Houston benefit from their strategic locations and diverse industrial bases.

By understanding the unique dynamics of each market, businesses can make informed decisions when seeking industrial space to support their operations and growth initiatives.

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