The FDA has steadily increased its enforcement focus on supplier controls – a critical potential weak link in medical product manufacturing. Manufacturers can outsource goods and services but not regulatory responsibility or product liability.
Devices pose a unique set of challenges because of the exceptionally wide range of supplied products and services and a reliance on suppliers from other fields, who have limited knowledge of medical risk factors and regulatory requirements.
Another hot-button issue in all segments of the life sciences industry is full service fulfillment outsourcing. In the medical device sector, outsourcing initially took hold in the manufacturing phase, and companies raced across borders and oceans to capitalize on low-cost labor for potentially large profit gains.
Several trends are driving the need for single-source partners. Among these trends are rapid market growth and the emergence of new industry-spanning market segments. New markets, such as those for combination products and advanced drug delivery, are more complex than traditional markets.
Top business thinkers have known for some time that logistical success often equals business success. If you can find a better way to move goods in and out of your
organization and put the right things in the right people’s hands at the right time—your chances of success go up dramatically!
As the logistics outsourcing model continues to mature, companies are realizing that outsourcing key areas of sourcing, kitting and fulfillment can impart large productivity gains that translate into competitive advantages.
Medical device companies and medical marketing consultants, in turn, expanded their universe of external partners. But problems arise when too many outsourced firms are involved. Relying on a number of different suppliers to get a medical device to market can be inefficient and time-consuming. In response, medical device manufacturers have begun seeking partners that can provide full-service outsourcing and mail order fulfillment services.
Partnerships typically begin with a formal assessment process that helps evaluate the strategic elements of an organization’s outsourcing needs and short or longer-term “consult-to-action” retainer relationships often develop.
Programs for a formal logistics assessment look at an integrated supply-chain management approach to ensure more efficient movement of materials in and out of an organization including: procurement, warehousing, packaging, assembly, kitting, distribution, returns management, quality inspections and tracking with the ultimate goal of improving inventory visibility and velocity.
By storing, assembling and distributing all manner of goods more efficiently, you will be able to positively impact your bottom-line. To learn more about how you can capitalize on low cost outsourcing, click here.
Jon Nugent | Director Client Services
Business Intelligence Solutions | www.busintellsol.com
A comprehensive global report on medical devices outsourcing titled “Medical Devices Outsourcing: A Global Strategic Business Report” projected the outsourcing market to reach $42.6 billion by the year 2015.
In today’s global marketplace, manufacturers are faced with intense competition, which is driving a demand for innovation, faster time-to market, and lower price premiums. Consequently, manufacturers must develop higher quality products faster and at a lower cost.
Primary drivers for medical device outsourcing include not only the growth pattern of overall medical device market, but also the extent to which device manufacturers choose to outsource their manufacturing, sourcing, kitting and assembly operations.
Medical device manufacturers face an even larger challenge by having to comply with strict regulatory requirements. Compliance requires that every decision and every step of the process be tracked and recorded, which adds a huge burden to medical device manufacturers trying to remain competitive.
When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the Quality System regulation.
The Quality System regulation is in Part 820 of Title 21 of the Code of Federal Regulations (CFR). This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records - full service fulfillment.
Companies that compete globally must assemble and label their medical device/diagnostic products to meet the specific regulatory requirements of the countries in which they are marketed. When you’re considering outsourcing, you need to address Quality System regulation regulations that pertain to the critical phases in the medical device development and production cycle.
Whether it is a few phases in the project cycle or the entire project, you need to work with a company that ensures the highest level of service and understands the regulatory requirements.
Growth in the market is especially driven by factors such as rising demand from device end market, an increased interest exhibited by OEMs on improving productivity and simplifying supplying chain network, emergence of one-stop shops, and ability of contract manufacturing to slash costs, an added impetus for adoption especially during tough economic and financial climate.
Concordia Medical, a medical device company that modernized their business practices, was driven by the need to remain competitive, and retain critical survival capabilities, agility and flexibility in a fast changing marketplace.
Jon Nugent | Director Client Services
Business Intelligence Solutions | www.busintellsol.com
According to a new article on third party logistics in Next Generation Pharmaceutical, “traditional pharmaceutical and medical device companies, along with newer biotech and equipment enterprises, are increasingly working together to produce systems that link drugs with devices and diagnostics. Their products are sent to consumers through multiple distribution channels: traditional wholesale, direct to pharmacies, to retailers for sale over-the-counter and directly to consumers’ homes”.
Bill Hook, UPS vice president of global strategy for healthcare logistics writes “These diversified channels can provide new revenue streams and new growth areas. However, manufacturers’ focus can be lost and critical errors made, particularly in transportation and distribution, when dozens of participants are involved”.
Outsourcing supply chain fulfillment operations is increasing for companies to regain their focus and remain competitive despite new market challenges. A third-party logistics (3PL) provider can help streamline the process – particularly in post-manufacturing handling and distribution.
In fact, more than two-thirds of pharmaceutical, medical device and diagnostics manufacturers surveyed in recent years by consultants at PRTM said they use or plan to soon use a 3PL. By using a 3PL, products can be moved quickly from manufacturing site to store shelf or dispensary. Quick market introduction is enabled because the distribution channels are already in place.
As the medical device industry continues to expand, companies are searching for ways to become more competitive. Medical device manufacturers are faced with intense competition, increasing regulatory pressures, shorter product life cycles, rapid new product introductions, globalization and higher quality standards. As a result, there is an increased focus on creating efficiencies in the supply chain similar to other industries.
Companies today are looking for Supply Chain Services and innovative technologies with proven best practices to improve service levels while reducing inventory and labor costs. In the process, customers gain end-to-end visibility to align their corporate business strategies and processes to their global supply chains.
Globalization
Perhaps the most prominent factor that medical device companies have embraced supply chain outsourcing has been the increase in the number of companies operating in the global marketplace. Companies are embracing global sourcing, production, centralization of inventories and the centralization of information.
The difficulties of operating in a global environment can’t be understated; logistics and supply-chain networks have become far more complicated. Meeting the need to plan and manage logistics as a complete and integrated system has also become far more difficult.
The best solution for a global company or a company wanting to become global is to outsource their logistics operations.
Jon Nugent | Director Client Services
Business Intelligence Solutions | www.busintellsol.com
I have been asked to provide several key definitions surrounding the Supply Chain:
Supply Chain Management is the organization, planning, control and execution of a product from development and purchasing, through production, warehousing and distribution to the final customer in the most cost effective way possible.
Logistics management is the planning, implementation and coordination of the details of the supply chain.
Third Party Logistics (3PL) is the function by which the owner of goods (The Client Company) outsources various elements of the supply chain to one 3 PL company that can perform the management function of the clients inbound freight, warehousing, order fulfillment, distribution, and outbound freight to the clients customers.
The Allied Group is a 3PL provider to the Life Science industry. While we don’t create the product we assist our customers with the logistics on the assembly, kitting, warehousing and distribution of medical devices to physicians and consumers. We are an outsourced Supply Chain Management solution.
An international market leader in the development, manufacturing and distribution of medical devices approached The Allied Group with an issue they were experiencing concerning the distribution of an adjunct product necessary in the demonstration of their device.
In other words, they needed help with third party fulfillment.
Their primary selling tool is to invite physicians to a weekend workshop to explore how they can expand their practices by offering new revenue streams. The company conducts approximately 80 workshops per year, avoiding the summer months and December. Typically, thirty-five to forty physicians will attend a workshop (the smallest being twenty and the largest being close to one hundred).
During the workshop, they demonstrate a variety of equipment and have testimonials from local doctors who have expanded their practice by offering these services. There are extensive hands-on demonstrations during break-out sessions that allow the physicians to see the tools in action.
Download the case study
ISSUES:
The Marketing Department at this company is responsible for the determination and coordination of these workshops. Marketing and Sales are responsible for the logistics of where and when to conduct the meetings, who to invite, and how to drive attendance. They are also responsible for coordinating the contracts for the locations and making sure all the participant materials are in place for a successful workshop.
• The company had tried several approaches to solve this issue and there was confusion among the ranks on how to return the protective eye wear.
• Some thought they were to forward to the next workshop in the area and others thought they needed to be returned but weren’t sure where
• Many times protective eye wear were mixed in containers and nobody was checking them before they went back out.
Click here to read about the other issues.
SOLUTIONS:
The Vice President of Marketing came to the realization that the coordination and distribution of the supplies was neither a core competency nor a focal point of their company and looked to an outside resource for help.
The company was experiencing issues with the coordination of protective eye wear needed and with properly conducting demonstrations at the workshops. Allied investigated what was happening and spoke to numerous workshop leaders, sales reps and other stakeholders in the process. The Allied Group was invited to help with the coordination and distribution of the supplies and marketing materials for each of these workshops.
To learn more about how The Allied Group’s Turn key Supply Chain Services helped an international market leader make continued improvements and save $70,000 in one year download the case study.
Jon Nugent | Business Intelligence Solutions
www.busintellsol.com | 1.800.782.0580 ext 6
Wow, you guys are brilliant! I can honestly say that I have not heard that statement too many times in my career. Those words were spoken to The Allied Group team by the member of a genomic testing company. I have to be honest; I had to ask my son who is in medical school to explain everything his company did. They were brilliant; we were a company that could supply them with business process outsourcing solutions like supply chain management, marketing solutions, contract packaging and direct mail fulfillment services.
We entered a dialogue and one by one we were able to help them improve their business processes. They understood what they do best which is the science and the laboratory to process the blood. We understood how to market the service, create a package that we could ship their clients and how to bill the client for the service. We became part of their back room operations.
We have helped several key genomic test companies improve their back room operations. How can we help your operation?
For many of our clients, outsourcing is the ideal fulfillment solution.
It allows our clients to focus on other core tasks while we become their partner and cover their warehousing, ordering, distribution and direct marketing campaigns.
What are some of the reasons that prompt businesses to seek a fulfillment solution?
Some may be tired of managing an on-site inventory system. Others may want to focus on growing their business rather than warehousing and distribution. Maybe you have too much inventory in house and you are looking for web-based ordering capabilities for your staff or team of sales people. You could be planning a direct mail marketing campaign but don't have the space or manpower to pull it off.
Since many fulfillment centers provide similar basic services, it is important to evaluate your choices thoroughly and choose wisely. The Allied Group has a variety of different services to choose from. You may initially just be looking for a fulfillment group to warehouse your inventory but then decide that you need to create a direct marketing campaign with the inventoried items. That's where your decision to choose The Allied group because of our business process outsourcing solutions really pays off. Not only can we take care of designing this campaign for you, we will also help you find a promotional product to include in the mailing, and mail it for you.
So what does this all mean? Here are 5 things to think about as you sip down a few energy drinks, put the pool toys away and shut off the air conditioners in favor of some good old fashioned fresh air:
1. This IS the 4th quarter. I know it isn't technically/literally, but, let's face it—this is the home stretch! Put your lead generation methods to the test and make your 2011 goals.
2. Quit goofing around. Time to make some tough decisions and "act" on those decisions. If you're considering an integrated marketing communications program, do it! Now's the time while your team is fresh, ready to get moving and motivated to make an impact on 2011.
3. There is still time! I just bought you an extra month. No, this isn't the 4th quarter, but if you treat it as though it is, you still have time to implement a personalized direct marketing program and get some results by the end of the year.
4. Social Media is not a fad! Ok, so this is more of a statement. But, trust me, if you are not either knee deep, sold, but haven't begun, or at least strongly considering a social media strategy as part of your corporate marketing communications plan, you're missing the boat. And it is quickly sailing away.
5. Just like the NFL, a shortened off-season can work! So you've condensed everything into 4 short months. It can be done. If you're implementing a marketing and sales support initiative, or considering fulfillment outsourcing, the window is open and the fresh air is pouring in. But the air is getting colder and before you know it, you'll have no choice but to shut it.
If you want to talk, you know how to reach me!
Would you hire a new employee without doing your due diligence? Without the interview and checking references? Well, you want a company that prides itself in its ability to execute what you both agreed upon. This is where due diligence of the current vendors is critical. Get a list of their current customers that you can contact and talk to them about their experience with the vendor you are considering.
Do they respond well? Do they meet and exceed their customers’ needs and expectations. Understand the customers’ they will provide you will be the best they have to offer. If those contacts provide you with any cause for concern be cautious. If they provide you with great reviews then it makes choosing your supply chain fulfillment partner much easier.
How much time do you spend focusing on your supply chain as opposed to growing your business? Let the experts at The Allied Group take away that burden so you can focus on what you do best: growing your business.
At The Allied Group, we can assist you with true 3rd Party Logistic (3PL) solutions that will positively impact your efficiency, and in turn your bottom line. Our warehouse management system allows you to outsource with confidence and help you with:
* Cross-docking of products, samples, parts, supplies and literature
* Decreasing operating costs
* Reducing staffing levels
* Concentrating on core competencies
* Improving customer satisfaction
Business experts all over the world continue to emphasize the need to improve supply-chains to improve productivity and profitability. Does your system measure up?
The Allied Group has resources that help you control the 7 key aspects of supply-chain management; planning, sourcing, production, assembly, packaging, inventory control and distribution. Because we do all this in-house, under one roof, we can offer a streamlined process that ensures superior efficiency and superior results!
For more information on the fulfillment supply chain fulfillment process, contact us today!
This process eliminates guess work and limits human error - whatever order you place is the order that should be fulfilled. You should feel comfortable that your 3PL providers will meet your ever changing needs.
Up next: PARTNERSHIP...
Are you environmentally friendly? Are you practicing sustainable living? We all hear these questions all the time, even in email signatures, but how bad is print?
The printing industry is not always viewed as environmentally friendly - we understand that. But what we want everyone to know is that printing and paper have their place and are still effective ways to communicate.
At Allied, paper is an important part of our fulfillment outsourcing and marketing and sales support solutions as well as recycling and being responsible. Furthermore, we want to make sure that people have all the facts about print and our industry.
Please, click here to read an article regarding the print industry and how paper has gotten a bad rap these days.
Visit our site to learn more about an integrated marketing communications program or full service fulfillment program that is right for you.
As we all know, Rhode Island has been hard hit by the economy and if that weren't enough, last years floods didn't help our efforts at all. Providence Business News reports that Rhode Island’s economy resumed its expansion in December, URI's economist Leonard Lardaro said as his economic index climbed to match its highest level of 2010 - great news.
"Lardaro’s Current Conditions Index rose to 58 in December, up from 50 in November and 42 in October. The index last peaked at 58 between June and September. December’s 58 reading was a significantly higher than the 33 recording a year earlier. Lardaro said seven of the 12 indicators improved compared with December 2009, including single-family house permits, retail sales, total manufacturing hours, manufacturing wage, unemployment rate and unemployment benefit exhaustion."
More great news for this state is that Providence has been listed as one of seven cities that has caught "start up" fever. Many companies are starting out in this state and much of that can be credited to Rhode Island School of Design’s graphic-design program and Brown’s computer-science department. Jack Templin is featured in the February DETAILS issue.
As a marketing strategy services and fulfillment outsourcing firm based in Rhode Island, this all brings a smile to our faces. Things are looking up and that's a great way to start 2011.
Source: PBN
are getting a rest but we're still communicating, possibly more than ever. we just aren’t using cans attached with string, pigeon carriers, or pagers anymore. Social media has revolutionized how we talk, meet, and increase S.E.O results.We all see the value in increasing traffic to our websites because the more traffic there is the greater the awareness becomes and the higher the sales climb. This makes our focus turn to Search Engine Optimization (S.E.O) and the more social media you utilize the more frequent and higher up your site will be positioned in search results. Customers are either searching for you by name or for a service they need. Start talking up your industry to help increase business and start talking up yourself for more opportunities.
DON'T: Infest social media with too much information pertaining to yourself or your company. People don’t find as much value in knowing absolutely everything your company is up to.
DO: Give them information, suggestions, tips, industry trends, and new techniques. Feed them less about you and more about the industry and they will see the benefit to following you.
Here is a list of some things we should all be utilizing-- how and why:
LinkedIn: A networking wonderland! Get referrals, reconnect and get the contacts you need. You know that ideal client your company has been trying to meet? Well, this site lets you see if any of your contacts are connected to them through what the site terms as ‘degrees of separation’. Instead of a cold call, ask one of your contacts for an introduction.
Youtube: People are information hungry. Help give them the information they are searching for. For instance, if your company's focus is on fulfillment outsourcing, and you have a video showing how your digital asset management solutions work, or a how to’ on outsourcing supply chain management, then upload it.
Facebook: Raise visibility, get customer feedback, promote events and post pictures, let your followers see a little of your personality. Also, engage your followers by asking them questions. For instance say your company focuses on marketing to college students and the majority of your followers are VP and Directors in Admission departments, ask them what fairs and conferences they are planning to attend. People love to talk about themselves, especially if given the chance.
Twitter: Short quick hitting updates on what you’re up to, links to articles you or your coworkers have written, recognition to followers on awards they have just won, thanks to anyone who has retweeted your article(s).
Blogs: Share your thoughts with the world or just at least get it out of your head. Show your audience that you are an expert in your field. Give them information, your opinions, address how things going on in the world are impacting business. Keep your articles related to the industry.
Ignoring social media is an amatuer move. It's a powerful tool that is helping companies and professionals increase awareness and growth. And remember, all of this is FREE. Sure, the true investment is your time, but we are pretty accustomed to spending both money and time, so consider the price tag of $0.00 a plus.
I don't know that there is too much I can say that this video clip doesn't illustrate more brilliantly than I could express in words. As the marketing & creative director at The Allied Group, a New England based Marketing Communications Company, it's my job to be up to speed, aware of and, in many ways, have an opinion on the validity, usefulness and practicality of "what's hot" in our industry. And while many of my conversations still center around marketing as it relates to creative design and redesigning websites etc..., more and more of my conversations are specifically about social media and it's place tactically in the marketing mix. It's taken me some time to come to this opinion, but here goes: to me, the significance of social media is beyond tremendous. It's fundamental to marketing itself...it's actually IN THE NAME! MARKETing. In other words, it is your market. It is where the people are. A colleague of mine said it best the other day: If you want to be a successful fisherman, you have to fish where the fish are! Now we can debate the proper way to harness its power and how to tactically implement, refine, test and tweak, but the bottom line is that it's where the customers are. All customers. All prospects. 
But don't be overwhelmed. For me, it has come down to a simple understanding. Social Media isn't so much about being brilliant or witty or profound. And, conversely, it isn't about telling the world about what you had for dinner last night or the fact that your dog just threw up on the carpet. It, like it has always been, is about content. Content that is easily found when your ideal prospects are looking for it. And then making sure that it doesn't let them down. So, again, it doesn't have to be brilliant—it has to be relevant and to-the-point. Social media to me is about search. When our ideal prospects are looking for a higher education marketing firm, we need to be found. When another prospect is looking for 3PL providers and new england marketing, and fulfillment outsourcing, we need to be found. And if we are found through a blog, or a tweet, or a Facebook post, it makes no difference to me. As a matter of fact, it's more likely that we'll be found that way because the content is bound to be more relevant, therefore more likely to be of interest to a prospect, therefore more likely to perform better in a search engine. What more could you want?
Well, according to Yahoo as of right now -- you've got a range from American Idol, to Chelsea Clinton, to Iran, to bear attacks of all things. But in the world of strategic marketing consultancy services and top 3pl companies, we've got to do a little better than just what's hot right now! Or do we? As much as we need to stick to the basics and practice what's tried and true...we get the most questions about what's hot and how we can best hitch on to that wagon. And, come to think of it, that's probably to be expected. What's HOT for us right now? How about small business supply chain management? Maybe marketing for higher education? A few promotional product ideas...and some digital asset management solutions. They might sound as disjointed as Chelsea Clinton is to bear attacks, but the bottom line is that's what our best prospects are looking for. And, basically, it's what The Allied Group is good at. As a marketing communications company that also offers total fulfillment outsourcing, we've got our best clients covered from marketing strategy to supply chain management strategies. If you need to attract, acquire or retain more of the right customers AND contain, reduce and remove operational costs, we should talk!
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