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3D Printing Goes Legit with FDA GuidanceIn the past two decades, 3D printing progressed from plastic novelties to prototype parts to wide-ranging additive manufacturing applications. Today, for example, GE Aviation is already producing FAA approved parts for aircraft engines. The health and wellness industry already embraces 3D printed tech inside and outside the body. We’ve seen advances in 3D printed cartilage implants, prosthetics, and more. In early December 2017, the U.S. Department of Health and Human Services Food and Drug Administration stepped in with guidance for industry and FDA staff regarding 3D printed medical device products. Technical Considerations for Additive Manufactured Medical Devices presents exactly what its title denotes: considerations, not rules or laws. Similar to the D.O.T.’s guidance for autonomous vehicles issued last fall, the FDA’s “considerations” are not requirements. The point is further hammered home with the header printed on each page, “Contains Nonbinding Recommendations.” The FDA uses this document type, self-described as “leapfrog guidance,” to share its early reactions and thoughts about emerging technologies. The document further qualifies itself as not addressing point-of-care device manufacturing or biological, cellular, or tissue-based products used or incorporated in additive manufacturing. The FDA guidance does give potential 3D medical device productsmanufacturers a path to follow to prepare for FDA approval. The guidance focuses on three aspects of 3D printed medical devices: design and manufacturing process; device testing; and labeling. The specific steps combine conventional manufacturing and testing considerations with additional elements relevant to 3D printing. This document is the FDA’s way of giving a heads up to anyone submitting 3D printed medical devices to the agency for approval. The guidance gives legitimacy to 3D printed medical technology in general and states, in essence, “Based on what we know today, here’s what’s important to us when we consider 3D printed medical device products for approval.” This will give companies one more tool with which to disrupt the status quo in healthcare. Source:http://blog.sina.com.cn/s/blog_139d16d8f0102xjwo.html
Offering a quotation to a client is not always as simple as it sounds and may take some time to master. As with most things in life, the key is to keep practicing and to gain experience because, as you know, practice makes perfect. So how can we swiftly attract clients and ensure effective communication with potential medical device suppliers in a short amount of time? Below are our 5 tips which may come in handy. Know yourself as well as your client Firstly, we should have a clear understanding of what clients are looking for, whether they are interested in goods or whether they have come to see what we offer and compare our prices with other service providers. Don’t be too anxious to justify the price. Clients often have preconceived ideas of a price so rather than going on a tangent to explain all that the offer entails, take another course of action. We all know that we should have a clear understanding of a client’s company. This will allow you to predict whether a client will accept the quotation you offer. If a client is willing to pay $1 for a vaccine and yet your quote was 4 times that, odds are they will reject your offer and so alternative methods of persuasion would be necessary. Be confident in your products Do you really know your products? Do you know the advantages and disadvantages of every product? Being informed about every aspect of your product allows you to speak about it with confide nce. There is nothing feebler than a sales consultant who is uninformed about their own product. Even if your product is of a much higher quality than all its competitors, badly informed sales personnel will sabotage your sales. Make good use of advantages Being knowledgeable about your own product is not where it ends. You will have to know your competitors’ products too. Know the advantages of your product and know how to explain the benefits your product holds over those of your competitors. Although there may be certain aspects in which your product is inferior to others, the advantages should be emphasized when comparisons are made. Keep in mind not to deny the inferior aspects as this will create distrust with the client. Consolidate step by step Once you have reached the point where you are able to give a quotation, be ready for the client’s counteroffer. Be sure to quote a reasonable price as over quoting may cause the client to lose interest and result in you losing the transaction. Also keep in mind that offering a quotation that is too low won’t benefit you or necessarily stop counteroffers from the client. Client’s psychology All clients want to get the best deal they possibly can and will try a wide range of tactics in order to get it. One way of doing this may be to tell you about an absurd offer they got from one of your competitors, one you cannot compete with. Not to worry. Don’t compete and shoot yourself in the foot, rather explain why your product is superior as well as other features such as after-sales services. About Ddu Ddu (www.drugdu.com) is a leading global B2B online platform focused on the cross-border trade of pharmaceutical and medical device products. As a pioneer in the industry, Ddu is committed to accelerating the circulation of pharmaceutical and medical device trade around the world, making it simpler and more efficient. With advanced technology and expertise in the international medical trade industry, Ddu has provided a full range of solutions for thousands of global suppliers and buyers to build and develop channels of communication and expand international business opportunities. source:http://forums.online-sweepstakes.com/blog.php?b=70027
amandahao добавил запись в блоге в Medical Device and EquipmentSeptember 18, 2017 Source: Ddu 183 After attending Shanghai CNEF and Hospitalar in Brazil you come home and look at the pile of name cards and the masses of client information you collected. Now what? We often establish new business relationships at exhibitions such as these but the key of securing them lies in how you follow up on your clients. Ddu (www.drugdu.com), the leading global pharmaceutical drugs and medical device products B2B online platform, today shares with you some insight on how to organize client materials and write your first follow up development letter. I. Organize and follow up on your clients with purpose The first step is to collect as much information as possible and pay special attention to all the relevant details at the exhibition. For example, what the client is looking for, what they are most concerned about, what kind of products and suppliers they have in mind and which business partners they would like to keep. After this you will be able to arrange the information according to clients’ interests and the thoroughness of information to help prioritize who to contact first. This will also help you to send them e-mails with content specifically addressing their needs. You can divide your clients as follows: Buyers who ink deals at the exhibition In the event that a client signs a contract at your booth, you are required to keep in touch with them. Regularly contact them to keep them up to date with the latest developments and to remind them of remittance. Potential buyers Many potential buyers will tell you exactly what they are looking for such as details about their desired products and price ranges. It would be wise to give priority to these clients since it’s clear that they are not browsing but ready to buy. Do thorough research on all the client’s key concerns before relying make sure that all samples are well prepared and updated. Learn all you can about the client and be sure to visit their website to get a clear understanding of who they are and what they do. Clients who show only slight interest by exchanging name cards and asking for product information. There are of course a number of people who leave their contact information and only show a bit of interest in your products rather than committing to you. Never underestimate the potential of these individuals and be sure to send them detailed product information and express your goals and willingness to do business with them. II. Do not expect too much from a development letter Generally speaking, clients are very willing to do business at exhibitions since they have the opportunity to speak to you as well as view and experience your products and services first hand. The purpose of a development letter is however more targeted since you now have all the clients’ information and understand what their interests are. When writing a post-exhibition development letter, we suggeststicking to the following three principles: 1. Concision The content of a development letter should be concise and no more than three paragraphs. 2. Simplicity Explain your idea in a clear and simple way to ensure that no words are mistaken especially if they are not English speakers. 3. Precision Don’t beat around the bush and go straight to the point. III. Make your development letter cut to the chase Besides sticking to the three principles above, be sure not to overload the development letter with irrelevant details. 1. Get straight to the point Introduce yourself and your company to the client briefly. 2. Highlight the products of interest Affixed detailed information and quotations of products including parameters, sizes and packing material. 3. Create a detailedcatalogue and catalogue classifications in PDF format and be sure to archive images and bestsellers. 4. Add your name card Affix an imageof your name card as well as the name card of your client to help make a deeper impression. The format of your development letter should firstly lead your clients to check the quotation directly and inform them that samples are available at any time. Secondly, since the quotation is attached, it’s not necessary to mention the MOQ for the time being. Lastly, remember to include alternative contact information like a telephone number, email address and website. This is Ddu’s suggested development letter template: Dear David, Good day! We were pleased to meet you at CMEF Shanghai and enjoyed our conversation. ****. We are ABC Co., Ltd from Shenzhen, China. Our company has been specializing in APIs for 10 years. We are currently a supplier of EFG and would like offer our services to you too. FREE SAMPLES & CATALOGUES will be sent if needed. We look forward to your reply and working with you in future. Best Regards Alice Sales Manager Often you don’t receive a reply to the email in which case it is advisable to phone them. From here on out you will be able to build a professional relationship with your newly acquired clients and so expand your business in the international market. This article is from DduNews, only for non-commercial use and reproduction. Please indicate the source when distributed. Source:http://forums.delphiforums.com/medicaldevice/messages/15/1
amandahao добавил тему в За Рулём3D printed medical device products are very high-end devices that are engaged in the process of utilizing digital models to develop a three-dimensional object.In the healthcare industry, many academic institutes make use of this technology for patient-specific treatment.The key 3D printed medical devices companies are working on strategies that would increase their market share. In terms of income, the global 3D print medical device and equipment market is expected to grow at a compound annual growth rate of 17.7% during the forecast period, which is expected to reach $1.4694 billion by the end of 2026. (Source: Future Market Insights, 2016)The key companies of 3D printed medical devices in the global 3D Systems, Inc., Arcam AB, Stratasys Ltd., FabRx Ltd., EOS GmbH Electro Optical Systems, EnvisionTEC, Cyfuse Biomedical K.K., and Bio3D Technologies taking innovative creating a successful strategic plan to increase their consumer base. Reasons 3D printing medical devices will have a foothold in the healthcare industry Applications of 3D Printing Medical Device Products 3D printing technology was used for the rapid manufacture of medical models in the begging.With remarkably the development of 3D printing technology, it is used to develop medical devices such as dental implants, orthopedic implants, complex surgical instruments, customized artificial joints, customized surgical consumables and hearing aids. Furthermore, hospitals and academic institutes need various 3D Printed models for training purposes. Unique Features of 3D Printed Medical Devices 3D printing technology not just creates copies of the same device, but makes it easy for designers to make more patient-matched devices without additional tools.The flexibility of 3D printing enables 3D printing medical devices matched to a specific patient with very complex internal structures. There is no unified standard for 3D printed medical devices.FDA still regulates 3D printed medical devices in the same way as traditional medical device products. According to its various applications in the medical industry and its unique features, 3D printed medical devices will certainly have great prospects fit in the future. Source:http://media.drugdu.com/latest-information/market-views/3-amazing-advances-in-pharmaceutical-drugs-in-2017.html