Harvesting biomechanical energy in vivo is an important route in obtaining sustainable electric energy for powering implantable medical devices. Here, we demonstrate an innovative implantable triboelectric nanogenerator (iTENG) for in vivo biomechanical energy harvesting. Driven by the heartbeat of adult swine, the output voltage and the corresponding current were improved by factors of 3.5 and 25, respectively, compared with the reported in vivo output performance of biomechanical energy conversion devices. In addition, the in vivo evaluation of the iTENG was demonstrated for over 72 h of implantation, during which the iTENG generated electricity continuously in the active animal. Due to its excellent in vivo performance, a self-powered wireless transmission system was fabricated for real-time wireless cardiac monitoring. Given its outstanding in vivo output and stability, iTENG can be applied not only to power implantable medical devices but also possibly to fabricate a self-powered, wireless healthcare monitoring system.(X-MOL)
Here’s what analysts are saying so far about what Donald Trump’s election as U.S. president could mean for the medical device industry.
The dust is starting to settle from this year’s U.S. presidential election. (Though, watch out for more drama: There are calls for vote recounts in some of the states Donald Trump won on the way to beating Hillary Clinton.)
As president-elect Trump moves forward with the transition before his January inauguration, many of his potential policy stances are works in progress. But a picture is nevertheless starting to form when it comes to how Trump could affect the medical device industry.
Read on to find out five things industry analysts saymedtechinsiders should watch out for.
1. Medical Device Tax: Dead for Good
The 2.3% medical device excise tax, much hated in the industry, has a good chance of being permanently repealed under the incoming Trump administration and Republican-controlled Congress.
Congress already chose in December 2015 to suspend the device tax for two years as part of a spending and tax breaks deal hammered out with President Barack Obama.
The industry has called the tax a jobs killer, but analysts at S&P Global Ratings do not expect a permanent device tax repeal to affect results much: “Although the tax on device companies is 2.3% of revenue, in practice that has often represented only about 1% of revenues for the global medical device companies we rate, because it only applies to U.S. sales, and even then only to the portion of value-chain created in the U.S. (for example, substantially less than the full value when the intellectual property assets and/or manufacturing process occurs overseas).”
2. The Affordable Care Act Is Dead, Too
Trump has been very clear on this point: He wants anObamacarerepeal passed through Congress as soon as he is inaugurated, replacing the outgoing president’s greatest legislative achievement with a to-be-determined program.“Trumpcare,” though, could nevertheless retain some of the Affordable Care Act’s more popular provisions. Trump, for example, has told media outlets that he would like to see people with preexisting medical conditions keep their coverage. He’s also promised to work to keep the provision enabling young adults to stay on their parents’ health plans.
The situation represents a mixed bag for medical device companies, according to analysts. “Under a repeal scenario, we would expect elective surgical procedures to decline. This would be a negative for orthopedic and spine companies,” RBC Capital Markets’s GlennNovarropredicted shortly before the election.
U.S. healthcare costs overall have reached unsustainable levels, so don’t expect a slowdown in the Centers for Medicare and Medicaid Services’s push toward value-based reimbursement, even though the strategy shift was part of theACA, according to S&P Global Ratings.
Says S&P: “We expect device companies to increasingly bear more contracts involving reimbursement tied to outcomes from their products or services.”
3. Reduced Regulation
If Trump nominates traditional Republicans to run FDA,HHS, and CMS, that could be good news for the industry, Wells Fargo senior analyst LarryBiegelsensaid in a post-election research noterecounted by MD+DI.
Such traditional Republican appointees would reduce regulatory scrutiny of the industry. But "it is possible, but not certain, that Trump would install leaders atHHS, CMS, and FDA who could attempt to take policy at these agencies in unpredictable directions,”Biegelsensays.
Becker’s Hospital Review in mid-Novembermade some guesses about a possibleHHSsecretary nominee. They included everyone from former LouisianaGov. BobbyJindalto FloridaGov. Rick Scott to former U.S. House Speaker Newt Gingrich.
Efforts to speed up FDA response time and approval processes have a much better chance of passing Congress now that Trump has been elected president, according to S&P Global Ratings.
4. Bringing Back Overseas Cash
Many major U.S.-basedmedtechand pharmaceutical companies have large amounts of cash “trapped” in overseas entities entities due to the high 39.1% U.S. corporate income tax rate. Trump has been a major proponent of tax reform that would would reduce the cost of U.S. companies bringing profits back from outside in the country, whether through a permanent lowering of the corporate tax rate or some kind of temporary “repatriation tax holiday.”
Large medical device companies in the U.S. could get a major cash infusion if any of these proposals are enacted, according to S&P Global Ratings.
5. Negative Trade Impacts
Trump’s trade policies could be a negative for the medical device industry. During the campaign, Trump voiced stances on trade that sounded downright protectionist.
“Nearly all our medical device companies rely on low-cost manufacturing outside the U.S., (with Mexico being a blossoming area in recent years) to keep costs low. Pressures to bring manufacturing back to the U.S. could be a material burden on these companies,” says S&P Global Ratings.
Join us on 20-22nd September 2017 Medtec China, sourcing the qualified supplier and material you need.
Sourcing medical devices in China can be a daunting task for companies that are unprepared to deal with cultural differences, differences in time zone, as well as the sheer geographical distance that separates Asia from the United States and Europe. Although sourcing in China can be a cost-effective option for a business, companies should be ready to invest considerable time and resources throughout the entire process, from initial supplier identification to final product delivery.
While many businesses are familiar with basic sourcing guidelines and procedures, there are a number of China-specific issues foreign companies should be aware of when sourcing medical devices in China. Listed here are the basic steps a foreign company should follow along with key issues that companies should be aware of when working with Chinese partners.
Identify the Proper Supplier
Identifying the proper supplier can save a company considerable time and money in the long run. While this step is self-evident, finding a competent supplier in China may require more work than finding a supplier elsewhere.
The first step in investigating a potential supplier is to examine the company's website, online presence, and any customer reviews that are available. Companies with an Alibaba profile page should have feedback and reviews that will provide a first impression of the company. If a particular Chinese company seems promising, the foreign company should follow up with a phone call to request additional information. At this early stage, the foreign company should ask to see relevant registration documents, certifications, and business licenses, which they can receive via e-mail. If the potential supplier delays or refuses to show these documents, the foreign device company should move on. If a supplier cannot provide this basic information in a timely manner (less than 10 days), then they generally cannot be relied on to deliver the actual product.
It is extremely helpful to have an on-the-ground presence in China to ensure that the supplier actually has manufacturing capabilities. Chinese companies can easily create a convincing website and sound authentic on the phone, but certain trading companies mask themselves as the actual manufacturers. By checking the address in person, the foreign company ensures that the company has a manufacturing facility with the proper equipment. In addition, this on-the-ground representative can speak with the staff and check the production line, quality assurance team, and technical staff.
In one case, Company A claimed to be the true manufacturer of various syringe products; however, when the foreign company’s local China team visited Company A’s offices, it was clear that there was no manufacturing equipment. In addition, Company A’s representatives had different business cards and lacked in-depth knowledge of the manufacturing process and the details of the actual products. Company A was actually a trading company acting as a “middle man” between the manufacturer and the foreign company.
The local team was only able to identify the actual syringe manufacturer by visiting Company B’s manufacturing facility. Initially, the local team tried calling Company B, but the representatives would refer callers to the various trading companies that would actually conduct business. Often times, these representatives were relatively low-level employees who were not in charge of client/customer accounts. They had little knowledge of current accounts and could not answer questions regarding product design or quality. By visiting the manufacturing facility, asking in-depth questions regarding the syringe products, and meeting with senior staff, the local team was finally able to confirm that Company B was indeed the manufacturer producing the products for the foreign company, instead of Company A. This anecdote illustrates the importance of conducting thorough checks before entering into a contract with a Chinese company.
These initial checks should be followed up with thorough on-site assessments that verify relevant information including the following:
- Company's full name and legal address.
- Company website.
- Year the company was established.
- Number of employees.
- Number of employees in the following departments: production team, quality team, technical team, sales team.
- Facilities, including the following: number of facilities, size of production facilities, size of warehouse.
- Main products manufactured.
- Main export markets.
- Annual revenue.
- Regulatory certifications (ISO 13485, CE mark certificate, FDA listing) to ensure that they are up to date.
In addition, this on-site assessment should determine if the following are true:
- The manufacturing facility is suited for the medical device product(s).
- The supplier's staff can speak English, are properly trained, and are experienced professionals.
- The company currently has other international customers and is not just a domestic Chinese supplier.
At this stage, typical negotiating and bargaining strategies apply. Naturally, foreign companies will want to bargain for low purchase prices and ensure that they pay as little up front as possible. While these basic business strategies apply across the board, there are a few China-specific caveats that should be kept in mind.
First, Chinese suppliers can be tough negotiators when it comes to down payments or deposits. To facilitate the process, companies must have a fluent Chinese speaker on their team to ensure that nothing gets lost in translation.
Second, companies should be aware of Chinese business practices. Conducting business in a personal, face-to-face setting is highly recommended, as many companies are not accustomed to conducting business over the phone or internet. Chinese suppliers know that foreign companies are sourcing in China for its low cost. Foreign device companies will attempt to secure the best purchase price for themselves. However, be aware that a low price may lead to a cheap, low-quality product.
Third, please note the differences in communication. Chinese businesses will rarely admit that they can't do something and will instead deflect questions or refuse to answer. Companies should also be prepared to engage in long negotiations. Chinese suppliers tend to initially make an offer that is around 50% higher than what they would accept. Having a clear understanding of the underlying costs will help you have a better understanding of a suitable price for the product.
Finally, be aware that Chinese suppliers may bring up points that have already been agreed and settled upon. This can be a frustrating issue, but it is common practice in China. Purchasers should be prepared to go over details that have already been agreed upon. Westerners prefer contracts while Chinese suppliers like to have vague contracts in order to maximize flexibility.
Product Samples and Initial Order
Foreign companies should first order small batches of samples to ensure product quality. In addition, companies should be aware that Chinese suppliers may be tempted to cut down on costs by sending pre-existing samples that don't meet the company’s exact specifications. The product evaluation department should analyze all product samples, identify mistakes or problems, and return comments to the manufacturer.
Suppliers may also tell a potential customer that they will adjust the product to the final specifications once a large order has been made. This may be convenient for the supplier, but foreign companies have no guarantee that these requirements can and will be met. Foreign companies must insist that the initial samples meet the final specifications.
Once again, at this stage it is helpful to have an on-the-ground Chinese speaker present who can directly communicate with the supplier. A large order should not be made until the supplier has completely satisfied all product requirements. If the foreign device company has conducted proper due diligence and identified the correct supplier, the supplier should be willing to meet the required specifications.
Making the First Large Product Order
Prior to making the first large purchase order, companies should ask suppliers for various legal business documents including the following:
- Tax registration certificate.
- SAIC filing.
- Organization code certificate.
- Invoice sample (from a previous purchase made by an actual customer; not just a blank template).
- Business license.
- Copies of the ISO and CE (if required).
Foreign device companies should use their own purchase order (PO) template. By using their own PO template, they ensure that all pertinent information is clearly included on the document. Companies should also be sure to include a quality guarantee clause in the PO to ensure that the final products meet all required specifications and, if they don’t, that they will be replaced at no additional cost.
At this stage, there may be some discrepancies with regard to the minimum order quantity. For example, there have been some instances where the supplier argued that the minimum order quantity does not match the freight container load requirements, therefore it is important to ensure that the minimum quantity required for a full container load (FCL) is addressed with the supplier in advance. By taking the time to clearly lay out the minimum order quantity early on in negotiations, companies can save time when drafting the first PO.
When the supplier fills out and returns the PO, the foreign company must thoroughly check the document. First, ensure that the vendor name matches the bank beneficiary name. There have been instances in which the supplier attempted to have a third-party accept payments on its behalf. If this is the case, the supplier should have clearly mentioned this detail early on in the negotiations. Companies can further verify the legitimacy of a supplier by requesting official company stamps.
Second, companies should check the document for careless mistakes or grammatical errors. Ensure that the "invoice" and "ship to" details are clearly and correctly spelled out. In addition, thoroughly check the purchase quantity, unit prices, and product SKUs. Grammatical errors could indicate an honest mistake or denote a misunderstanding. Rather than let a grammatical error pass by, you must follow up and make sure that the supplier understands each and every detail on the PO as well as the pro-forma invoice.
Only after checking the bank account details, validating legal business licenses and regulatory data, and doing final compliance checks should a foreign company feel confident to move forward with the order.
After the purchase order has been completed, companies will need to send the relevant regulatory and laboratory packaging requirements to the suppliers. Chinese suppliers may be tempted to cut costs at this stage, and the foreign company's quality control department will need to be diligent.
One potential issue involves the artwork specifications. When the customer sends the artwork details (logo and color requirements, labels, packaging), the supplier will typically verify that they understand and will proceed with the printing. Oftentimes, however, a supplier will misunderstand the requirements. The on-the-ground Chinese representative can help foreign companies avoid this problem.
Color requirements are often a point of contention. The Chinese supplier may attempt to cut costs by choosing one color printing rather than two-tone or simply use black and white. At times there may be a discrepancy between the approved artwork and the actual printed copy. Also, be certain to check for careless transcription mistakes regarding the address, product details, and contents.
There may be issues where the supplier argues that previous details had been verbally agreed to by the on-the-ground representative. In one specific case, a Chinese supplier argued that the foreign company had authorized them to use old packaging and artwork for a different customer’s product. Without written proof from previous correspondence with the supplier, this detail would have been hard to verify and the order could have been delayed. Fortunately, the local team had ample notes and records showing that the foreign company had never agreed to use old artwork and packaging for their new products.
The supplier will also need to fill out a regulatory form that will be sent to the relevant national regulatory authorities (depending on which country companies are importing the products to) prior to full-scale production. The regulatory form should have:
- Basic purchaser and supplier details.
- Product description.
- Product functionality.
- Required samples.
- Product sizes and specifications.
- Relevant attachments.
Once again, the purchaser’s regulatory team should review the documents to ensure that they are error-free, clear, and contain all of the required information such as the correct ISO certificate number, risk class, and GMDN code. Rather than provide the required information, suppliers may also attempt to write vague details such as "see certificate" or "information as on the certificate." These comments will not be acceptable to local regulatory agencies and do not provide the necessary level of detail.
Companies should be aware that some suppliers lack a qualified regulatory department that is dedicated to completing basic regulatory forms. Instead, suppliers may have a secretary or another employee fill out the regulatory forms in lieu of a qualified professional. While the supplier may be forced to revise the regulatory form numerous times, it is important to ensure that the final document is correct and error-free.
Quality Control Inspections
Once production begins, companies should have an experienced quality inspector visit the manufacturing facility on a regular basis to ensure that Good Manufacturing Practice regulations are being followed. This inspector can be a member of the foreign company’s in-house team or a third-party, contracted on-the-ground quality assurance professional or quality assurance company with sufficient references. Inspectors must be willing to monitor the product at both the manufacturing facility as well as the freight forwarding centers. Generally, it is best to focus exclusively on quality checks at the Chinese factory.
Potential problems can emerge when the following occur:
- The supplier does not have a clear understanding of the client’s product design and specifications. The more technically sophisticated the product, the more trouble the supplier may have in manufacturing it correctly.
- The purchaser does not maintain a presence during the production and quality control process. Last minute "surprises" can occur, so it is enormously helpful to be knowledgeable about what is actually going on inside the production facility. Even if companies have conducted proper due diligence, they may find that the end product does not meet specifications. Purchasers should be on the lookout for mislabeled or low-quality products.
- There is a disagreement over the final quality of the product. Customers must draft the contract so that final payment is only delivered once the quality of all final products has been checked, tested, and verified.
Other issues can emerge if there are unexpected power outages or if there is a national holiday. Delivery may be interrupted depending on the time of year and season. Foreign customers should be ready to deal with problems even after the first purchase order has been successfully delivered. Problems may still arise with future orders, so the purchaser must always be aware.
An excellent Chinese supplier will be able to deliver quality products on-time at the agreed cost. By maintaining constant contact with the supplier, foreign companies can facilitate the production process and ensure that potential problems are avoided before they transform into costly, time-consuming issues.
If done correctly, sourcing medical devices or components in China can save foreign companies valuable time and resources. While Chinese suppliers can offer reasonably priced and quality products, finding the proper supplier can be a difficult task for those without the proper knowledge, experience, and on-the-ground capabilities. By exercising proper due diligence throughout the process and utilizing an experienced on-the-ground professional team, foreign companies can ensure that their orders meet the required specifications.
Finally, keep in mind that the costs are a lot higher in China today than they were 5 years ago. Thus, in many instances, foreign companies are looking to source products currently made in other locations, such as India or Vietnam.
Resource From MDDI
Medtec China show team
T：+86 10 5765 2825
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