This is a special supplement to the December 2016 issue of Taiwan Business TOPICS, sponsored by the AmCham Taipei Medical Devices Committee. The full PDF document is available for download here.
Table of Contents:
- Preface, Challenges and Opportunities
- The Value of Technology
- Streamlining the Medical Device Registration Process
- Referencing Japan
- Strengthening the Pricing and Reimbursement System
- The Benefits from Medical Device Clinical Trials
1. Challenges and Opportunities
The members of AmCham Taipei’s Medical Device Committee are proud to be part of an industry that is at the forefront of bringing constantly improving health conditions – including longer lives and better-quality living conditions – to millions of people around the world. We are also proud to be an integral part of the healthcare system here in Taiwan, where the National Health Insurance program has won widespread international recognition for its effectiveness in providing coverage to nearly every member of the population. Our aim is to work in close collaboration with Taiwan’s governmental authorities to ensure that Taiwan can continue to offer universal national healthcare that is not only financially sustainable but also consistently makes new and innovative technologies available to Taiwanese doctors and patients in need of the most efficacious treatments.
Medical devices also constitute an unusually complex industry, which presents challenges for both the manufacturers and the regulators. One reason is the extraordinary breadth of the products that come within its parameters – everything from simple tapes and adhesives to apparatus used in surgical procedures to sophisticated testing and diagnostic equipment. For our member companies, the main focus is on Class II and Class III devices, which come under the most regulatory scrutiny.
Another reason for the complexity of the industry is the fast-paced nature of technological change in the medical-device field. For many devices, a new generation of technology is launched every few years, encompassing substantial new developments or refinements in terms of safety, ease of use, and functionality. Any unnecessary delays in introducing more advanced technologies into the market will mean, in many cases, confining patients to outdated procedures and preventing physicians from developing their professional skills to the level achieved by their counterparts in other countries. In addition, obstacles to introducing innovative treatments may discourage manufacturers from committing the resources to this market that they might otherwise assign.
2. The Value of Technology
Advanced medical devices and diagnostics allow people to live longer, healthier, more productive and independent lives. Studies have shown that between 1980 and 2013, medical advancements helped add over five years to U.S. life expectancy, with heart disease fatalities cut by 59%, stroke deaths by 62%, and breast cancer mortality by 35%. Just since the year 2000, medical advancements helped add two years to U.S. life expectancy. Similarly significant gains can be expected to have occurred in Taiwan as well.
In addition, medical technology helps people overcome functional limitations, enabling them to continue to live independently in their own homes. At the same time, the increasing use of minimally invasive surgery has contributed to lower costs, shorter hospital stays, and fewer lost days at work for the patients.
Remarkable improvements have been seen in recent decades in the treatment of a wide range of ailments. Some examples include:
- Heart disease and stroke. Procedures such as angioplasty and stenting (including drug-eluting and retrievable stents) and implantable cardioverter defibrillators, as well as vastly improved diagnostics, have had a dramatic positive impact on outcomes.
- Osteoarthritis of the knee and hip. Total knee and hip arthoplasty has greatly reduced mortality rates and long-term cardiovascular disease and depression, and enabled most patients to lead productive lives instead of suffering from disability.
- The rate of complications has been dropping sharply through advancements in blood glucose monitoring and insulin pumps and other controls.
- Better screening mechanisms for early detection and prevention, and improvements in surgical techniques and combination therapies, have substantially decreased mortality rates for various types of cancer.
- Surgery, including the use of intraocular lenses and other advanced technologies, has been shown to improve vision and overall quality of life, helping patients to regain their independence.
In recent years, the pace of technological change in medical devices has been accelerating rapidly, generating exciting new possibilities for accomplishing health benefits in the future. Technology is enabling researchers to break away from traditional modes of thinking to embrace radically new approaches.
A number of pioneering companies, for example, have been working on products that might appear to be video games but in fact serve as medical devices. One of them, Akili Interactive Labs of Boston, Massachusetts, is in clinical trials on a “game” aimed at treating Attention Deficit Hyperactivity Disorder (ADHD) in children, and is in the process of developing other products for autism, depression, Alzheimer’s, and brain trauma.
Another example is Verily Life Sciences, formerly named Google Life Sciences, which has put together a multidisciplinary team of doctors, engineers, chemists, and data specialists to tackle medical challenges in new ways, including the development of wearable medical devices and miniature sensors. This fall Verily and Sanofi launched a joint venture aimed at improving care for diabetics through solutions that combine medical devices, software, medicine, and professional care.
“Thousands of startups, as well as today’s data giants (Google, Apple Microsoft, SAP, IBM, etc.) will all enter this lucrative $3.8 trilliion healthcare industry with new business models that dematerialize, demonetize and democratize today’s bureaucratic and inefficient system,” predicts Peter Diamondis, the noted engineer, physician, entrepreneur, and futurologist. “Biometric sensing (wearables) and AI [artificial intelligence] will make each of us the CEOs of our own health. Large-scale genomic sequencing and machine learning will allow us to understand the root cause of cancer, heart disease and neurodegeneraitve disease and what to do about it. Robotic surgeons can carry out an autonomous surgical procedure perfectly (every time) for pennies on the dollar.”
Exciting new opportunities will be emerging from both established companies and startups, and close communications between suppliers and regulators will be necessary to pave the way for continuous absorption of these new procedures and technologies into the existing healthcare system.
3. Streamlining the Medical Device Registration Process
Considering the rapid evolution of technology in the medical device field, time to market is an extremely crucial factor for the industry. An overly long licensing (and then reimbursement) process can mean that devices become available to physicians for use in treating patients only late in the product life-cycle, long after they have been introduced to other markets. When these new and innovative treatments are delayed in entering the market, the result is that hospitals, doctors, and their patients are all put at a distinct disadvantage.
Industry concern about the lengthy product registration and review process in Taiwan compared with most other markets has long been reflected in the AmCham Taipei Medical Device Committee’s position paper in the Chamber’s annual Taiwan White Paper. It has also become an item for discussion in the bilateral trade talks conducted between Taiwan and the United States under the Trade and Investment Framework Agreement (TIFA).
In November last year, there was widespread hope that a new, two-step review system introduced by the Taiwan Food and Drug Administration (TFDA) would help in shortening the amount of time needed for registration. Industry members also expected that a steep increase in registration fees that the TFDA adopted – from the equivalent of about US$315 for class II devices to about US$800 – would provide the agency with additional resources in order to expand its staff and expedite the review process.
“Until now, we haven’t seen those results,” says one regulatory affairs manager. The TFDA’s explanation is that various factors combined to cause an unusually heavy workload during the past year. A backlog developed as companies rushed to file applications before the increased fees came into effect, and many TFDA personnel were summoned from their regular duties to help arrange for skin graft donations for victims of the Formosa Fun Coast explosion. In addition, new reviewers were still being trained.
TFDA officials have given assurances that the system should run more smoothly going forward. Industry welcomes the attention that the government is paying to this issue, and looks forward to continuous communication with the regulators to monitor the degree of progress and look for ways to introduce further improvements.
The new system introduced last year was designed to address the TFDA’s concern that it was receiving too many incomplete applications, with the result that reviewers had to spend a great deal of time requesting and processing missing documents. The revised system involves a two-step review process. In the first stage, all administrative documents – including quality system documentation (QSD) approval letters/QSD application letters, authorization letters, certificates to foreign governments (CFG) or certificates of free sale (CFS), and technical files (for example, product information and pre-clinical testing documents) – are to be submitted for review of their completeness within 10 days of submission.
In the second stage, the registration process continues with a technical review by the TFDA of required pre-clinical testing documents pertaining to product safety and performance for Class II and Class III devices.
Because of their low risk, Class I products can be registered quickly, in as little as one day to three months. For Class II and Class III products, however, which require the submission of a CFG or CFS, the registration period can be much longer. According to industry members, the first feedback from the TFDA on Class II products now has typically come after four to six months (compared with two to three months under the old system), with final approval in about nine to 12 months (previously six to nine months). For Class III devices, the approval process is even more protracted, typically anywhere from nine to 15 months. For certain devices with innovative new technology, it could take 18 months for the approval process to be completed, whereas in the past the usual timing was about nine to 12 months.
As part of a simplified track, Class II devices already approved for sale in the United States and Europe Union may qualify for consideration without the need for preclinical testing documents. Industry representatives commend the TFDA for adopting this provision. But they add the caveat that if the device is not used in exactly the same way in both the United States and EU, it does not qualify for the simplified review, a condition that prevents many products from taking advantage of this procedure. In addition, companies frequently find that utilizing the simplified procedure is not to their benefit if having to wait for both U.S. and EU accreditation actually delays their market entry.
As outlined in the Medical Device position paper in the 2016 Taiwan White Paper, it would help in speeding up the process if the TFDA were to accept approval from just the U.S. FDA as sufficient to qualify for the simplified procedure. The U.S. FDA is widely recognized as a supportive reference by international health authorities. Yet another White Paper recommendation to streamline the process is to permit the CFG/CFS to be provided to the TFDA at any point before licensing, not only at the time of submission, as is already the practice for pharmaceuticals.
A further area that has presented challenges to foreign medical device companies operating in Taiwan is the way in which the “manufacturer” of a product is defined. In the past, the TFDA has regarded the manufacturer to be the factory or facility where the physical production took place, rather than the entity responsible for the design and whose name appears on the product. The global medical device industry operates with complex supply chains that often involve outsourcing and the assembly of products by different producers. Those contracted factories often have difficulty providing the necessary certification to meet Taiwan’s regulatory requirements, again slowing down the registration process.
Recently, TFDA has agreed to change its practice to follow the example of the United States, the EU, and other major advanced countries in recognizing the “legal manufacturer” of a medical device as subject to regulation. Our understanding is that a revision of the relevant regulation along these lines is in the process of being drafted. We support that approach as bringing Taiwan into closer harmonization with international practice, as well as contributing to expediting the approval system for the benefit of patients, doctors, and the industry.
Fuller and more frequent communication between industry representatives and the regulators, including the individual reviewers – who may be either TFDA staff or contracted personnel – would go a long way in improving the efficiency of the system and increasing transparency.
Applicants find it frustrating that different reviewers often seem to apply different standards, and the justification for certain decisions may involve reference to “internal guidelines” that are not made public. Having clear and open review standards leading to consistent interpretations would resolve many of the current difficulties.
At the same time, reviewers also have had complaints about the quality of the submissions they receive, including incomplete documentation. An effective way for the TFDA to ameliorate the problem would be to hold more workshops and training sessions with the manufacturers’ regulatory affairs specialists to narrow any gaps in understanding about the reviewers’ requirements.
Industry is also aware that a plan is under consideration to upgrade the existing Center for Drug Evaluation (CDE) – a non-governmental and non-profit organization that assists the TFDA with technical reviews of pharmaceuticals and medical devices – into a National Reviewing Center that would take over full responsibility for such reviews, allowing the TFDA to concentrate entirely on policy. If the Legislation Yuan passes the necessary enabling legislation to create the new organization, it will be important for the National Reviewing Center to have sufficient personnel and other resources at its disposal to carry out its intended mission effectively.
A second proposed legal change would create a new law governing the regulation of medical devices, which are currently covered under the Pharmaceutical Affairs Law despite the many differences between drugs and medical devices. The TFDA is still working on drafting the new legislation. The AmCham Taipei Medical Device Committee views this initiative as a highly positive step, and welcomes the opportunity for continued engagement with the regulators in the interest of ensuring that the law is as effective as possible. It will be imperative for the proposed regulations to be harmonized with global standards and practices to help bring about a more expeditious review process for medical devices.
Industry stakeholders encourage policymakers to see medical-device manufacturers as more than equipment suppliers. Usually devices are associated with specific clinical procedures, and manufacturers take their obligation to educate healthcare professionals about these procedures very seriously. In addition, medical-device makers can be essential partners in the creation and introduction to Taiwan of innovative medical technology – technology that assists healthcare professionals as they endeavor to provide the very best possible patient outcomes.
4. Referencing Japan
According to AdvaMed, the Washington, D.C.-based Advanced Medical Technology Association, the regulatory system in Japan for licensing medical devices for many years was considered to be the “slowest and most onerous among any major-country system in the world.” The burdensome rules and requirements that were out of synch with those adopted by other major countries, as well as the extremely slow review process, resulted in a “device lag” – a long delay between the time products became available to patients in the United States and EU and their approval for use in Japan – and a “device gap,” the greater number of products available outside of Japan versus those available to Japanese patients.
To address the problem, AdvaMed first communicated with stakeholders in Japan, including members of the Japanese Diet, and then worked with Japan’s regulatory bodies – the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) – to develop an Action Program for the Speedy Approval of Medical Devices. Under the program, which took effect in April 2009, Japan tripled the number of medical device reviewers from 35 to 104 over five years. It also streamlined the review process, committing to use the least burdensome approach in reviewing submissions and to set performance goals.
By 2014, says AdvaMed, the median approval time for the most innovative products had improved from 21 months to seven months. For me-too products, the largest category, the median approval time was cut in half from eight months to four.
The Action Program has since been followed by a new five-year program, the Collaboration Plan, which aims to further speed approval times until they are faster than those of the U.S. FDA.
The Japanese experience could serve as an inspiration and model for Taiwan, showing what can be achieved when government has the political will – and collaborates closely with stakeholders – to accomplish substantial change. From being at the bottom of the list in terms of its efficiency among developed countries in regulating medical devices, Japan now aspires to be the very best.
5. Strengthening the Pricing and Reimbursement System
In recent years, the National Health Insurance Administration (NHIA) under the Ministry of Health and Welfare has taken significant steps to improve the medical-device pricing and reimbursement program for the benefit of Taiwan’s healthcare system as a whole. For instance, Taiwan has introduced balance billing and self-pay management guidelines, jettisoned unhelpful indicators such as reference countries’ GDP to determine medical-device reimbursement, and regularly reviewed the price-volume survey mechanism.
These measures have given manufacturers a more positive view of Taiwan’s medical-device market, resulting in the introduction to the market of new technology and devices even as NHI faces financial constraints.
Yet considerable challenges remain. One is the use of functional categories to determine the reimbursement pricing for medical devices in Taiwan. Under that system, two devices deemed to be performing the same basic function will generally receive an identical reimbursement price – without reference to objective evidence, including global clinical and health economics data, or consideration of such factors as differences in features and quality, the length of time the devices have been in the market, and their manufacturing costs (which may vary considerably). This methodology favors the lowest cost devices –to the disadvantage of both patients and physicians.
In fairness, the system now includes a provision allowing manufacturers to apply for recognition that a device is functionally superior to its peers, qualifying it to receive a reimbursement price up to 15% more than normal. However, proving the better quality requires a much longer review time and the 15% mark-up is not a strong incentive. Nevertheless, numerous devices have applied for this option, but very few have received the higher price.
Price-volume agreements, the floating point value, price-volume surveys, and Tw-DRGs (diagnostic-related groups) are also key elements in setting pricing. In combination, these price determinants, at least in their current forms, do not contribute to the healthy development of Taiwan’s medical-device market. Without substantial reform, the current practices will further reduce manufacturers’ eagerness to bring the most cutting-edge medical technology and products to Taiwan.
The reality of these challenges can be illustrated by the near-flat growth of medical-device imports. The latest report on Taiwan’s medical-device sector from U.K.-based BMI Research noted that imports fell by 2.5% year-on-year in the second quarter of 2016, and increased by a mere 0.1% (to US$1.5 billion) for the 12 months ending June 2016.
Foreign manufacturers produce most of the advanced medical devices used by Taiwanese hospitals. When fewer of those devices enter the market, doctors may lack access to equipment that could produce a better outcome in the treatment of their patients.
Seeking win-win results
Industry stakeholders point to ways in which product pricing and reimbursement procedures could be ameliorated. At present, for instance, when a new product enters the market, it must go through a Reimbursement Review Committee, which benchmarks a basket of prices in 10 pre-identified markets. Invariably, however, the price accorded in Taiwan is at the lower end of the scale.
Another complication is the variation in market practices in different countries. In Taiwan, once the reimbursement price is set, suppliers enter into negotiations with the individual hospitals to arrive at the actual transaction price. The hospitals invariably ask for steep discounts as a means of increasing their operating funds. Industry players say the situation has worsened in recent years, with hospitals demanding discounts far beyond the “reasonable” margin of 15% that the government expects them to earn. It is therefore misleading and unfair to set a Taiwan reimbursement price by benchmarking prices in markets in which the hospitals take little or no margin.
The system, exacerbated by the price-volume surveys that lead to further price cuts, drives down the actual prices paid for medical devices to the point that manufacturers may hesitate to launch a new product in this market, fearing that other larger markets may use the Taiwan price as a reference price. The result – compounding the problem caused by the lengthy licensing process – is that innovative new technology is often available to Taiwan’s doctors and patients much later than in other countries.
Guidelines introduced in 2013 regulating the products that can enter Taiwan as self-pay items are another area of concern. During the reimbursement review process, which can be as long as 18 months in duration, patients have the option to pay for a device out of pocket. But in order for the device to qualify for this option, it is expected to have a self-pay code assigned by the NHIA – and that process can take from three months to one year to complete.
The process of qualifying for self-pay involves other obstacles as well. If manufacturers are dissatisfied with the reimbursement price being offered, they are permitted a single appeal. If they still consider the offered reimbursement price to be unreasonable, the device’s self-pay code may be annulled. Under this scenario, a medical device would be effectively frozen out of the Taiwan market.
As noted in AmCham’s 2016 White Paper, there may be many reasons why a medical-device maker would reject an offered reimbursement price. Companies have to take into account not just the reimbursement price, but the subsequent discounts that will be requested by hospitals, plus the price reductions that will follow price-volume surveys. Furthermore, if the reimbursement price is based on another device in the same functional group, it may not accurately reflect the cost of the company’s own product.
“The reimbursement process is a substantial hurdle for medical devices entering the Taiwan market, and the situation needs to be looked at from the standpoint of how Taiwan can access the very best medical technology,” says one executive. “We need to consider the short product lifecycle of medical devices. Every few years, a product becomes obsolete, but it’s the newest and most advanced products that surgeons and patients will benefit most from.”
In fact, introducing a new generation of technology into the market will naturally drive down the price of the old generation. If those older devices continue to be a satisfactory alternative, the healthcare system can enjoy a financial benefit from the reduced cost.
With these concerns in mind, industry stakeholders encourage the NHIA to allow medical devices to remain in the self-pay market even if the makers reject the offered reimbursement price.
Tw-DRGs and the future market
In the years ahead, industry experts say, the broader implementation of Tw-DRGs in an effort to control spending will pose additional complications for medical-device manufacturers. Under the Tw-DRG system, hospital procedures are classified into 1,716 different groups based primarily on illness and treatment requirements. For each procedure performed in a given group, hospitals receive a pre-determined payment.
In principle, the DRG system can bring benefits in reducing superfluous tests and medications and shortening inpatient stays. The implementation of standard operating procedures in hospitals should also boost the quality and efficiency of Taiwan’s healthcare services. The problem is how to ensure that a fixed payment per procedure will not discriminate against higher-quality products deserving of a higher price.
In late January, the Ministry of Health and Welfare announced it would expand the system to cover 58% of all hospitalization claims by March 1, but the plan was shelved due to various objections from the healthcare community and political figures. In May 2016, NHIA Director General Lee Po-chang confirmed that the Tw-DRG system would continue to be expanded.
For the Tw-DRG system to work well, a key element will be transparency as to how the pricing is determined, including clarity regarding what costs should be incorporated within the DRG and what should remain outside (for example through self-pay or balance billing). An adequate mechanism will also be needed for accommodating new innovations, such as providing for a two-year “technology add-on” to the DRG cost while the economic benefits undergo assessment. In addition, certain new products could be made eligible to apply for fee-for-service, excluded from the DRG cap.
With respect to balance billing, the ability to share the cost of the device between NHIA and the patient is a way to make more treatment options available without adding to the NHI financial burden. Under the current system, however, the application for a device to be offered on a balance-billing basis must not only go through the regular assessment and review process, but also be approved by the NHI committee. This step may prolong the reimbursement timeline without doing much to relieve NHI’s financial burden.
From a broader perspective, the reimbursement system – like the registration system –could benefit from greater transparency and communication with stakeholders. For example, adding a function on the NHIA website to permit tracing the progress of reimbursement applications for medical devices and therapeutic procedures would not only help manufacturers plan their inventories but also enable clinicians and patients to make treatment plans more effectively.
There would also be enormous benefit in streamlining the system by allowing the TFDA’s registration review and NHIA’s reimbursement review to proceed simultaneously. Currently valuable time is lost while the reimbursement portion waits for the licensing procedures to be completed. The U.S. Centers for Medicare and Medicaid Services have recently run pilot programs involving such parallel reviews and found the results so encouraging as to warrant indefinite continuation of the practice.
6. The Benefits from Medical Device Clinical Trials
Of the multiple benefits derived from being a hub for clinical trials, perhaps the two most significant are the potential early access to cutting-edge technologies it provides to patients and the updated knowledge and skills it brings to the medical personnel working on the trials. If Taiwan is able to enhance its attractiveness as a location for conducting medical-device clinical trials, that development could give a major boost to the biotech and healthcare sector that the government of President Tsai Ing-wen has targeted for development.
Medical devices differ from pharmaceutical products in two key aspects. More often than not, a “new” medical device is an iteration of an existing device. Additionally, medical devices often involve not just the product itself, but also the surgical procedure in which it will be used. The greater the change in the new version of a device, the more likely that the procedure will involve substantial changes as well.
In Taiwan, the approval process for medical devices – unlike pharmaceuticals – does not require the conducting of clinical trials, but such trials may be done for other reasons, including:
- Validating the device
- Helping determine what technique will deliver the best outcomes
- Comparing devices to facilitate the best selection
- Collecting economic data to determine the most cost-efficient way to treat an ailment
- Differentiating among competitors who have very similar products
The results of the trials, said a Taipei-based medical device executive, help determine “which techniques and which products should be put forward as best-in-class, or are the ones that healthcare systems might want to adopt and pay for.”
Taiwan already possesses many of the attributes needed to increase its appeal as a center for conducting medical-device clinical trials. “Taiwan has exceptionally advanced clinical expertise,” the executive said. “Its physicians are among the best-educated members of the population. They’ve gone through excellent training in Taiwan and very often abroad in countries like the U.S. or Japan.” In addition, “Taiwanese physicians have the ability to publish in English or Chinese and speak about the data in meetings in English or Chinese,” he said. “That’s a great strength.”
Besides quality surgeons, Taiwan’s nurses and other staff deliver high-quality care, working in a system that incentivizes a focus on the patient. “One of Taiwan’s strengths with regard to clinical trials is the close relationship between investigators and patients,” said a clinical research associate at a Taipei-based contract research organization (CRO). “This often leads to greater willingness by the patient to participate, and a higher level of study participation.”
Perhaps most importantly, Taiwan enjoys a global reputation as a research hub.
“Data published by Taiwan is seen as having been done at world-class standards,” said the medical-device executive. “And it can often be published in world-class journals as a result.”
Obstacles to progress
Despite these advantages, Taiwan also faces numerous challenges if it wishes to enhance its appeal as a center for clinical trials of medical devices. In general, the process to get a clinical trial up and running is highly bureaucratic. While legitimate concerns exist regarding questions of ethics and documentation, excessive requirements can present a stultifying barrier.
In Taiwan, physicians are often eager to be involved in clinical studies, but the task of judging the merits of a trial protocol falls to hospital ethics committees, known as institutional review boards (IRBs). Every hospital has its own IRB and its own guidelines, and confusion often exists about the role the IRB should play with regard to ethics and scientific reviews, especially when weighed against concerns about insurance and liability. The end result is often inefficiency at the micro level, and lost opportunities at the macro level.
Members of the industry note that globally companies have the choice of multiple centers for clinical trials to be performed. If it appears that starting a trial in Taiwan is likely to take six to ten months longer than in other areas, the likely decision is to begin elsewhere, if not to skip Taiwan entirely in favor of another location. “At best, Taiwan is left with less room to gain access to the total number of patients,” notes the executive. “And at worst Taiwan is eliminated from consideration. That’s a major issue.”
In hopes of moving the process along more rapidly, Taiwan has experimented with such options as joint IRBs (JIRBs) and central IRBs (CIRBs), both of which lessen the influence of the individual hospitals.
“A collaborative and unified review committee that functions across hospitals would certainly be helpful in facilitating all regulatory reviewing processes,” the CRO associate said. “At present, CIRBs serve as a prototype of sorts for the ideal committee. However, the desire of hospitals to have their say on a host of issues creates repetitive and time-consuming submission requirements.”
Another current shortcoming in Taiwan is the underdevelopment of a clinical trial infrastructure – often provided by universities or government agencies – especially in terms of people to manage the data, create forms, and perform data analysis. Companies looking to run clinical trials on medical devices are thus left with two options: run the trials in-house (which requires resources) or hire a CRO (which takes money).
One model that might offer a new way forward for medical device clinical trials in Taiwan is that of Investigator-Sponsored Studies (ISS), in which a private company funds – but does not sponsor – a study. Instead, the trial is officially sponsored by a doctor or group of doctors.
Currently the structure of most contracts calls for companies to be both the funder and sponsor. Whether the ISS model will appeal to Taiwanese hospitals and doctors is uncertain, especially when sponsorship raises such attendant issues as liability and rights to data ownership and access.
If Taiwan can marshal the necessary resources, find ways to streamline the paperwork aspect of clinical trials, and address the other major challenges, it could serve as an appealing destination for global medical device companies to conduct studies. The fact that Taiwan is a relatively homogeneous society means consistency in the data. The island’s manageable size and population are also assets.
What does Taiwan stand to gain from more medical device clinical trials? For pre-market trials or new indications, a number of patients and physicians would receive earlier access to cutting-edge technologies. For the patients it would mean enhanced opportunities for treatment, while for surgeons it would contribute to raising professional skills and morale. It would also help raise Taiwan’s global profile.
Further, the more that a country’s medical community is involved in global studies and exchanges of information, the higher the standards it is able to maintain.
Another benefit of making clinical trials more streamlined and predictable would be to create a more favorable environment for medical device startups. That outcome would dovetail nicely with the government’s objective of promoting development of the biotech and medical care sectors.
The global medical device industry foresees a new era arising of expanded opportunities to serve the public and healthcare professionals with even more advanced and effective products. In this regard, the members of AmCham Taipei’s Medical Device Committee look forward to continued, frequent productive interaction with the relevant authorities in Taiwan to help ensure that developments in this market can meet their full potential. In our view, given the right regulatory environment, Taiwan has a strong chance to leverage its excellent medical professionals and institutions to develop itself into the leader in this region in the provision of quality healthcare, providing a model for other countries to strive to emulate and serving as an added source of pride for the people of Taiwan.
A nurturing regulatory environment that encourages innovation will also be essential for developing Taiwan’s own medical technology industries, taking advantage of this country’s well-established enterprises and research institutes in the fields of information technology, electronics, and other sectors.
Our companies hope that the observations and suggestions in this brief report will provide useful reference contributing to an ever more effective and sustainable healthcare system for all residents of Taiwan.