By Andrew Trew
Andrew Trew is Chairman of Cleveland Clinic Health System IRB, lawyer, and bioethicist.
Here are some guidelines to help investors and entrepreneurs get into the medical equipment marketplace as it continues to expand into a multi-billion dollar sector of the economy.
The medical-device market reflects today’s reality: the business of health care is business. More patients are increasingly placing demands on nationwide medical facilities, which in turn, drive a growing need for more efficient, technology-driven solutions to medical problems. To meet this need, a range of innovative products is emerging, from technology-assisted diagnosis and monitoring equipment to implantable devices and neurotechnology applications. These new medical devices center on quality of life improvements for patients and life-saving, spare-part surgery.
Many new and more diversified applications for medical devices and associated technology are available. For example, both ultrasound and digital x-ray machines are increasingly becoming more compact and portable. Such portability lets them fit more easily in operating theaters, emergency and intensive-care settings, doctors’ offices, and small clinics.
One major growth sector is in manufacturing implantable devices for the orthopedic market. Knee and hip implants already well established are now supplemented by spinal, hand, arm, and foot implants. Also, a complimentary development has emerged in the neurotechnology market. Here we find spinal cord and muscle stimulation devices for paralyzed patients, as well as cortical stimulators to assist stroke victims. Computerized diagnostic and remote patient monitoring devices offer new hope for patients confined to their homes or in understaffed medical facilities.
One of the most dramatic developments in the new medical device market concerns deep brain stimulation (DBS) technology. Patients who are in long-term unconscious states may be able to recover interactive functions with small, targeted probes inserted into the brain that apply electrical stimulation. The results offer new hope, particularly to patients in a so-called marginal state of consciousness. DBS technology, originally developed at the Cleveland Clinic in Ohio, holds the promise of wider application in the treatment of certain types of brain traumas and serious depression.
Getting in the market
How can you compete as a new entrant in the field of medical technology and develop ideas for new or improved medical devices and develop them into marketable products? Moreover, what do you as a CEO or a manager in a startup business or a small to medium-size corporate environment need to know about regulatory and ethical issues surrounding this specialized market place?
First, understand how highly regulated this market is. A product manufactured for the medical market is fundamentally different from other types of products. The end user of the medical device is a vulnerable patient. Death or injury resulting from the use of unsafe or badly engineered products is a real possibility. For this reason, the FDA (Food and drug Administration) plays a vital watchdog role here by thoroughly reviewing safety and efficacy of new products. The FDA also monitors the ethical treatment of patients involved in clinical trials of devices. The agency ensures the ethical conduct of clinical research through a local IRB (Institutional Review Board) that oversees such issues as research integrity, conflicts of interest, and reporting safety issues to the FDA.
Equally, the inventions you develop need to be safeguarded by patent protection. The contractual relationship between inventor and manufacturer also needs to be clearly stated in contracts or licensing agreements. Throughout the process of getting an idea to market, trust and confidentiality are crucial ingredients of success. Many doctors do not have the manufacturing know how to develop their ideas beyond simple prototypes or drawings. It is critical to draft confidentiality and non-disclosure agreements at an early stage, to discuss ownership rights, and patent and licensing issues. Who is paying for what aspects of the product’s development? If the inventor is a doctor, what is an appropriate method of compensation? Whether you plan to improve on existing products, have an idea for something new, or want to assist an outside inventor (doctor) get to market, realize that success often depends on a partnership between medical and business expertise.
Most inventors who are doctors and medical researchers are in the same position as you. They have an idea that they want to get to market. They need to connect with people who can turn the concept of new medical devices into reality. The original idea has value. It is what lawyers call intellectual property. So it is essential to protect early concepts, designs, and notes, which may form the basis of later patent applications. Once again, confidentiality is crucial here. So it is advisable, early in discussions about co-operative ventures with medical professionals, to consult your lawyer for advice on possible patent registration and future licensing agreements. You will also need to sort out how any future disputes might be handled. Often arbitration is a better option than rushing to court.
You should also be aware that applying for patent protection is an essential part of the journey to market. Patent claims raise highly complex issues and a patent attorney’s services are indispensable. However you can initially search patent databases on line to establish how far the proposed device differs from existing patented inventions. You will need to document in patent claims how your invention improves on the state of the art. Be aware that existing patent owners, particularly well-known corporations, pursue patent litigation actively. Do not be discouraged by this knowledge; a good patent lawyer will help you minimize possibilities of litigation.
Medical professionals are often associated with a hospital or university medical school. Larger medical facilities have a long track record of pioneering medical devices. Establishing contact with existing or potential inventors is essential. Many hospitals have established innovation centers to encourage their staff to partner with industry. So, making local researchers and hospitals aware of your specific corporate expertise is vital in developing new products. Today, larger hospitals and universities benefit from the Beyh Dole Act of 1980, which facilitates the commercialization of medical research and inventions originating in a non-profit setting. This law has led to the explosive growth of commercially sponsored medical research in the context of medical device testing, safety, and efficacy.
Initial R&D frequently involves research undertaken on animals (regulated by in-hospital ethics review boards), followed by clinical trials with human subjects. Research is, therefore, the avenue of choice to validate medical products which either your company or a medical professional has designed. To get an idea of research that is being undertaken in your field of interest you may find web sites such as www.clinicaltrials.gov/ useful. A search of the Medline database at a local or medical school library will also assist in identifying clinical trial results for relevant new products.
Clinical trials of medical devices and related technology are crucial. They involve detailed FDA regulations and much paperwork. Without persuasive safety and efficacy data from clinical trials, you are unlikely to gain FDA approval to market a new or innovative product. Clinical research trials are likely to be undertaken in a hospital environment. In the case of many devices, doctors need to practice using them in clinical settings in order to refine safety and design issues. The research may be supported by public or private sponsorship. If your company pays for all or part of the costs of the device trials, it is vital to avoid conflicts-of-interest problems.
To clear regulatory hurdles, the research must be seen to be unbiased. An ethical conflict of loyalties is seen to exist whenever doctors conducting the trials receive financial payments or intangible support from the sponsor company. They will have to declare this potential financial conflict, whether or not there is actual evidence of a resulting bias in the way research is conducted or data collected. Institutional guidelines are emerging from medical professional bodies, resulting in most hospitals setting a $10,000 ceiling on commercial payment for doctors and others conducting research. Payments in kind will also be examined. These include conference engagements, fees and consultancy arrangements with sponsor companies. In short, as a research sponsor your company will need to ensure ethical, arms-length relationships with researchers. It is worth obtaining advice on conflicts-of-interest issues from a bioethics consultant, or experienced research nurse, who can also advise on the design and implementation of any clinical trials. Be aware that, without safety and efficacy data from clinical trials, it may be impossible to get FDA approval to proceed to market your device.
New medical devices require formal approval on three levels by the FDA before they can be marketed. The simplest level is for home health-care products or hospital supplies. For these Class-One devices, manufacturers must comply with FDA manufacturing standards, related quality controls, and provide lists of all relevant products. Devices that involve moderate risks fall under Class Two, for example, monitoring devices or x-ray equipment. Here, there is usually a requirement to provide the FDA with notification three months before the product is launched on the market. The Class-Three products are limited to innovative and high-risk products, for example implanted devices. Pre-market approval is needed, including detailed safety and efficacy data from relevant clinical trials. The FDA offers guidance on these technicalities in “Getting to Market with a Medical Device” on line: www.fda.gov/cdhr/devadvice/3122.html
Finally, to get a feel for what is going on in this fast expanding market, make contact with the trade associations that represent the industry. A useful web site for product news and market trends is http://www.advamed.org/ (Advanced Medical Technology Association).
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