Doctors and New Technologies – Part 2

Part 2 of 2 Parts

This part covers the wished for options and information about medical devices.

What I’d like to see on the websites This is what the doctor would like. While I can agree with the list as a valuable list, there should not be a segregation unless the device is for mainly clinicians. If the device is primarily for patients and caregivers, then everything should be applicable to the clinician, patient, and caregiver. I will go one step farther by saying that often the website for most devices are for sales only and of little or no value for clinicians, patients, or caregivers. Most are all hype and have little usable information and then we know that the device is of little value. The more hype, the less value the device has.

Have a section formatted for clinicians in particular. If the device is primarily for clinicians, then I agree. If the device is for all, then the website should get rid of the glitz and hype, and cough up valuable information to let the customers know what the product can do in the real world, not the hyped world. Again, I have found that the more hype, the less value there is for the usefulness of the device.

Have a “how it works” section with screenshots and concise text. While many people seem to love videos, too often, they miss the points and the videos leave us wondering about why all the hype. And, this I mean sincerely. We are consumers and want information about a device, not glitz and hype. Whether the person viewing the site is a clinician, patient, or caregiver, we want to know what the device does for the patient, and what other devices it may communicate with to make it more useful. Videos are great for entertainment, but not so great for information. If you are a visual learner, great, but don't force non-visual learners to constantly replay a video. This will only drive them to abandon the website and your product.

Provide a downloadable brochure for patients/families and another for clinicians. Now if manufacturers want to make separate downloadable brochures for clinicians and one for patients/caregivers, I will not object as this could help both. I do strongly agree with the doctor on this point, brochures are easier to read and mark up than many PDF files. Both may be easily forwarded, but the brochure will be the easiest for the patient to understand.

Include information regarding the relevant evidence-base supporting use of the product. Yes, this would be nice for both the clinician and patients. The more hype we have to read the less likely we are to consider the device.

Include information on how valid/accurate the data collection is compared to conventional clinical practice. This would be appropriate for most devices, especially since the specifications will probably be not as restrictive as devices that are used in the proper way in a lab setting. Most clinicians will need to realize this to understand that the devices are not for use in a lab, but out in the real world by real patients trying to help themselves. Most websites are not properly set up clearly to explain what clinicians are seeking and often not what patients are seeking. Often there is so much “feel good” hype and glitz that patients and clinicians can find little useful information. This will lead both to look elsewhere and maybe overlook a device that could be very useful. When will manufacturers learn?

Offer a free 30-day trial. This is purely a sales pitch and why a doctor would suggest this is hard to understand. The reason many companies offer this is because they know that if people order something, they are seldom going to return it unless it is so bad that people are angry with the product. Even then some people will not return the product and companies are counting on this and know the sale has been made.

Summarize how the product is different or better than similar available products.

This is also a sales tactic and we see this done when a company feels they have a superior product, but be careful, as often this is done to hide weaknesses as many are familiar with in software products.

Summing it up. The doctor has in general done her homework and offers good advice to manufacturers. Like many products, medical devices will be one product that doctors will often be called on to give an opinion about. Some doctors are blogging about devices and some patients are doing this. Should we rely on the information? This is difficult to answer, as not everyone is honest about relationships they may have with a manufacturer.

Some doctors are very reputable and will clearly state if they have any relationship with a manufacturer. In general these devices can be relied upon. Most patients are also very clear that they have a relationship with a manufacturer or if they are speaking from experience with the device. If they are actual users speaking from experience, generally these reviews can be relied on.

The weakness is that there is seldom a database of device reviews and everyone is not privy to the reviews that have been made. As much as we want to have information we can rely on, I seriously doubt this is a priority for manufacturers as most are only concerned about sales and will continue to put out all the hype they can to “convince” consumers their device is what they need.

Maybe the doctor was engaging in some wishful thinking, but until enough people speak up, we will not have reliable information for most devices. Until manufacturers understand what may drive sales, we will continue to have hype, glitz, and very little information of value. If people, doctors, patients, caregivers, and others will refuse to promote medical devices from manufacturers that have poor glitzy websites and refuse to give the information needed by all concerned, then we have lost and hype will continue in device promotions.

Yes, I have been overly expressive about hype and glitz, but from experience, this is the biggest turn off for me about the few devices I have investigated. Websites that say “This is a must have for your peace of mind,” or similar statements have made me leave the website and look elsewhere for something similar. My peace of mind is knowing that this is probably the poorest product available.

Doctors and New Technologies – Part 1

Part 1 of 2 Parts

This doctor has a lot to say about new technologies, some good and some bad. I agree with her for most of the statements and I must question some of her qualifiers. She is right that deciding if a new technology will help a patient or a patient's caregiver is important. Often this is as difficult for a physician as it is for the patient or caregiver. Since this doctor is working with the elderly, her decisions are compounded by what the patient or caregiver may be capable of managing.

One question that many people forget to ask or consider is, does this device communicate with other devices and if not, does this make the device less of a help. Too often, our high-tech devices are proprietary to the extreme and therefore useless except in very narrow limits. Until ethics can become part of doing business, most products available today are more of a hindrance because most data has to be transferred manually between devices. When time is important, devices that don't communicate are a fraud on the buying public to say nothing about medical care.

Here are her questions and my comments as a patient.

Does it help me do something I’m already trying to do for clinical reasons?

This is a question every doctor must ask and every patient should want to know. For the patient or caregiver, they also need to ask if it will meet their needs. Also, what does the device handle and is it a tool that would be useful.

What evidence is there that using it will improve the health and well being of an older adult (or of a caregiver)? This is the one question that this doctor fails, as she uses a meta-analysis study to say there is no clear benefit for non-insulin people with type 2 diabetes to regularly self-monitor blood glucose. I have blogged about rigged studies here and do not doubt that many of the studies in the USA were also constructed to give the desired results. Then in my email of Feb 5, 2013, I received my newsletter from The Behavioral Diabetes Institute, which has this link to information in Diabetes Care on the ADA website. The link is to a file that is a PDF and you will need to use Adobe Reader or a PDF compatible reader to download it. It has seven pages and is good reading with the ADA “experts” for the first three pages and the rest is written by Dr. William H. Polonsky and Dr. Lawrence Fisher. They are a voice of reason about self-monitoring of blood glucose (SMBG) and how important it is to all people with diabetes. Then they cover people with type 2 diabetes not on insulin as they are the ones not given the education and training in SMBG and could really benefit.

How does the data gathering compare to the gold standard? Talk about being vague, gold standard is what? When medical people refer to this, there are too many meanings that could be applied and this leaves all types of variables open for speculation. I sincerely wish they would use lay-speak. I do doubt that many devices actually meet gold standards since some may not have gone through FDA approval. If they have, then they should be more reliable, but maybe not reliable enough to meet a gold standard. Also, we need to remember that specifications for some devices will be more liberal simply because the manufacturer knows that the device may not be used under ideal conditions when used by patients or caregivers.

How exactly does it work? Come on doctor, they are not going to give away these secrets. They are only going to disclose what the device is made to do and if it communicates with other devices and which ones. If we are able to read through all the hype, we may discover what the outcome of its use is, but don't expect much until you get the device and instruction book in hand. As a doctor, you have to expect little information about clinical use, unless it is for clinical use. Most of the devices are not made for doctor use, but for patient use and many manufacturers could care less about what the doctors find useful. In fact, they might sell more devices if they did care about what doctors thought of the device.

How easy is it to use? Now this would be a good place to have a doctor's opinion and to know if it is easy to use by a wide range of patients including the elderly. For the elderly, ease of use is a must because often the elderly may have limited vision and or lack of dexterity in their hands.

How easy is it to try? This can be the key to many medical devices. Does it require a large financial outlay, or cost of training, as this could very easily send it to the back of the list of devices finding unfavorable recommendations and interest.

How cost-effective is using this technology? Here the doctor really nails it when she says, “Sometimes we have simpler and cheaper ways to get the job done almost as well.” Some devices will be overly complicated in what they can accomplish when a simpler method may work more effectively.

Can this technology provide multiple services to the patient? Many patients may have more than one medical condition. This is especially true among the elderly and knowing whether a device has only one function or multiple areas that it covers, may make it more desirable than a single function device. Here is where one device may have a clear advantage by being able to export or import information to or from another device.

Does this technology work well for someone who has lots of medical complexity? This is where a medical device will shine, or show that it is useless. It must be operable by patients having multiple medical problems. If it is too complicated, it will not be worth the money, unless it is operated by a caregiver that is with the patient every day.

While this may not be an exhaustive list of qualifications for a medical device, it is a great start and shows that the doctor has a good understanding of her patients. This will be a must for any doctor giving an opinion about medical devices. This should also be a strong consideration for patients and caregivers and serve as a way to avoid being misled by the inevitable hype on many websites.

FDA Creates Group to Speed Medical Devices to Market

Will this be the answer for many people, to accelerate medical devices to market, or just another stepping-stone to slow the process? I hope for many people that the first is true. Yes, the FDA has created a group – nonprofit, public-private partnership. The object of this partnership is to speed safe medical devices to market. The underlying aim is to encourage competing manufacturers to pool their knowledge about product testing. This last part may be the death of many medical devices as some manufacturers do not want to share information and may leave the market rather than be forced to share information.

Sounds great for patients if products do make it to market sooner, but in telephone conversations with a couple of manufacturers, there is little enthusiasm for the idea. Many are concerned about the procedures and who will have control of the testing. If the FDA is the only one doing the testing with only people from the company's device present during testing, then maybe this will work. If any company can be present during testing, it is doubtful some companies will participate. Both agreed that it is still too early in the process to know how this will work.

One spokesperson did say that this will make acquiring some of the good ideas from cash strapped start-ups a lot more difficult. He also said that the value added from FDA approval will be great for the smaller companies, some will be able to find the funds for manufacturing, and others will still sell the product to larger manufacturers.

Both admitted that if this group, called the Medical Device Innovation Consortium (MDIC), was actually able to make it easier to bring products to FDA approval, then everyone would gain, including the patients.