iPod's and pacemakers

Medgadget reported some time ago:

Cell phones have been getting a lot of flak in ERs and hospitals, while iPods are seen as the pinnacle of design. Leave it to a 17-year old to bring the real troublemaker out into the open. Apparently iPods interfere with pacemakers, sometimes causing them to stop working completely. Here's more from Reuters:

The study tested the effect of the portable music devices on 100 patients, whose mean age was 77, outfitted with pacemakers. Electrical interference was detected half of the time when the iPod was held just 2 inches from the patient's chest for 5 to 10 seconds.

This is unpleasant news and something we're in the middle of dealing with at my company (shielding and hazard analysis). We are not making an implant, so the shielding task is quite a bit easier than the pacemaker maker's.

However, hazard analysis is never easy and the trend is to get more and more detailed. Where once we assumed a certain level of competence from the operator, now we assume less. Part of this is greater ability on the device's part to monitor and measure various systems as electronics and programming have advanced. We are more able to catch operator and equipment errors. But part of this is a safer society as a whole, we move towards airbags and bicycle helmets where before it was acceptable to do without.

Medical Devices are flavor of the month for VCs

According to the NY Times, medical devices are the venture capitalist's flavor of the month:

Venture capitalists, apparently, are going cuckoo for medical-device companies at the expense of past favorites like computer-related start-ups or drug-development companies.

In the first quarter of this year, seed investors put $1.1 billion into such businesses, a quarterly record for the medical-device industry, and a 60 percent increase over the same period in 2006, according to the National Venture Capital Association, a trade group.

I was just saying that medical devices deserved more investor attention few days ago! Medical Connectivity Consulting also looks at the article and notes some concerns. Obviously I think this is a good thing, but you know I'm biased.

Clinical trails in foreign countries

Pharmalot explores the benefits of clinical trials in China:

Running a trial in China may cost as little as 15 percent of what a company would pay in the West, says Reenita Das, Asia-Pacific health care vp at Frost & Sullivan. Vital Therapies, which makes artificial livers, says a trial costs about $15,000 per patient, versus $50,000 in the US. The decision to run tests in Beijing is “a no-brainer,” says Terry Winters, the company’s chairman. “China beckons.”

It is getting pretty close to the point where it is hardly considered to do clinical trials in the US first, we're not quite there, but we're headed that way as it becomes easier and easier to do them elsewhere for cheaper. You're generally losing some quality and adding some more risk, but if you plan your trials well, you can minimize this. Its not just the third world, my company corresponds with doctors in Europe and you have to be clear when sending them unapproved devices that you don't want them trying them out. This is not a bad thing, if carefully done, off shore clinical trials benefit everyone involved.

Device and Drug developement

Freakonomics quotes Arthor D. Levinson, head of Genentech, on the development of drugs:

You don’t just crank these drugs out. My lab cloned a portion of the breast-cancer gene in 1982. And we started making antibodies to it in the mid-’80s. Then we got cell-culture results in the late ’80s and by the early ’90s we were getting animal results. And then approval was in December ‘98. So this goes back a long, long time. Unless these companies can get a return, we are not going to get the new medicines that are making such a difference to patients’ lives right now.

Luckily for me, medical devices are much easier to bring to market, you can get FDA approval for a new device in under 5 years, if its a 510(k) device, you could do it in 2-3 if you know what you're doing. I'm always surprised that devices don't get more venture capitalist attention (or attention in general) you get quicker results, the profits are lower, but there is less risk and less investment required. I guess wonder drugs are just sexier!

Delegating in a small medical device company

Creo Quality discusses delegating:

In my experience, engineers are typically poor at delegating tasks and activities. In fact, I often have heard engineers say they want something done a certain way and usually add “. . . if I want it done right, I’ll do it myself”.

This is largely how I feel (I'm an engineer), or perhaps it should be "if I want things done in a timely manner, I'll do it myself." Positions in small companies are not usually rigorously defined, people will have several roles. However, if you give out a task outside of their main one or two roles, it often gets put off while the person focuses on his or her primary roles. I do this too, at my company I'm in charge of the computer network, unless the P or VP of the company is asking, I'm not going to jump right on your computer problem until I feel I have nothing else important to do.

Creo then discusses another pitfall to watch out for:

Delegation is not always a good thing–especially with a small, growing company. I delegated some documentation tasks to a resource within the company. Perhaps this was my error. In hindsight, the resource probably does not have the skill set required to take on the type of task assigned.

This is true in my company too, I can generally recognize it when things are taking way too long to get done. If a task is dragging out weeks when it could have been finished in a day or something along those lines.

The difficult part is what to do about it. I or someone else could take the job over and do it, but you don't want to do that necessarily, everyone is already busy, so extra work isn't usually welcome, especially if it is something that does not require any special skills. How long do you let the person struggle at it? The best way is to find some middle ground, where you end up doing plenty of the work, but the person learns from it. But this only works if the person is interested in applying themselves.

You will have less problems if you make smart hiring decisions, I think small companies in particular shouldn't skimp on hiring experience, an extra $10k a year in salary can really be the difference between paying one person to do the job or having to get two to figure it all out. Don't go overboard, you don't need to hire engineers for assembly or anything like that, but for engineering, QA (maybe QC), and production management, experienced medical device people can save you a lot of trouble.